Observational Data Collection of Surgical Outcomes in the Treatment of Vaginal Prolapse With AMS Products

Completed

Conditions studied: Vaginal Prolapse

In brief

This registry was observational (only collected information typically noted by the surgeon when their patients were routinely seen); there was no change to the care the patient received as a result of being part of the registry). Data collection focused on the surgical outcomes of AMS prolapse products.

Key facts

Study ID

NCT00388947

Run by

ASTORA Women's Health

People needed

1543

Starts

2006-09-01

Expected to finish

2010-05-01

Last updated by the study team

2016-08-11

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female at least 21 years old
• Has pelvic organ prolapse requiring surgical repair
• Receives at least one of the AMS Prolapse Repair devices in the treatment of their pelvic organ prolapse

You may not qualify if…

• Is contraindicated for an AMS Prolapse Repair per the product's Instruction for Use.

Where it is running

• Samuel Zylstra, MD — Whitinsville, Massachusetts, United States

Full record on ClinicalTrials.gov

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