Pelvic Organ Prolapse
Conditions
Keywords
Pelvic floor repair, prolapse, mesh
Brief summary
1. This is a prospective, multi-center, post market study, which will be conducted under a common protocol. 2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair. 3. The study population is female subjects \> 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse. 4. The clinical data will be analyzed by comparing post-treatment data with the baseline data, with the subject acting as her own control. The follow-up is for two years after the procedure. 5. Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary endpoint of the study. The secondary endpoints include quality of life changes from baseline and adverse event rates.
Interventions
DEVICEAMS Apogee™ with IntePro
Mesh implant for posterior wall pelvic organ prolapse
DEVICEAMS Apogee™ with Intexen LP
Graft implant for posterior wall pelvic organ prolapse
DEVICEAMS Perigee™ with IntePro
Mesh implant for anterior wall pelvic organ prolapse
DEVICEAMS Perigee™ with IntePro Lite
Mesh implant for anterior wall pelvic organ prolapse
DEVICEAMS Apogee™ with IntePro Lite
Mesh implant for posterior wall pelvic organ prolapse
DEVICEAMS Elevate™ Apical & Posteiror with IntePro Lite
Mesh implant for apical and posterior wall pelvic organ prolapse
DEVICEAMS Elevate™ Apical & Posteiror with IntXen LP
Graft implant for apical and posterior wall pelvic organ prolapse
DEVICEAMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)
Mesh implant for anteiror and apical wall pelvic organ prolapse
DEVICEAMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)
Mesh implant for anteiror and apical wall pelvic organ prolapse
Sponsors
ASTORA Women's Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Have been diagnosed with one or more clinically significant anterior, apical or posterior genital prolapse disorder(s) (symptomatic POP-Q stage II or higher) requiring surgical repair
Exclusion criteria
* The Investigator determines the subject is not a candidate for surgical repair of her genital prolapse. * Subject has had a prior prolapse implant/procedure (i.e., IVS tunneler, Perigee, Apogee, graft augmented repair, etc) Note: previous traditional repairs are allowed. * Subject has active or latent systemic infection or signs of tissue necrosis. * Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement/prosthesis. * Subject is currently pregnant or intends to become pregnant during the study period. Note: the risks and benefits of performing the procedure if the subject is planning future pregnancies should be carefully considered. * Subject has had radiation therapy to the pelvic area. * Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months. * Subject has a known hypersensitivity to the graft material(s). * Subject has uncontrolled diabetes. * Subject is on any medication which could result in compromised immune response, such as immune modulators. * Subject was involved in any other research trial \< 30 days of enrollment into this study. * Subject has undergone previous pelvic surgery \< 6 months prior to enrollment in this study. * Subject is unwilling or unable to give valid informed consent. * Subject is unwilling or unable to comply with the requirements of the protocol, complete all Quality of Life questionnaires and return for all follow-up visits. * Subject is contraindicated based on intended use and warnings in the AMS PFR System devices for prolapse repair Instructions for Use (IFU).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure | 12-months | Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure | 12-months | Analysis includes only subjects with uterine descent \>= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure | 12-months | Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss | Approximately 30 minutes | Estimated Blood Loss - defined as the estimated blood loss associated with the implantation of the study device, measured in ml |
| Percent of Subjects Experiencing Major Device Related Complications | Through 24 months | This may have included: perforation of internal organs during the implant procedure; graft erosion; serious infection requiring intravenous antibiotics; death, related to procedure or device; blood loss related to device placement which may have required blood transfusion during the procedure |
| Rate of Graft Extrusions | Through 24 months | Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall |
| Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Through 24 months | Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence |
| Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | baseline and 6 weeks | Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale (scale of 0-10, with 10 indicating hurts worst) at baseline, and 6 weeks post procedure |
| Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | 6 Months | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. |
| Surgical Revision Rate | Through 24 months | The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution. |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | 6 months | The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | 24 months | The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. Note: 1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII 2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design |
| Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | 12 months | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. |
| Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | 24 months | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. Note: 1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII 2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design |
| Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | 6 months | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. |
| Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | 12 months | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure. |
| Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | 24 months | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note: 1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII 2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design |
| Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | 6 months | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. |
| Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | 12 months | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure. |
| Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | 24 months | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note: 1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII 2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design |
| Wong-Baker Faces Pain Scale at 3 Months Post Procedure | baseline and 3 months | Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale at baseline and 3 months post procedure |
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | baseline and 6 months | Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. . |
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | baseline and 12 months | Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | baseline and 24 months | Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | baseline and 6 months | Quality of Life as measure by PFDI subscale UDI. UDI scale ranges from 0-100 with 100 representing the most urinary distress. Changes in UDI scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | baseline and 12 months | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | baseline and 24 months | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | baseline and 6 months | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | baseline and 6 months | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | baseline and 12 months | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | baseline and 24 months | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | baseline and 12 months | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | baseline and 24 months | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure | 6 months | Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure | 6 months | Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure | 24 months | Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure | 24 months | Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | 6 Months | Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). A higher or increasing score represents an improvement in perceived sexual function versus baseline. Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included. |
| Procedural Time | Approximately 30 minutes | Procedural time was measured as the time between the first incision to place the study device and the time to close the vaginal incision for the study device. Procedure duration in minutes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure | 6 months | Analysis includes only subjects with uterine descent \>= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure | 24 months | Analysis includes only subjects with uterine descent \>= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. |
Countries
Belgium, France, Germany, Netherlands, Spain, United Kingdom, United States
Participant flow
Recruitment details
Phases duration: Phase I: May 2006 - Oct 2009 Phase II: Feb 2007 - Jun 2010 Phase III/IV: Apr 2007 - May 2010 Phase V: Apr 2008 - Jan 2011 Phase VI: Oct 2008 - Mar 2010 Phase VII: Apr 2009 - Feb 2012
Pre-assignment details
Only those subjects who meet all study criteria, provide written consent and are implanted with an AMS PFR System device for prolapse repair will be considered evaluable for analysis in the study
Participants by arm
| Arm | Count |
|---|---|
| Phase I (IntePro, US Only) AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse | 141 |
| Phase I (Intexen LP, US Only) AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse | 26 |
| Phase II (France Only) AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse | 81 |
| Phase III/IV (Perigee IntePro Lite, US Only) AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | 56 |
| Phase III/IV (Apogee IntePro Lite, US Only) AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices | 55 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) AMS Elevate™ Apical & Posterior with IntePro Lite: Mesh for the treatment of apical & posterior vaginal wall prolapse | 139 |
| Phase V (Elevate Posterior InteXen LP, US Only) AMS Elevate™ Apical & Posterior with InteXen LP: Graft for the treatment of apical & posterior vaginal wall prolapse | 23 |
| Phase VI (Elevate Anterior Gen 1, EU Only) AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) | 35 |
| Phase VII (Elevate Anterior Gen 2, US & EU) AMS Elevate™ Anterior & Apical with IntePro Lite: Mesh for the treatment of anterior & apical vaginal wall prolapse (Generation 2) | 142 |
| Total | 698 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 31 | 3 | 18 | 10 | 13 | 26 | 0 | 1 | 18 |
Baseline characteristics
| Characteristic | Phase I (IntePro, US Only) | Phase I (Intexen LP, US Only) | Phase II (France Only) | Phase III/IV (Perigee IntePro Lite, US Only) | Phase III/IV (Apogee IntePro Lite, US Only) | Phase V (Elevate Posterior IntePro Lite, US & EU) | Phase V (Elevate Posterior InteXen LP, US Only) | Phase VI (Elevate Anterior Gen 1, EU Only) | Phase VII (Elevate Anterior Gen 2, US & EU) | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 12.2 | 63.4 years STANDARD_DEVIATION 9 | 69.7 years STANDARD_DEVIATION 10.9 | 63.4 years STANDARD_DEVIATION 11.1 | 63.3 years STANDARD_DEVIATION 11.8 | 62.5 years STANDARD_DEVIATION 11.6 | 63.4 years STANDARD_DEVIATION 9.6 | 65.4 years STANDARD_DEVIATION 8.4 | 63.9 years STANDARD_DEVIATION 9.8 | NA years STANDARD_DEVIATION 0 |
| Sex: Female, Male Female | 141 Participants | 26 Participants | 81 Participants | 56 Participants | 55 Participants | 139 Participants | 23 Participants | 35 Participants | 142 Participants | 698 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 30 / 141 | 3 / 26 | 30 / 81 | 20 / 56 | 20 / 55 | 30 / 139 | 3 / 23 | 7 / 35 | 62 / 142 |
