Overview

This trial is active, not recruiting.

Condition sexual function
Treatment perineorrhaphy
Sponsor University of Alabama at Birmingham
Start date July 2012
End date July 2016
Trial size 66 participants
Trial identifier NCT01779739, FaVR@UAB2012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
Subjects will not have a perineorrhaphy procedure added to the vaginal prolapse repair
(Active Comparator)
Subjects will have a perineorrhaphy added to the vaginal repair of prolapse
perineorrhaphy
Procedure to build up the vaginal opening

Primary Outcomes

Measure
Change in sexual function as measured by validated questionnaire
time frame: 6 months and 12 months after surgery

Secondary Outcomes

Measure
Prolapse recurrence
time frame: 6 months, 12 months

Eligibility Criteria

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

Additional Information

Official title Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy
Principal investigator Holly E Richter, PhD, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Alabama at Birmingham.