Pelvic Floor Repair Systems for Prolapse Repair

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

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

Sponsors & Collaborators

• ASTORA Women's Health

  lead INDUSTRY

Principal Investigators

• James C. Lukban, DO · Eastern Virginia Medical School

Eligibility

Min Age

21 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-05-31

Primary Completion

2011-02-28

Completion

2012-09-30

Countries

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

Study Locations