| serious Total, serious adverse events | 10 / 141 | 1 / 26 | 11 / 81 | 3 / 56 | 3 / 55 | 8 / 139 | 1 / 23 | 8 / 35 | 11 / 142 |
Outcome results
Primary
Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure
Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Time frame: 12-months
Population: Analysis conducted only for those subjects with posterior vaginal wall prolapse \>= stage II at baseline. Where a zero is indicated, no subjects meeting this criteria were enrolled.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I (IntePro, US Only) | Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure | 93.2 percentage of participant |
| Phase I (Intexen LP, US Only) | Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure | 100 percentage of participant |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure | 93.2 percentage of participant |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure | 92.5 percentage of participant |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure | 100 percentage of participant |
Primary
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure
Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Time frame: 12-months
Population: Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase II (France Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure | 71.2 percentage of participant |
| Phase III/IV (Perigee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure | 85.1 percentage of participant |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure | 58.8 percentage of participant |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure | 87.4 percentage of participant |
Primary
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure
Analysis includes only subjects with uterine descent \>= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Time frame: 12-months
Population: Analysis includes only subjects with uterine descent \>=stage II at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I (IntePro, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure | 86.1 percentage of participant |
| Phase I (Intexen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure | 100 percentage of participant |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure | 100 percentage of participant |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure | 89.2 percentage of participant |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure | 90.9 percentage of participant |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure | 90.0 percentage of participant |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure | 95.9 percentage of participant |
Secondary
Estimated Blood Loss
Estimated Blood Loss - defined as the estimated blood loss associated with the implantation of the study device, measured in ml
Time frame: Approximately 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I (IntePro, US Only) | Estimated Blood Loss | 68.6 milliliters | Standard Deviation 67.8 |
| Phase I (Intexen LP, US Only) | Estimated Blood Loss | 67.7 milliliters | Standard Deviation 43.9 |
| Phase II (France Only) | Estimated Blood Loss | 48.8 milliliters | Standard Deviation 29.3 |
| Phase III/IV (Perigee IntePro Lite, US Only) | Estimated Blood Loss | 58.4 milliliters | Standard Deviation 54.7 |
| Phase III/IV (Apogee IntePro Lite, US Only) | Estimated Blood Loss | 58.9 milliliters | Standard Deviation 44.6 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Estimated Blood Loss | 55.4 milliliters | Standard Deviation 45.7 |
| Phase V (Elevate Posterior InteXen LP, US Only) | Estimated Blood Loss | 62.4 milliliters | Standard Deviation 39 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Estimated Blood Loss | 84.4 milliliters | Standard Deviation 60.9 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Estimated Blood Loss | 75.5 milliliters | Standard Deviation 76.3 |
Secondary
Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
Time frame: 12 months
Population: Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Worse than before surgery | 1.7 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | A lot of improvement from before surgery | 80.7 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Did not answer this question | 0 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Some improvement from before surgery | 17.6 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | No improvement from before surgery | 4.2 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Worse than before surgery | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Some improvement from before surgery | 12.5 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Did not answer this question | 4.2 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | A lot of improvement from before surgery | 79.2 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Did not answer this question | 7.0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Some improvement from before surgery | 14.1 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Worse than before surgery | 0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | A lot of improvement from before surgery | 78.9 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Some improvement from before surgery | 13.3 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Did not answer this question | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | A lot of improvement from before surgery | 86.7 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Worse than before surgery | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Worse than before surgery | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | A lot of improvement from before surgery | 93.2 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Did not answer this question | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | No improvement from before surgery | 2.3 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Some improvement from before surgery | 4.5 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Worse than before surgery | 1.6 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Some improvement from before surgery | 23.0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | A lot of improvement from before surgery | 71.4 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | No improvement from before surgery | 2.4 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Did not answer this question | 1.6 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Did not answer this question | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | A lot of improvement from before surgery | 73.9 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Some improvement from before surgery | 26.1 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Worse than before surgery | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Some improvement from before surgery | 8.8 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Did not answer this question | 2.9 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Worse than before surgery | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | A lot of improvement from before surgery | 88.2 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | No improvement from before surgery | 2.4 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Worse than before surgery | 0.8 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Did not answer this question | 0 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | A lot of improvement from before surgery | 90.4 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Some improvement from before surgery | 6.4 Percentage of participants |
Secondary
Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.
Time frame: 12 months
Population: How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Did not answer this question | 0 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Moderately satisfied | 13.4 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Slightly satisfied | 4.2 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Extremely satisfied | 48.7 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Very satisfied | 32.8 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Not at all satisfied | 0.8 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Moderately satisfied | 8.3 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Not at all satisfied | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Did not answer this question | 4.2 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Extremely satisfied | 50 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Slightly satisfied | 4.2 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Very satisfied | 33.3 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Not at all satisfied | 0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Very satisfied | 45.1 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Moderately satisfied | 9.9 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Slightly satisfied | 0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Did not answer this question | 7.0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Extremely satisfied | 38.0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Very satisfied | 40 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Not at all satisfied | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Slightly satisfied | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Moderately satisfied | 17.8 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Extremely satisfied | 42.2 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Did not answer this question | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Did not answer this question | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Moderately satisfied | 6.8 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Slightly satisfied | 2.3 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Very satisfied | 40.9 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Not at all satisfied | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Extremely satisfied | 50.0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Very satisfied | 42.1 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Did not answer this question | 0.8 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Not at all satisfied | 2.4 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Slightly satisfied | 2.4 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Moderately satisfied | 13.5 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Extremely satisfied | 38.9 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Very satisfied | 26.1 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Slightly satisfied | 8.7 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Not at all satisfied | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Moderately satisfied | 4.3 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Did not answer this question | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Extremely satisfied | 60.9 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Not at all satisfied | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Slightly satisfied | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Moderately satisfied | 8.8 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Very satisfied | 52.9 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Did not answer this question | 2.9 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Extremely satisfied | 35.3 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Moderately satisfied | 3.2 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Not at all satisfied | 0.8 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Extremely satisfied | 58.4 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Slightly satisfied | 4.8 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Very satisfied | 32.8 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Did not answer this question | 0 Percentage of participants |
Secondary
Patient Satisfaction Questionnaire at 12 Months by Question (Q#3)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.
