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NCT03885791 · ClinicalTrials.gov registry record · NA
Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain
A NA study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 165
- Enrollment target
NCT03885791: Completed NA study, sponsored by Washington University School of Medicine.
NCT03885791 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 165 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03885791, a NA study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 165 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE vaginal cryotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2019-03-22 |
| Est. Completion | 2024-07-24 |
| Phase | NA |
What the finished NCT03885791 record still lists
NCT03885791 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which vaginal cryotherapy is the first listed.
NCT03885791 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03885791 about?
NCT03885791 is a clinical study titled "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...
What is the current status of trial NCT03885791?
This trial is currently completed. It is a NA study. The enrollment target is 165 participants. The study started on 2019-03-22. Estimated completion is 2024-07-24.
What interventions are being tested in trial NCT03885791?
The interventions under investigation include: vaginal cryotherapy (DEVICE).
Who is sponsoring clinical trial NCT03885791?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03885791's enrollment target sits among peer trials
165 626th of 2000 higher than 1,375 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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