Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy

Not Applicable

Completed

• Conditions: Sexual Function
• Interventions: Procedure: Perineorrhaphy

• Registration Number: NCT01779739
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-01-28
• Study First Submitted QC: 2013-01-28
• Study First Posted: 2013-01-30
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

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

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Exclusion Criteria

• genital hiatus > 6 cm
• planned obliterative procedure
• perineal body length <0.5cm
• disrupted external anal sphincter

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Perineorrhaphy	Perineorrhaphy	Subjects will have a perineorrhaphy added to the vaginal repair of prolapse

Primary Outcome Measures

Name	Time	Method
Change in sexual function as measured by validated questionnaire	6 months and 12 months after surgery	Validated questionnaires will be administered prior to surgery, as well as at intervals after surgery.

Secondary Outcome Measures

Name	Time	Method
Prolapse recurrence	6 months, 12 months	A composite outcome score to define success of prolapse surgery will be applied to subjects at 6 and 12 months specifically looking for return of prolapse symptoms, anatomic recurrence, and need for retreatment

Trial Locations

Locations (2)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States