Time frame: 12 months
Population: Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Did not answer this question | 1.7 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | No | 5.9 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Yes | 92.4 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | No | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Yes | 95.8 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Did not answer this question | 4.2 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Yes | 93.0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Did not answer this question | 7.0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | No | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | No | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Did not answer this question | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Yes | 100 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Yes | 97.7 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Did not answer this question | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | No | 2.3 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Yes | 96.0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Did not answer this question | 2.4 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | No | 1.6 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | No | 4.3 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Did not answer this question | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Yes | 95.7 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Yes | 94.1 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | No | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Did not answer this question | 5.9 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Yes | 96.8 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | No | 1.6 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Did not answer this question | 1.6 Percentage of participants |
Secondary
Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. Note: 1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII 2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design
Time frame: 24 months
Population: Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Did not answer this question | 0 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | A lot of improvement from before surgery | 85.5 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Some improvement from before surgery | 10.9 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | No improvement from before surgery | 0.9 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Worse than before surgery | 2.7 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Worse than before surgery | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Some improvement from before surgery | 4.3 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | A lot of improvement from before surgery | 91.3 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Did not answer this question | 4.3 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Worse than before surgery | 0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | A lot of improvement from before surgery | 81.0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Did not answer this question | 11.1 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Some improvement from before surgery | 7.9 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | A lot of improvement from before surgery | 76.1 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Did not answer this question | 2.2 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Worse than before surgery | 4.3 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Some improvement from before surgery | 17.4 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Did not answer this question | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Worse than before surgery | 2.4 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Some improvement from before surgery | 11.9 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | A lot of improvement from before surgery | 85.7 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | No improvement from before surgery | 3.5 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Some improvement from before surgery | 20.4 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Worse than before surgery | 4.4 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Did not answer this question | 0.9 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | A lot of improvement from before surgery | 70.8 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Did not answer this question | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Worse than before surgery | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | A lot of improvement from before surgery | 69.6 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Some improvement from before surgery | 30.4 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | A lot of improvement from before surgery | 84.7 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Some improvement from before surgery | 12.1 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Did not answer this question | 0.8 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | No improvement from before surgery | 1.6 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Worse than before surgery | 0.8 Percentage of participants |
Secondary
Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note: 1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII 2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design
Time frame: 24 months
Population: How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Extremely satisfied | 59.1 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Did not answer this question | 0 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Not at all satisfied | 3.6 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Slightly satisfied | 1.8 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Very satisfied | 23.6 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Moderately satisfied | 11.8 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Slightly satisfied | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Did not answer this question | 4.3 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Moderately satisfied | 4.3 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Extremely satisfied | 65.2 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Not at all satisfied | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Very satisfied | 26.1 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Very satisfied | 44.4 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Slightly satisfied | 0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Not at all satisfied | 0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Moderately satisfied | 6.3 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Extremely satisfied | 38.1 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Did not answer this question | 11.1 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Very satisfied | 41.3 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Did not answer this question | 2.2 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Not at all satisfied | 4.3 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Slightly satisfied | 2.2 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Moderately satisfied | 8.7 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Extremely satisfied | 41.3 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Very satisfied | 35.7 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Not at all satisfied | 2.4 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Extremely satisfied | 47.6 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Did not answer this question | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Moderately satisfied | 9.5 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Slightly satisfied | 4.8 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Slightly satisfied | 8.0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Moderately satisfied | 9.7 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Not at all satisfied | 2.7 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Very satisfied | 40.7 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Did not answer this question | 0.9 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Extremely satisfied | 38.1 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Moderately satisfied | 8.7 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Very satisfied | 47.8 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Did not answer this question | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Slightly satisfied | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Extremely satisfied | 43.5 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Not at all satisfied | 0 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Moderately satisfied | 5.6 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Slightly satisfied | 3.2 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Extremely satisfied | 58.1 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Very satisfied | 29.8 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Did not answer this question | 0.8 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Not at all satisfied | 2.4 Percentage of participants |
Secondary
Patient Satisfaction Questionnaire at 24 Months by Question (Q#3)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note: 1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII 2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design
Time frame: 24 months
Population: Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | No | 8.2 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Did not answer this question | 0.9 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Yes | 90.9 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | No | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Did not answer this question | 4.3 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Yes | 95.7 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Did not answer this question | 11.1 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Yes | 87.3 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | No | 1.6 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Did not answer this question | 2.2 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | No | 4.3 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Yes | 93.5 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | No | 4.8 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Yes | 95.2 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Did not answer this question | 0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | No | 7.1 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Yes | 92.0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Did not answer this question | 0.9 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | No | 4.3 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Did not answer this question | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Yes | 95.7 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Yes | 94.4 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Did not answer this question | 2.4 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | No | 3.2 Percentage of participants |
Secondary
Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
Time frame: 6 Months
Population: Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Worse than before surgery | 0 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Did not answer this question | 0.8 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Some improvement from before surgery | 17.1 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | A lot of improvement from before surgery | 82.2 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Some improvement from before surgery | 15.4 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Worse than before surgery | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | A lot of improvement from before surgery | 84.6 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Did not answer this question | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | A lot of improvement from before surgery | 86.3 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Did not answer this question | 5.5 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Worse than before surgery | 0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Some improvement from before surgery | 8.2 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | A lot of improvement from before surgery | 74.5 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Did not answer this question | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Worse than before surgery | 4.3 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Some improvement from before surgery | 21.3 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Did not answer this question | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Worse than before surgery | 2.2 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | A lot of improvement from before surgery | 89.1 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Some improvement from before surgery | 8.7 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | No improvement from before surgery | 0.8 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Some improvement from before surgery | 21.4 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Worse than before surgery | 1.5 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | A lot of improvement from before surgery | 74.0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Did not answer this question | 2.3 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Some improvement from before surgery | 13.0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Did not answer this question | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Worse than before surgery | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | A lot of improvement from before surgery | 87.0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Worse than before surgery | 2.9 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | No improvement from before surgery | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | A lot of improvement from before surgery | 82.4 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Some improvement from before surgery | 11.8 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Did not answer this question | 2.9 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Worse than before surgery | 1.5 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Some improvement from before surgery | 12.2 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | No improvement from before surgery | 1.5 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Did not answer this question | 0.8 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | A lot of improvement from before surgery | 84.0 Percentage of participants |
Secondary
Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
Time frame: 6 months
