Pelvic Floor Repair Systems for Prolapse Repair

Study Overview
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Brief Summary
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This is a prospective, multi-center, post market study, which will be conducted under a common protocol. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair. The study population is female subjects > 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse. The clinical data will be analyzed by comparing post-treatment data with the baseline data, with the subject acting as her own control. The follow-up is for two years after the procedure. Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary endpoint of the study. The secondary endpoints include quality of life changes from baseline and adverse event rates.

Official Title
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A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair

Conditions
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Pelvic Organ Prolapse

Intervention / Treatment
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* Device: AMS Apogee™ with IntePro
* Device: AMS Apogee™ with Intexen LP
* Device: AMS Perigee™ with IntePro
* Device: AMS Perigee™ with IntePro Lite
* Device: AMS Apogee™ with IntePro Lite
* Device: AMS Elevate™ Apical & Posteiror with IntePro Lite
* Device: AMS Elevate™ Apical & Posteiror with IntXen LP
* Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)
* Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Have been diagnosed with one or more clinically significant anterior, apical or posterior genital prolapse disorder(s) (symptomatic POP-Q stage II or higher) requiring surgical repair Exclusion Criteria: The Investigator determines the subject is not a candidate for surgical repair of her genital prolapse. Subject has had a prior prolapse implant/procedure (i.e., IVS tunneler, Perigee, Apogee, graft augmented repair, etc) Note: previous traditional repairs are allowed. Subject has active or latent systemic infection or signs of tissue necrosis. Subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement/prosthesis. Subject is currently pregnant or intends to become pregnant during the study period. Note: the risks and benefits of performing the procedure if the subject is planning future pregnancies should be carefully considered. Subject has had radiation therapy to the pelvic area. Subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months. Subject has a known hypersensitivity to the graft material(s). Subject has uncontrolled diabetes. Subject is on any medication which could result in compromised immune response, such as immune modulators. Subject was involved in any other research trial < 30 days of enrollment into this study. Subject has undergone previous pelvic surgery < 6 months prior to enrollment in this study. Subject is unwilling or unable to give valid informed consent. Subject is unwilling or unable to comply with the requirements of the protocol, complete all Quality of Life questionnaires and return for all follow-up visits. Subject is contraindicated based on intended use and warnings in the AMS PFR System devices for prolapse repair Instructions for Use (IFU).

