Pelvic Organ Prolapse (POP)
Conditions
Keywords
POP, pelvic organ prolapse, anterior prolapse, posterior prolapse, vaginal prolapse, vaginal floor reconstruction
Brief summary
This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A&P mesh after vaginal reconstruction surgery.
Interventions
DEVICERestorelle Direct Fix A&P
Restorelle Direct Fix A&P is a permanently implantable synthetic mesh for reconstruction of the pelvic floor secondary to the prolapse or protrusion of the pelvic organs into or out of the vaginal canal.
Sponsors
Coloplast A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult female at least 18 years of age * Willing and able to provide written informed consent * Diagnosed with clinically significant pelvic organ prolapse of Stage 2 or higher as determined by Pelvic Organ Prolapse Quantification System (POP-Q) requiring surgical intervention in the anterior and/or posterior compartment * Willing and able to complete all follow-up visits and procedures indicated in the protocol
Exclusion criteria
* Concurrent surgical treatment of pelvic organ prolapse using anything other than the Restorelle Direct Fix A&P * Confirmed Stage 2 or higher prolapse as determined by POP-Q for a compartment that is not being repaired in the same procedure * Previous pelvic organ prolapse repair using synthetic grafts * Patients requiring a total hysterectomy (i.e. removal of the cervix) at the time of vaginal reconstruction * Patients requiring a procedure for fecal incontinence (i.e.) anal sphincteroplasty) at the time of vaginal reconstruction * Pregnant or a desire to become pregnant * Previous radiation or other treatments for cancer in the pelvic area * Immunosuppression and/or current systemic steroid user * On any anticoagulation therapy at the time of implant or with bleeding diathesis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Baseline | Measured via palpability scale with possible outcomes of none, mild, moderate, or severe. |
| Palpability of the Restorelle Direct Fix A&P | 6 weeks | Measured via palpability scale with possible outcomes of none, mild, moderate, or severe. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Weeks | 6 weeks | Surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 weeks. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring). |
| Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 3 Months | 3 months | Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 3 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring). |
| Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Months | 6 months | Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring). |
| Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 12 Months | 12 months | Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 12 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring). |
| Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. | 12 months | The PGI-I Index consists on one question and was collected at 12 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response. |
| Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 12 Months. | 12 months | Percentage of participants with anterior and posterior compartment mesh exposure/extrusion after vaginal reconstruction with Restorelle Direct Fix at 12 months. Per the protocol, mesh extrusion is defined as passage gradually out of a body structure or tissue. Mesh exposure is defined as a condition of displaying, revealing, exhibiting or making accessible e.g. vaginal mesh visualized through separated vaginal epithelium. |
| Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Week Visit | 6 week | Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 week visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring). |
| Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 3 Month Visit | 3 month | Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 3 month visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring). |
| Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Month Visit | 6 month | Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 month visit Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring). |
| Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the12 Month Visit | 12 month | Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 12 month visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring). |
| Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. | 6 weeks | The PGI-I Index consists on one question and was collected at 6 weeks. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response. |
| Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. | 3 months | The PGI-I Index consists on one question and was collected at 3 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response. |
| Rates of de Novo Dyspareunia | 6 weeks | Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 6 weeks. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always. |
| Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 3 Months | Baseline and 3 months | Bladder function is measured by UDI-6 Questionnaire at 3 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms. |
| Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Months | Baseline and 6 months | Bladder function is measured by UDI-6 Questionnaire at 6 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms. |
| Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 12 Months | Baseline and 12 months | Bladder function is measured by UDI-6 Questionnaire at 12 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms. |
| Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Weeks | Baseline and 6 weeks | Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 weeks. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items. |
| Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 3 Months | Baseline and 3 months | Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 3 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items. |
| Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Months | Baseline and 6 months | Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items. |
| Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 12 Months | Baseline and 12 months | Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at12 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items. |
| Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Week Visit | Baseline and 6 weeks | Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 weeks. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). |
| Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 3 Month Visit | Baseline and 3 months | Colorectal-anal Distress Inventory is measured by the CRADI-8 at 3 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). |
| Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Month Visit | Baseline and 6 months | Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). |
| Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the12 Month Visit | Baseline and 12 months | Colorectal-anal Distress Inventory is measured by the CRADI-8 at 12 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress). |
| Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Weeks | Baseline and 6 weeks | Bladder function is measured by UDI-6 Questionnaire at 6 weeks. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms. |
| Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. | 6 months | The PGI-I Index consists on one question and was collected at 6 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Restorelle Direct Fix Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment. | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Restorelle Direct Fix |
|---|---|
| Age, Continuous | 62.1 years STANDARD_DEVIATION 12.8 |
| Body Mass Index (BMI) | 27.9 Kg/m^2 STANDARD_DEVIATION 5.6 |
| Height | 64.3 Inches STANDARD_DEVIATION 2.9 |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 0 Participants |
| Weight | 164.7 pound STANDARD_DEVIATION 36.8 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 30 |
| serious Total, serious adverse events | 2 / 30 |
Outcome results
Primary
Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P)
Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.