Population: How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Not at all satisfied | 0.8 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Very satisfied | 34.1 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Moderately satisfied | 11.6 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Did not answer this question | 0.8 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Extremely satisfied | 51.9 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Slightly satisfied | 0.8 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Did not answer this question | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Not at all satisfied | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Slightly satisfied | 3.8 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Very satisfied | 38.5 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Extremely satisfied | 53.8 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Moderately satisfied | 3.8 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Moderately satisfied | 6.8 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Did not answer this question | 5.5 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Extremely satisfied | 39.7 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Not at all satisfied | 0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Slightly satisfied | 0 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Very satisfied | 47.9 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Slightly satisfied | 2.1 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Very satisfied | 46.8 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Moderately satisfied | 6.4 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Did not answer this question | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Not at all satisfied | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Extremely satisfied | 44.7 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Not at all satisfied | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Extremely satisfied | 58.7 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Moderately satisfied | 4.3 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Slightly satisfied | 2.2 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Did not answer this question | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Very satisfied | 34.8 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Very satisfied | 38.2 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Did not answer this question | 2.3 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Not at all satisfied | 1.5 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Slightly satisfied | 4.6 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Moderately satisfied | 12.2 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Extremely satisfied | 41.2 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Very satisfied | 47.8 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Extremely satisfied | 52.2 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Not at all satisfied | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Moderately satisfied | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Slightly satisfied | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Did not answer this question | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Moderately satisfied | 5.9 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Slightly satisfied | 2.9 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Very satisfied | 61.8 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Not at all satisfied | 2.9 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Did not answer this question | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Extremely satisfied | 26.5 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Moderately satisfied | 5.3 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Not at all satisfied | 3.1 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Extremely satisfied | 48.9 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Slightly satisfied | 1.5 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Very satisfied | 40.5 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Did not answer this question | 0.8 Percentage of participants |
Secondary
Patient Satisfaction Questionnaire at 6 Months by Question (Q#3)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
Time frame: 6 months
Population: Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | No | 3.1 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Yes | 94.6 Percentage of participants |
| Phase I (IntePro, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Did not answer this question | 2.3 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Did not answer this question | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | No | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Yes | 100 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Yes | 94.5 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Did not answer this question | 5.5 Percentage of participants |
| Phase II (France Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | No | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | No | 4.3 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Did not answer this question | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Yes | 95.7 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Yes | 93.5 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Did not answer this question | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | No | 6.5 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Yes | 96.9 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Did not answer this question | 2.3 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | No | 0.8 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | No | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Did not answer this question | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Yes | 100 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Yes | 97.1 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | No | 2.9 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Did not answer this question | 0 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Yes | 96.9 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | No | 2.3 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Did not answer this question | 0.8 Percentage of participants |
Secondary
Percent of Subjects Experiencing Major Device Related Complications
This may have included: perforation of internal organs during the implant procedure; graft erosion; serious infection requiring intravenous antibiotics; death, related to procedure or device; blood loss related to device placement which may have required blood transfusion during the procedure
Time frame: Through 24 months
Population: Total subjects experienced major complications(%)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I (IntePro, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Graft erosion | 0.7 Percentage of participants |
| Phase I (IntePro, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Serious infe | 0 Percentage of participants |
| Phase I (IntePro, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Blood loss | 0 Percentage of participants |
| Phase I (IntePro, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Death related to procedure or device | 0 Percentage of participants |
| Phase I (IntePro, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Perforation | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Graft erosion | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Blood loss | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Serious infe | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Perforation | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Death related to procedure or device | 0 Percentage of participants |
| Phase II (France Only) | Percent of Subjects Experiencing Major Device Related Complications | Graft erosion | 0 Percentage of participants |
| Phase II (France Only) | Percent of Subjects Experiencing Major Device Related Complications | Blood loss | 0 Percentage of participants |
| Phase II (France Only) | Percent of Subjects Experiencing Major Device Related Complications | Death related to procedure or device | 0 Percentage of participants |
| Phase II (France Only) | Percent of Subjects Experiencing Major Device Related Complications | Serious infe | 0 Percentage of participants |
| Phase II (France Only) | Percent of Subjects Experiencing Major Device Related Complications | Perforation | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Serious infe | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Graft erosion | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Perforation | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Blood loss | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Death related to procedure or device | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Perforation | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Serious infe | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Death related to procedure or device | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Blood loss | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Graft erosion | 0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects Experiencing Major Device Related Complications | Death related to procedure or device | 0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects Experiencing Major Device Related Complications | Blood loss | 0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects Experiencing Major Device Related Complications | Serious infe | 0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects Experiencing Major Device Related Complications | Perforation | 0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects Experiencing Major Device Related Complications | Graft erosion | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Death related to procedure or device | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Perforation | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Serious infe | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Graft erosion | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects Experiencing Major Device Related Complications | Blood loss | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Percent of Subjects Experiencing Major Device Related Complications | Perforation | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Percent of Subjects Experiencing Major Device Related Complications | Serious infe | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Percent of Subjects Experiencing Major Device Related Complications | Death related to procedure or device | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Percent of Subjects Experiencing Major Device Related Complications | Blood loss | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Percent of Subjects Experiencing Major Device Related Complications | Graft erosion | 0 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects Experiencing Major Device Related Complications | Perforation | 0 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects Experiencing Major Device Related Complications | Serious infe | 0 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects Experiencing Major Device Related Complications | Graft erosion | 0 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects Experiencing Major Device Related Complications | Death related to procedure or device | 0 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects Experiencing Major Device Related Complications | Blood loss | 0.7 Percentage of participants |
Secondary
Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months
The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. Note: 1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII 2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design
Time frame: 24 months
Population: POP-Q analysis employed last failure carried forward method, which carries subject's objective failure at previous visits if the results are missing in the visit of interest. It's also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I (IntePro, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Anterior Compartment Success | NA Percentage of participants |
| Phase I (IntePro, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Apical Compartment Success | 84.4 Percentage of participants |
| Phase I (IntePro, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Posterior Compartment Success | 93.5 Percentage of participants |
| Phase I (Intexen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Anterior Compartment Success | NA Percentage of participants |
| Phase I (Intexen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Apical Compartment Success | 100 Percentage of participants |
| Phase I (Intexen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Posterior Compartment Success | 95.7 Percentage of participants |
| Phase II (France Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Posterior Compartment Success | NA Percentage of participants |
| Phase II (France Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Anterior Compartment Success | 69.1 Percentage of participants |
| Phase II (France Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Apical Compartment Success | NA Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Anterior Compartment Success | 87.0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Posterior Compartment Success | NA Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Apical Compartment Success | NA Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Anterior Compartment Success | NA Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Posterior Compartment Success | 90.9 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Apical Compartment Success | 75.0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Posterior Compartment Success | 91.5 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Anterior Compartment Success | NA Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Apical Compartment Success | 88.2 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Apical Compartment Success | 100 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Posterior Compartment Success | 90.9 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Anterior Compartment Success | NA Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Apical Compartment Success | 96.2 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Anterior Compartment Success | 81.6 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | Posterior Compartment Success | NA Percentage of participants |
Secondary
Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months
The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Time frame: 6 months
Population: POP-Q analysis employed last failure carried forward method, which carries subject's objective failure at previous visits if the results are missing in the visit of interest. It's also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I (IntePro, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Posterior Compartment Success | 94.4 Percentage of participants |
| Phase I (IntePro, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Anterior Compartment Success | NA Percentage of participants |
| Phase I (IntePro, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Apical Compartment Success | 94.7 Percentage of participants |
| Phase I (Intexen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Posterior Compartment Success | 100 Percentage of participants |
| Phase I (Intexen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Apical Compartment Success | 100 Percentage of participants |
| Phase I (Intexen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Anterior Compartment Success | NA Percentage of participants |
| Phase II (France Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Apical Compartment Success | NA Percentage of participants |
| Phase II (France Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Anterior Compartment Success | 76.7 Percentage of participants |