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase I (IntePro, US only)<br>AMS Apogee™ with IntePro(Began May 2006 - Closed) | Device: AMS Apogee™ with IntePro<br>* Mesh implant for posterior wall pelvic organ prolapse<br>|
| Phase I (InteXen LP, US only)<br>AMS Apogee™ with InteXen LP (Began May 2006 - Closed) | Device: AMS Apogee™ with Intexen LP<br>* Graft implant for posterior wall pelvic organ prolapse<br>|
| Phase II (France only)<br>AMS Perigee™ with IntePro (Began February 2007 - Closed) | Device: AMS Perigee™ with IntePro<br>* Mesh implant for anterior wall pelvic organ prolapse<br>|
| Phase III/IV (Perigee IntePro Lite, US only)<br>AMS Perigee™ with IntePro Lite (Began April 2007 - Closed) | Device: AMS Perigee™ with IntePro Lite<br>* Mesh implant for anterior wall pelvic organ prolapse<br>|
| Phase III/IV (Apogee IntePro Lite, US only)<br>AMS Apogee™ with IntePro Lite (Began April 2007 - Closed) | Device: AMS Apogee™ with IntePro Lite<br>* Mesh implant for posterior wall pelvic organ prolapse<br>|
| Phase V (Elevate Posterior IntePro Lite, US & EU)<br>AMS Elevate™ Apical & Posteiror with IntePro Lite (Began April 2008 - Closed) | Device: AMS Elevate™ Apical & Posteiror with IntePro Lite<br>* Mesh implant for apical and posterior wall pelvic organ prolapse<br>|
| Phase V (Elevate Posterior InteXen, US only)<br>AMS Elevate™ Apical & Posteiror with IntXen LP (Began April 2008 - Closed) | Device: AMS Elevate™ Apical & Posteiror with IntXen LP<br>* Graft implant for apical and posterior wall pelvic organ prolapse<br>|
| Phase VI (Elevate Anterior Gen 1, For Study Use Only, EU only)<br>AMS Elevate™ Anterior & Apical with IntePro Lite (Generation 1, For Study Use Only, Began October 2008 - Closed) | Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)<br>* Mesh implant for anteiror and apical wall pelvic organ prolapse<br>|
| Phase VII (Elevate Anterior Gen 2, US & EU)<br>AMS Elevate™ Anterior & Apical with IntePro Lite (Generation 2, Began April 2009 - Closed) | Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)<br>* Mesh implant for anteiror and apical wall pelvic organ prolapse<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure | Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 12-months | 
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure | Analysis includes only subjects with uterine descent >= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 12-months | 
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure | Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). A higher or increasing score represents an improvement in perceived sexual function versus baseline. Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included. | 6 Months | 
| Procedural Time | Procedural time was measured as the time between the first incision to place the study device and the time to close the vaginal incision for the study device. Procedure duration in minutes | Approximately 30 minutes | 
| Estimated Blood Loss | Estimated Blood Loss - defined as the estimated blood loss associated with the implantation of the study device, measured in ml | Approximately 30 minutes | 
| Percent of Subjects Experiencing Major Device Related Complications | This may have included: perforation of internal organs during the implant procedure; graft erosion; serious infection requiring intravenous antibiotics; death, related to procedure or device; blood loss related to device placement which may have required blood transfusion during the procedure | Through 24 months | 
| Rate of Graft Extrusions | Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall | Through 24 months | 
| Rates of de Novo or Worsening Urinary and/or Anal Incontinence | Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence | Through 24 months | 
| Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure | Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale (scale of 0-10, with 10 indicating hurts worst) at baseline, and 6 weeks post procedure | baseline and 6 weeks | 
| Patient Satisfaction Questionnaire at 6 Months by Question (Q#1) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. | 6 Months | 
| Surgical Revision Rate | The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution. | Through 24 months | 
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months | The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 6 months | 
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months | The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. Note: Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design | 24 months | 
| Patient Satisfaction Questionnaire at 12 Months by Question (Q#1) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. | 12 months | 
| Patient Satisfaction Questionnaire at 24 Months by Question (Q#1) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. Note: Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design | 24 months | 
| Patient Satisfaction Questionnaire at 6 Months by Question (Q#2) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. | 6 months | 
| Patient Satisfaction Questionnaire at 12 Months by Question (Q#2) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure. | 12 months | 
| Patient Satisfaction Questionnaire at 24 Months by Question (Q#2) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note: Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design | 24 months | 
| Patient Satisfaction Questionnaire at 6 Months by Question (Q#3) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. | 6 months | 
| Patient Satisfaction Questionnaire at 12 Months by Question (Q#3) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure. | 12 months | 
| Patient Satisfaction Questionnaire at 24 Months by Question (Q#3) | Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note: Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design | 24 months | 
| Wong-Baker Faces Pain Scale at 3 Months Post Procedure | Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale at baseline and 3 months post procedure | baseline and 3 months | 
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | 12 months | 
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12 | Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 24 months | 
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M | Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. . | baseline and 6 months | 
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M | Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 12 months | 
| QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M | Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 24 months | 
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M | Quality of Life as measure by PFDI subscale UDI. UDI scale ranges from 0-100 with 100 representing the most urinary distress. Changes in UDI scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 6 months | 
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 12 months | 
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 24 months | 
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 6 months | 
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 6 months | 
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 12 months | 
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 24 months | 
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 12 months | 
| QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M | Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. | baseline and 24 months | 
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure | Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 6 months | 
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure | Analysis includes only subjects with posterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 24 months | 
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure | Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 6 months | 
| Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure | Analysis includes only subjects with anterior vaginal wall prolapse >= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage < stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pelvic floor repair, prolapse, mesh