Time frame: Baseline
Population: All subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Anterior - apex: Mild | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Anterior - apex: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Anterior - apex: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Posterior - inside hymenal ring: None | 30 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Posterior - inside hymenal ring: Mild | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Posterior - apex: None | 29 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Anterior - inside hymenal ring: None | 30 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Anterior - inside hymenal ring: Mild | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Anterior - inside hymenal ring: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Anterior - inside hymenal ring: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Anterior - 4 cm from introitus at midline: None | 30 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Anterior - 4 cm from introitus at midline: Mild | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Anterior - 4 cm from introitus at midline: Moderat | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Anterior - 4 cm from introitus at midline: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Anterior - apex: None | 30 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Posterior - inside hymenal ring: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Posterior - inside hymenal ring: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Posterior - 4 cm from introitus at midline: None | 29 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Posterior - 4 cm from introitus at midline: Mild | 1 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Posterior - 4 cm from introitus at midline: Modera | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Posterior - 4 cm from introitus at midline:Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Posterior - apex: Mild | 1 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Posterior - apex: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix Anterior and Posterior (A&P) | Posterior - apex: Severe | 0 participants |
Primary
Palpability of the Restorelle Direct Fix A&P
Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.
Time frame: 6 weeks
Population: All subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: None | 29 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: Mild | 1 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: None | 27 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: Mild | 3 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: Moderat | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: None | 26 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: Mild | 4 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: None | 30 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: Mild | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline: None | 27 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline: Mild | 2 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline: Modera | 1 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline:Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: None | 27 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: Mild | 2 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: Moderate | 1 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: Severe | 0 participants |
Primary
Palpability of the Restorelle Direct Fix A&P
Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.
Time frame: 12 months
Population: All subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: None | 29 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: Mild | 1 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: None | 26 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: Mild | 3 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: Moderat | 1 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: None | 26 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: Mild | 4 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: None | 29 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: Mild | 1 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline: None | 28 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline: Mild | 2 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline: Modera | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline:Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: None | 27 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: Mild | 3 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: Severe | 0 participants |
Primary
Palpability of the Restorelle Direct Fix A&P
Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.
Time frame: 6 months
Population: All subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: None | 30 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: Mild | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: None | 25 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: Mild | 4 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: Moderat | 1 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: None | 25 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: Mild | 2 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: Moderate | 3 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: None | 28 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: Mild | 1 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: Moderate | 1 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline: None | 26 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline: Mild | 3 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline: Modera | 1 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline:Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: None | 27 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: Mild | 1 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: Moderate | 2 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: Severe | 0 participants |
Primary
Palpability of the Restorelle Direct Fix A&P
Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.
Time frame: 3 months
Population: All study subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: Mild | 1 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: None | 26 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: Mild | 4 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: Moderat | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: Mild | 2 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - inside hymenal ring: None | 29 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - 4 cm from introitus at midline: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: None | 26 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: Mild | 4 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Anterior - apex: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: None | 28 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - inside hymenal ring: Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline: None | 28 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline: Mild | 2 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline: Modera | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - 4 cm from introitus at midline:Severe | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: None | 28 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: Mild | 2 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: Moderate | 0 participants |
| Restorelle Direct Fix | Palpability of the Restorelle Direct Fix A&P | Posterior - apex: Severe | 0 participants |
Secondary
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 12 Months
Bladder function is measured by UDI-6 Questionnaire at 12 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.
Time frame: Baseline and 12 months
Population: All subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restorelle Direct Fix | Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 12 Months | Baseline | 45.1 units on a scale | Standard Deviation 27.2 |
| Restorelle Direct Fix | Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 12 Months | 12 months | 18.1 units on a scale | Standard Deviation 21.3 |
p-value: <0.001t-test, 2 sided
Secondary
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 3 Months
Bladder function is measured by UDI-6 Questionnaire at 3 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.