| Phase II (France Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Posterior Compartment Success | NA Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Posterior Compartment Success | NA Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Anterior Compartment Success | 91.5 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Apical Compartment Success | NA Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Posterior Compartment Success | 91.3 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Apical Compartment Success | 100 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Anterior Compartment Success | NA Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Apical Compartment Success | 92.5 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Posterior Compartment Success | 96.8 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Anterior Compartment Success | NA Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Anterior Compartment Success | NA Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Posterior Compartment Success | 100 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Apical Compartment Success | 90.9 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Apical Compartment Success | 90.0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Anterior Compartment Success | 61.8 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Posterior Compartment Success | NA Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Apical Compartment Success | 98.8 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Anterior Compartment Success | 86.3 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | Posterior Compartment Success | NA Percentage of participants |
Secondary
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure
Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Time frame: 24 months
Population: Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase II (France Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure | 69.1 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure | 87.0 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure | 81.6 Percentage of participants |
Secondary
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure
Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Time frame: 6 months
Population: Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase II (France Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure | 76.7 percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure | 91.5 percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure | 61.8 percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure | 86.3 percentage of participants |
Secondary
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure
Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Time frame: 24 months
Population: Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I (IntePro, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure | 93.5 percentage of participants |
| Phase I (Intexen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure | 95.7 percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure | 90.9 percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure | 91.5 percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure | 100 percentage of participants |
Secondary
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure
Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Time frame: 6 months
Population: Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I (IntePro, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure | 94.4 percentage of participants |
| Phase I (Intexen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure | 100 percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure | 91.3 percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure | 96.8 percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure | 100 percentage of participants |
Secondary
Procedural Time
Procedural time was measured as the time between the first incision to place the study device and the time to close the vaginal incision for the study device. Procedure duration in minutes
Time frame: Approximately 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase I (IntePro, US Only) | Procedural Time | 44.8 minutes | Standard Deviation 20.3 |
| Phase I (Intexen LP, US Only) | Procedural Time | 40.8 minutes | Standard Deviation 17.7 |
| Phase II (France Only) | Procedural Time | 50.2 minutes | Standard Deviation 38.3 |
| Phase III/IV (Perigee IntePro Lite, US Only) | Procedural Time | 42.4 minutes | Standard Deviation 16.4 |
| Phase III/IV (Apogee IntePro Lite, US Only) | Procedural Time | 51.7 minutes | Standard Deviation 23.1 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Procedural Time | 45.8 minutes | Standard Deviation 19.2 |
| Phase V (Elevate Posterior InteXen LP, US Only) | Procedural Time | 48.6 minutes | Standard Deviation 14.8 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Procedural Time | 63.5 minutes | Standard Deviation 19 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Procedural Time | 54.6 minutes | Standard Deviation 21.5 |
Secondary
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M
Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Time frame: baseline and 12 months
Population: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at baseline | 64.9 Percentage of participants | Standard Deviation 70.5 |
| Phase I (IntePro, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at 12M | 13.1 Percentage of participants | Standard Deviation 27.8 |
| Phase I (Intexen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at baseline | 59.3 Percentage of participants | Standard Deviation 48.2 |
| Phase I (Intexen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at 12M | 10.0 Percentage of participants | Standard Deviation 19.8 |
| Phase II (France Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at baseline | 59.1 Percentage of participants | Standard Deviation 57.4 |
| Phase II (France Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at 12M | 9.1 Percentage of participants | Standard Deviation 16 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at baseline | 61.7 Percentage of participants | Standard Deviation 74.6 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at 12M | 10.7 Percentage of participants | Standard Deviation 21.8 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at baseline | 57.5 Percentage of participants | Standard Deviation 65 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at 12M | 8.8 Percentage of participants | Standard Deviation 26.7 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at 12M | 17.9 Percentage of participants | Standard Deviation 39.9 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at baseline | 65.6 Percentage of participants | Standard Deviation 59.7 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at 12M | 8.5 Percentage of participants | Standard Deviation 17.3 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at baseline | 60.2 Percentage of participants | Standard Deviation 40 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at baseline | 73.0 Percentage of participants | Standard Deviation 68.1 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at 12M | 8.7 Percentage of participants | Standard Deviation 13.6 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at baseline | 55.8 Percentage of participants | Standard Deviation 60.5 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | PFIQ-7 mean score at 12M | 14.0 Percentage of participants | Standard Deviation 39 |
Secondary
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M
Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Time frame: baseline and 24 months
Population: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at baseline | 59.1 Percentage of participants | Standard Deviation 63.8 |
| Phase I (IntePro, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at 24M | 15.8 Percentage of participants | Standard Deviation 40.9 |
| Phase I (Intexen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at baseline | 55.6 Percentage of participants | Standard Deviation 46 |
| Phase I (Intexen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at 24M | 5.0 Percentage of participants | Standard Deviation 8 |
| Phase II (France Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at baseline | 60.9 Percentage of participants | Standard Deviation 59.3 |
| Phase II (France Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at 24M | 11.9 Percentage of participants | Standard Deviation 27.8 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at baseline | 56.5 Percentage of participants | Standard Deviation 71.6 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at 24M | 10.5 Percentage of participants | Standard Deviation 36.1 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at baseline | 59.0 Percentage of participants | Standard Deviation 69.5 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at 24M | 7.8 Percentage of participants | Standard Deviation 23.4 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at baseline | 64.3 Percentage of participants | Standard Deviation 56.5 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at 24M | 17.9 Percentage of participants | Standard Deviation 34.7 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at 24M | 9.7 Percentage of participants | Standard Deviation 15 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at baseline | 60.2 Percentage of participants | Standard Deviation 40 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at baseline | 54.8 Percentage of participants | Standard Deviation 56.1 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | PFIQ-7 mean score at 24M | 9.3 Percentage of participants | Standard Deviation 24.8 |
Secondary
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M
Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. .
Time frame: baseline and 6 months
Population: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at baseline | 70.4 Percentage of participants | Standard Deviation 72.2 |
| Phase I (IntePro, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at 6M | 16.3 Percentage of participants | Standard Deviation 35.7 |
| Phase I (Intexen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at baseline | 68.2 Percentage of participants | Standard Deviation 62.8 |
| Phase I (Intexen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at 6M | 21.7 Percentage of participants | Standard Deviation 44 |
| Phase II (France Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at baseline | 54.9 Percentage of participants | Standard Deviation 55.7 |
| Phase II (France Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at 6M | 9.9 Percentage of participants | Standard Deviation 21.1 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at baseline | 61.5 Percentage of participants | Standard Deviation 75.7 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at 6M | 8.4 Percentage of participants | Standard Deviation 20.5 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at baseline | 58.9 Percentage of participants | Standard Deviation 70.1 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at 6M | 9.2 Percentage of participants | Standard Deviation 28.3 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at 6M | 22.3 Percentage of participants | Standard Deviation 40.8 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at baseline | 65.4 Percentage of participants | Standard Deviation 59.8 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at 6M | 6.0 Percentage of participants | Standard Deviation 13.6 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at baseline | 60.2 Percentage of participants | Standard Deviation 40 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at baseline | 71.4 Percentage of participants | Standard Deviation 67.2 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at 6M | 22.8 Percentage of participants | Standard Deviation 36.5 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at baseline | 59.8 Percentage of participants | Standard Deviation 61.1 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | PFIQ-7 mean score at 6M | 12.9 Percentage of participants | Standard Deviation 29 |
Secondary
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Time frame: baseline and 24 months
Population: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 32.4 Percentage of participants | Standard Deviation 7.4 |
| Phase I (IntePro, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 24M | 36.9 Percentage of participants | Standard Deviation 6.4 |
| Phase I (Intexen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 31.7 Percentage of participants | Standard Deviation 5.4 |
| Phase I (Intexen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 24M | 36.6 Percentage of participants | Standard Deviation 5.3 |
| Phase II (France Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 34.5 Percentage of participants | Standard Deviation 6.5 |
| Phase II (France Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 24M | 36.0 Percentage of participants | Standard Deviation 4.4 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 32.4 Percentage of participants | Standard Deviation 5.3 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 24M | 35.3 Percentage of participants | Standard Deviation 4.6 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 31.9 Percentage of participants | Standard Deviation 5.2 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 24M | 35.9 Percentage of participants | Standard Deviation 4.8 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 34.9 Percentage of participants | Standard Deviation 5.8 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 24M | 36.6 Percentage of participants | Standard Deviation 6.5 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 24M | 34.6 Percentage of participants | Standard Deviation 5.5 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 33.6 Percentage of participants | Standard Deviation 4.2 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 32.0 Percentage of participants | Standard Deviation 8.4 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 24M | 36.3 Percentage of participants | Standard Deviation 6.1 |
Secondary
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Time frame: 12 months
Population: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 33.4 Percentage of participants | Standard Deviation 7.3 |
| Phase I (IntePro, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 12M | 37.2 Percentage of participants | Standard Deviation 5.9 |
| Phase I (Intexen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 31.7 Percentage of participants | Standard Deviation 5.4 |
| Phase I (Intexen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 12M | 33.8 Percentage of participants | Standard Deviation 9.3 |
| Phase II (France Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 35.3 Percentage of participants | Standard Deviation 5.3 |
| Phase II (France Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 12M | 36.3 Percentage of participants | Standard Deviation 4.9 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 32.8 Percentage of participants | Standard Deviation 5.5 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 12M | 34.9 Percentage of participants | Standard Deviation 5.6 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 33.0 Percentage of participants | Standard Deviation 6.2 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 12M | 36.4 Percentage of participants | Standard Deviation 5.8 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 12M | 36.5 Percentage of participants | Standard Deviation 5.5 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 34.1 Percentage of participants | Standard Deviation 6.1 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 12M | 35.6 Percentage of participants | Standard Deviation 5.5 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 34.3 Percentage of participants | Standard Deviation 4.5 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 33.4 Percentage of participants | Standard Deviation 4.8 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 12M | 37.7 Percentage of participants | Standard Deviation 5.8 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 31.9 Percentage of participants | Standard Deviation 8.4 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 12M | 37.4 Percentage of participants | Standard Deviation 5.7 |
Secondary
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). A higher or increasing score represents an improvement in perceived sexual function versus baseline. Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included.
