Pelvic Floor Repair Systems for Prolapse Repair (PROPEL)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by American Medical Systems.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
American Medical Systems
Information provided by:
American Medical Systems
ClinicalTrials.gov Identifier:
NCT00638235
First received: February 28, 2008
Last updated: January 27, 2011
Last verified: January 2011
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Purpose
- This is a prospective, single arm, 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.
| Condition | Intervention |
|---|---|
|
Pelvic Organ Prolapse |
Device: AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic) Device: AMS Perigee™ with IntePro Device: AMS Apogee™ with IntePro Lite and/or AMS Perigee™ with IntePro Lite Device: AMS Elevate™ Apical & Posterior Device: AMS Elevate™ Apical & Anterior (original design) Device: AMS Elevate™ Apical & Anterior |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair |
Resource links provided by NLM:
Further study details as provided by American Medical Systems:
Primary Outcome Measures:
- Percent of subjects with an ICS POP-Q Stage of </= Stage I [ Time Frame: 12-months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of Life as measure by Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Floor Distress Inventory (PFDI), and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) [ Time Frame: 6, 12, & 24 months ] [ Designated as safety issue: No ]
- Procedural time [ Time Frame: Procedure ] [ Designated as safety issue: No ]
- Estimated blood loss [ Time Frame: Procedure ] [ Designated as safety issue: Yes ]
- Percent of subjects experiencing major device related complications [ Time Frame: Through 24 months ] [ Designated as safety issue: Yes ]
- Rate of graft extrusions [ Time Frame: Through 24 months ] [ Designated as safety issue: Yes ]
- Rates of de novo or worsening urinary and/or anal incontinence [ Time Frame: Through 24 months ] [ Designated as safety issue: Yes ]
- Percent of subjects with an ICS POP-Q Stage of </= Stage I [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]
- Wong-Baker Faces Pain Scale [ Time Frame: 6 weeks and 3 months ] [ Designated as safety issue: Yes ]
- Patient Satisfaction Questionnaire [ Time Frame: 6, 12, & 24 months ] [ Designated as safety issue: No ]
- Surgical revision rate [ Time Frame: Through 24 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 750 |
| Study Start Date: | May 2006 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Phase I (US only)
AMS Apogee™ with IntePro or InteXen (Began May 2006 - Closed)
|
Device: AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic)
Mesh implant for posterior wall pelvic organ prolapse
|
|
Phase II (France only)
Perigee™ with IntePro (Began February 2007 - Closed)
|
Device: AMS Perigee™ with IntePro
Mesh implant for anterior wall pelvic organ prolapse
|
|
Phase III/IV (US only)
AMS Apogee™ with IntePro Lite and/or AMS Perigee™ with IntePro Lite (Began April 2007 - Closed)
|
Device: AMS Apogee™ with IntePro Lite and/or AMS Perigee™ with IntePro Lite
Mesh implant for the treatment of anterior and/or posterior wall pelvic organ prolapse.
|
|
Phase V (US & Europe)
AMS Elevate™ Apical & Posterior (Began April 2008 - Closed to enrollment)
|
Device: AMS Elevate™ Apical & Posterior
Mesh implant for the treatment of apical and posterior wall pelvic organ prolapse
|
|
Phase VI (Europe only)
AMS Elevate™ Apical & Anterior (Original design - began October 2008 - Closed)
|
Device: AMS Elevate™ Apical & Anterior (original design)
Mesh implant for treatment of apical and anterior wall pelvic organ prolapse.
|
|
Phase VII (US & Europe)
AMS Elevate™ Apical & Anterior (Current design - began April 2009 - Closed to enrollment)
|
Device: AMS Elevate™ Apical & Anterior
Mesh implant for the treatment of apical and anterior wall pelvic organ prolapse.
