Dilators for Dyspareunia Prevention

Medstar Health Research Institute60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Post-operative Dyspareunia

Interventions

Dilator useBEHAVIORAL

Women randomized to vaginal dilators will be given instructions to perform exercises with vaginal dilators from postoperative weeks 4 to 8

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington Hospital Center

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

Sexual function

Change in sexual function after vaginal reconstructive surgery with or without vaginal dilator use as assessed by FSFI and PISQ-12

Time frame: 6 month

Physical exam

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.

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.