Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy

Sexual Function Clinical Trial

— FaVR  

Official title:

Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779739
• Other study ID #: IRB00037135
• Status: Completed
• Phase: N/A
• First received: January 28, 2013
• Last updated: February 21, 2018
• Start date: July 2012
• Est. completion date: February 2017

Study information

• Verified date: February 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT03333811

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 105 Years

Eligibility

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

Related Conditions & MeSH terms

• Sexual Function

Intervention

Procedure:
• Perineorrhaphy
Procedure to build up the vaginal opening

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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