Pelvic Organ Prolapse
Conditions
Keywords
prolapse, urinary incontinence, uterosacral vaginal vault ligament suspension, sacrospinous ligament fixation, behavioral therapy, pelvic muscle training
Brief summary
Women will be invited to participate in E-OPTIMAL at their last clinical follow-up visit for OPTIMAL (at 24 months post surgery). E-OPTIMAL is an extension of the ongoing OPTIMAL study and no new study treatment interventions will be given. Rather an enrollment intervention will be investigated with potential E-OPTIMAL participants randomly assigned to watch a standardized video prior to consent or undergo the standard informed consent process. The standardized video will review the rationale for women's health research, the importance of long-term follow-up and a detailed invitation to participate in E-OPTIMAL. The video has undergone review by potential subjects, coordinators and physician researchers to ensure that the relevance and importance of issues potentially impacting on long-term participation in studies such as E-OPTIMAL are covered. Participation in E-OPTIMAL will occur up to three additional years. Women will be strongly encouraged to participate in annual examinations and annual telephone surveys but may participate in only one of these study parts if needed. We propose to test the following null hypotheses: 1. There will be no difference in time to surgical failure between uterosacral vaginal vault ligament suspension (ULS) and sacrospinous ligament fixation (SSLF) up to 5 years after surgery. 2. The addition of a standardized video detailing the importance of long-term follow-up studies for POP to the informed consent process will not improve enrollment or retention in E-OPTIMAL.
Detailed description
The goal of this long-term follow-up study is to extend the follow-up of women in the OPTIMAL study up to 5 years from the time of surgery and to compare the success and complication rates of the two surgical treatment groups over this extended time period. The Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) study is a randomized trial designed to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament suspension (ULS) and to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in women undergoing vaginal surgery for apical or uterine prolapse and stress urinary incontinence (SUI). The OPTIMAL study includes a two-year follow up from the time of surgery, which is too short to evaluate the long-term sequelae of the surgical procedures. A further goal of E-OPTIMAL is to investigate a strategy for improving enrollment and retention in long-term studies of women undergoing surgery for pelvic organ prolapse and SUI, by randomizing subjects to two different recruitment methods. The primary aims of this extension study are to compare SSLF and ULS for the following outcomes up to 5 years after surgery in women with Stage 2-4 prolapse involving the vaginal apex or uterus and stress urinary incontinence: 1. time to surgical failure; 2. the long-term functional and health-related quality of life (QOL), adjusted for PMT treatment group; 3. the annual and cumulative incidence, resolution, and persistence of pelvic floor symptoms (urinary, bowel, and prolapse), adjusted for PMT treatment group. An additional primary aim (aim 4) is to determine whether exposure to a standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process will improve enrollment and/or retention in E-OPTIMAL. We will utilize a conceptual framework that assesses three concepts (motivation, barriers and pragmatic issues) at two levels (study level and personal/individual level). This conceptual framework was developed following a review of the scant available literature on the topic, as well as during discussions with investigators who are experienced in recruiting and retaining participants in pelvic floor disorders studies.
Interventions
BEHAVIORALEnrollment video
Standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process
PROCEDURESSLF
sacrospinous ligament fixation to suspend the vaginal apex
PROCEDUREULS
uterosacral ligament suspension to suspend the vaginal apex
BEHAVIORALPMT
perioperative behavioral therapy / pelvic muscle training with formal individualized PMT program that begins two to four weeks prior to surgery and continues for three months after surgery
OTHERUsual Care
usual care both before and after prolapse surgery with respect to pelvic muscle training
Sponsors
NICHD Pelvic Floor Disorders Network
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\. Completion of the Year 2 OPTIMAL in-person visit
Exclusion criteria
1. Inability to provide informed consent. 2. Subjects who are long-term residents of a skilled nursing facility (that is, residency is not limited to short-term rehabilitation) at the time of enrollment into E-OPTIMAL. Note: Subjects unable to return for annual visits are not excluded as they can participate in the telephone interview. However, every attempt will be made to encourage in-person participation. Criteria for termination of participation: (Due to evidence or likelihood that the subject can no longer consent for herself) 1. Subjects 75 years and older that fail the telephone mini-mental status examination. If the participant gets 5 or more of the 10 items incorrect the interviewer says thank you very much for your time, that completes the interview for today. In other words, the interviewer in no way implies to the participant that they did not pass a test to continue. The interviewer contacts the appropriate site coordinator immediately after the interview to let them know of the outcome. 2. Subjects younger than 75 who appear to have cognitive deficits during the quality of life telephone interview will be administered the mini-mental status examination; those who fail will be excluded from further participation. (Proxy respondents will not be used.) Subjects who appear to have cognitive deficits during the in-person visit or site telephone interview will be withdrawn from the study by the study coordinator. 3. Subjects who become long-term residents of a skilled nursing facility. 4. Withdrawal of consent. Verbal assent will be obtained prior to each telephone interview and each in-person visit. Note: Subjects that are unable to complete telephone interviews (for example, because of hearing loss) may complete the interview portion of the survey in person, either at the site or in the home.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Failure | 6 months and 1, 2, 3, 4, and 5 years | Surgical failure was defined as Pelvic Organ Prolapse Quantification (POP-Q) point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; bothersome vaginal bulge symptoms were reported by the participant; or the participant received retreatment. The apex is point C (cervix), and posteriorly is point D (pouch of Douglas). In women after hysterectomy, point C is the vaginal cuff and point D is omitted. This outcome measure is cumulatively across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.) |
| Recruitment Into E-OPTIMAL | At 24 Months post OPTIMAL Treatment | Eligible OPTIMAL participants were to receive a video (or no video) about the importance of follow-up in clinical trials. The outcome is measured as the number of OPTIMAL participants that consented to participate in E-OPTIMAL. |
| Retention in E-OPTIMAL | 3, 4, and 5 Years Post OPTIMAL Treatment | Retention is defined as those participants who consented to participate in E-OPTIMAL that remained in the E-OPTIMAL study (i.e. completed follow-up visits and were not otherwise dropped from the study). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anatomic Failure | 6 months and 1, 2, 3, 4, and 5 years | Anatomic failure was defined as POPQ system point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; or the participant received retreatment during follow-up. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.) |
| Bothersome Bulge Symptoms | 6 months and 1, 2, 3, 4, and 5 years | Bothersome bulge symptoms were reported by the participant in response to the questions, 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' on the Pelvic Floor Disorders Inventory. An answer of Yes to either question indicates a failure while an answer to No for both questions indicates a non-failure.This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.) |
| Retreatment for Pelvic Organ Prolapse | 6 months and 1, 2, 3, 4, and 5 years | Retreatment is defined as any additional POP surgery or the use of pessary. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-retreatments tracked either until retreatment or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline POPIQ Score | 6 months, and 1, 2, 3, 4, and 5 years | The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
| Change From Baseline UIQ Score | 6 months, and 1, 2, 3, 4, and 5 years | The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
| Change From Baseline CRADI Score | 6 months, and 1, 2, 3, 4, and 5 years | The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
| Change From Baseline POPDI Score | 6 months, and 1, 2, 3, 4, and 5 years | The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of POPDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
| Change From Baseline UDI Score | 6 months, and 1, 2, 3, 4, and 5 years | The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of UDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
| Change From Baseline Hunskaar Score | 6 months, and 1, 2, 3, 4, and 5 years | The Hunskaar Urinary Incontinence assessment measures the severity of a participant's urinary incontinence. Scores range from 1 to 8 with higher score indicating more severe incontinence. Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). |
| Change From Baseline CRAIQ Score | 6 months, and 1, 2, 3, 4, and 5 years | The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms. |
| Change From Baseline SF-36 Mental Health Score | 6 months, and 1, 2, 3, 4, and 5 years | The health assessment questionnaire Short Form 36 Version (SF-36) determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst - 100 best). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). |
| Change From Baseline Brink Score | 6 months, and 2, 3, 4, and 5 years | The Brink scale considers three pelvic floor muscle contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner fingers, and duration of contraction. The score ranges from 3 to 12 with higher scores indicating greater PFM function. Change = (Year \[0.5, 2, 3, 4, 5\] Score - Baseline Score). |
| POP-Q Point Ba | 6 months, and 1, 2, 3, 4, and 5 years | POPQ Point Ba represents the most distal (i.e. most dependent) position of any part of the upper anterior vaginal wall (between the vaginal cuff or anterior vaginal fornix and Point Aa). The range for point Ba is -3 to total vaginal length (TVL). Point Ba coincides with Point Aa (-3 cm) in a woman who has no anterior POP. In a woman with severe POP, Ba coincides with Point C. For Point Ba, better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is -3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum). |
| POP-Q Point Bp | 6 months, and 1, 2, 3, 4, and 5 years | POP-Q Point Bp represents the most distal position of any part of the upper posterior vaginal wall (between the vaginal cuff or posterior vaginal fornix and Point Ap). It ranges from -3 to total vaginal length (TVL). Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse. |
| POP-Q Point C | 6 months, and 1 2, 3, 4, and 5 years | POP-Q Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. It ranges from -TVL to +TVL. Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse. |
| Change From Baseline SF-36 Physical Health Score | 6 months, and 1, 2, 3, 4, and 5 years | The health assessment questionnaire Short Form 36 Version (SF-36) determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst - 100 best). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). |
| Number of Participants With Granulation Tissue | 2, 3, 4, and 5 years | Cumulative number of participants with granulation tissue. Granulation tissue was reported on the adverse event log. |
| Number of Participants With Suture Exposure | 2, 3, 4, and 5 years | Cumulative number of participants with suture exposure. Suture exposure was reported on the adverse event log. |
| Number of Participants With Midurethral Sling Erosion or Exposure | 2, 3, 4, and 5 years | Cumulative number of participants with mesh erosion or exposure. Mesh erosion and exposure was reported on the adverse event log. |
| Number of Participants With Pelvic Organ Prolapse Surgery | 2, 3, 4, and 5 years | Cumulative number of participants with pelvic organ prolapse. Pelvic organ prolapse was reported on the adverse event log. |
| PGI-I | 6 months, and 1, 2, 3, 4, and 5 years | The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse).This outcome measure is shows results from the original OPTIMAL trial as well as results from the E-OPTIMAL trial (for those that consented to the extended follow-up) |
Countries
United States
Participant flow
Recruitment details
The goal of the video/no video intervention was to gauge differences in recruitment for and retention in E-OPTIMAL, thus the video/no video randomization occurred before E-OPTIMAL consent.
Pre-assignment details
Treatment groups are from the original OPTIMAL trial. Participants in the E-OPTIMAL trial were recruited from OPTIMAL participants that completed the Year 2 OPTIMAL visit.
Participants by arm
| Arm | Count |
|---|---|
| SSLF+BPMT Sacrospinous Ligament Fixation plus Perioperative Behavioral Therapy/Pelvic Muscle Training | 72 |
| SSLF+USUAL Sacrospinous Ligament Fixation plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | 66 |
| ULS+BPMT Uterosacral Ligament Suspension plus Perioperative Behavioral Therapy/Pelvic Muscle Training | 69 |
| ULS+USUAL Uterosacral Ligament Suspension plus No Perioperative Behavioral Therapy/Pelvic Muscle Training | 78 |
| Total | 285 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 | 2 | 2 |
| Overall Study | Physician Decision | 1 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 2 | 3 |
Baseline characteristics
| Characteristic | ULS+BPMT | SSLF+USUAL | SSLF+BPMT | Total | ULS+USUAL |
|---|---|---|---|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 10.5 | 58.6 years STANDARD_DEVIATION 10.6 | 55.4 years STANDARD_DEVIATION 10.8 | 57.2 years STANDARD_DEVIATION 10.8 | 56.3 years STANDARD_DEVIATION 11.2 |
| Body Mass Index | 28.8 kg/m^2 STANDARD_DEVIATION 4.9 | 28.2 kg/m^2 STANDARD_DEVIATION 5.3 | 30.2 kg/m^2 STANDARD_DEVIATION 6.5 | 28.9 kg/m^2 STANDARD_DEVIATION 5.5 | 28.3 kg/m^2 STANDARD_DEVIATION 5.2 |
| Connective tissue disease No | 68 Participants | 65 Participants | 70 Participants | 275 Participants | 72 Participants |
| Connective tissue disease Unknown | 0 Participants | 1 Participants | 1 Participants | 5 Participants | 3 Participants |
| Connective tissue disease Yes | 1 Participants | 0 Participants | 1 Participants | 5 Participants | 3 Participants |
| Current Smoker No | 64 Participants | 61 Participants | 64 Participants | 262 Participants | 73 Participants |
| Current Smoker Yes | 5 Participants | 5 Participants | 8 Participants | 23 Participants | 5 Participants |
| Diabetes No | 58 Participants | 59 Participants | 59 Participants | 248 Participants | 72 Participants |
| Diabetes Unknown | 0 Participants | 2 Participants | 4 Participants | 7 Participants | 1 Participants |
| Diabetes Yes | 11 Participants | 5 Participants | 9 Participants | 30 Participants | 5 Participants |
| Estrogen Use: Oral or patch No | 60 Participants | 56 Participants | 63 Participants | 249 Participants | 70 Participants |
| Estrogen Use: Oral or patch Yes | 9 Participants | 10 Participants | 9 Participants | 36 Participants | 8 Participants |
| Estrogen Use: Vaginal cream or tablets No | 49 Participants | 50 Participants | 59 Participants | 218 Participants | 60 Participants |
| Estrogen Use: Vaginal cream or tablets Yes | 20 Participants | 16 Participants | 13 Participants | 67 Participants | 18 Participants |
| Hysterectomy No | 52 Participants | 42 Participants | 58 Participants | 211 Participants | 59 Participants |
| Hysterectomy Yes | 17 Participants | 24 Participants | 14 Participants | 74 Participants | 19 Participants |
| Insurance: Medicare or Medicaid No | 47 Participants | 46 Participants | 55 Participants | 204 Participants | 56 Participants |
| Insurance: Medicare or Medicaid Yes | 22 Participants | 20 Participants | 17 Participants | 81 Participants | 22 Participants |
| Insurance: Other No | 59 Participants | 55 Participants | 57 Participants | 231 Participants | 60 Participants |
| Insurance: Other Yes | 10 Participants | 11 Participants | 15 Participants | 54 Participants | 18 Participants |
| Insurance: Private/HMO No | 68 Participants | 65 Participants | 70 Participants | 279 Participants | 76 Participants |
| Insurance: Private/HMO Yes | 1 Participants | 1 Participants | 2 Participants | 6 Participants | 2 Participants |
| Insurance: Self-pay No | 68 Participants | 65 Participants | 70 Participants | 279 Participants | 76 Participants |
| Insurance: Self-pay Yes | 1 Participants | 1 Participants | 2 Participants | 6 Participants | 2 Participants |
| Menstrual Status Not sure | 3 Participants | 4 Participants | 5 Participants | 15 Participants | 3 Participants |
| Menstrual Status Postmenopausal | 49 Participants | 48 Participants | 42 Participants | 188 Participants | 49 Participants |
| Menstrual Status premenopausal | 17 Participants | 14 Participants | 25 Participants | 82 Participants | 26 Participants |
| Number of Cesarean Deliveries | 0 Deliveries | 0 Deliveries | 0 Deliveries | 0 Deliveries | 0 Deliveries |
| Number of Vaginal Deliveries | 3 Deliveries | 2 Deliveries | 3 Deliveries | 3 Deliveries | 3 Deliveries |
| Pelvic Organ Prolapse-Q stage 2 | 26 Participants | 23 Participants | 27 Participants | 107 Participants | 31 Participants |
| Pelvic Organ Prolapse-Q stage 3 | 41 Participants | 37 Participants | 43 Participants | 166 Participants | 45 Participants |
| Pelvic Organ Prolapse-Q stage 4 | 2 Participants | 6 Participants | 2 Participants | 12 Participants | 2 Participants |
| Prior POP Surgery No | 67 Participants | 58 Participants | 68 Participants | 267 Participants | 74 Participants |
| Prior POP Surgery Yes | 2 Participants | 8 Participants | 4 Participants | 18 Participants | 4 Participants |
| Prior SUI Surgery No | 67 Participants | 62 Participants | 71 Participants | 275 Participants | 75 Participants |
| Prior SUI Surgery Yes | 2 Participants | 4 Participants | 1 Participants | 10 Participants | 3 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants | 3 Participants | 7 Participants | 21 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic/Latina | 13 Participants | 10 Participants | 15 Participants | 56 Participants | 18 Participants |
| Race/Ethnicity, Customized Not Hispanic/Latina | 56 Participants | 56 Participants | 57 Participants | 229 Participants | 60 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 5 Participants | 5 Participants | 22 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 58 Participants | 55 Participants | 59 Participants | 238 Participants | 66 Participants |
| Sex/Gender, Customized Female | 69 Participants | 66 Participants | 72 Participants | 285 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 72 | 0 / 66 | 2 / 69 | 1 / 78 |
| other Total, other adverse events | 29 / 72 | 17 / 66 | 27 / 69 | 34 / 78 |
| serious Total, serious adverse events | 0 / 72 | 0 / 66 | 0 / 69 | 0 / 78 |
Outcome results
Primary
Recruitment Into E-OPTIMAL
Eligible OPTIMAL participants were to receive a video (or no video) about the importance of follow-up in clinical trials. The outcome is measured as the number of OPTIMAL participants that consented to participate in E-OPTIMAL.
Time frame: At 24 Months post OPTIMAL Treatment
Population: The objective of the Outcome Measure was to compare retention rates for the Enrollment video arm and No video arm, and the OPTIMAL treatment received was not relevant to this analysis
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SSLF+BPMT | Recruitment Into E-OPTIMAL | Consented to E-OPTIMAL | 142 Participants |
| SSLF+BPMT | Recruitment Into E-OPTIMAL | Did not Consent to E-OPTIMAL | 11 Participants |
| SSLF+USUAL | Recruitment Into E-OPTIMAL | Consented to E-OPTIMAL | 143 Participants |
| SSLF+USUAL | Recruitment Into E-OPTIMAL | Did not Consent to E-OPTIMAL | 8 Participants |
Primary
Retention in E-OPTIMAL
Retention is defined as those participants who consented to participate in E-OPTIMAL that remained in the E-OPTIMAL study (i.e. completed follow-up visits and were not otherwise dropped from the study).
Time frame: 3, 4, and 5 Years Post OPTIMAL Treatment
Population: The objective of the Outcome Measure was to compare retention rates after consent into E-OPTIMAL for the Enrollment video arm and No video arm, and the OPTIMAL treatment received was not relevant to this analysis
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SSLF+BPMT | Retention in E-OPTIMAL | 4-Year Follow-up | Not Retained | 11 Participants |
| SSLF+BPMT | Retention in E-OPTIMAL | 3-Year Follow-up | Not Retained | 3 Participants |
| SSLF+BPMT | Retention in E-OPTIMAL | 5-Year Follow-up | Retained | 124 Participants |
| SSLF+BPMT | Retention in E-OPTIMAL | 4-Year Follow-up | Retained | 131 Participants |
| SSLF+BPMT | Retention in E-OPTIMAL | 5-Year Follow-up | Not Retained | 18 Participants |
| SSLF+BPMT | Retention in E-OPTIMAL | 3-Year Follow-up | Retained | 139 Participants |
| SSLF+USUAL | Retention in E-OPTIMAL | 5-Year Follow-up | Not Retained | 23 Participants |
| SSLF+USUAL | Retention in E-OPTIMAL | 3-Year Follow-up | Retained | 135 Participants |
| SSLF+USUAL | Retention in E-OPTIMAL | 4-Year Follow-up | Retained | 124 Participants |
| SSLF+USUAL | Retention in E-OPTIMAL | 4-Year Follow-up | Not Retained | 19 Participants |
| SSLF+USUAL | Retention in E-OPTIMAL | 5-Year Follow-up | Retained | 120 Participants |
| SSLF+USUAL | Retention in E-OPTIMAL | 3-Year Follow-up | Not Retained | 8 Participants |
Primary
Surgical Failure
Surgical failure was defined as Pelvic Organ Prolapse Quantification (POP-Q) point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; bothersome vaginal bulge symptoms were reported by the participant; or the participant received retreatment. The apex is point C (cervix), and posteriorly is point D (pouch of Douglas). In women after hysterectomy, point C is the vaginal cuff and point D is omitted. This outcome measure is cumulatively across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
Time frame: 6 months and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SSLF+BPMT | Surgical Failure | 3 years | Failure | 37 Participants |
| SSLF+BPMT | Surgical Failure | 5 years | Failure | 47 Participants |
| SSLF+BPMT | Surgical Failure | 1 years | Non-failure | 58 Participants |
| SSLF+BPMT | Surgical Failure | 0.5 years | Failure | 17 Participants |
| SSLF+BPMT | Surgical Failure | 4 years | Failure | 41 Participants |
| SSLF+BPMT | Surgical Failure | 1 years | Failure | 28 Participants |
| SSLF+BPMT | Surgical Failure | 2 years | Failure | 31 Participants |
| SSLF+BPMT | Surgical Failure | 3 years | Non-failure | 39 Participants |
| SSLF+BPMT | Surgical Failure | 5 years | Non-failure | 22 Participants |
| SSLF+BPMT | Surgical Failure | 4 years | Non-failure | 30 Participants |
| SSLF+BPMT | Surgical Failure | 2 years | Non-failure | 51 Participants |
| SSLF+BPMT | Surgical Failure | 0.5 years | Non-failure | 73 Participants |
| SSLF+USUAL | Surgical Failure | 2 years | Non-failure | 39 Participants |
| SSLF+USUAL | Surgical Failure | 4 years | Failure | 55 Participants |
| SSLF+USUAL | Surgical Failure | 3 years | Failure | 52 Participants |
| SSLF+USUAL | Surgical Failure | 0.5 years | Non-failure | 65 Participants |
| SSLF+USUAL | Surgical Failure | 3 years | Non-failure | 26 Participants |
| SSLF+USUAL | Surgical Failure | 5 years | Failure | 57 Participants |
| SSLF+USUAL | Surgical Failure | 1 years | Failure | 35 Participants |
| SSLF+USUAL | Surgical Failure | 0.5 years | Failure | 22 Participants |
| SSLF+USUAL | Surgical Failure | 1 years | Non-failure | 51 Participants |
| SSLF+USUAL | Surgical Failure | 5 years | Non-failure | 20 Participants |
| SSLF+USUAL | Surgical Failure | 4 years | Non-failure | 22 Participants |
| SSLF+USUAL | Surgical Failure | 2 years | Failure | 45 Participants |
| ULS+BPMT | Surgical Failure | 5 years | Non-failure | 26 Participants |
| ULS+BPMT | Surgical Failure | 0.5 years | Failure | 20 Participants |
| ULS+BPMT | Surgical Failure | 0.5 years | Non-failure | 66 Participants |
| ULS+BPMT | Surgical Failure | 1 years | Failure | 30 Participants |
| ULS+BPMT | Surgical Failure | 1 years | Non-failure | 56 Participants |
| ULS+BPMT | Surgical Failure | 2 years | Failure | 39 Participants |
| ULS+BPMT | Surgical Failure | 2 years | Non-failure | 44 Participants |
| ULS+BPMT | Surgical Failure | 3 years | Failure | 46 Participants |
| ULS+BPMT | Surgical Failure | 3 years | Non-failure | 31 Participants |
| ULS+BPMT | Surgical Failure | 4 years | Failure | 49 Participants |
| ULS+BPMT | Surgical Failure | 4 years | Non-failure | 26 Participants |
| ULS+BPMT | Surgical Failure | 5 years | Failure | 49 Participants |
| ULS+USUAL | Surgical Failure | 4 years | Failure | 43 Participants |
| ULS+USUAL | Surgical Failure | 2 years | Failure | 37 Participants |
| ULS+USUAL | Surgical Failure | 1 years | Non-failure | 62 Participants |
| ULS+USUAL | Surgical Failure | 5 years | Non-failure | 25 Participants |
| ULS+USUAL | Surgical Failure | 4 years | Non-failure | 32 Participants |
| ULS+USUAL | Surgical Failure | 1 years | Failure | 29 Participants |
| ULS+USUAL | Surgical Failure | 0.5 years | Non-failure | 77 Participants |
| ULS+USUAL | Surgical Failure | 3 years | Non-failure | 40 Participants |
| ULS+USUAL | Surgical Failure | 5 years | Failure | 45 Participants |
| ULS+USUAL | Surgical Failure | 3 years | Failure | 41 Participants |
| ULS+USUAL | Surgical Failure | 2 years | Non-failure | 52 Participants |
| ULS+USUAL | Surgical Failure | 0.5 years | Failure | 14 Participants |
Secondary
Anatomic Failure
Anatomic failure was defined as POPQ system point C descended more than one-third of total vaginal length; POPQ points Aa, Ba, Ap, or Bp were beyond the hymen; or the participant received retreatment during follow-up. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
Time frame: 6 months and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SSLF+BPMT | Anatomic Failure | 2 years | Non-failure | 59 Participants |
| SSLF+BPMT | Anatomic Failure | 1 years | Non-failure | 67 Participants |
