Dilators for Dyspareunia Prevention

Completed · Phase 4

Conditions studied: Post-operative Dyspareunia

In brief

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.

Key facts

Study ID

NCT01299363

Run by

Medstar Health Research Institute

People needed

60

Starts

2010-09-01

Expected to finish

2013-08-01

Last updated by the study team

2015-04-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Washington Hospital Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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