NCT00638235

Pelvic Floor Repair Systems for Prolapse Repair

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 725 (actual)
• Sponsor: ASTORA Women's Health · Industry
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
DEVICE	AMS Apogee™ with IntePro	Mesh implant for posterior wall pelvic organ prolapse
DEVICE	AMS Apogee™ with Intexen LP	Graft implant for posterior wall pelvic organ prolapse
DEVICE	AMS Perigee™ with IntePro	Mesh implant for anterior wall pelvic organ prolapse
DEVICE	AMS Perigee™ with IntePro Lite	Mesh implant for anterior wall pelvic organ prolapse
DEVICE	AMS Apogee™ with IntePro Lite	Mesh implant for posterior wall pelvic organ prolapse
DEVICE	AMS Elevate™ Apical & Posteiror with IntePro Lite	Mesh implant for apical and posterior wall pelvic organ prolapse
DEVICE	AMS Elevate™ Apical & Posteiror with IntXen LP	Graft implant for apical and posterior wall pelvic organ prolapse
DEVICE	AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 1, For Study Use Only)	Mesh implant for anteiror and apical wall pelvic organ prolapse
DEVICE	AMS Elevate™ Anterior & Apical with IntePro Lite (Gen 2)	Mesh implant for anteiror and apical wall pelvic organ prolapse

Timeline

• Start date: 2006-05-01
• Primary completion: 2011-02-01
• Completion: 2012-09-01
• First posted: 2008-03-19
• Last updated: 2016-10-28
• Results posted: 2016-10-28

Locations

28 sites across 7 countries: United States, Belgium, France, Germany, Netherlands, Spain, United Kingdom