Dilators for Dyspareunia Prevention (DDS)

April 7, 2015 updated by: Medstar Health Research Institute

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No dilator use
Active Comparator: Dilator use
Women randomized to vaginal dilators will be given instructions to perform softening exercises from postoperative weeks 4 to 8
Behavioral: Dilator use
Women randomized to vaginal dilators will be given instructions to perform exercises with vaginal dilators from postoperative weeks 4 to 8

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 month
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medstar Health Research Institute

Collaborators

American College of Obstetricians and Gynecologists

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 17, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Estimate)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-229

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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