CompletedNot Applicable

Anterior Prolapse Repair With and Without Graft Augmentation

114 participantsStarted 2005-01

Plain-language summary

This is a randomized control trial comparing anterior colporrhaphy with augmentation with dermal allograft (ARCUS) to anterior colporrhaphy with a suture-based repair (native tissue). Patients were randomized to one treatment and then were followed post-operatively for 7-10 years. Prior to surgery patients had a POPQ vaginal prolapse exam and completed a quality of life questionaire (PFDI). They had a repeat POPQ exam and quality of life questionaires at their post-op operative visits. We compare recurrent prolapse rates between these 2 groups.

Who can participate

Age range18 Years – 100 Years

SexFEMALE

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: Any patient planning to undergo surgery for anterior compartment prolapse, English speaking. \- Exclusion Criteria: Any patient who does not speak English due to standardized English language based questionaires, and patients without anterior compartment prolapse. \-

What they're measuring

1-Year Recurrent prolapse- anatomic

Timeframe: 1 year post-operative

7-10 Years Recurrent prolapse-anatomic

Timeframe: 7-10 years post-operative

Trial details

NCT IDNCT04085952

SponsorEndeavor Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-01

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials