Dilators for Dyspareunia Prevention (DDS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Medstar Research Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
American College of Obstetricians and Gynecologists
Information provided by (Responsible Party):
Danielle M. Antosh, Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01299363
First received: February 14, 2011
Last updated: April 13, 2012
Last verified: April 2012
  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: 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sexual function [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 54
Study Start Date: September 2010
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299363

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

No publications provided by Medstar Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Danielle M. Antosh, Principal Investigator, Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01299363     History of Changes
Other Study ID Numbers: 2010-229
Study First Received: February 14, 2011
Last Updated: April 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medstar 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
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014