Pelvic Floor Repair Systems for Prolapse Repair

Pelvic Organ Prolapse Clinical Trial

— PROPEL  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00638235
• Other study ID #: 1004
• Status: Active, not recruiting
• Phase: N/A
• First received: February 28, 2008
• Last updated: January 27, 2011
• Start date: May 2006
• Est. completion date: March 2012

Study information

• Verified date: January 2011
• Source: American Medical Systems
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardEurope: Ethics Committees
• Study type: Interventional

Clinical Trial Summary

1. This is a prospective, single arm, 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.

Other known NCT identifiers

• NCT00793039

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 750
• Est. completion date: March 2012
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• AMS Apogee™ with IntePro (Synthetic) or InteXen (Biologic)
Mesh implant for posterior wall pelvic organ prolapse
• AMS Perigee™ with IntePro
Mesh implant for anterior wall pelvic organ prolapse
• 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.
• AMS Elevate™ Apical & Posterior
Mesh implant for the treatment of apical and posterior wall pelvic organ prolapse
• AMS Elevate™ Apical & Anterior (original design)
Mesh implant for treatment of apical and anterior wall pelvic organ prolapse.
• AMS Elevate™ Apical & Anterior
Mesh implant for the treatment of apical and anterior wall pelvic organ prolapse.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
American Medical Systems

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of subjects with an ICS POP-Q Stage of </= Stage I		12-months	No
Secondary	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)		6, 12, & 24 months	No
Secondary	Procedural time		Procedure	No
Secondary	Estimated blood loss		Procedure	Yes
Secondary	Percent of subjects experiencing major device related complications		Through 24 months	Yes
Secondary	Rate of graft extrusions		Through 24 months	Yes
Secondary	Rates of de novo or worsening urinary and/or anal incontinence		Through 24 months	Yes
Secondary	Percent of subjects with an ICS POP-Q Stage of </= Stage I		6 and 24 months	No
Secondary	Wong-Baker Faces Pain Scale		6 weeks and 3 months	Yes
Secondary	Patient Satisfaction Questionnaire		6, 12, & 24 months	No
Secondary	Surgical revision rate		Through 24 months	Yes

External Links

•   AMS website