Dilators for Dyspareunia Prevention

Phase 4

Completed

• Conditions: Post-operative Dyspareunia
• Interventions: Behavioral: Dilator use

• Registration Number: NCT01299363
• Lead Sponsor: Medstar Health Research Institute

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 Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Women who undergo pelvic organ prolapse surgery with a posterior repair
• Age ≥18 years
• Sexually active with heterosexual vaginal intercourse
• English speaking
• Available for 6 month follow up
• Able to complete study questionnaires
• Able to use dilators

Exclusion Criteria

• Significant baseline dyspareunia
• Pregnancy by self-report or positive pregnancy test
• Prior pelvic radiation therapy
• Active pelvic infection, herpes, candidiasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dilator use	Dilator use	Women randomized to vaginal dilators will be given instructions to perform softening exercises from postoperative weeks 4 to 8

Primary Outcome Measures

Name	Time	Method
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).	6 months

Secondary Outcome Measures

Name	Time	Method
Sexual function	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	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.

Trial Locations

Locations (1)

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States