Time frame: 6 Months
Population: Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 6M | 37.1 scores on a scale | Standard Deviation 5.7 |
| Phase I (IntePro, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 32.5 scores on a scale | Standard Deviation 7.1 |
| Phase I (Intexen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 32.1 scores on a scale | Standard Deviation 5.6 |
| Phase I (Intexen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 6M | 36.8 scores on a scale | Standard Deviation 7.2 |
| Phase II (France Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 34.8 scores on a scale | Standard Deviation 5.5 |
| Phase II (France Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 6M | 36.8 scores on a scale | Standard Deviation 4.7 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 6M | 35.4 scores on a scale | Standard Deviation 5.9 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 33.4 scores on a scale | Standard Deviation 5.6 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 32.4 scores on a scale | Standard Deviation 6.4 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 6M | 35.4 scores on a scale | Standard Deviation 5.9 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 34.0 scores on a scale | Standard Deviation 5.9 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 6M | 36.3 scores on a scale | Standard Deviation 5.5 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 33.9 scores on a scale | Standard Deviation 4.4 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 6M | 35.0 scores on a scale | Standard Deviation 7.7 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 6M | 38.1 scores on a scale | Standard Deviation 6.4 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 34.0 scores on a scale | Standard Deviation 4.8 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at baseline | 32.6 scores on a scale | Standard Deviation 8.1 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | PISQ-12 mean score at 6M | 36.6 scores on a scale | Standard Deviation 6.1 |
Secondary
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M
Quality of Life as measure by PFDI subscale UDI. UDI scale ranges from 0-100 with 100 representing the most urinary distress. Changes in UDI scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Time frame: baseline and 6 months
Population: Changes in QoL scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at baseline | 98.4 scores on a scale | Standard Deviation 59.6 |
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at 6M | 29.1 scores on a scale | Standard Deviation 37.2 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at baseline | 106.7 scores on a scale | Standard Deviation 63.4 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at 6M | 36.4 scores on a scale | Standard Deviation 38.4 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at baseline | 65.5 scores on a scale | Standard Deviation 34.5 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at 6M | 15.4 scores on a scale | Standard Deviation 19.1 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at baseline | 93.2 scores on a scale | Standard Deviation 55.1 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at 6M | 21.8 scores on a scale | Standard Deviation 22.4 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at baseline | 93.0 scores on a scale | Standard Deviation 55 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at 6M | 29.2 scores on a scale | Standard Deviation 37.7 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at 6M | 31.2 scores on a scale | Standard Deviation 35.6 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at baseline | 97.6 scores on a scale | Standard Deviation 59.8 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at 6M | 14.6 scores on a scale | Standard Deviation 23.4 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at baseline | 83.0 scores on a scale | Standard Deviation 40.4 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at baseline | 75.5 scores on a scale | Standard Deviation 54.2 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at 6M | 29.7 scores on a scale | Standard Deviation 33.5 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at baseline | 87.0 scores on a scale | Standard Deviation 55.5 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | PFDI- UDI mean score at 6M | 23.2 scores on a scale | Standard Deviation 27.2 |
Secondary
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Time frame: baseline and 12 months
Population: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at baseline | 129.8 Percentage of participants | Standard Deviation 88.9 |
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at 12M | 46.6 Percentage of participants | Standard Deviation 60.5 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at baseline | 123.5 Percentage of participants | Standard Deviation 73.8 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at 12M | 47.3 Percentage of participants | Standard Deviation 51.2 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at baseline | 50.9 Percentage of participants | Standard Deviation 49.3 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at 12M | 27.3 Percentage of participants | Standard Deviation 36.2 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at baseline | 85.1 Percentage of participants | Standard Deviation 72.3 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at 12M | 29.9 Percentage of participants | Standard Deviation 42.1 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at baseline | 100.8 Percentage of participants | Standard Deviation 72.8 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at 12M | 22.7 Percentage of participants | Standard Deviation 30.6 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at 12M | 49.6 Percentage of participants | Standard Deviation 55.1 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at baseline | 108.2 Percentage of participants | Standard Deviation 71.7 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at 12M | 32.5 Percentage of participants | Standard Deviation 41 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at baseline | 102.1 Percentage of participants | Standard Deviation 65.9 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at baseline | 70.5 Percentage of participants | Standard Deviation 60.7 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at 12M | 39.4 Percentage of participants | Standard Deviation 42.8 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at baseline | 77.2 Percentage of participants | Standard Deviation 66.9 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | PFDI- CRADI mean score at 12M | 29.4 Percentage of participants | Standard Deviation 44.7 |
Secondary
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Time frame: baseline and 24 months
Population: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at 24M | 40.2 Percentage of participants | Standard Deviation 53.5 |
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at baseline | 126.9 Percentage of participants | Standard Deviation 84.9 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at baseline | 110.6 Percentage of participants | Standard Deviation 73.2 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at 24M | 22.0 Percentage of participants | Standard Deviation 30.6 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at baseline | 58.3 Percentage of participants | Standard Deviation 50.4 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at 24M | 33.7 Percentage of participants | Standard Deviation 41.3 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at 24M | 25.1 Percentage of participants | Standard Deviation 38.5 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at baseline | 79.8 Percentage of participants | Standard Deviation 73.2 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at baseline | 95.5 Percentage of participants | Standard Deviation 74.3 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at 24M | 27.2 Percentage of participants | Standard Deviation 37.8 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at 24M | 42.7 Percentage of participants | Standard Deviation 52.7 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at baseline | 105.9 Percentage of participants | Standard Deviation 70.3 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at baseline | 102.1 Percentage of participants | Standard Deviation 65.9 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at 24M | 29.4 Percentage of participants | Standard Deviation 36.7 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at 24M | 28.9 Percentage of participants | Standard Deviation 35.3 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | PFDI- CRADI mean score at baseline | 77.2 Percentage of participants | Standard Deviation 65.2 |
Secondary
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Time frame: baseline and 6 months
Population: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at baseline | 129.6 Percentage of participants | Standard Deviation 88.1 |
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at 6M | 49.2 Percentage of participants | Standard Deviation 63.1 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at baseline | 125.8 Percentage of participants | Standard Deviation 83.3 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at 6M | 45.3 Percentage of participants | Standard Deviation 42.6 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at baseline | 52.6 Percentage of participants | Standard Deviation 48.3 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at 6M | 30.6 Percentage of participants | Standard Deviation 38.9 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at baseline | 82.4 Percentage of participants | Standard Deviation 75.1 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at 6M | 23.4 Percentage of participants | Standard Deviation 28.3 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at baseline | 94.1 Percentage of participants | Standard Deviation 71.8 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at 6M | 31.2 Percentage of participants | Standard Deviation 36.5 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at 6M | 52.9 Percentage of participants | Standard Deviation 62.5 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at baseline | 110.0 Percentage of participants | Standard Deviation 74 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at 6M | 29.0 Percentage of participants | Standard Deviation 35.6 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at baseline | 102.1 Percentage of participants | Standard Deviation 65.9 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at baseline | 70.5 Percentage of participants | Standard Deviation 60.7 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at 6M | 41.8 Percentage of participants | Standard Deviation 44.1 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at baseline | 80.6 Percentage of participants | Standard Deviation 68.1 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | PFDI- CRADI mean score at 6M | 36.3 Percentage of participants | Standard Deviation 46.5 |
Secondary
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Time frame: baseline and 12 months
Population: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at baseline | 135.1 Percentage of participants | Standard Deviation 68.9 |
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at 12M | 45.2 Percentage of participants | Standard Deviation 49.3 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at baseline | 128.2 Percentage of participants | Standard Deviation 55.4 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at 12M | 42.4 Percentage of participants | Standard Deviation 50.5 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at baseline | 103.3 Percentage of participants | Standard Deviation 45.6 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at 12M | 25.8 Percentage of participants | Standard Deviation 30.3 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at baseline | 105.7 Percentage of participants | Standard Deviation 58.8 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at 12M | 23.6 Percentage of participants | Standard Deviation 30.3 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at baseline | 116.1 Percentage of participants | Standard Deviation 65.9 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at 12M | 19.9 Percentage of participants | Standard Deviation 28 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at 12M | 43.0 Percentage of participants | Standard Deviation 52.5 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at baseline | 122.0 Percentage of participants | Standard Deviation 63.7 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at 12M | 29.9 Percentage of participants | Standard Deviation 27.7 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at baseline | 115.5 Percentage of participants | Standard Deviation 53.5 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at baseline | 105.4 Percentage of participants | Standard Deviation 61.3 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at 12M | 32.5 Percentage of participants | Standard Deviation 34.2 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at baseline | 104.4 Percentage of participants | Standard Deviation 62.6 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | PFDI- POPDI mean score at 12M | 23.8 Percentage of participants | Standard Deviation 36.5 |
