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Completed

NCT Number: NCT03885791

Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

This is a placebo-controlled, randomized controlled trial to investigate the role of vaginal cryotherapy on pelvic floor myofascial pain in women. This study involves randomizing patients who are found to have pelvic floor myofascial pain on examination into one of two treatment groups: transvaginal cryotherapy or transvaginal application of a room-temperature tube. Patients will be followed up at two different time points in order to assess response to treatment. Follow-up times include immediately after application (Specific Aim #1) and two weeks following use of the intervention alone (Specific Aim #2). Patients will receive verbal and written instructions on using the intravaginal tubes by the research assistant who will not be blinded to treatment allocation. Patients will not be blinded to their treatment assignment but will not be given information on the alternative treatment. Patients will be referred to pelvic floor PT, which is considered the standard of care for treatment of pelvic floor myofascial pain at this time. As it typically takes 2-3 weeks to get in to see one of the pelvic floor PT providers at Wash U, follow up for this study will be completed prior to their attendance at pelvic floor PT. Patients will complete validated questionnaires assessing their pain, other pelvic floor symptoms, and acceptance of the intervention as a treatment option at the follow up time points.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Outpatient Health/Washington University in St. Louis

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult (>18yo)
  • Women
  • Patients found to have pelvic floor myofascial pain of at least 4/10 in severity at any of the four sites (right obturator internus, right levator ani, left levator ani, left obturator internus)

Exclusion criteria

  • Age <18
  • Non-English speaking
  • Current diagnosis of dementia
  • Limited physical mobility that would prevent full participation in pelvic floor PT.
  • Prior use of vaginal cryotherapy
  • Chief complaint or known history of pelvic pain

Treatment and study plan

vaginal cryotherapy

Device

Both groups will be given the same instructions for use, which will include intravaginal placement of one tube for 10 minutes while resting in a supine position. A lubricant may be used for comfort with insertion.

Patients will perform their first intervention in the office with a repeat examination within 10 minutes of completing therapy. Patients participating in Specific Aims #2 will perform the intervention once daily at home. Patients will be asked to complete a short diary for each session, which will include the time of day, duration of application, pain score prior to and after application, and presence of any pelvic floor disorder symptoms prior to and after application.

Primary outcomes

  1. change in myofascial pain score

    Time frame: 10-15 minutes (Pre- to post-treatment)

    Primary outcome is change in pelvic floor myofascial pain scores at each site (bilateral OI and LA) as measured on a 0-10 visual pain rating scale where 0 indicates no pain on palpation and 10 indicates 'worst pain imaginable' on palpation.

Secondary outcomes

  1. Pelvic Floor Distress Inventory-20

    Time frame: 2 weeks

    Short form of the validated questionnaire to assess presence and degree of bother of common pelvic floor symptoms

  2. Pelvic Floor Impact Questionnaire-7

    Time frame: 2 weeks

    Short form of the validated questionnaire to assess impact of pelvic floor symptoms on daily activities

  3. Prolapse and Incontinence Sexual Questionnaire

    Time frame: 2 weeks

    Short form of the validated questionnaire to assess the impact of pelvic floor symptoms on sexual activity

  4. Urogenital Distress Inventory

    Time frame: 2 weeks

    Validated questionnaire to assess presence and degree of bother of lower urinary tract symptoms

  5. Lower Urinary Tract Symptoms (LUTS) Tool

    Time frame: 2 weeks

    Validated questionnaire to assess lower urinary tract symptoms

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Mar 22, 2019
Registry last updated
Feb 24, 2026

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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