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Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

Saint Louis, MO
N/A
Waitlist Available
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10-15 minutes (pre- to post-treatment)

Summary

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.

See full description
Eligible Conditions
  • Pelvic Floor Dysfunction
  • Chronic Prostatitis/Pelvic Pain Syndrome
  • Pelvic Pain
  • Myofascial Pain Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10-15 minutes (pre- to post-treatment)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10-15 minutes (pre- to post-treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
change in myofascial pain score
Secondary study objectives
Lower Urinary Tract Symptoms (LUTS) Tool
Pelvic Floor Distress Inventory-20
Pelvic Floor Impact Questionnaire-7
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vaginal cryotherapy - interventionExperimental Treatment1 Intervention
The intervention group will be provided with one vaginal cryotherapy tube, filled with a mixture of isopropyl alcohol (2ml) and water (8ml) that has been kept in the freezer. This mixture results in a "slushy" consistency and prevents the solution from freezing solid thus decreases the risk of discomfort or injury due to the temperature of the tube. Patients will insert this tube into the vagina to a comfortable depth. A lubricant will be provided for comfort with tube insertion, if necessary. At the conclusion of the treatment, this tube will be washed thoroughly and given to the patient in a clean plastic baggie for use at home. They will be instructed to store these tubes in their home freezer.
Group II: Vaginal cryotherapy - controlPlacebo Group1 Intervention
The control group will be provided with an identical tube that is empty. An empty tube was chosen as the control because a tube with room-temperature liquid may still be perceived as cold. Patients will insert this tube into the vagina to a comfortable depth. A lubricant will be provided for comfort with tube insertion, if necessary. At the conclusion of the treatment, this tube will be washed thoroughly and given to the patient in a clean plastic baggie for use at home. They will be instructed to store these tubes in their home at room temperature.

Find a Location

Closest Location:Center for Outpatient Health/Washington University in St. Louis· Saint Louis, MO

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
2,019 Previous Clinical Trials
2,349,415 Total Patients Enrolled
~19 spots leftby Mar 2026