CompletedPhase 4

Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair

United States75 participantsStarted 2005-01

Plain-language summary

The purpose of this study is determine whether grafted anterior vaginal prolapse repair is more effective and associated with less complications than prolapse repair with suture.

Who can participate

Age range21 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: * stage II or greater anterior vaginal prolapse requiring surgical correction * age 21 years and older Exclusion Criteria: * less than Stage II anterior vaginal prolapse * decline participation * pregnant or contemplating future pregnancy * prior anterior vaginal prolapse repair with biologic or synthetic graft * active or latent systemic infection * compromised immune system * previous pelvic irradiation or cancer * known hypersensitivity to polypropylene * uncontrolled diabetes mellitus * unable or unwilling to give valid informed consent * unable or unwilling to comply with the protocol * scheduled to undergo concomitant Burch colposuspension or pubovaginal sling

What they're measuring

Recurrent Stage II or Greater Anterior Vaginal Prolapse

Timeframe: three years

Trial details

NCT IDNCT00535301

SponsorKaiser Permanente

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-04

Results submitted2011-05-04

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