| SSLF+BPMT | Anatomic Failure | 5 years | Non-failure | 28 Participants |
| SSLF+BPMT | Anatomic Failure | 2 years | Failure | 23 Participants |
| SSLF+BPMT | Anatomic Failure | 5 years | Failure | 38 Participants |
| SSLF+BPMT | Anatomic Failure | 0.5 years | Non-failure | 80 Participants |
| SSLF+BPMT | Anatomic Failure | 4 years | Failure | 33 Participants |
| SSLF+BPMT | Anatomic Failure | 4 years | Non-failure | 36 Participants |
| SSLF+BPMT | Anatomic Failure | 3 years | Non-failure | 46 Participants |
| SSLF+BPMT | Anatomic Failure | 1 years | Failure | 18 Participants |
| SSLF+BPMT | Anatomic Failure | 0.5 years | Failure | 10 Participants |
| SSLF+BPMT | Anatomic Failure | 3 years | Failure | 29 Participants |
| SSLF+USUAL | Anatomic Failure | 0.5 years | Non-failure | 74 Participants |
| SSLF+USUAL | Anatomic Failure | 0.5 years | Failure | 12 Participants |
| SSLF+USUAL | Anatomic Failure | 1 years | Failure | 23 Participants |
| SSLF+USUAL | Anatomic Failure | 1 years | Non-failure | 61 Participants |
| SSLF+USUAL | Anatomic Failure | 2 years | Failure | 31 Participants |
| SSLF+USUAL | Anatomic Failure | 2 years | Non-failure | 50 Participants |
| SSLF+USUAL | Anatomic Failure | 3 years | Failure | 37 Participants |
| SSLF+USUAL | Anatomic Failure | 3 years | Non-failure | 33 Participants |
| SSLF+USUAL | Anatomic Failure | 4 years | Failure | 40 Participants |
| SSLF+USUAL | Anatomic Failure | 4 years | Non-failure | 29 Participants |
| SSLF+USUAL | Anatomic Failure | 5 years | Failure | 42 Participants |
| SSLF+USUAL | Anatomic Failure | 5 years | Non-failure | 26 Participants |
| ULS+BPMT | Anatomic Failure | 2 years | Non-failure | 55 Participants |
| ULS+BPMT | Anatomic Failure | 1 years | Failure | 19 Participants |
| ULS+BPMT | Anatomic Failure | 5 years | Failure | 33 Participants |
| ULS+BPMT | Anatomic Failure | 3 years | Failure | 31 Participants |
| ULS+BPMT | Anatomic Failure | 3 years | Non-failure | 40 Participants |
| ULS+BPMT | Anatomic Failure | 0.5 years | Failure | 13 Participants |
| ULS+BPMT | Anatomic Failure | 4 years | Failure | 32 Participants |
| ULS+BPMT | Anatomic Failure | 0.5 years | Non-failure | 72 Participants |
| ULS+BPMT | Anatomic Failure | 4 years | Non-failure | 36 Participants |
| ULS+BPMT | Anatomic Failure | 1 years | Non-failure | 65 Participants |
| ULS+BPMT | Anatomic Failure | 2 years | Failure | 25 Participants |
| ULS+BPMT | Anatomic Failure | 5 years | Non-failure | 34 Participants |
| ULS+USUAL | Anatomic Failure | 2 years | Non-failure | 58 Participants |
| ULS+USUAL | Anatomic Failure | 5 years | Non-failure | 31 Participants |
| ULS+USUAL | Anatomic Failure | 2 years | Failure | 29 Participants |
| ULS+USUAL | Anatomic Failure | 4 years | Non-failure | 38 Participants |
| ULS+USUAL | Anatomic Failure | 3 years | Failure | 31 Participants |
| ULS+USUAL | Anatomic Failure | 0.5 years | Non-failure | 80 Participants |
| ULS+USUAL | Anatomic Failure | 5 years | Failure | 35 Participants |
| ULS+USUAL | Anatomic Failure | 1 years | Non-failure | 66 Participants |
| ULS+USUAL | Anatomic Failure | 3 years | Non-failure | 47 Participants |
| ULS+USUAL | Anatomic Failure | 1 years | Failure | 25 Participants |
| ULS+USUAL | Anatomic Failure | 0.5 years | Failure | 11 Participants |
| ULS+USUAL | Anatomic Failure | 4 years | Failure | 33 Participants |
Secondary
Bothersome Bulge Symptoms
Bothersome bulge symptoms were reported by the participant in response to the questions, 'Do you usually have a sensation of bulging or protrusion from the vaginal area?' or 'Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?' on the Pelvic Floor Disorders Inventory. An answer of Yes to either question indicates a failure while an answer to No for both questions indicates a non-failure.This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-failures tracked either until failure or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
Time frame: 6 months and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SSLF+BPMT | Bothersome Bulge Symptoms | 4 years | Non-failure | 45 Participants |
| SSLF+BPMT | Bothersome Bulge Symptoms | 5 years | Non-failure | 36 Participants |
| SSLF+BPMT | Bothersome Bulge Symptoms | 3 years | Non-failure | 47 Participants |
| SSLF+BPMT | Bothersome Bulge Symptoms | 0.5 years | Failure | 10 Participants |
| SSLF+BPMT | Bothersome Bulge Symptoms | 4 years | Failure | 27 Participants |
| SSLF+BPMT | Bothersome Bulge Symptoms | 1 years | Failure | 21 Participants |
| SSLF+BPMT | Bothersome Bulge Symptoms | 1 years | Non-failure | 68 Participants |
| SSLF+BPMT | Bothersome Bulge Symptoms | 0.5 years | Non-failure | 80 Participants |
| SSLF+BPMT | Bothersome Bulge Symptoms | 5 years | Failure | 30 Participants |
| SSLF+BPMT | Bothersome Bulge Symptoms | 2 years | Failure | 24 Participants |
| SSLF+BPMT | Bothersome Bulge Symptoms | 2 years | Non-failure | 61 Participants |
| SSLF+BPMT | Bothersome Bulge Symptoms | 3 years | Failure | 27 Participants |
| SSLF+USUAL | Bothersome Bulge Symptoms | 0.5 years | Non-failure | 73 Participants |
| SSLF+USUAL | Bothersome Bulge Symptoms | 3 years | Failure | 29 Participants |
| SSLF+USUAL | Bothersome Bulge Symptoms | 1 years | Non-failure | 64 Participants |
| SSLF+USUAL | Bothersome Bulge Symptoms | 4 years | Failure | 32 Participants |
| SSLF+USUAL | Bothersome Bulge Symptoms | 4 years | Non-failure | 40 Participants |
| SSLF+USUAL | Bothersome Bulge Symptoms | 3 years | Non-failure | 45 Participants |
| SSLF+USUAL | Bothersome Bulge Symptoms | 0.5 years | Failure | 12 Participants |
| SSLF+USUAL | Bothersome Bulge Symptoms | 2 years | Non-failure | 56 Participants |
| SSLF+USUAL | Bothersome Bulge Symptoms | 2 years | Failure | 27 Participants |
| SSLF+USUAL | Bothersome Bulge Symptoms | 1 years | Failure | 19 Participants |
| SSLF+USUAL | Bothersome Bulge Symptoms | 5 years | Non-failure | 34 Participants |
| SSLF+USUAL | Bothersome Bulge Symptoms | 5 years | Failure | 34 Participants |
| ULS+BPMT | Bothersome Bulge Symptoms | 3 years | Non-failure | 43 Participants |
| ULS+BPMT | Bothersome Bulge Symptoms | 0.5 years | Failure | 8 Participants |
| ULS+BPMT | Bothersome Bulge Symptoms | 0.5 years | Non-failure | 76 Participants |
| ULS+BPMT | Bothersome Bulge Symptoms | 1 years | Failure | 15 Participants |
| ULS+BPMT | Bothersome Bulge Symptoms | 1 years | Non-failure | 67 Participants |
| ULS+BPMT | Bothersome Bulge Symptoms | 2 years | Failure | 21 Participants |
| ULS+BPMT | Bothersome Bulge Symptoms | 2 years | Non-failure | 58 Participants |
| ULS+BPMT | Bothersome Bulge Symptoms | 3 years | Failure | 28 Participants |
| ULS+BPMT | Bothersome Bulge Symptoms | 4 years | Failure | 31 Participants |
| ULS+BPMT | Bothersome Bulge Symptoms | 4 years | Non-failure | 39 Participants |
| ULS+BPMT | Bothersome Bulge Symptoms | 5 years | Failure | 33 Participants |
| ULS+BPMT | Bothersome Bulge Symptoms | 5 years | Non-failure | 35 Participants |
| ULS+USUAL | Bothersome Bulge Symptoms | 2 years | Non-failure | 69 Participants |
| ULS+USUAL | Bothersome Bulge Symptoms | 2 years | Failure | 17 Participants |
| ULS+USUAL | Bothersome Bulge Symptoms | 0.5 years | Failure | 5 Participants |
| ULS+USUAL | Bothersome Bulge Symptoms | 4 years | Non-failure | 46 Participants |
| ULS+USUAL | Bothersome Bulge Symptoms | 1 years | Non-failure | 81 Participants |
| ULS+USUAL | Bothersome Bulge Symptoms | 1 years | Failure | 9 Participants |
| ULS+USUAL | Bothersome Bulge Symptoms | 5 years | Non-failure | 42 Participants |
| ULS+USUAL | Bothersome Bulge Symptoms | 5 years | Failure | 23 Participants |
| ULS+USUAL | Bothersome Bulge Symptoms | 3 years | Non-failure | 55 Participants |
| ULS+USUAL | Bothersome Bulge Symptoms | 3 years | Failure | 20 Participants |
| ULS+USUAL | Bothersome Bulge Symptoms | 0.5 years | Non-failure | 88 Participants |
| ULS+USUAL | Bothersome Bulge Symptoms | 4 years | Failure | 22 Participants |
Secondary
Retreatment for Pelvic Organ Prolapse
Retreatment is defined as any additional POP surgery or the use of pessary. This outcome measure is cumulative across the original OPTIMAL trial and continued through the E-OPTIMAL follow-up with non-retreatments tracked either until retreatment or until study completion/dropping out of the study (lost to follow-up, withdrawal, etc.)
Time frame: 6 months and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SSLF+BPMT | Retreatment for Pelvic Organ Prolapse | 3 years | Retreated | 7 Participants |
| SSLF+BPMT | Retreatment for Pelvic Organ Prolapse | 2 years | Not retreated | 76 Participants |
| SSLF+BPMT | Retreatment for Pelvic Organ Prolapse | 1 years | Not retreated | 83 Participants |
| SSLF+BPMT | Retreatment for Pelvic Organ Prolapse | 5 years | Not retreated | 52 Participants |
| SSLF+BPMT | Retreatment for Pelvic Organ Prolapse | 2 years | Retreated | 5 Participants |
| SSLF+BPMT | Retreatment for Pelvic Organ Prolapse | 5 years | Retreated | 8 Participants |
| SSLF+BPMT | Retreatment for Pelvic Organ Prolapse | 0.5 years | Not retreated | 90 Participants |
| SSLF+BPMT | Retreatment for Pelvic Organ Prolapse | 0.5 years | Retreated | 1 Participants |
| SSLF+BPMT | Retreatment for Pelvic Organ Prolapse | 4 years | Retreated | 7 Participants |
| SSLF+BPMT | Retreatment for Pelvic Organ Prolapse | 3 years | Not retreated | 61 Participants |
| SSLF+BPMT | Retreatment for Pelvic Organ Prolapse | 1 years | Retreated | 2 Participants |
| SSLF+BPMT | Retreatment for Pelvic Organ Prolapse | 4 years | Not retreated | 52 Participants |
| SSLF+USUAL | Retreatment for Pelvic Organ Prolapse | 4 years | Retreated | 4 Participants |
| SSLF+USUAL | Retreatment for Pelvic Organ Prolapse | 0.5 years | Retreated | 0 Participants |
| SSLF+USUAL | Retreatment for Pelvic Organ Prolapse | 0.5 years | Not retreated | 86 Participants |
| SSLF+USUAL | Retreatment for Pelvic Organ Prolapse | 1 years | Retreated | 3 Participants |
| SSLF+USUAL | Retreatment for Pelvic Organ Prolapse | 1 years | Not retreated | 82 Participants |
| SSLF+USUAL | Retreatment for Pelvic Organ Prolapse | 2 years | Retreated | 3 Participants |
| SSLF+USUAL | Retreatment for Pelvic Organ Prolapse | 2 years | Not retreated | 77 Participants |
| SSLF+USUAL | Retreatment for Pelvic Organ Prolapse | 3 years | Retreated | 3 Participants |
| SSLF+USUAL | Retreatment for Pelvic Organ Prolapse | 3 years | Not retreated | 59 Participants |
| SSLF+USUAL | Retreatment for Pelvic Organ Prolapse | 4 years | Not retreated | 51 Participants |
| SSLF+USUAL | Retreatment for Pelvic Organ Prolapse | 5 years | Retreated | 4 Participants |
| SSLF+USUAL | Retreatment for Pelvic Organ Prolapse | 5 years | Not retreated | 50 Participants |
| ULS+BPMT | Retreatment for Pelvic Organ Prolapse | 5 years | Retreated | 10 Participants |
| ULS+BPMT | Retreatment for Pelvic Organ Prolapse | 1 years | Retreated | 2 Participants |
| ULS+BPMT | Retreatment for Pelvic Organ Prolapse | 3 years | Retreated | 10 Participants |
| ULS+BPMT | Retreatment for Pelvic Organ Prolapse | 0.5 years | Retreated | 1 Participants |
| ULS+BPMT | Retreatment for Pelvic Organ Prolapse | 3 years | Not retreated | 55 Participants |
| ULS+BPMT | Retreatment for Pelvic Organ Prolapse | 0.5 years | Not retreated | 82 Participants |
| ULS+BPMT | Retreatment for Pelvic Organ Prolapse | 4 years | Retreated | 10 Participants |
| ULS+BPMT | Retreatment for Pelvic Organ Prolapse | 4 years | Not retreated | 52 Participants |
| ULS+BPMT | Retreatment for Pelvic Organ Prolapse | 1 years | Not retreated | 79 Participants |
| ULS+BPMT | Retreatment for Pelvic Organ Prolapse | 5 years | Not retreated | 51 Participants |
| ULS+BPMT | Retreatment for Pelvic Organ Prolapse | 2 years | Retreated | 6 Participants |
| ULS+BPMT | Retreatment for Pelvic Organ Prolapse | 2 years | Not retreated | 73 Participants |
| ULS+USUAL | Retreatment for Pelvic Organ Prolapse | 1 years | Retreated | 2 Participants |
| ULS+USUAL | Retreatment for Pelvic Organ Prolapse | 2 years | Not retreated | 85 Participants |
| ULS+USUAL | Retreatment for Pelvic Organ Prolapse | 5 years | Not retreated | 53 Participants |
| ULS+USUAL | Retreatment for Pelvic Organ Prolapse | 5 years | Retreated | 6 Participants |
| ULS+USUAL | Retreatment for Pelvic Organ Prolapse | 2 years | Retreated | 2 Participants |
| ULS+USUAL | Retreatment for Pelvic Organ Prolapse | 3 years | Retreated | 2 Participants |
| ULS+USUAL | Retreatment for Pelvic Organ Prolapse | 0.5 years | Not retreated | 92 Participants |
| ULS+USUAL | Retreatment for Pelvic Organ Prolapse | 4 years | Not retreated | 52 Participants |
| ULS+USUAL | Retreatment for Pelvic Organ Prolapse | 0.5 years | Retreated | 0 Participants |
| ULS+USUAL | Retreatment for Pelvic Organ Prolapse | 3 years | Not retreated | 68 Participants |
| ULS+USUAL | Retreatment for Pelvic Organ Prolapse | 1 years | Not retreated | 87 Participants |
| ULS+USUAL | Retreatment for Pelvic Organ Prolapse | 4 years | Retreated | 5 Participants |
Other Pre-specified
Change From Baseline Brink Score
The Brink scale considers three pelvic floor muscle contraction variables: vaginal pressure or muscle force, elevation or vertical displacement of the examiner fingers, and duration of contraction. The score ranges from 3 to 12 with higher scores indicating greater PFM function. Change = (Year \[0.5, 2, 3, 4, 5\] Score - Baseline Score).
