Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy
This trial is active, not recruiting.
|Sponsor||University of Alabama at Birmingham|
|Start date||July 2012|
|End date||July 2016|
|Trial size||66 participants|
|Trial identifier||NCT01779739, FaVR@UAB2012|
This is a single center, double-blind, randomized controlled trial evaluating the change in sexual function in women undergoing vaginal repair for pelvic organ prolapse. Participants will be sexually active women who agree to randomization to having perineorrhaphy added to or excluded from their surgical repair. We hypothesize that sexual function will improve more significantly in women undergoing vaginal repair with perineorrhaphy.
|Intervention model||single group assignment|
|Masking||double blind (subject, outcomes assessor)|
Change in sexual function as measured by validated questionnaire
time frame: 6 months and 12 months after surgery
time frame: 6 months, 12 months
Female participants from 19 years up to 105 years old.
Inclusion Criteria: - sexually active - genital hiatus measured between 4 and 6 centimeters - desires sexual function - undergoing vaginal repair with native tissues - agrees to use vaginal estrogen for 12 months after surgery Exclusion Criteria: - genital hiatus > 6 cm - planned obliterative procedure - perineal body length <0.5cm - disrupted external anal sphincter
|Official title||Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy|
|Principal investigator||Holly E Richter, PhD, MD|
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