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 range21 Years

SexFEMALE

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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.

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