Clinical Trial: Dilators for Dyspareunia Prevention

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Vaginal Dilators for Prevention of De Novo Dyspareunia After Prolapse Surgery: A Randomized Controlled Trial

Brief Summary: This is a randomized clinical trial comparing rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with traditional posterior repair. Our hypothesis is daily use of vaginal dilators from post-op week 4 through week 8 after posterior repair will reduce the rate of de novo dyspareunia.

Detailed Summary:
Sponsor: Medstar Health Research Institute

Current Primary Outcome: To compare rates of de novo dyspareunia in women with and without vaginal dilator use following surgery for pelvic organ prolapse with posterior repair (colporrhaphy). [ Time Frame: 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Sexual function [ Time Frame: 6 month ]
  Change in sexual function after vaginal reconstructive surgery with or without vaginal dilator use as assessed by FSFI and PISQ-12
• Physical exam [ Time Frame: 6 months ]
  Change in vaginal caliber and POP Q measurements 3 and 6 months after vaginal reconstructive surgery and its relation to sexual function scores and rates of dyspareunia.

Original Secondary Outcome: Same as current

Information By: Medstar Health Research Institute

Dates:
Date Received: February 14, 2011
Date Started: September 2010
Date Completion:
Last Updated: April 7, 2015
Last Verified: April 2015