Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy (FaVR)

Wake Forest University (WFU)

Status: Completed

Conditions: Sexual Function

Treatments: Procedure: Perineorrhaphy

Study type: Interventional

Funder types: Other

Identifiers

NCT01779739

IRB00037135

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: Female

Ages: 19 to 105 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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44 participants in 2 patient groups

No perineorrhaphy

No Intervention group

Description:

Subjects will not have a perineorrhaphy procedure added to the vaginal prolapse repair

Perineorrhaphy

Active Comparator group

Description:

Subjects will have a perineorrhaphy added to the vaginal repair of prolapse

Treatment:

Procedure: Perineorrhaphy