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Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy (FaVR)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
University of Alabama at Birmingham Identifier:
First received: January 28, 2013
Last updated: June 15, 2016
Last verified: June 2016
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.

Condition Intervention
Sexual Function
Procedure: Perineorrhaphy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Change in sexual function as measured by validated questionnaire [ Time Frame: 6 months and 12 months after surgery ] [ Designated as safety issue: No ]
    Validated questionnaires will be administered prior to surgery, as well as at intervals after surgery.

Secondary Outcome Measures:
  • Prolapse recurrence [ Time Frame: 6 months, 12 months ] [ Designated as safety issue: No ]
    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

Estimated Enrollment: 66
Study Start Date: July 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No perineorrhaphy
Subjects will not have a perineorrhaphy procedure added to the vaginal prolapse repair
Active Comparator: Perineorrhaphy
Subjects will have a perineorrhaphy added to the vaginal repair of prolapse
Procedure: Perineorrhaphy
Procedure to build up the vaginal opening


Ages Eligible for Study:   19 Years to 105 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01779739

United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Study Director: Candace Y Parker-Autry, MD University of Alabama at Birmingham
Principal Investigator: Holly E Richter, PhD, MD University of Alabama at Birmingham
  More Information

Responsible Party: University of Alabama at Birmingham Identifier: NCT01779739     History of Changes
Other Study ID Numbers: FaVR@UAB2012 
Study First Received: January 28, 2013
Last Updated: June 15, 2016
Health Authority: United States: Federal Government

Keywords provided by University of Alabama at Birmingham:
vaginal prolapse
sexual function
sexual dysfunction
prolapse surgery processed this record on October 21, 2016