Secondary
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Time frame: baseline and 24 months
Population: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at baseline | 132.4 Percentage of participants | Standard Deviation 68.3 |
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at 24M | 36.4 Percentage of participants | Standard Deviation 48.9 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at baseline | 113.2 Percentage of participants | Standard Deviation 56.6 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at 24M | 13.8 Percentage of participants | Standard Deviation 18.1 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at baseline | 107.4 Percentage of participants | Standard Deviation 46.3 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at 24M | 31.7 Percentage of participants | Standard Deviation 37.6 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at baseline | 104.7 Percentage of participants | Standard Deviation 60.1 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at 24M | 23.8 Percentage of participants | Standard Deviation 28.1 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at baseline | 116.1 Percentage of participants | Standard Deviation 65.1 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at 24M | 31.1 Percentage of participants | Standard Deviation 36.7 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at baseline | 121.7 Percentage of participants | Standard Deviation 63 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at 24M | 37.6 Percentage of participants | Standard Deviation 51.9 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at 24M | 21.9 Percentage of participants | Standard Deviation 21.6 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at baseline | 115.5 Percentage of participants | Standard Deviation 53.5 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at baseline | 103.3 Percentage of participants | Standard Deviation 59.1 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | PFDI- POPDI mean score at 24M | 24.8 Percentage of participants | Standard Deviation 32.3 |
Secondary
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Time frame: baseline and 6 months
Population: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at baseline | 137.0 Percentage of participants | Standard Deviation 69.9 |
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at 6M | 37.5 Percentage of participants | Standard Deviation 43.4 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at baseline | 128.9 Percentage of participants | Standard Deviation 65.9 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at 6M | 34.7 Percentage of participants | Standard Deviation 48.8 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at baseline | 102.3 Percentage of participants | Standard Deviation 45.4 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at 6M | 27.8 Percentage of participants | Standard Deviation 34.8 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at baseline | 112.0 Percentage of participants | Standard Deviation 67.2 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at 6M | 19.1 Percentage of participants | Standard Deviation 21.9 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at baseline | 115.7 Percentage of participants | Standard Deviation 69.9 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at 6M | 30.3 Percentage of participants | Standard Deviation 35.2 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at 6M | 42.9 Percentage of participants | Standard Deviation 50.9 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at baseline | 122.7 Percentage of participants | Standard Deviation 64.3 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at 6M | 21.6 Percentage of participants | Standard Deviation 24.4 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at baseline | 115.5 Percentage of participants | Standard Deviation 53.5 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at baseline | 105.4 Percentage of participants | Standard Deviation 61.3 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at 6M | 36.1 Percentage of participants | Standard Deviation 48.3 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at baseline | 107.8 Percentage of participants | Standard Deviation 65.9 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | PFDI- POPDI mean score at 6M | 31.8 Percentage of participants | Standard Deviation 40.7 |
Secondary
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Time frame: baseline and 12 months
Population: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at baseline | 97.5 Percentage of participants | Standard Deviation 59.1 |
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at 12M | 34.8 Percentage of participants | Standard Deviation 44.3 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at baseline | 103.6 Percentage of participants | Standard Deviation 53.1 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at 12M | 28.3 Percentage of participants | Standard Deviation 40.7 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at baseline | 66.7 Percentage of participants | Standard Deviation 33.7 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at 12M | 14.0 Percentage of participants | Standard Deviation 14.6 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at baseline | 92.4 Percentage of participants | Standard Deviation 51.7 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at 12M | 22.8 Percentage of participants | Standard Deviation 25.4 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at baseline | 93.4 Percentage of participants | Standard Deviation 54.4 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at 12M | 20.3 Percentage of participants | Standard Deviation 28.9 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at 12M | 33.0 Percentage of participants | Standard Deviation 36.5 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at baseline | 97.6 Percentage of participants | Standard Deviation 58.6 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at 12M | 19.8 Percentage of participants | Standard Deviation 22.6 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at baseline | 83.0 Percentage of participants | Standard Deviation 40.4 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at baseline | 75.5 Percentage of participants | Standard Deviation 54.2 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at 12M | 26.4 Percentage of participants | Standard Deviation 30.8 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at baseline | 84.4 Percentage of participants | Standard Deviation 50.8 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | PFDI- UDI mean score at 12M | 21.0 Percentage of participants | Standard Deviation 28.1 |
Secondary
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Time frame: baseline and 24 months
Population: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at baseline | 96.5 Percentage of participants | Standard Deviation 56.7 |
| Phase I (IntePro, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at 24M | 28.1 Percentage of participants | Standard Deviation 35.7 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at baseline | 94.9 Percentage of participants | Standard Deviation 55.8 |
| Phase I (Intexen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at 24M | 13.2 Percentage of participants | Standard Deviation 17.1 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at baseline | 69.9 Percentage of participants | Standard Deviation 34.5 |
| Phase II (France Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at 24M | 19.8 Percentage of participants | Standard Deviation 22.7 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at baseline | 89.6 Percentage of participants | Standard Deviation 51.5 |
| Phase III/IV (Perigee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at 24M | 20.3 Percentage of participants | Standard Deviation 21.8 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at baseline | 95.8 Percentage of participants | Standard Deviation 56.9 |
| Phase III/IV (Apogee IntePro Lite, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at 24M | 29.8 Percentage of participants | Standard Deviation 39.1 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at baseline | 97.6 Percentage of participants | Standard Deviation 57.1 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at 24M | 29.4 Percentage of participants | Standard Deviation 30.9 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at 24M | 15.1 Percentage of participants | Standard Deviation 14.1 |
| Phase V (Elevate Posterior InteXen LP, US Only) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at baseline | 83.0 Percentage of participants | Standard Deviation 40.4 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at baseline | 82.5 Percentage of participants | Standard Deviation 50.6 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | PFDI- UDI mean score at 24M | 20.5 Percentage of participants | Standard Deviation 25 |
Secondary
Rate of Graft Extrusions
Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall
Time frame: Through 24 months
Population: Rate of subjects experiencing graft exposure through the vagina (%)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I (IntePro, US Only) | Rate of Graft Extrusions | 9.2 Percentage of participants |
| Phase I (Intexen LP, US Only) | Rate of Graft Extrusions | 0 Percentage of participants |
| Phase II (France Only) | Rate of Graft Extrusions | 3.7 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Rate of Graft Extrusions | 5.4 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Rate of Graft Extrusions | 7.3 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Rate of Graft Extrusions | 7.9 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Rate of Graft Extrusions | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Rate of Graft Extrusions | 5.7 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Rate of Graft Extrusions | 5.6 Percentage of participants |
Secondary
Rates of de Novo or Worsening Urinary and/or Anal Incontinence
Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence
Time frame: Through 24 months
Population: Rate of subjects experiencing different type of incontinenece (%)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase I (IntePro, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Urge | 0 Percentage of participants |
| Phase I (IntePro, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Mixed | 0 Percentage of participants |
| Phase I (IntePro, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - worsening Stress | 0 Percentage of participants |
| Phase I (IntePro, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Stress | 0 Percentage of participants |
| Phase I (IntePro, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Fecal Incontinence | 0 Percentage of participants |
| Phase I (IntePro, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Urge | 0 Percentage of participants |
| Phase I (IntePro, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Mixed | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - worsening Stress | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Urge | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Fecal Incontinence | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Mixed | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Mixed | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Urge | 0 Percentage of participants |
| Phase I (Intexen LP, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Stress | 3.8 Percentage of participants |
