CompletedNot Applicable

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

United States1,543 participantsStarted 2006-09

Plain-language summary

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.

Who can participate

Age range

21 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Is contraindicated for an AMS Prolapse Repair per the product's Instruction for Use.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Count of Patients With at Least One Adverse Event Related to Any AMS Prolapse Device

Timeframe: up to 2-years post-implant

Trial details

NCT IDNCT00388947

SponsorASTORA Women's Health

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2010-05

Results submitted2012-08-03

View on ClinicalTrials.gov More Vaginal Prolapse trials