Time frame: 6 months, and 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SSLF+BPMT | Change From Baseline Brink Score | 5 years | 0.2 units on a scale |
| SSLF+BPMT | Change From Baseline Brink Score | 4 years | 0.1 units on a scale |
| SSLF+BPMT | Change From Baseline Brink Score | 0.5 years | 0.2 units on a scale |
| SSLF+BPMT | Change From Baseline Brink Score | 2 years | -0.1 units on a scale |
| SSLF+BPMT | Change From Baseline Brink Score | 3 years | 0 units on a scale |
| SSLF+USUAL | Change From Baseline Brink Score | 3 years | -0.3 units on a scale |
| SSLF+USUAL | Change From Baseline Brink Score | 0.5 years | 0 units on a scale |
| SSLF+USUAL | Change From Baseline Brink Score | 2 years | 0.1 units on a scale |
| SSLF+USUAL | Change From Baseline Brink Score | 4 years | -0.5 units on a scale |
| SSLF+USUAL | Change From Baseline Brink Score | 5 years | -0.6 units on a scale |
| ULS+BPMT | Change From Baseline Brink Score | 4 years | 0.2 units on a scale |
| ULS+BPMT | Change From Baseline Brink Score | 5 years | 0.4 units on a scale |
| ULS+BPMT | Change From Baseline Brink Score | 2 years | 0.4 units on a scale |
| ULS+BPMT | Change From Baseline Brink Score | 3 years | 0.3 units on a scale |
| ULS+BPMT | Change From Baseline Brink Score | 0.5 years | 0.6 units on a scale |
| ULS+USUAL | Change From Baseline Brink Score | 5 years | -0.3 units on a scale |
| ULS+USUAL | Change From Baseline Brink Score | 0.5 years | 0.4 units on a scale |
| ULS+USUAL | Change From Baseline Brink Score | 3 years | -0.5 units on a scale |
| ULS+USUAL | Change From Baseline Brink Score | 4 years | -0.5 units on a scale |
| ULS+USUAL | Change From Baseline Brink Score | 2 years | 0 units on a scale |
Other Pre-specified
Change From Baseline CRADI Score
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of responses for the CRADI is: 0-400 with 0 (least distress) to 400 (most distress). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SSLF+BPMT | Change From Baseline CRADI Score | 3 years | -45.3 units on a scale |
| SSLF+BPMT | Change From Baseline CRADI Score | 4 years | -35.1 units on a scale |
| SSLF+BPMT | Change From Baseline CRADI Score | 5 years | -37.4 units on a scale |
| SSLF+BPMT | Change From Baseline CRADI Score | 2 years | -46.2 units on a scale |
| SSLF+BPMT | Change From Baseline CRADI Score | 0.5 years | -72.3 units on a scale |
| SSLF+BPMT | Change From Baseline CRADI Score | 1 years | -64.1 units on a scale |
| SSLF+USUAL | Change From Baseline CRADI Score | 1 years | -67.5 units on a scale |
| SSLF+USUAL | Change From Baseline CRADI Score | 3 years | -53.1 units on a scale |
| SSLF+USUAL | Change From Baseline CRADI Score | 5 years | -43.1 units on a scale |
| SSLF+USUAL | Change From Baseline CRADI Score | 4 years | -54.1 units on a scale |
| SSLF+USUAL | Change From Baseline CRADI Score | 0.5 years | -71.8 units on a scale |
| SSLF+USUAL | Change From Baseline CRADI Score | 2 years | -49.1 units on a scale |
| ULS+BPMT | Change From Baseline CRADI Score | 5 years | -39.1 units on a scale |
| ULS+BPMT | Change From Baseline CRADI Score | 0.5 years | -69.6 units on a scale |
| ULS+BPMT | Change From Baseline CRADI Score | 1 years | -77.7 units on a scale |
| ULS+BPMT | Change From Baseline CRADI Score | 2 years | -62 units on a scale |
| ULS+BPMT | Change From Baseline CRADI Score | 3 years | -48.7 units on a scale |
| ULS+BPMT | Change From Baseline CRADI Score | 4 years | -44.8 units on a scale |
| ULS+USUAL | Change From Baseline CRADI Score | 2 years | -50.4 units on a scale |
| ULS+USUAL | Change From Baseline CRADI Score | 0.5 years | -56.3 units on a scale |
| ULS+USUAL | Change From Baseline CRADI Score | 4 years | -48.8 units on a scale |
| ULS+USUAL | Change From Baseline CRADI Score | 1 years | -63.3 units on a scale |
| ULS+USUAL | Change From Baseline CRADI Score | 5 years | -39.8 units on a scale |
| ULS+USUAL | Change From Baseline CRADI Score | 3 years | -44.7 units on a scale |
Other Pre-specified
Change From Baseline CRAIQ Score
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SSLF+BPMT | Change From Baseline CRAIQ Score | 3 years | -54.6 units on a scale |
| SSLF+BPMT | Change From Baseline CRAIQ Score | 2 years | -47.5 units on a scale |
| SSLF+BPMT | Change From Baseline CRAIQ Score | 0.5 years | -71.3 units on a scale |
| SSLF+BPMT | Change From Baseline CRAIQ Score | 5 years | -35.7 units on a scale |
| SSLF+BPMT | Change From Baseline CRAIQ Score | 4 years | -40 units on a scale |
| SSLF+BPMT | Change From Baseline CRAIQ Score | 1 years | -73.3 units on a scale |
| SSLF+USUAL | Change From Baseline CRAIQ Score | 1 years | -43.4 units on a scale |
| SSLF+USUAL | Change From Baseline CRAIQ Score | 0.5 years | -45.5 units on a scale |
| SSLF+USUAL | Change From Baseline CRAIQ Score | 2 years | -25.1 units on a scale |
| SSLF+USUAL | Change From Baseline CRAIQ Score | 3 years | -20.9 units on a scale |
| SSLF+USUAL | Change From Baseline CRAIQ Score | 4 years | -16.6 units on a scale |
| SSLF+USUAL | Change From Baseline CRAIQ Score | 5 years | -14.8 units on a scale |
| ULS+BPMT | Change From Baseline CRAIQ Score | 1 years | -37.6 units on a scale |
| ULS+BPMT | Change From Baseline CRAIQ Score | 3 years | -12.9 units on a scale |
| ULS+BPMT | Change From Baseline CRAIQ Score | 5 years | 7.4 units on a scale |
| ULS+BPMT | Change From Baseline CRAIQ Score | 4 years | -8.5 units on a scale |
| ULS+BPMT | Change From Baseline CRAIQ Score | 0.5 years | -35 units on a scale |
| ULS+BPMT | Change From Baseline CRAIQ Score | 2 years | -19.2 units on a scale |
| ULS+USUAL | Change From Baseline CRAIQ Score | 2 years | -38.9 units on a scale |
| ULS+USUAL | Change From Baseline CRAIQ Score | 5 years | -22.7 units on a scale |
| ULS+USUAL | Change From Baseline CRAIQ Score | 4 years | -39.1 units on a scale |
| ULS+USUAL | Change From Baseline CRAIQ Score | 3 years | -36.1 units on a scale |
| ULS+USUAL | Change From Baseline CRAIQ Score | 0.5 years | -66.8 units on a scale |
| ULS+USUAL | Change From Baseline CRAIQ Score | 1 years | -60.5 units on a scale |
Other Pre-specified
Change From Baseline Hunskaar Score
The Hunskaar Urinary Incontinence assessment measures the severity of a participant's urinary incontinence. Scores range from 1 to 8 with higher score indicating more severe incontinence. Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score).