| Phase II (France Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Urge | 1.2 Percentage of participants |
| Phase II (France Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Urge | 0 Percentage of participants |
| Phase II (France Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - worsening Stress | 8.6 Percentage of participants |
| Phase II (France Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Fecal Incontinence | 0 Percentage of participants |
| Phase II (France Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Mixed | 0 Percentage of participants |
| Phase II (France Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Stress | 12.3 Percentage of participants |
| Phase II (France Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Mixed | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Fecal Incontinence | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Stress | 1.8 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Mixed | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Urge | 1.8 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Urge | 1.8 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - worsening Stress | 0 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Mixed | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Urge | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - worsening Stress | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Stress | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Urge | 1.8 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Mixed | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Mixed | 0 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Fecal Incontinence | 0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Stress | 0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Urge | 0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Fecal Incontinence | 0.7 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Urge | 0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - worsening Stress | 0.7 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Mixed | 0 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Mixed | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - worsening Stress | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Mixed | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Fecal Incontinence | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Stress | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Mixed | 0 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Urge | 4.3 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Urge | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Urge | 2.9 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Urge | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Mixed | 2.9 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - worsening Stress | 11.4 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Fecal Incontinence | 0 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Mixed | 2.9 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Stress | 11.4 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Mixed | 0.7 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - worsening Stress | 0 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Fecal Incontinence | 0 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Mixed | 0 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Urge | 0.7 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - de novo Stress | 4.2 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Urinary Incontinence - Worsening Urge | 0.7 Percentage of participants |
Secondary
Surgical Revision Rate
The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
Time frame: Through 24 months
Population: Percentage of total subjects experienced surgical revision (%)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I (IntePro, US Only) | Surgical Revision Rate | 7.1 Percentage of participants |
| Phase I (Intexen LP, US Only) | Surgical Revision Rate | 0 Percentage of participants |
| Phase II (France Only) | Surgical Revision Rate | 11.1 Percentage of participants |
| Phase III/IV (Perigee IntePro Lite, US Only) | Surgical Revision Rate | 5.4 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Surgical Revision Rate | 3.6 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Surgical Revision Rate | 8.6 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Surgical Revision Rate | 4.3 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Surgical Revision Rate | 25.7 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Surgical Revision Rate | 9.2 Percentage of participants |
Secondary
Wong-Baker Faces Pain Scale at 3 Months Post Procedure
Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale at baseline and 3 months post procedure
Time frame: baseline and 3 months
Population: Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at 3 months post-op | 0.5 Percentage of participants | Standard Deviation 1 |
| Phase I (IntePro, US Only) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at baseline | 1.9 Percentage of participants | Standard Deviation 2.5 |
| Phase I (Intexen LP, US Only) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at baseline | 2.0 Percentage of participants | Standard Deviation 2.2 |
| Phase I (Intexen LP, US Only) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at 3 months post-op | 0.2 Percentage of participants | Standard Deviation 0.6 |
| Phase II (France Only) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at 3 months post-op | 0.9 Percentage of participants | Standard Deviation 1.5 |
| Phase II (France Only) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at baseline | 1.5 Percentage of participants | Standard Deviation 1.8 |
| Phase III/IV (Perigee IntePro Lite, US Only) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at baseline | 1.2 Percentage of participants | Standard Deviation 2.2 |
| Phase III/IV (Perigee IntePro Lite, US Only) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at 3 months post-op | 0.2 Percentage of participants | Standard Deviation 0.6 |
| Phase III/IV (Apogee IntePro Lite, US Only) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at baseline | 1.6 Percentage of participants | Standard Deviation 2.2 |
| Phase III/IV (Apogee IntePro Lite, US Only) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at 3 months post-op | 0.2 Percentage of participants | Standard Deviation 0.6 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at baseline | 1.7 Percentage of participants | Standard Deviation 2 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at 3 months post-op | 0.3 Percentage of participants | Standard Deviation 0.9 |
| Phase V (Elevate Posterior InteXen LP, US Only) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at 3 months post-op | 0.4 Percentage of participants | Standard Deviation 0.8 |
| Phase V (Elevate Posterior InteXen LP, US Only) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at baseline | 2.2 Percentage of participants | Standard Deviation 2.8 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at 3 months post-op | 0.4 Percentage of participants | Standard Deviation 1 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at baseline | 1.2 Percentage of participants | Standard Deviation 1.5 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at 3 months post-op | 0.5 Percentage of participants | Standard Deviation 1.2 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Mean level of pain per WBPS at baseline | 1.4 Percentage of participants | Standard Deviation 2 |
Secondary
Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure
Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale (scale of 0-10, with 10 indicating hurts worst) at baseline, and 6 weeks post procedure
Time frame: baseline and 6 weeks
Population: Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase I (IntePro, US Only) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at 6 weeks post-op | 0.7 scores on a scale | Standard Deviation 1.3 |
| Phase I (IntePro, US Only) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at baseline | 1.9 scores on a scale | Standard Deviation 2.5 |
| Phase I (Intexen LP, US Only) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at 6 weeks post-op | 0.2 scores on a scale | Standard Deviation 0.6 |
| Phase I (Intexen LP, US Only) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at baseline | 2.0 scores on a scale | Standard Deviation 2.2 |
| Phase II (France Only) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at 6 weeks post-op | 0.9 scores on a scale | Standard Deviation 1.5 |
| Phase II (France Only) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at baseline | 1.5 scores on a scale | Standard Deviation 1.8 |
| Phase III/IV (Perigee IntePro Lite, US Only) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at baseline | 1.2 scores on a scale | Standard Deviation 2.1 |
| Phase III/IV (Perigee IntePro Lite, US Only) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at 6 weeks post-op | 0.5 scores on a scale | Standard Deviation 1.1 |
| Phase III/IV (Apogee IntePro Lite, US Only) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at baseline | 1.4 scores on a scale | Standard Deviation 2.1 |
| Phase III/IV (Apogee IntePro Lite, US Only) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at 6 weeks post-op | 0.7 scores on a scale | Standard Deviation 1.4 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at baseline | 1.8 scores on a scale | Standard Deviation 2.2 |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at 6 weeks post-op | 0.6 scores on a scale | Standard Deviation 1.3 |
| Phase V (Elevate Posterior InteXen LP, US Only) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at 6 weeks post-op | 0.8 scores on a scale | Standard Deviation 1.4 |
| Phase V (Elevate Posterior InteXen LP, US Only) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at baseline | 2.1 scores on a scale | Standard Deviation 2.9 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at baseline | 1.1 scores on a scale | Standard Deviation 1.5 |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at 6 weeks post-op | 0.5 scores on a scale | Standard Deviation 1 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at baseline | 1.4 scores on a scale | Standard Deviation 2 |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Mean level of pain per WBPS at 6 weeks post-op | 0.7 scores on a scale | Standard Deviation 1.3 |
Other Pre-specified
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure
Analysis includes only subjects with uterine descent \>= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Time frame: 24 months
Population: Analysis includes only subjects with uterine descent \>=stage II at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I (IntePro, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure | 84.4 Percentage of participants |
| Phase I (Intexen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure | 100 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure | 85.4 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure | 88.2 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure | 90.9 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure | 96.2 Percentage of participants |
Other Pre-specified
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure
Analysis includes only subjects with uterine descent \>= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Time frame: 6 months
Population: Analysis includes only subjects with uterine descent \>=stage II at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase I (IntePro, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure | 94.7 Percentage of participants |
| Phase I (Intexen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure | 100 Percentage of participants |
| Phase III/IV (Apogee IntePro Lite, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure | 100 Percentage of participants |
| Phase V (Elevate Posterior IntePro Lite, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure | 92.5 Percentage of participants |
| Phase V (Elevate Posterior InteXen LP, US Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure | 90.9 Percentage of participants |
| Phase VI (Elevate Anterior Gen 1, EU Only) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure | 90.0 Percentage of participants |
| Phase VII (Elevate Anterior Gen 2, US & EU) | Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure | 98.8 Percentage of participants |