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Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy (FaVR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Alabama at Birmingham
Sponsor:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01779739
First received: January 28, 2013
Last updated: October 15, 2014
Last verified: January 2014
  Purpose

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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01779739

Contacts
Contact: Velria Willis, RN 205975-8522 vwillis@uabmc.edu
Contact: Candace Y Parker-Autry, MD 3367163779 cparkera@wakehealth.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Holly E Richter, PhD, MD    205-934-7874    hrichter@uabmc.edu   
Contact: Velria Willis, RN    2059758522    vwillis@uabmc.edu   
Principal Investigator: Holly E Richter, PhD, MD         
Sub-Investigator: Candace Parker-Autry, MD         
Sub-Investigator: R. Edward Varner, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01779739     History of Changes
Other Study ID Numbers: FaVR@UAB2012
Study First Received: January 28, 2013
Last Updated: October 15, 2014
Health Authority: United States: UAB Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
vaginal prolapse
sexual function
sexual dysfunction
prolapse surgery

ClinicalTrials.gov processed this record on November 20, 2014