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SSLF+BPMT | Change From Baseline Hunskaar Score | 1 years | -3.6 units on a scale |
| SSLF+BPMT | Change From Baseline Hunskaar Score | 4 years | -2.5 units on a scale |
| SSLF+BPMT | Change From Baseline Hunskaar Score | 0.5 years | -3.6 units on a scale |
| SSLF+BPMT | Change From Baseline Hunskaar Score | 3 years | -2.5 units on a scale |
| SSLF+BPMT | Change From Baseline Hunskaar Score | 2 years | -3 units on a scale |
| SSLF+BPMT | Change From Baseline Hunskaar Score | 5 years | -1.6 units on a scale |
| SSLF+USUAL | Change From Baseline Hunskaar Score | 2 years | -3.2 units on a scale |
| SSLF+USUAL | Change From Baseline Hunskaar Score | 3 years | -2.6 units on a scale |
| SSLF+USUAL | Change From Baseline Hunskaar Score | 5 years | -2.6 units on a scale |
| SSLF+USUAL | Change From Baseline Hunskaar Score | 1 years | -3.3 units on a scale |
| SSLF+USUAL | Change From Baseline Hunskaar Score | 4 years | -2.5 units on a scale |
| SSLF+USUAL | Change From Baseline Hunskaar Score | 0.5 years | -2.9 units on a scale |
| ULS+BPMT | Change From Baseline Hunskaar Score | 3 years | -2.5 units on a scale |
| ULS+BPMT | Change From Baseline Hunskaar Score | 0.5 years | -3.2 units on a scale |
| ULS+BPMT | Change From Baseline Hunskaar Score | 1 years | -3.4 units on a scale |
| ULS+BPMT | Change From Baseline Hunskaar Score | 2 years | -2.8 units on a scale |
| ULS+BPMT | Change From Baseline Hunskaar Score | 4 years | -2.4 units on a scale |
| ULS+BPMT | Change From Baseline Hunskaar Score | 5 years | -2 units on a scale |
| ULS+USUAL | Change From Baseline Hunskaar Score | 5 years | -2.4 units on a scale |
| ULS+USUAL | Change From Baseline Hunskaar Score | 4 years | -2.6 units on a scale |
| ULS+USUAL | Change From Baseline Hunskaar Score | 0.5 years | -3.5 units on a scale |
| ULS+USUAL | Change From Baseline Hunskaar Score | 3 years | -2.8 units on a scale |
| ULS+USUAL | Change From Baseline Hunskaar Score | 2 years | -2.7 units on a scale |
| ULS+USUAL | Change From Baseline Hunskaar Score | 1 years | -3.2 units on a scale |
Other Pre-specified
Change From Baseline POPDI Score
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of POPDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SSLF+BPMT | Change From Baseline POPDI Score | 4 years | -70.7 units on a scale |
| SSLF+BPMT | Change From Baseline POPDI Score | 1 years | -90.6 units on a scale |
| SSLF+BPMT | Change From Baseline POPDI Score | 5 years | -64.8 units on a scale |
| SSLF+BPMT | Change From Baseline POPDI Score | 2 years | -76 units on a scale |
| SSLF+BPMT | Change From Baseline POPDI Score | 3 years | -69.5 units on a scale |
| SSLF+BPMT | Change From Baseline POPDI Score | 0.5 years | -95.1 units on a scale |
| SSLF+USUAL | Change From Baseline POPDI Score | 1 years | -96 units on a scale |
| SSLF+USUAL | Change From Baseline POPDI Score | 0.5 years | -90.2 units on a scale |
| SSLF+USUAL | Change From Baseline POPDI Score | 2 years | -79.1 units on a scale |
| SSLF+USUAL | Change From Baseline POPDI Score | 3 years | -77.7 units on a scale |
| SSLF+USUAL | Change From Baseline POPDI Score | 5 years | -75.8 units on a scale |
| SSLF+USUAL | Change From Baseline POPDI Score | 4 years | -78.3 units on a scale |
| ULS+BPMT | Change From Baseline POPDI Score | 0.5 years | -92.3 units on a scale |
| ULS+BPMT | Change From Baseline POPDI Score | 1 years | -91.9 units on a scale |
| ULS+BPMT | Change From Baseline POPDI Score | 4 years | -65.1 units on a scale |
| ULS+BPMT | Change From Baseline POPDI Score | 3 years | -66.9 units on a scale |
| ULS+BPMT | Change From Baseline POPDI Score | 5 years | -63.7 units on a scale |
| ULS+BPMT | Change From Baseline POPDI Score | 2 years | -76.9 units on a scale |
| ULS+USUAL | Change From Baseline POPDI Score | 5 years | -61.1 units on a scale |
| ULS+USUAL | Change From Baseline POPDI Score | 0.5 years | -72.6 units on a scale |
| ULS+USUAL | Change From Baseline POPDI Score | 1 years | -81.1 units on a scale |
| ULS+USUAL | Change From Baseline POPDI Score | 2 years | -65.9 units on a scale |
| ULS+USUAL | Change From Baseline POPDI Score | 3 years | -61.7 units on a scale |
| ULS+USUAL | Change From Baseline POPDI Score | 4 years | -62.8 units on a scale |
Other Pre-specified
Change From Baseline POPIQ Score
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SSLF+BPMT | Change From Baseline POPIQ Score | 2 years | -68.9 units on a scale |
| SSLF+BPMT | Change From Baseline POPIQ Score | 0.5 years | -95 units on a scale |
| SSLF+BPMT | Change From Baseline POPIQ Score | 4 years | -84.5 units on a scale |
| SSLF+BPMT | Change From Baseline POPIQ Score | 1 years | -100.2 units on a scale |
| SSLF+BPMT | Change From Baseline POPIQ Score | 3 years | -82.6 units on a scale |
| SSLF+BPMT | Change From Baseline POPIQ Score | 5 years | -72.1 units on a scale |
| SSLF+USUAL | Change From Baseline POPIQ Score | 0.5 years | -61.3 units on a scale |
| SSLF+USUAL | Change From Baseline POPIQ Score | 2 years | -56.6 units on a scale |
| SSLF+USUAL | Change From Baseline POPIQ Score | 3 years | -48.7 units on a scale |
| SSLF+USUAL | Change From Baseline POPIQ Score | 4 years | -42.3 units on a scale |
| SSLF+USUAL | Change From Baseline POPIQ Score | 1 years | -68.8 units on a scale |
| SSLF+USUAL | Change From Baseline POPIQ Score | 5 years | -50.3 units on a scale |
| ULS+BPMT | Change From Baseline POPIQ Score | 0.5 years | -55.2 units on a scale |
| ULS+BPMT | Change From Baseline POPIQ Score | 5 years | -16.8 units on a scale |
| ULS+BPMT | Change From Baseline POPIQ Score | 2 years | -42.8 units on a scale |
| ULS+BPMT | Change From Baseline POPIQ Score | 1 years | -58.9 units on a scale |
| ULS+BPMT | Change From Baseline POPIQ Score | 4 years | -32.9 units on a scale |
| ULS+BPMT | Change From Baseline POPIQ Score | 3 years | -29.3 units on a scale |
| ULS+USUAL | Change From Baseline POPIQ Score | 3 years | -76.9 units on a scale |
| ULS+USUAL | Change From Baseline POPIQ Score | 0.5 years | -98.6 units on a scale |
| ULS+USUAL | Change From Baseline POPIQ Score | 2 years | -79.3 units on a scale |
| ULS+USUAL | Change From Baseline POPIQ Score | 1 years | -95.9 units on a scale |
| ULS+USUAL | Change From Baseline POPIQ Score | 4 years | -73 units on a scale |
| ULS+USUAL | Change From Baseline POPIQ Score | 5 years | -71.9 units on a scale |
Other Pre-specified
Change From Baseline SF-36 Mental Health Score
The health assessment questionnaire Short Form 36 Version (SF-36) determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst - 100 best). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score).
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SSLF+BPMT | Change From Baseline SF-36 Mental Health Score | 5 years | 3.1 units on a scale |
| SSLF+BPMT | Change From Baseline SF-36 Mental Health Score | 3 years | 3 units on a scale |
| SSLF+BPMT | Change From Baseline SF-36 Mental Health Score | 0.5 years | 2.5 units on a scale |
| SSLF+BPMT | Change From Baseline SF-36 Mental Health Score | 2 years | 0.8 units on a scale |
| SSLF+BPMT | Change From Baseline SF-36 Mental Health Score | 4 years | 1.4 units on a scale |
| SSLF+BPMT | Change From Baseline SF-36 Mental Health Score | 1 years | 4.1 units on a scale |
| SSLF+USUAL | Change From Baseline SF-36 Mental Health Score | 4 years | 1.7 units on a scale |
| SSLF+USUAL | Change From Baseline SF-36 Mental Health Score | 5 years | 1.8 units on a scale |
| SSLF+USUAL | Change From Baseline SF-36 Mental Health Score | 1 years | 3.4 units on a scale |
| SSLF+USUAL | Change From Baseline SF-36 Mental Health Score | 0.5 years | 3.1 units on a scale |
| SSLF+USUAL | Change From Baseline SF-36 Mental Health Score | 2 years | 2 units on a scale |
| SSLF+USUAL | Change From Baseline SF-36 Mental Health Score | 3 years | 2.4 units on a scale |
| ULS+BPMT | Change From Baseline SF-36 Mental Health Score | 1 years | 0.6 units on a scale |
| ULS+BPMT | Change From Baseline SF-36 Mental Health Score | 4 years | 0.5 units on a scale |
| ULS+BPMT | Change From Baseline SF-36 Mental Health Score | 3 years | 1.6 units on a scale |
| ULS+BPMT | Change From Baseline SF-36 Mental Health Score | 0.5 years | 2.6 units on a scale |
| ULS+BPMT | Change From Baseline SF-36 Mental Health Score | 5 years | 0.8 units on a scale |
| ULS+BPMT | Change From Baseline SF-36 Mental Health Score | 2 years | 3.1 units on a scale |
| ULS+USUAL | Change From Baseline SF-36 Mental Health Score | 5 years | 1.2 units on a scale |
| ULS+USUAL | Change From Baseline SF-36 Mental Health Score | 0.5 years | 1.3 units on a scale |
| ULS+USUAL | Change From Baseline SF-36 Mental Health Score | 1 years | 2.7 units on a scale |
| ULS+USUAL | Change From Baseline SF-36 Mental Health Score | 3 years | 2.3 units on a scale |
| ULS+USUAL | Change From Baseline SF-36 Mental Health Score | 4 years | 1.2 units on a scale |
| ULS+USUAL | Change From Baseline SF-36 Mental Health Score | 2 years | 1.6 units on a scale |
Other Pre-specified
Change From Baseline SF-36 Physical Health Score
The health assessment questionnaire Short Form 36 Version (SF-36) determines participants' overall quality of life by assessing 1. limitations in physical functioning due to health problems; 2. limitations in usual role because of physical health problems; 3. bodily pain; 4. general health perceptions; 5. vitality; 6. limitations in social functioning because of physical or emotional problems; 7. limitations in usual role due to emotional problems; and 8. general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 worst - 100 best). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score).
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SSLF+BPMT | Change From Baseline SF-36 Physical Health Score | 1 years | 8 units on a scale |
| SSLF+BPMT | Change From Baseline SF-36 Physical Health Score | 4 years | 4.8 units on a scale |
| SSLF+BPMT | Change From Baseline SF-36 Physical Health Score | 0.5 years | 7.1 units on a scale |
| SSLF+BPMT | Change From Baseline SF-36 Physical Health Score | 2 years | 7.6 units on a scale |
| SSLF+BPMT | Change From Baseline SF-36 Physical Health Score | 3 years | 4.3 units on a scale |
| SSLF+BPMT | Change From Baseline SF-36 Physical Health Score | 5 years | 3.2 units on a scale |
| SSLF+USUAL | Change From Baseline SF-36 Physical Health Score | 4 years | 0.3 units on a scale |
| SSLF+USUAL | Change From Baseline SF-36 Physical Health Score | 5 years | 0.9 units on a scale |
| SSLF+USUAL | Change From Baseline SF-36 Physical Health Score | 0.5 years | 4.3 units on a scale |
| SSLF+USUAL | Change From Baseline SF-36 Physical Health Score | 1 years | 5.6 units on a scale |
| SSLF+USUAL | Change From Baseline SF-36 Physical Health Score | 2 years | 5.2 units on a scale |
| SSLF+USUAL | Change From Baseline SF-36 Physical Health Score | 3 years | 1.1 units on a scale |
| ULS+BPMT | Change From Baseline SF-36 Physical Health Score | 1 years | 6.6 units on a scale |
| ULS+BPMT | Change From Baseline SF-36 Physical Health Score | 5 years | 2.5 units on a scale |
| ULS+BPMT | Change From Baseline SF-36 Physical Health Score | 4 years | 2.9 units on a scale |
| ULS+BPMT | Change From Baseline SF-36 Physical Health Score | 0.5 years | 5.6 units on a scale |
| ULS+BPMT | Change From Baseline SF-36 Physical Health Score | 3 years | 3.5 units on a scale |
| ULS+BPMT | Change From Baseline SF-36 Physical Health Score | 2 years | 4.9 units on a scale |
| ULS+USUAL | Change From Baseline SF-36 Physical Health Score | 5 years | 2.7 units on a scale |
| ULS+USUAL | Change From Baseline SF-36 Physical Health Score | 1 years | 6.8 units on a scale |
| ULS+USUAL | Change From Baseline SF-36 Physical Health Score | 0.5 years | 7.7 units on a scale |
| ULS+USUAL | Change From Baseline SF-36 Physical Health Score | 2 years | 6.1 units on a scale |
| ULS+USUAL | Change From Baseline SF-36 Physical Health Score | 3 years | 3.1 units on a scale |
| ULS+USUAL | Change From Baseline SF-36 Physical Health Score | 4 years | 2.9 units on a scale |
Other Pre-specified
Change From Baseline UDI Score
The Pelvic Floor Distress Inventory is a validated, self-reported instrument used to evaluate pelvic floor symptoms. It consists of 3 scales: 1. Pelvic Organ Prolapse Distress Inventory (with 3 subscales), 2. Colorectal Anal Distress Inventory (with 4 subscales), and 3. Urinary Distress Inventory (with 3 subscales). Scores are calculated by multiplying the mean value of all questions answered by 25 for the subscales and then adding the subscales. The range of UDI responses is: 0-300 with 0 (least distress) to 300 (most distress). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SSLF+BPMT | Change From Baseline UDI Score | 0.5 years | -105.7 units on a scale |
| SSLF+BPMT | Change From Baseline UDI Score | 3 years | -84.9 units on a scale |
| SSLF+BPMT | Change From Baseline UDI Score | 4 years | -81.7 units on a scale |
| SSLF+BPMT | Change From Baseline UDI Score | 5 years | -73.9 units on a scale |
| SSLF+BPMT | Change From Baseline UDI Score | 1 years | -102.9 units on a scale |
| SSLF+BPMT | Change From Baseline UDI Score | 2 years | -90.8 units on a scale |
| SSLF+USUAL | Change From Baseline UDI Score | 2 years | -89.1 units on a scale |
| SSLF+USUAL | Change From Baseline UDI Score | 1 years | -95.9 units on a scale |
| SSLF+USUAL | Change From Baseline UDI Score | 3 years | -75 units on a scale |
| SSLF+USUAL | Change From Baseline UDI Score | 0.5 years | -96 units on a scale |
| SSLF+USUAL | Change From Baseline UDI Score | 5 years | -77.9 units on a scale |
| SSLF+USUAL | Change From Baseline UDI Score | 4 years | -76.2 units on a scale |
| ULS+BPMT | Change From Baseline UDI Score | 5 years | -69 units on a scale |
| ULS+BPMT | Change From Baseline UDI Score | 0.5 years | -95 units on a scale |
| ULS+BPMT | Change From Baseline UDI Score | 1 years | -94 units on a scale |
| ULS+BPMT | Change From Baseline UDI Score | 2 years | -81.2 units on a scale |
| ULS+BPMT | Change From Baseline UDI Score | 3 years | -70.5 units on a scale |
| ULS+BPMT | Change From Baseline UDI Score | 4 years | -70.8 units on a scale |
| ULS+USUAL | Change From Baseline UDI Score | 2 years | -81.3 units on a scale |
| ULS+USUAL | Change From Baseline UDI Score | 5 years | -74.4 units on a scale |
| ULS+USUAL | Change From Baseline UDI Score | 4 years | -75.3 units on a scale |
| ULS+USUAL | Change From Baseline UDI Score | 0.5 years | -88.9 units on a scale |
| ULS+USUAL | Change From Baseline UDI Score | 1 years | -96.8 units on a scale |
| ULS+USUAL | Change From Baseline UDI Score | 3 years | -72 units on a scale |
Other Pre-specified
Change From Baseline UIQ Score
The Pelvic Floor Impact Questionnaire measuring the impact of bladder, bowel, and vaginal symptoms on a woman's daily activities, relationships and emotions is composed of 3 scales: the Urinary Impact Questionnaire (UIQ; 4 subscales, range 0-400), the Pelvic Organ Prolapse Impact Questionnaire (POPIQ; 4 subscales, range 0-400), and the Colorectal-Anal Impact Questionnaire (CRAIQ; 4 subscales, range 0-400). Scores are calculated by multiplying the mean value of all answered questions for a subscale by 100 divided by 3. The subscales are then added together. The range of responses is: 0-400 with 0 (least negative impact) to 400 (most negative impact). Change = (Year \[0.5, 1, 2, 3, 4, 5\] Score - Baseline Score). Lower scores indicate better function / fewer symptoms.
