Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Sexual Function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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No perineorrhaphy

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Perineorrhaphy

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

Group Type ACTIVE_COMPARATOR

Perineorrhaphy

Intervention Type PROCEDURE

Procedure to build up the vaginal opening

Interventions

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Perineorrhaphy

Procedure to build up the vaginal opening

Intervention Type PROCEDURE

Eligibility Criteria

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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