Time frame: Baseline and 3 months
Population: All subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restorelle Direct Fix | Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 3 Months | Baseline | 45.1 units on a scale | Standard Deviation 27.2 |
| Restorelle Direct Fix | Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 3 Months | 3 months | 17.1 units on a scale | Standard Deviation 17.3 |
p-value: <0.001t-test, 2 sided
Secondary
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Months
Bladder function is measured by UDI-6 Questionnaire at 6 months. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.
Time frame: Baseline and 6 months
Population: All subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restorelle Direct Fix | Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Months | Baseline | 45.1 units on a scale | Standard Deviation 27.2 |
| Restorelle Direct Fix | Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Months | 6 months | 16.4 units on a scale | Standard Deviation 18.7 |
p-value: <0.001t-test, 2 sided
Secondary
Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Weeks
Bladder function is measured by UDI-6 Questionnaire at 6 weeks. The UDI-6 measures bladder function. The range of responses is: 1-4 with (1) not at all, (2) somewhat, (3) moderately, and (4 quite a bit). To allow for missing responses, the average score of items responded to, rather than the total, is taken. The average, which ranges from 1 to 4, is multiplied by 25 to put scores on a scale of 0 to 100. Higher scores indicate worse symptoms.
Time frame: Baseline and 6 weeks
Population: All subjects.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restorelle Direct Fix | Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Weeks | Baseline | 45.1 units on a scale | Standard Deviation 27.2 |
| Restorelle Direct Fix | Bladder Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Urinary Distress Inventory-6 (UDI-6) Questionnaire at 6 Weeks | 6 weeks | 25.7 units on a scale | Standard Deviation 19 |
p-value: <0.001t-test, 2 sided
Secondary
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the12 Month Visit
Colorectal-anal Distress Inventory is measured by the CRADI-8 at 12 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).
Time frame: Baseline and 12 months
Population: All subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restorelle Direct Fix | Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the12 Month Visit | Baseline | 24.9 units on a scale | Standard Deviation 20.7 |
| Restorelle Direct Fix | Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the12 Month Visit | 12 months | 10.8 units on a scale | Standard Deviation 14 |
Comparison: Analysis baseline to 12 months.p-value: <0.001t-test, 2 sided
Secondary
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 3 Month Visit
Colorectal-anal Distress Inventory is measured by the CRADI-8 at 3 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).
Time frame: Baseline and 3 months
Population: All subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restorelle Direct Fix | Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 3 Month Visit | Baseline | 24.9 units on a scale | Standard Deviation 20.7 |
| Restorelle Direct Fix | Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 3 Month Visit | 3 months | 15.3 units on a scale | Standard Deviation 16.7 |
Comparison: Analysis baseline to 3 months.p-value: 0.004t-test, 2 sided
Secondary
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Month Visit
Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 months. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).
Time frame: Baseline and 6 months
Population: All subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restorelle Direct Fix | Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Month Visit | Baseline | 24.9 units on a scale | Standard Deviation 20.7 |
| Restorelle Direct Fix | Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Month Visit | 6 months | 14.1 units on a scale | Standard Deviation 16.1 |
Comparison: Analysis baseline to 6 months.p-value: <0.001t-test, 2 sided
Secondary
Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Week Visit
Colorectal-anal Distress Inventory is measured by the CRADI-8 at 6 weeks. The range of responses is 1-4 with (1) Not at all, (2) Somewhat, (3) Moderately, and (4), Quite a bit. Scores are calculated by multiplying the mean value of all questions answered by 25. The range of responses is: 0-100 with 0 (least distress) to 100 (most distress).
Time frame: Baseline and 6 weeks
Population: All subjects
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restorelle Direct Fix | Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Week Visit | Baseline | 24.9 units on a scale | Standard Deviation 20.7 |
| Restorelle Direct Fix | Bowel Function After Vaginal Reconstruction Surgery With Restorelle Direct Fix A & P Measured by Colorectal-Anal Distress Inventory 8 (CRADI-8) Questionnaire at the 6 Week Visit | 6 weeks | 15.7 units on a scale | Standard Deviation 15.7 |
Comparison: Analysis baseline to 6 weeks.p-value: 0.001t-test, 2 sided
Secondary
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months.
The PGI-I Index consists on one question and was collected at 12 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response.
