Pelvic Floor Repair Systems for Prolapse Repair

Completed

Conditions studied: Pelvic Organ Prolapse

In brief

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.

Key facts

Study ID: NCT00638235
Run by: ASTORA Women's Health
People needed: 725
Starts: 2006-05-01
Expected to finish: 2012-09-01
Last updated by the study team: 2016-10-28

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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).

Where it is running

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
Rosemark Womencare Specialists — Idaho Falls, Idaho, United States
Fore River Urology — Portland, Maine, United States
Maine Medical Partners — Portland, Maine, 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
Women's Health Care Specialists, PC — Paw Paw, Michigan, United States
Metro Urology — Plymouth, Minnesota, United States
Piedmont Urology Associates — Gastonia, North Carolina, United States
Huey & Weprin Obstetrics & Gynecology — Englewood, Ohio, United States
South Carolina OB/GYN — Columbia, South Carolina, 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
Eastern Virginia Medical School — Norfolk, Virginia, United States
UZ Leuven Dept of Urology — Leuven, Belgium
CMC Beau Soleil — Montpellier, France
Service urologie de Paris l'Hôpital Tenon — Paris, France
Hopital Cochin - Saint-Vincent de Paul - Groupement hospitalier universitaire Ouest — Paris, France
CHU de Rouen - Pavillon Derocque - Rez de Chaussée — Rouen, France
Clinique Adassa — Strasbourg, France
Dr. Rainer Lange — Alzey, Germany
Beckenbodenzentrum Munich — Munich, Germany

Full record on ClinicalTrials.gov

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