Outcomes of Anterior Colporrhaphy Versus Graft Reinforced Anterior Prolapse Repair
Completed · Phase 4
Conditions studied: Cystocele, Uterine Prolapse, Urinary Incontinence
In brief
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.
Key facts
- Study ID
- NCT00535301
- Run by
- Kaiser Permanente
- People needed
- 75
- Starts
- 2005-01-01
- Expected to finish
- 2008-04-01
- Last updated by the study team
- 2015-04-22
Who can join
Age: 21 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- stage II or greater anterior vaginal prolapse requiring surgical correction
- age 21 years and older
You may not qualify if…
- 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
Where it is running
- Kaiser Permanente — Downey, California, United States
Full record on ClinicalTrials.gov
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