Time frame: 12 months
Population: All subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. | Very much better | 18 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. | Much better | 4 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. | A little better | 4 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. | No change | 3 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. | A little worse | 1 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. | Much worse | 0 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 12 Months. | Very much worse | 0 participants |
Secondary
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months.
The PGI-I Index consists on one question and was collected at 3 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response.
Time frame: 3 months
Population: The 29 subjects who completed the PGI-I at the three month follow up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. | Very much better | 14 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. | Much better | 9 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. | A little better | 2 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. | No change | 3 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. | A little worse | 1 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. | Much worse | 0 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 3 Months. | Very much worse | 0 participants |
Secondary
Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months.
The PGI-I Index consists on one question and was collected at 6 months. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response.
Time frame: 6 months
Population: The 29 subjects who completed the PGI-I at the six month follow up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. | Much worse | 1 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. | Very much better | 12 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. | Much better | 7 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. | A little better | 6 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. | No change | 2 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. | A little worse | 1 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Index Since Treatment at 6 Months. | Very much worse | 0 participants |
Secondary
Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks.
The PGI-I Index consists on one question and was collected at 6 weeks. The question is Check the box that best describes how your condition is now, compared with how it was before you had the operation. There are seven possible responses including very much better, much better, a little better, no change, a little worse, much worse and very much worse and the subject chooses one response.
Time frame: 6 weeks
Population: The 29 subjects who completed the PGI-I at the six week follow up visit.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. | Very much better | 15 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. | Much better | 10 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. | A little better | 1 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. | No change | 1 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. | A little worse | 0 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. | Much worse | 2 participants |
| Restorelle Direct Fix | Patient Global Impression of Improvement (PGI-I) Questionnaire Since Treatment at 6 Weeks. | Very much worse | 0 participants |
Secondary
Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 12 Months.
Percentage of participants with anterior and posterior compartment mesh exposure/extrusion after vaginal reconstruction with Restorelle Direct Fix at 12 months. Per the protocol, mesh extrusion is defined as passage gradually out of a body structure or tissue. Mesh exposure is defined as a condition of displaying, revealing, exhibiting or making accessible e.g. vaginal mesh visualized through separated vaginal epithelium.
Time frame: 12 months
Population: All study subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Restorelle Direct Fix | Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 12 Months. | Rate of mesh exposure | 3.3 percentage of subjects |
| Restorelle Direct Fix | Percentage of Participants With Mesh Exposure/Extrusion After Vaginal Reconstruction Surgery at 12 Months. | Rate of mesh extrusion | 0.0 percentage of subjects |
Secondary
Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the12 Month Visit
Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 12 month visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).
Time frame: 12 month
Population: The 6 subjects who were treated in the posterior compartment with Restorelle Direct Fix.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restorelle Direct Fix | Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the12 Month Visit | 100 percentage of subjects |
Secondary
Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 3 Month Visit
Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 3 month visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).
Time frame: 3 month
Population: The six subjects who had posterior compartment vaginal reconstruction surgery.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restorelle Direct Fix | Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 3 Month Visit | 100 percentage of subjects |
Secondary
Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Month Visit
Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 month visit Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).
Time frame: 6 month
Population: The 5 subjects who were treated in the posterior compartment with Restorelle Direct Fix and have POP-Q measurement recorded at the six month follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restorelle Direct Fix | Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Month Visit | 100 percentage of subjects |
Secondary
Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Week Visit
Percentage of participants with surgical success of the posterior compartment after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at the 6 week visit. Surgical success is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).
Time frame: 6 week
Population: The 6 subjects who were treated in the posterior compartment with Restorelle Direct Fix.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restorelle Direct Fix | Percentage of Participants With Surgical Success of the Posterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at the 6 Week Visit | 100 percentage of subjects |
Secondary
Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 12 Months
Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 12 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).
Time frame: 12 months
Population: The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restorelle Direct Fix | Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 12 Months | 100 percentage of subjects |
Secondary
Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 3 Months
Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 3 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).
Time frame: 3 months
Population: The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restorelle Direct Fix | Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 3 Months | 100 percentage of subjects |
Secondary
Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Months
Percentage of participants with surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 months. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).
Time frame: 6 months
Population: The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restorelle Direct Fix | Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Months | 96.3 percentage of subjects |
Secondary
Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Weeks
Surgical success rates of the anterior compartments after vaginal reconstruction surgery via Pelvic Organ Prolapse Quantification system (POP-Q) at 6 weeks. Surgical success rate is defined as the post-operative point of maximal prolapse being less than 0 cm (i.e. above the hymenal ring).
Time frame: 6 weeks
Population: The 27 subjects who were treated with Restorelle Direct Fix in the anterior compartment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restorelle Direct Fix | Percentage of Participants With Surgical Success Rates of the Anterior Compartment After Vaginal Reconstruction Surgery Via Pelvic Organ Prolapse Quantification System (POP-Q) at 6 Weeks | 100 percentage of subjects |
Secondary
Rates of de Novo Dyspareunia
Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 6 weeks. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always.
Time frame: 6 weeks
Population: The 12 sexually active subjects without dyspareunia at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restorelle Direct Fix | Rates of de Novo Dyspareunia | 8.3 percentage of subjects |
Secondary
Rates of de Novo Dyspareunia
Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 3 months. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always.
Time frame: 3 months
Population: The 12 sexually active subjects without dyspareunia at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restorelle Direct Fix | Rates of de Novo Dyspareunia | 8.3 percentage of subjects |
Secondary
Rates of de Novo Dyspareunia
Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at six months. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always.
Time frame: 6 months
Population: The 12 sexually active subjects without dyspareunia at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restorelle Direct Fix | Rates of de Novo Dyspareunia | 0 percentage of subjects |
Secondary
Rates of de Novo Dyspareunia
Percentage of de novo dyspareunia measured via validated Participant Sexual Function Questionnaire-12 (PISQ-12) questionnaire at 12 months. The specific PISQ-12 score was based upon Question 3.5, Do you feel pain during sexual intercourse? The subjects' response was counted as having de novo dyspareunia if the response was sometimes usually or always.
Time frame: 12 months
Population: The 11 sexually active subjects without dyspareunia at baseline. At the 12 month follow-up visit, only 11 subjects were sexually active and thus only 11 subjects completed Question 3.5 on the PISQ-12 questionnaire. Therefore, the number of participants analyzed for this outcome was 11 at the 12 month follow-up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Restorelle Direct Fix | Rates of de Novo Dyspareunia | 9.1 percentage of subjects |
Secondary
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 12 Months
Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at12 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
Time frame: Baseline and 12 months
Population: The 25 subjects who completed the PISQ-12 at the twelve month follow up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restorelle Direct Fix | Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 12 Months | 12 month | 12.8 units on a scale | Standard Deviation 6.2 |
| Restorelle Direct Fix | Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 12 Months | Baseline | 15.7 units on a scale | Standard Deviation 6.2 |
p-value: 0.034t-test, 2 sided
Secondary
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 3 Months
Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 3 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
Time frame: Baseline and 3 months
Population: The 25 subjects who completed the PISQ-12 at the three month follow up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restorelle Direct Fix | Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 3 Months | 3 month | 12.2 units on a scale | Standard Deviation 5.2 |
| Restorelle Direct Fix | Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 3 Months | Baseline | 15.7 units on a scale | Standard Deviation 6.2 |
p-value: 0.001t-test, 2 sided
Secondary
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Months
Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 months. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
Time frame: Baseline and 6 months
Population: The 26 subjects who completed the PISQ-12 at the six month follow up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restorelle Direct Fix | Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Months | 6 months | 12.8 units on a scale | Standard Deviation 5.4 |
| Restorelle Direct Fix | Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Months | Baseline | 15.7 units on a scale | Standard Deviation 6.2 |
p-value: 0.004t-test, 2 sided
Secondary
Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Weeks
Sexual function in women with pelvic organ prolapse is measured by the PISQ-12 at 6 weeks. The scores range from 0-48 with lower scores indicating better sexual function. Scores are calculated by totalling the scores for each question with (4) always, (3) usually, (2) sometimes, (1) seldom, and (0) never. Reverse scoring is used for items 1, 2, 3 and 4. The short form questionnaire can be used with up to two missing responses. To handle missing values, the sum is calculated by multiplying the number of items by the mean of the answered items.
Time frame: Baseline and 6 weeks
Population: The 28 subjects who completed the PISQ-12 at the six week follow up visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Restorelle Direct Fix | Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Weeks | Baseline | 15.7 units on a scale | Standard Deviation 6.2 |
| Restorelle Direct Fix | Sexual Function After Vaginal Reconstruction With Restorelle Direct Fix Measured by Participant Sexual Function Questionnaire-12 (PISQ-12) at 6 Weeks | 6 weeks | 14.7 units on a scale | Standard Deviation 4.9 |
p-value: 0.202t-test, 2 sided