|
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638235
Hide Study Locations
Hide Study LocationsLocations
| United States, California | |
| Kaiser Permanente - Dept. of Obstetrics & Gynecology | |
| Downey, California, United States, 90242 | |
| United States, Florida | |
| Institute for Women's Health & Body | |
| Wellington, Florida, United States, 33414 | |
| United States, Georgia | |
| Atlanta Medical Research Institute | |
| Alpharetta, Georgia, United States, 30005 | |
| United States, Idaho | |
| Rosemark Womencare Specialists | |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Maine | |
| Maine Medical Partners | |
| Portland, Maine, United States, 04102 | |
| Fore River Urology | |
| Portland, Maine, United States, 04102 | |
| United States, Massachusetts | |
| Female Pelvic Health | |
| Whitinsville, Massachusetts, United States, 01588 | |
| United States, Michigan | |
| Female Pelvic Medicine and Urogynecology Inst. of Michigan | |
| Grand Rapids, Michigan, United States, 49503 | |
| Michigan Medical P.C. | |
| Grand Rapids, Michigan, United States, 49546 | |
| Women's Health Care Specialists, PC | |
| Paw Paw, Michigan, United States, 49079 | |
| United States, Minnesota | |
| Metro Urology | |
| Plymouth, Minnesota, United States, 55441 | |
| United States, North Carolina | |
| Piedmont Urology Associates | |
| Gastonia, North Carolina, United States, 28054 | |
| United States, Ohio | |
| Huey & Weprin Obstetrics & Gynecology | |
| Englewood, Ohio, United States, 45322 | |
| United States, South Carolina | |
| South Carolina OB/GYN | |
| Columbia, South Carolina, United States, 29201 | |
| United States, Tennessee | |
| University of Tennessee - Dept of Obstetrics & Gynecology | |
| Memphis, Tennessee, United States, 38103 | |
| United States, Texas | |
| Texas Tech University Health Science Center - OB/GYN Department | |
| El Paso, Texas, United States, 79905 | |
| United States, Virginia | |
| Eastern Virginia Medical School | |
| Norfolk, Virginia, United States, 23507 | |
| Belgium | |
| UZ Leuven Dept of Urology | |
| Leuven, Belgium | |
| France | |
| CMC Beau Soleil | |
| Montpellier, France, 34070 | |
| Service urologie de Paris l'Hôpital Tenon | |
| Paris, France, 75020 | |
| Hopital Cochin - Saint-Vincent de Paul - Groupement hospitalier universitaire Ouest | |
| Paris, France | |
| CHU de Rouen - Pavillon Derocque - Rez de Chaussée | |
| Rouen, France, 76031 | |
| Clinique Adassa | |
| Strasbourg, France, 67082 | |
| Germany | |
| Dr. Rainer Lange | |
| Alzey, Germany, 55232 | |
| Beckenbodenzentrum Munich | |
| Munich, Germany, 81679 | |
| Netherlands | |
| University of Amsterdam, Academic Medical Center - Department of Gynaecology and Obstetrics | |
| Amsterdam, Netherlands, 1105AZ | |
| Spain | |
| Hospitalet General de l'Hospitalet | |
| Barcelona, Spain, 08906 | |
| United Kingdom | |
| University Hospital of Leicester NHS Trust | |
| Leicester, United Kingdom, LE5 4PW | |
Sponsors and Collaborators
American Medical Systems
Investigators
| Principal Investigator: | James C. Lukban, DO | Eastern Virginia Medical School |
More Information
Additional Information:
No publications provided
| Responsible Party: | Steven Madej/Clinical Project Leader, AMS |
| ClinicalTrials.gov Identifier: | NCT00638235 History of Changes |
| Obsolete Identifiers: | NCT00793039 |
| Other Study ID Numbers: | 1004 |
| Study First Received: | February 28, 2008 |
| Last Updated: | January 27, 2011 |
| Health Authority: | United States: Institutional Review Board Europe: Ethics Committees |
Keywords provided by American Medical Systems:
|
Pelvic floor repair prolapse mesh |
Additional relevant MeSH terms:
|
Prolapse Pelvic Organ Prolapse Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 19, 2013