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SSLF+BPMT | Change From Baseline UIQ Score | 2 years | -90.3 units on a scale |
| SSLF+BPMT | Change From Baseline UIQ Score | 0.5 years | -107.7 units on a scale |
| SSLF+BPMT | Change From Baseline UIQ Score | 1 years | -116.3 units on a scale |
| SSLF+BPMT | Change From Baseline UIQ Score | 3 years | -94.3 units on a scale |
| SSLF+BPMT | Change From Baseline UIQ Score | 4 years | -89.5 units on a scale |
| SSLF+BPMT | Change From Baseline UIQ Score | 5 years | -75.9 units on a scale |
| SSLF+USUAL | Change From Baseline UIQ Score | 2 years | -80.4 units on a scale |
| SSLF+USUAL | Change From Baseline UIQ Score | 5 years | -72.1 units on a scale |
| SSLF+USUAL | Change From Baseline UIQ Score | 3 years | -69.1 units on a scale |
| SSLF+USUAL | Change From Baseline UIQ Score | 1 years | -92 units on a scale |
| SSLF+USUAL | Change From Baseline UIQ Score | 0.5 years | -85.4 units on a scale |
| SSLF+USUAL | Change From Baseline UIQ Score | 4 years | -68.3 units on a scale |
| ULS+BPMT | Change From Baseline UIQ Score | 3 years | -59 units on a scale |
| ULS+BPMT | Change From Baseline UIQ Score | 1 years | -84.3 units on a scale |
| ULS+BPMT | Change From Baseline UIQ Score | 2 years | -67.7 units on a scale |
| ULS+BPMT | Change From Baseline UIQ Score | 5 years | -47.8 units on a scale |
| ULS+BPMT | Change From Baseline UIQ Score | 4 years | -59.2 units on a scale |
| ULS+BPMT | Change From Baseline UIQ Score | 0.5 years | -77.3 units on a scale |
| ULS+USUAL | Change From Baseline UIQ Score | 2 years | -99.1 units on a scale |
| ULS+USUAL | Change From Baseline UIQ Score | 0.5 years | -116.4 units on a scale |
| ULS+USUAL | Change From Baseline UIQ Score | 1 years | -121.8 units on a scale |
| ULS+USUAL | Change From Baseline UIQ Score | 4 years | -90.3 units on a scale |
| ULS+USUAL | Change From Baseline UIQ Score | 3 years | -92.3 units on a scale |
| ULS+USUAL | Change From Baseline UIQ Score | 5 years | -84.8 units on a scale |
Other Pre-specified
Number of Participants With Granulation Tissue
Cumulative number of participants with granulation tissue. Granulation tissue was reported on the adverse event log.
Time frame: 2, 3, 4, and 5 years
Population: An analysis which included all participants that completed the primary OPTIMAL trial though 2 years and who were consented to extended follow-up through 5 years.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SSLF+BPMT | Number of Participants With Granulation Tissue | 2 years | Yes | 14 Participants |
| SSLF+BPMT | Number of Participants With Granulation Tissue | 5 years | No | 43 Participants |
| SSLF+BPMT | Number of Participants With Granulation Tissue | 3 years | No | 54 Participants |
| SSLF+BPMT | Number of Participants With Granulation Tissue | 3 years | Yes | 14 Participants |
| SSLF+BPMT | Number of Participants With Granulation Tissue | 2 years | No | 58 Participants |
| SSLF+BPMT | Number of Participants With Granulation Tissue | 5 years | Yes | 15 Participants |
| SSLF+BPMT | Number of Participants With Granulation Tissue | 4 years | Yes | 14 Participants |
| SSLF+BPMT | Number of Participants With Granulation Tissue | 4 years | No | 49 Participants |
| SSLF+USUAL | Number of Participants With Granulation Tissue | 3 years | No | 54 Participants |
| SSLF+USUAL | Number of Participants With Granulation Tissue | 2 years | No | 60 Participants |
| SSLF+USUAL | Number of Participants With Granulation Tissue | 2 years | Yes | 6 Participants |
| SSLF+USUAL | Number of Participants With Granulation Tissue | 3 years | Yes | 6 Participants |
| SSLF+USUAL | Number of Participants With Granulation Tissue | 4 years | No | 49 Participants |
| SSLF+USUAL | Number of Participants With Granulation Tissue | 4 years | Yes | 6 Participants |
| SSLF+USUAL | Number of Participants With Granulation Tissue | 5 years | No | 48 Participants |
| SSLF+USUAL | Number of Participants With Granulation Tissue | 5 years | Yes | 6 Participants |
| ULS+BPMT | Number of Participants With Granulation Tissue | 2 years | No | 52 Participants |
| ULS+BPMT | Number of Participants With Granulation Tissue | 5 years | Yes | 19 Participants |
| ULS+BPMT | Number of Participants With Granulation Tissue | 5 years | No | 41 Participants |
| ULS+BPMT | Number of Participants With Granulation Tissue | 4 years | No | 43 Participants |
| ULS+BPMT | Number of Participants With Granulation Tissue | 2 years | Yes | 17 Participants |
| ULS+BPMT | Number of Participants With Granulation Tissue | 4 years | Yes | 18 Participants |
| ULS+BPMT | Number of Participants With Granulation Tissue | 3 years | Yes | 17 Participants |
| ULS+BPMT | Number of Participants With Granulation Tissue | 3 years | No | 48 Participants |
| ULS+USUAL | Number of Participants With Granulation Tissue | 3 years | Yes | 15 Participants |
| ULS+USUAL | Number of Participants With Granulation Tissue | 4 years | No | 50 Participants |
| ULS+USUAL | Number of Participants With Granulation Tissue | 5 years | Yes | 16 Participants |
| ULS+USUAL | Number of Participants With Granulation Tissue | 4 years | Yes | 16 Participants |
| ULS+USUAL | Number of Participants With Granulation Tissue | 3 years | No | 56 Participants |
| ULS+USUAL | Number of Participants With Granulation Tissue | 2 years | Yes | 15 Participants |
| ULS+USUAL | Number of Participants With Granulation Tissue | 5 years | No | 45 Participants |
| ULS+USUAL | Number of Participants With Granulation Tissue | 2 years | No | 63 Participants |
Other Pre-specified
Number of Participants With Midurethral Sling Erosion or Exposure
Cumulative number of participants with mesh erosion or exposure. Mesh erosion and exposure was reported on the adverse event log.
Time frame: 2, 3, 4, and 5 years
Population: An analysis which included all participants that completed the primary OPTIMAL trial though 2 years and who were consented to extended follow-up through 5 years.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SSLF+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 2 years | Yes | 1 Participants |
| SSLF+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 4 years | No | 60 Participants |
| SSLF+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 2 years | No | 70 Participants |
| SSLF+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 3 years | Yes | 2 Participants |
| SSLF+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 3 years | No | 65 Participants |
| SSLF+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 4 years | Yes | 3 Participants |
| SSLF+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 5 years | No | 53 Participants |
| SSLF+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 5 years | Yes | 3 Participants |
| SSLF+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 5 years | No | 51 Participants |
| SSLF+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 5 years | Yes | 1 Participants |
| SSLF+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 4 years | Yes | 1 Participants |
| SSLF+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 2 years | No | 66 Participants |
| SSLF+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 3 years | Yes | 1 Participants |
| SSLF+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 4 years | No | 53 Participants |
| SSLF+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 2 years | Yes | 0 Participants |
| SSLF+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 3 years | No | 59 Participants |
| ULS+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 3 years | Yes | 1 Participants |
| ULS+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 4 years | No | 58 Participants |
| ULS+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 4 years | Yes | 1 Participants |
| ULS+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 5 years | No | 54 Participants |
| ULS+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 5 years | Yes | 2 Participants |
| ULS+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 2 years | No | 68 Participants |
| ULS+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 2 years | Yes | 1 Participants |
| ULS+BPMT | Number of Participants With Midurethral Sling Erosion or Exposure | 3 years | No | 63 Participants |
| ULS+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 5 years | No | 57 Participants |
| ULS+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 4 years | Yes | 0 Participants |
| ULS+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 3 years | No | 70 Participants |
| ULS+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 2 years | Yes | 0 Participants |
| ULS+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 4 years | No | 63 Participants |
| ULS+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 5 years | Yes | 0 Participants |
| ULS+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 3 years | Yes | 0 Participants |
| ULS+USUAL | Number of Participants With Midurethral Sling Erosion or Exposure | 2 years | No | 78 Participants |
Other Pre-specified
Number of Participants With Pelvic Organ Prolapse Surgery
Cumulative number of participants with pelvic organ prolapse. Pelvic organ prolapse was reported on the adverse event log.
Time frame: 2, 3, 4, and 5 years
Population: An analysis which included all participants that completed the primary OPTIMAL trial though 2 years and who were consented to extended follow-up through 5 years.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SSLF+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 2 years | No | 72 Participants |
| SSLF+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 2 years | Yes | 0 Participants |
| SSLF+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 3 years | No | 64 Participants |
| SSLF+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 3 years | Yes | 1 Participants |
| SSLF+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 4 years | No | 55 Participants |
| SSLF+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 4 years | Yes | 1 Participants |
| SSLF+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 5 years | No | 55 Participants |
| SSLF+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 5 years | Yes | 2 Participants |
| SSLF+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 4 years | Yes | 3 Participants |
| SSLF+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 4 years | No | 51 Participants |
| SSLF+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 2 years | Yes | 2 Participants |
| SSLF+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 5 years | Yes | 3 Participants |
| SSLF+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 5 years | No | 50 Participants |
| SSLF+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 3 years | Yes | 2 Participants |
| SSLF+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 3 years | No | 59 Participants |
| SSLF+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 2 years | No | 64 Participants |
| ULS+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 5 years | No | 54 Participants |
| ULS+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 3 years | No | 58 Participants |
| ULS+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 3 years | Yes | 5 Participants |
| ULS+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 4 years | No | 55 Participants |
| ULS+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 4 years | Yes | 5 Participants |
| ULS+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 5 years | Yes | 5 Participants |
| ULS+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 2 years | No | 67 Participants |
| ULS+BPMT | Number of Participants With Pelvic Organ Prolapse Surgery | 2 years | Yes | 2 Participants |
| ULS+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 3 years | No | 68 Participants |
| ULS+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 3 years | Yes | 2 Participants |
| ULS+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 2 years | Yes | 2 Participants |
| ULS+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 2 years | No | 76 Participants |
| ULS+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 4 years | No | 53 Participants |
| ULS+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 5 years | Yes | 5 Participants |
| ULS+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 5 years | No | 54 Participants |
| ULS+USUAL | Number of Participants With Pelvic Organ Prolapse Surgery | 4 years | Yes | 4 Participants |
Other Pre-specified
Number of Participants With Suture Exposure
Cumulative number of participants with suture exposure. Suture exposure was reported on the adverse event log.
