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Completed

NCT Number: NCT01299363

Dilators for Dyspareunia Prevention

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.

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Key information

Conditions

Post-operative Dyspareunia Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Prolapse Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dilator use

Behavioral

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

Primary outcomes

  1. 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

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Collaborators

  • American College of Obstetricians and Gynecologists

Registry information

Official study title

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

Acronym: DDS

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Feb 18, 2011
Registry last updated
Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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