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Dilators for Dyspareunia Prevention (DDS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01299363
First Posted: February 18, 2011
Last Update Posted: April 9, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American College of Obstetricians and Gynecologists
Information provided by (Responsible Party):
Medstar Health Research Institute
  Purpose
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.

Condition Intervention Phase
Post-operative Dyspareunia Behavioral: Dilator use Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Vaginal Dilators for Prevention of De Novo Dyspareunia After Prolapse Surgery: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Medstar Health Research Institute:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 60
Study Start Date: September 2010
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299363


Locations
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Health Research Institute
American College of Obstetricians and Gynecologists
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT01299363     History of Changes
Other Study ID Numbers: 2010-229
First Submitted: February 14, 2011
First Posted: February 18, 2011
Last Update Posted: April 9, 2015
Last Verified: April 2015

Keywords provided by Medstar Health Research Institute:
Prolapse
Pain with intercourse
Dyspareunia
Post operative pain

Additional relevant MeSH terms:
Dyspareunia
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Mental Disorders