Time frame: 2, 3, 4, and 5 years
Population: An analysis which included all participants that completed the primary OPTIMAL trial though 2 years and who were consented to extended follow-up through 5 years.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SSLF+BPMT | Number of Participants With Suture Exposure | 2 years | No | 57 Participants |
| SSLF+BPMT | Number of Participants With Suture Exposure | 2 years | Yes | 15 Participants |
| SSLF+BPMT | Number of Participants With Suture Exposure | 3 years | No | 53 Participants |
| SSLF+BPMT | Number of Participants With Suture Exposure | 3 years | Yes | 16 Participants |
| SSLF+BPMT | Number of Participants With Suture Exposure | 4 years | No | 49 Participants |
| SSLF+BPMT | Number of Participants With Suture Exposure | 4 years | Yes | 17 Participants |
| SSLF+BPMT | Number of Participants With Suture Exposure | 5 years | No | 42 Participants |
| SSLF+BPMT | Number of Participants With Suture Exposure | 5 years | Yes | 17 Participants |
| SSLF+USUAL | Number of Participants With Suture Exposure | 4 years | Yes | 12 Participants |
| SSLF+USUAL | Number of Participants With Suture Exposure | 4 years | No | 44 Participants |
| SSLF+USUAL | Number of Participants With Suture Exposure | 2 years | Yes | 11 Participants |
| SSLF+USUAL | Number of Participants With Suture Exposure | 5 years | Yes | 12 Participants |
| SSLF+USUAL | Number of Participants With Suture Exposure | 5 years | No | 42 Participants |
| SSLF+USUAL | Number of Participants With Suture Exposure | 3 years | Yes | 11 Participants |
| SSLF+USUAL | Number of Participants With Suture Exposure | 3 years | No | 50 Participants |
| SSLF+USUAL | Number of Participants With Suture Exposure | 2 years | No | 55 Participants |
| ULS+BPMT | Number of Participants With Suture Exposure | 5 years | No | 49 Participants |
| ULS+BPMT | Number of Participants With Suture Exposure | 3 years | No | 57 Participants |
| ULS+BPMT | Number of Participants With Suture Exposure | 3 years | Yes | 9 Participants |
| ULS+BPMT | Number of Participants With Suture Exposure | 4 years | No | 51 Participants |
| ULS+BPMT | Number of Participants With Suture Exposure | 4 years | Yes | 10 Participants |
| ULS+BPMT | Number of Participants With Suture Exposure | 5 years | Yes | 11 Participants |
| ULS+BPMT | Number of Participants With Suture Exposure | 2 years | No | 60 Participants |
| ULS+BPMT | Number of Participants With Suture Exposure | 2 years | Yes | 9 Participants |
| ULS+USUAL | Number of Participants With Suture Exposure | 3 years | No | 52 Participants |
| ULS+USUAL | Number of Participants With Suture Exposure | 3 years | Yes | 19 Participants |
| ULS+USUAL | Number of Participants With Suture Exposure | 2 years | Yes | 18 Participants |
| ULS+USUAL | Number of Participants With Suture Exposure | 2 years | No | 60 Participants |
| ULS+USUAL | Number of Participants With Suture Exposure | 4 years | No | 46 Participants |
| ULS+USUAL | Number of Participants With Suture Exposure | 5 years | Yes | 20 Participants |
| ULS+USUAL | Number of Participants With Suture Exposure | 5 years | No | 40 Participants |
| ULS+USUAL | Number of Participants With Suture Exposure | 4 years | Yes | 20 Participants |
Other Pre-specified
PGI-I
The Patient Global Impression of Improvement (PGI-I) is a patient-reported measure of perceived improvement with treatment, as assessed on a scale of 1 (very much better) to 7 (very much worse).This outcome measure is shows results from the original OPTIMAL trial as well as results from the E-OPTIMAL trial (for those that consented to the extended follow-up)
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| SSLF+BPMT | PGI-I | 2 years | Very much better | 21 Participants |
| SSLF+BPMT | PGI-I | 2 years | No change | 4 Participants |
| SSLF+BPMT | PGI-I | 1 years | Much better | 22 Participants |
| SSLF+BPMT | PGI-I | 5 years | A little worse | 2 Participants |
| SSLF+BPMT | PGI-I | 2 years | Much worse | 3 Participants |
| SSLF+BPMT | PGI-I | 1 years | Much worse | 0 Participants |
| SSLF+BPMT | PGI-I | 0.5 years | A little better | 12 Participants |
| SSLF+BPMT | PGI-I | 2 years | Much better | 20 Participants |
| SSLF+BPMT | PGI-I | 2 years | A little worse | 3 Participants |
| SSLF+BPMT | PGI-I | 1 years | No change | 4 Participants |
| SSLF+BPMT | PGI-I | 5 years | A little better | 13 Participants |
| SSLF+BPMT | PGI-I | 1 years | Very much worse | 1 Participants |
| SSLF+BPMT | PGI-I | 1 years | Very much better | 26 Participants |
| SSLF+BPMT | PGI-I | 0.5 years | A little worse | 5 Participants |
| SSLF+BPMT | PGI-I | 5 years | Very much worse | 2 Participants |
| SSLF+BPMT | PGI-I | 4 years | Very much worse | 2 Participants |
| SSLF+BPMT | PGI-I | 4 years | Very much better | 13 Participants |
| SSLF+BPMT | PGI-I | 0.5 years | Much better | 23 Participants |
| SSLF+BPMT | PGI-I | 5 years | Very much better | 12 Participants |
| SSLF+BPMT | PGI-I | 4 years | No change | 3 Participants |
| SSLF+BPMT | PGI-I | 4 years | Much worse | 4 Participants |
| SSLF+BPMT | PGI-I | 0.5 years | Much worse | 1 Participants |
| SSLF+BPMT | PGI-I | 5 years | No change | 4 Participants |
| SSLF+BPMT | PGI-I | 4 years | Much better | 21 Participants |
| SSLF+BPMT | PGI-I | 4 years | A little worse | 4 Participants |
| SSLF+BPMT | PGI-I | 0.5 years | No change | 2 Participants |
| SSLF+BPMT | PGI-I | 5 years | Much worse | 4 Participants |
| SSLF+BPMT | PGI-I | 4 years | A little better | 9 Participants |
| SSLF+BPMT | PGI-I | 3 years | Very much worse | 0 Participants |
| SSLF+BPMT | PGI-I | 0.5 years | Very much better | 26 Participants |
| SSLF+BPMT | PGI-I | 2 years | A little better | 14 Participants |
| SSLF+BPMT | PGI-I | 3 years | Very much better | 23 Participants |
| SSLF+BPMT | PGI-I | 3 years | No change | 5 Participants |
| SSLF+BPMT | PGI-I | 0.5 years | Very much worse | 0 Participants |
| SSLF+BPMT | PGI-I | 1 years | A little worse | 4 Participants |
| SSLF+BPMT | PGI-I | 3 years | Much worse | 6 Participants |
| SSLF+BPMT | PGI-I | 3 years | Much better | 18 Participants |
| SSLF+BPMT | PGI-I | 1 years | A little better | 13 Participants |
| SSLF+BPMT | PGI-I | 5 years | Much better | 17 Participants |
| SSLF+BPMT | PGI-I | 3 years | A little worse | 7 Participants |
| SSLF+BPMT | PGI-I | 3 years | A little better | 5 Participants |
| SSLF+BPMT | PGI-I | 2 years | Very much worse | 1 Participants |
| SSLF+USUAL | PGI-I | 5 years | A little worse | 4 Participants |
| SSLF+USUAL | PGI-I | 1 years | A little worse | 1 Participants |
| SSLF+USUAL | PGI-I | 3 years | Much worse | 2 Participants |
| SSLF+USUAL | PGI-I | 0.5 years | A little worse | 2 Participants |
| SSLF+USUAL | PGI-I | 0.5 years | Much better | 22 Participants |
| SSLF+USUAL | PGI-I | 0.5 years | Much worse | 1 Participants |
| SSLF+USUAL | PGI-I | 0.5 years | No change | 1 Participants |
| SSLF+USUAL | PGI-I | 0.5 years | Very much better | 26 Participants |
| SSLF+USUAL | PGI-I | 0.5 years | Very much worse | 1 Participants |
| SSLF+USUAL | PGI-I | 1 years | A little better | 10 Participants |
| SSLF+USUAL | PGI-I | 1 years | Much better | 24 Participants |
| SSLF+USUAL | PGI-I | 1 years | Much worse | 0 Participants |
| SSLF+USUAL | PGI-I | 1 years | No change | 2 Participants |
| SSLF+USUAL | PGI-I | 1 years | Very much better | 25 Participants |
| SSLF+USUAL | PGI-I | 1 years | Very much worse | 0 Participants |
| SSLF+USUAL | PGI-I | 2 years | A little better | 14 Participants |
| SSLF+USUAL | PGI-I | 2 years | A little worse | 5 Participants |
| SSLF+USUAL | PGI-I | 2 years | Much better | 20 Participants |
| SSLF+USUAL | PGI-I | 2 years | Much worse | 0 Participants |
| SSLF+USUAL | PGI-I | 2 years | No change | 1 Participants |
| SSLF+USUAL | PGI-I | 2 years | Very much better | 21 Participants |
| SSLF+USUAL | PGI-I | 2 years | Very much worse | 0 Participants |
| SSLF+USUAL | PGI-I | 3 years | A little better | 19 Participants |
| SSLF+USUAL | PGI-I | 3 years | A little worse | 3 Participants |
| SSLF+USUAL | PGI-I | 3 years | Much better | 24 Participants |
| SSLF+USUAL | PGI-I | 3 years | No change | 2 Participants |
| SSLF+USUAL | PGI-I | 3 years | Very much better | 10 Participants |
| SSLF+USUAL | PGI-I | 3 years | Very much worse | 0 Participants |
| SSLF+USUAL | PGI-I | 4 years | A little better | 14 Participants |
| SSLF+USUAL | PGI-I | 4 years | A little worse | 6 Participants |
| SSLF+USUAL | PGI-I | 4 years | Much better | 19 Participants |
| SSLF+USUAL | PGI-I | 4 years | Much worse | 1 Participants |
| SSLF+USUAL | PGI-I | 4 years | No change | 2 Participants |
| SSLF+USUAL | PGI-I | 4 years | Very much better | 12 Participants |
| SSLF+USUAL | PGI-I | 4 years | Very much worse | 0 Participants |
| SSLF+USUAL | PGI-I | 5 years | A little better | 16 Participants |
| SSLF+USUAL | PGI-I | 0.5 years | A little better | 11 Participants |
| SSLF+USUAL | PGI-I | 5 years | Much better | 19 Participants |
| SSLF+USUAL | PGI-I | 5 years | Much worse | 0 Participants |
| SSLF+USUAL | PGI-I | 5 years | No change | 5 Participants |
| SSLF+USUAL | PGI-I | 5 years | Very much better | 11 Participants |
| SSLF+USUAL | PGI-I | 5 years | Very much worse | 0 Participants |
| ULS+BPMT | PGI-I | 2 years | Very much worse | 2 Participants |
| ULS+BPMT | PGI-I | 4 years | Much worse | 4 Participants |
| ULS+BPMT | PGI-I | 3 years | Very much better | 21 Participants |
| ULS+BPMT | PGI-I | 0.5 years | Much better | 17 Participants |
| ULS+BPMT | PGI-I | 0.5 years | A little better | 10 Participants |
| ULS+BPMT | PGI-I | 4 years | No change | 4 Participants |
| ULS+BPMT | PGI-I | 3 years | A little better | 10 Participants |
| ULS+BPMT | PGI-I | 5 years | Very much better | 18 Participants |
| ULS+BPMT | PGI-I | 5 years | No change | 3 Participants |
| ULS+BPMT | PGI-I | 4 years | Very much better | 19 Participants |
| ULS+BPMT | PGI-I | 5 years | A little worse | 4 Participants |
| ULS+BPMT | PGI-I | 0.5 years | A little worse | 5 Participants |
| ULS+BPMT | PGI-I | 3 years | Much better | 17 Participants |
| ULS+BPMT | PGI-I | 3 years | Very much worse | 3 Participants |
| ULS+BPMT | PGI-I | 4 years | Very much worse | 3 Participants |
