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Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy (FaVR)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01779739
First Posted: January 30, 2013
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  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 (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy

Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Estimated Enrollment: 66
Study Start Date: July 2012
Estimated Study Completion Date: December 2017
Primary Completion Date: February 2017 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 105 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01779739


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Study Director: Candace Y Parker-Autry, MD Wake Forest
Principal Investigator: Holly E Richter, PhD, MD University of Alabama at Birmingham
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01779739     History of Changes
Other Study ID Numbers: IRB 36987
First Submitted: January 28, 2013
First Posted: January 30, 2013
Last Update Posted: October 24, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:
vaginal prolapse
sexual function
sexual dysfunction
prolapse surgery