Pelvic Floor Repair Systems for Prolapse Repair

Completed

Conditions: Pelvic Organ Prolapse

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

Registration Number: NCT00638235

Lead Sponsor: ASTORA Women's Health

Brief Summary: 1. This is a prospective, multi-center, post market study, which will be conducted under a common protocol.

2. The primary objective of the study is to evaluate long-term efficacy of the AMS Pelvic Floor Repair System devices for prolapse repair.

3. The study population is female subjects \> 21 years of age who require surgical reconstruction of their pelvic floor due to prolapse.

4. The clinical data will be analyzed by comparing post-treatment data with the baseline data, with the subject acting as her own control. The follow-up is for two years after the procedure.

5. Prolapse improvement measured by ICS POP-Q Stage at 12-months will be the primary endpoint of the study. The secondary endpoints include quality of life changes from baseline and adverse event rates.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 725

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).

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase I (IntePro, US only)	AMS Apogee™ with IntePro	AMS Apogee™ with IntePro(Began May 2006 - Closed)
Phase I (InteXen LP, US only)	AMS Apogee™ with Intexen LP	AMS Apogee™ with InteXen LP (Began May 2006 - Closed)
Phase V (Elevate Posterior InteXen, US only)	AMS Elevate™ Apical & Posteiror with IntXen LP	AMS Elevate™ Apical \& Posteiror with IntXen LP (Began April 2008 - Closed)
Phase VI (Elevate Anterior Gen 1, For Study Use Only, EU only)	AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)	AMS Elevate™ Anterior \& Apical with IntePro Lite (Generation 1, For Study Use Only, Began October 2008 - Closed)
Phase II (France only)	AMS Perigee™ with IntePro	AMS Perigee™ with IntePro (Began February 2007 - Closed)
Phase III/IV (Perigee IntePro Lite, US only)	AMS Perigee™ with IntePro Lite	AMS Perigee™ with IntePro Lite (Began April 2007 - Closed)
Phase III/IV (Apogee IntePro Lite, US only)	AMS Apogee™ with IntePro Lite	AMS Apogee™ with IntePro Lite (Began April 2007 - Closed)
Phase V (Elevate Posterior IntePro Lite, US & EU)	AMS Elevate™ Apical & Posteiror with IntePro Lite	AMS Elevate™ Apical \& Posteiror with IntePro Lite (Began April 2008 - Closed)
Phase VII (Elevate Anterior Gen 2, US & EU)	AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)	AMS Elevate™ Anterior \& Apical with IntePro Lite (Generation 2, Began April 2009 - Closed)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (28): Kaiser Permanente - Dept. of Obstetrics & Gynecology
🇺🇸
Downey, California, United States
Institute for Women's Health & Body
🇺🇸
Wellington, Florida, United States
Atlanta Medical Research Institute
🇺🇸
Alpharetta, Georgia, United States
Female Pelvic Health
🇺🇸
Whitinsville, Massachusetts, United States
Female Pelvic Medicine and Urogynecology Inst. of Michigan
🇺🇸
Grand Rapids, Michigan, United States
Michigan Medical P.C.
🇺🇸
Grand Rapids, Michigan, United States
Piedmont Urology Associates
🇺🇸
Gastonia, North Carolina, United States
Women's Health Care Specialists, PC
🇺🇸
Paw Paw, Michigan, United States
Metro Urology
🇺🇸
Plymouth, Minnesota, United States
University of Tennessee - Dept of Obstetrics & Gynecology
🇺🇸
Memphis, Tennessee, United States
Texas Tech University Health Science Center - OB/GYN Department
🇺🇸
El Paso, Texas, United States
CMC Beau Soleil
🇫🇷
Montpellier, France
UZ Leuven Dept of Urology
🇧🇪
Leuven, Belgium
Service urologie de Paris l'Hôpital Tenon
🇫🇷
Paris, France
CHU de Rouen - Pavillon Derocque - Rez de Chaussée
🇫🇷
Rouen, France
Hopital Cochin - Saint-Vincent de Paul - Groupement hospitalier universitaire Ouest
🇫🇷
Paris, France
Dr. Rainer Lange
🇩🇪
Alzey, Germany
Beckenbodenzentrum Munich
🇩🇪
Munich, Germany
University of Amsterdam, Academic Medical Center - Department of Gynaecology and Obstetrics
🇳🇱
Amsterdam, Netherlands
Hospitalet General de l'Hospitalet
🇪🇸
Barcelona, Spain
University Hospital of Leicester NHS Trust
🇬🇧
Leicester, United Kingdom
Eastern Virginia Medical School
🇺🇸
Norfolk, Virginia, United States
Clinique Adassa
🇫🇷
Strasbourg, France
Maine Medical Partners
🇺🇸
Portland, Maine, United States
South Carolina OB/GYN
🇺🇸
Columbia, South Carolina, United States
Rosemark Womencare Specialists
🇺🇸
Idaho Falls, Idaho, United States
Fore River Urology
🇺🇸
Portland, Maine, United States
Huey & Weprin Obstetrics & Gynecology
🇺🇸
Englewood, Ohio, United States