Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy (FaVR)

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.

Study Overview

• Status: Completed
• Conditions: Sexual Function
• Intervention / Treatment: Procedure: Perineorrhaphy

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sexual function as measured by validated questionnaire	Validated questionnaires will be administered prior to surgery, as well as at intervals after surgery.	6 months and 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prolapse recurrence	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	6 months, 12 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Study Director: Candace Y Parker-Autry, MD, Wake Forest

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: January 28, 2013
• First Submitted That Met QC Criteria: January 28, 2013
• First Posted (Estimate): January 30, 2013

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 21, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: sexual dysfunction; vaginal prolapse; sexual function; prolapse surgery
• Other Study ID Numbers: IRB00037135

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No