Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sexual Function Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Sexual Dysfunction, Physiological Urogenital Diseases Uterine Diseases Uterine Prolapse

Age range

19 year–105 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Perineorrhaphy

Procedure

Procedure to build up the vaginal opening

Primary outcomes

Change in sexual function as measured by validated questionnaire

Time frame: 6 months and 12 months after surgery

Validated questionnaires will be administered prior to surgery, as well as at intervals after surgery.

Secondary outcomes

Prolapse recurrence

Time frame: 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

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Acronym: FaVR

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Jan 30, 2013
Registry last updated: Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed