Pelvic Floor Repair Systems for Prolapse Repair (PROPEL)

Astora Women's Health

Status: Completed

Conditions: Pelvic Organ Prolapse

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

Study type: Observational

Funder types: Industry

Identifiers

NCT00638235

1004

Details and patient eligibility

About

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.

Enrollment: 725 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

725 participants in 9 patient groups

Phase I (IntePro, US only)

Description:

AMS Apogee™ with IntePro(Began May 2006 - Closed)

Treatment:

Device: AMS Apogee™ with IntePro

Phase I (InteXen LP, US only)

Description:

AMS Apogee™ with InteXen LP (Began May 2006 - Closed)

Treatment:

Device: AMS Apogee™ with Intexen LP

Phase II (France only)

Description:

AMS Perigee™ with IntePro (Began February 2007 - Closed)

Treatment:

Device: AMS Perigee™ with IntePro

Phase III/IV (Perigee IntePro Lite, US only)

Description:

AMS Perigee™ with IntePro Lite (Began April 2007 - Closed)

Treatment:

Device: AMS Perigee™ with IntePro Lite

Phase III/IV (Apogee IntePro Lite, US only)

Description:

AMS Apogee™ with IntePro Lite (Began April 2007 - Closed)

Treatment:

Device: AMS Apogee™ with IntePro Lite

Phase V (Elevate Posterior IntePro Lite, US & EU)

Description:

AMS Elevate™ Apical \& Posteiror with IntePro Lite (Began April 2008 - Closed)

Treatment:

Device: AMS Elevate™ Apical & Posteiror with IntePro Lite

Phase V (Elevate Posterior InteXen, US only)

Description:

AMS Elevate™ Apical \& Posteiror with IntXen LP (Began April 2008 - Closed)

Treatment:

Device: AMS Elevate™ Apical & Posteiror with IntXen LP

Phase VI (Elevate Anterior Gen 1, For Study Use Only, EU only)

Description:

AMS Elevate™ Anterior \& Apical with IntePro Lite (Generation 1, For Study Use Only, Began October 2008 - Closed)

Treatment:

Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)

Phase VII (Elevate Anterior Gen 2, US & EU)

Description:

AMS Elevate™ Anterior \& Apical with IntePro Lite (Generation 2, Began April 2009 - Closed)

Treatment:

Device: AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)