| ULS+BPMT | PGI-I | 1 years | Very much better | 30 Participants |
| ULS+BPMT | PGI-I | 1 years | A little better | 6 Participants |
| ULS+BPMT | PGI-I | 1 years | No change | 5 Participants |
| ULS+BPMT | PGI-I | 0.5 years | No change | 2 Participants |
| ULS+BPMT | PGI-I | 1 years | Very much worse | 2 Participants |
| ULS+BPMT | PGI-I | 0.5 years | Very much worse | 1 Participants |
| ULS+BPMT | PGI-I | 2 years | A little better | 9 Participants |
| ULS+BPMT | PGI-I | 4 years | A little better | 7 Participants |
| ULS+BPMT | PGI-I | 2 years | A little worse | 6 Participants |
| ULS+BPMT | PGI-I | 1 years | Much better | 18 Participants |
| ULS+BPMT | PGI-I | 1 years | Much worse | 1 Participants |
| ULS+BPMT | PGI-I | 5 years | A little better | 13 Participants |
| ULS+BPMT | PGI-I | 2 years | Much better | 20 Participants |
| ULS+BPMT | PGI-I | 3 years | Much worse | 0 Participants |
| ULS+BPMT | PGI-I | 5 years | Much worse | 6 Participants |
| ULS+BPMT | PGI-I | 4 years | A little worse | 1 Participants |
| ULS+BPMT | PGI-I | 2 years | Much worse | 0 Participants |
| ULS+BPMT | PGI-I | 5 years | Much better | 12 Participants |
| ULS+BPMT | PGI-I | 0.5 years | Much worse | 1 Participants |
| ULS+BPMT | PGI-I | 5 years | Very much worse | 1 Participants |
| ULS+BPMT | PGI-I | 2 years | No change | 3 Participants |
| ULS+BPMT | PGI-I | 3 years | No change | 4 Participants |
| ULS+BPMT | PGI-I | 1 years | A little worse | 2 Participants |
| ULS+BPMT | PGI-I | 4 years | Much better | 14 Participants |
| ULS+BPMT | PGI-I | 2 years | Very much better | 25 Participants |
| ULS+BPMT | PGI-I | 3 years | A little worse | 5 Participants |
| ULS+BPMT | PGI-I | 0.5 years | Very much better | 29 Participants |
| ULS+USUAL | PGI-I | 4 years | Very much better | 19 Participants |
| ULS+USUAL | PGI-I | 2 years | Very much worse | 1 Participants |
| ULS+USUAL | PGI-I | 5 years | A little worse | 5 Participants |
| ULS+USUAL | PGI-I | 3 years | A little better | 13 Participants |
| ULS+USUAL | PGI-I | 3 years | A little worse | 6 Participants |
| ULS+USUAL | PGI-I | 0.5 years | Very much worse | 2 Participants |
| ULS+USUAL | PGI-I | 3 years | Much better | 23 Participants |
| ULS+USUAL | PGI-I | 3 years | Much worse | 3 Participants |
| ULS+USUAL | PGI-I | 0.5 years | Very much better | 31 Participants |
| ULS+USUAL | PGI-I | 3 years | No change | 1 Participants |
| ULS+USUAL | PGI-I | 5 years | Much better | 21 Participants |
| ULS+USUAL | PGI-I | 3 years | Very much better | 21 Participants |
| ULS+USUAL | PGI-I | 0.5 years | No change | 3 Participants |
| ULS+USUAL | PGI-I | 1 years | Very much worse | 1 Participants |
| ULS+USUAL | PGI-I | 3 years | Very much worse | 1 Participants |
| ULS+USUAL | PGI-I | 5 years | Very much better | 15 Participants |
| ULS+USUAL | PGI-I | 4 years | A little better | 16 Participants |
| ULS+USUAL | PGI-I | 0.5 years | Much worse | 1 Participants |
| ULS+USUAL | PGI-I | 4 years | A little worse | 2 Participants |
| ULS+USUAL | PGI-I | 5 years | Much worse | 2 Participants |
| ULS+USUAL | PGI-I | 4 years | Much better | 19 Participants |
| ULS+USUAL | PGI-I | 0.5 years | Much better | 20 Participants |
| ULS+USUAL | PGI-I | 1 years | Much better | 28 Participants |
| ULS+USUAL | PGI-I | 4 years | Much worse | 1 Participants |
| ULS+USUAL | PGI-I | 4 years | No change | 2 Participants |
| ULS+USUAL | PGI-I | 0.5 years | A little worse | 5 Participants |
| ULS+USUAL | PGI-I | 5 years | No change | 3 Participants |
| ULS+USUAL | PGI-I | 1 years | No change | 4 Participants |
| ULS+USUAL | PGI-I | 1 years | Very much better | 27 Participants |
| ULS+USUAL | PGI-I | 4 years | Very much worse | 1 Participants |
| ULS+USUAL | PGI-I | 0.5 years | A little better | 12 Participants |
| ULS+USUAL | PGI-I | 2 years | A little better | 13 Participants |
| ULS+USUAL | PGI-I | 1 years | Much worse | 0 Participants |
| ULS+USUAL | PGI-I | 2 years | Much better | 25 Participants |
| ULS+USUAL | PGI-I | 2 years | A little worse | 3 Participants |
| ULS+USUAL | PGI-I | 5 years | A little better | 11 Participants |
| ULS+USUAL | PGI-I | 2 years | Much worse | 1 Participants |
| ULS+USUAL | PGI-I | 1 years | A little worse | 6 Participants |
| ULS+USUAL | PGI-I | 2 years | No change | 4 Participants |
| ULS+USUAL | PGI-I | 5 years | Very much worse | 2 Participants |
| ULS+USUAL | PGI-I | 2 years | Very much better | 23 Participants |
| ULS+USUAL | PGI-I | 1 years | A little better | 6 Participants |
Other Pre-specified
POP-Q Point Ba
POPQ Point Ba represents the most distal (i.e. most dependent) position of any part of the upper anterior vaginal wall (between the vaginal cuff or anterior vaginal fornix and Point Aa). The range for point Ba is -3 to total vaginal length (TVL). Point Ba coincides with Point Aa (-3 cm) in a woman who has no anterior POP. In a woman with severe POP, Ba coincides with Point C. For Point Ba, better vaginal support is assigned a negative value (ie, if there is no prolapse, point Ba is -3 cm by definition). Vaginal prolapse beyond the hymen, indicating worse vaginal support, is assigned a positive value (this may be equal to the total vaginal length at the maximum).
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SSLF+BPMT | POP-Q Point Ba | 2 years | -0.9 cm |
| SSLF+BPMT | POP-Q Point Ba | 4 years | -0.8 cm |
| SSLF+BPMT | POP-Q Point Ba | 0.5 years | -1.2 cm |
| SSLF+BPMT | POP-Q Point Ba | 3 years | -1.1 cm |
| SSLF+BPMT | POP-Q Point Ba | 5 years | -0.8 cm |
| SSLF+BPMT | POP-Q Point Ba | 1 years | -0.9 cm |
| SSLF+USUAL | POP-Q Point Ba | 5 years | -1 cm |
| SSLF+USUAL | POP-Q Point Ba | 2 years | -0.8 cm |
| SSLF+USUAL | POP-Q Point Ba | 1 years | -1.2 cm |
| SSLF+USUAL | POP-Q Point Ba | 4 years | -0.9 cm |
| SSLF+USUAL | POP-Q Point Ba | 3 years | -0.7 cm |
| SSLF+USUAL | POP-Q Point Ba | 0.5 years | -1.2 cm |
| ULS+BPMT | POP-Q Point Ba | 3 years | -0.8 cm |
| ULS+BPMT | POP-Q Point Ba | 4 years | -0.8 cm |
| ULS+BPMT | POP-Q Point Ba | 5 years | -0.7 cm |
| ULS+BPMT | POP-Q Point Ba | 0.5 years | -1.4 cm |
| ULS+BPMT | POP-Q Point Ba | 1 years | -1 cm |
| ULS+BPMT | POP-Q Point Ba | 2 years | -1.1 cm |
| ULS+USUAL | POP-Q Point Ba | 5 years | -0.9 cm |
| ULS+USUAL | POP-Q Point Ba | 0.5 years | -1.3 cm |
| ULS+USUAL | POP-Q Point Ba | 1 years | -1.2 cm |
| ULS+USUAL | POP-Q Point Ba | 2 years | -1.1 cm |
| ULS+USUAL | POP-Q Point Ba | 3 years | -1.1 cm |
| ULS+USUAL | POP-Q Point Ba | 4 years | -1.1 cm |
Other Pre-specified
POP-Q Point Bp
POP-Q Point Bp represents the most distal position of any part of the upper posterior vaginal wall (between the vaginal cuff or posterior vaginal fornix and Point Ap). It ranges from -3 to total vaginal length (TVL). Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse.
Time frame: 6 months, and 1, 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SSLF+BPMT | POP-Q Point Bp | 0.5 years | -2.3 cm |
| SSLF+BPMT | POP-Q Point Bp | 1 years | -2.2 cm |
| SSLF+BPMT | POP-Q Point Bp | 2 years | -2 cm |
| SSLF+BPMT | POP-Q Point Bp | 3 years | -2.3 cm |
| SSLF+BPMT | POP-Q Point Bp | 4 years | -2.2 cm |
| SSLF+BPMT | POP-Q Point Bp | 5 years | -2.2 cm |
| SSLF+USUAL | POP-Q Point Bp | 5 years | -2.3 cm |
| SSLF+USUAL | POP-Q Point Bp | 3 years | -2.4 cm |
| SSLF+USUAL | POP-Q Point Bp | 0.5 years | -2.5 cm |
| SSLF+USUAL | POP-Q Point Bp | 2 years | -2.3 cm |
| SSLF+USUAL | POP-Q Point Bp | 1 years | -2.4 cm |
| SSLF+USUAL | POP-Q Point Bp | 4 years | -2.3 cm |
| ULS+BPMT | POP-Q Point Bp | 1 years | -2.2 cm |
| ULS+BPMT | POP-Q Point Bp | 2 years | -2.2 cm |
| ULS+BPMT | POP-Q Point Bp | 3 years | -2.1 cm |
| ULS+BPMT | POP-Q Point Bp | 5 years | -1.9 cm |
| ULS+BPMT | POP-Q Point Bp | 4 years | -2.2 cm |
| ULS+BPMT | POP-Q Point Bp | 0.5 years | -2.2 cm |
| ULS+USUAL | POP-Q Point Bp | 4 years | -2 cm |
| ULS+USUAL | POP-Q Point Bp | 5 years | -1.9 cm |
| ULS+USUAL | POP-Q Point Bp | 1 years | -2.2 cm |
| ULS+USUAL | POP-Q Point Bp | 3 years | -2.2 cm |
| ULS+USUAL | POP-Q Point Bp | 0.5 years | -2.2 cm |
| ULS+USUAL | POP-Q Point Bp | 2 years | -2 cm |
Other Pre-specified
POP-Q Point C
POP-Q Point C is measured in cm relative to the hymen with negative values being proximal to the hymen and positive values distal to the hymen. Point C represents either the most distal edge of the cervix or the leading edge of the vaginal cuff after total hysterectomy. It ranges from -TVL to +TVL. Negative values indicate vaginal support above the hymen, so the more negative number the closer to normal/perfect support; positive values show prolapse beyond the hymen, so larger positive numbers are worse prolapse.
Time frame: 6 months, and 1 2, 3, 4, and 5 years
Population: The primary analysis was conducted using an intention-to-treat principle as closely as possible by analyzing all successfully followed up participants in the OPTIMAL treatment group to which they were randomized.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SSLF+BPMT | POP-Q Point C | 0.5 years | -7.2 cm |
| SSLF+BPMT | POP-Q Point C | 1 years | -7 cm |
| SSLF+BPMT | POP-Q Point C | 2 years | -6.8 cm |
| SSLF+BPMT | POP-Q Point C | 3 years | -6.9 cm |
| SSLF+BPMT | POP-Q Point C | 4 years | -6.3 cm |
| SSLF+BPMT | POP-Q Point C | 5 years | -6.5 cm |
| SSLF+USUAL | POP-Q Point C | 5 years | -6.4 cm |
| SSLF+USUAL | POP-Q Point C | 3 years | -6.4 cm |
| SSLF+USUAL | POP-Q Point C | 0.5 years | -7.3 cm |
| SSLF+USUAL | POP-Q Point C | 2 years | -6.6 cm |
| SSLF+USUAL | POP-Q Point C | 1 years | -6.5 cm |
| SSLF+USUAL | POP-Q Point C | 4 years | -6.2 cm |
| ULS+BPMT | POP-Q Point C | 1 years | -6.6 cm |
| ULS+BPMT | POP-Q Point C | 2 years | -6.5 cm |
| ULS+BPMT | POP-Q Point C | 3 years | -6.3 cm |
| ULS+BPMT | POP-Q Point C | 5 years | -5.8 cm |
| ULS+BPMT | POP-Q Point C | 4 years | -6.4 cm |
| ULS+BPMT | POP-Q Point C | 0.5 years | -6.5 cm |
| ULS+USUAL | POP-Q Point C | 4 years | -6.6 cm |
| ULS+USUAL | POP-Q Point C | 5 years | -6.6 cm |
| ULS+USUAL | POP-Q Point C | 1 years | -6.8 cm |
| ULS+USUAL | POP-Q Point C | 3 years | -6.3 cm |
| ULS+USUAL | POP-Q Point C | 0.5 years | -7 cm |
| ULS+USUAL | POP-Q Point C | 2 years | -6.8 cm |