Overview

This trial is active, not recruiting.

Condition pelvic organ prolapse
Treatments ams apogee™ with intepro (synthetic) or intexen (biologic), ams perigee™ with intepro, ams apogee™ with intepro lite and/or ams perigee™ with intepro lite, ams elevate™ apical & posterior, ams elevate™ apical & anterior (original design), ams elevate™ apical & anterior
Sponsor American Medical Systems
Start date May 2006
End date February 2011
Trial size 750 participants
Trial identifier NCT00638235, 1004, NCT00793039

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
AMS Apogee™ with IntePro or InteXen (Began May 2006 - Closed)
ams apogee™ with intepro (synthetic) or intexen (biologic)
Mesh implant for posterior wall pelvic organ prolapse
(Other)
Perigee™ with IntePro (Began February 2007 - Closed)
ams perigee™ with intepro
Mesh implant for anterior wall pelvic organ prolapse
(Other)
AMS Apogee™ with IntePro Lite and/or AMS Perigee™ with IntePro Lite (Began April 2007 - Closed)
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.
(Other)
AMS Elevate™ Apical & Posterior (Began April 2008 - Closed to enrollment)
ams elevate™ apical & posterior
Mesh implant for the treatment of apical and posterior wall pelvic organ prolapse
(Other)
AMS Elevate™ Apical & Anterior (Original design - began October 2008 - Closed)
ams elevate™ apical & anterior (original design)
Mesh implant for treatment of apical and anterior wall pelvic organ prolapse.
(Other)
AMS Elevate™ Apical & Anterior (Current design - began April 2009 - Closed to enrollment)
ams elevate™ apical & anterior
Mesh implant for the treatment of apical and anterior wall pelvic organ prolapse.

Primary Outcomes

Measure
Percent of subjects with an ICS POP-Q Stage of </= Stage I
time frame: 12-months

Secondary Outcomes

Measure
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
Procedural time
time frame: Procedure
Estimated blood loss
time frame: Procedure
Percent of subjects experiencing major device related complications
time frame: Through 24 months
Rate of graft extrusions
time frame: Through 24 months
Rates of de novo or worsening urinary and/or anal incontinence
time frame: Through 24 months
Percent of subjects with an ICS POP-Q Stage of </= Stage I
time frame: 6 and 24 months
Wong-Baker Faces Pain Scale
time frame: 6 weeks and 3 months
Patient Satisfaction Questionnaire
time frame: 6, 12, & 24 months
Surgical revision rate
time frame: Through 24 months

Eligibility Criteria

Female participants at least 21 years old.

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).

Additional Information

Official title A Prospective, Multi-Center Study to Assess the AMS Pelvic Floor Repair System Devices for Prolapse Repair
Principal investigator James C. Lukban, DO
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by American Medical Systems.