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Could a cold tube ease pelvic pain? new study tests simple At-Home remedy

NCT ID NCT03885791

Symptom relief Sponsor: Washington University School of Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether placing a cold tube in the vagina for 10 minutes can reduce pelvic floor muscle pain in women. 165 women with pelvic pain used either a cold or room-temperature tube. Researchers measured pain changes right after use and after two weeks of daily use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
vaginal cryotherapy device
What this could lead to
If it works, this could offer a simple, at-home option for women to temporarily reduce pelvic floor muscle pain.
What could go wrong
This is a small, early-stage trial with no blinding, so results may be influenced by expectation. The treatment is only a short-term fix and not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

165 people

The number who actually took part.

Started

Mar 2019

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

myofascial pain syndrome Pelvic Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myofascial pain Pelvic floor myofascial pain Pelvic pain

Contacts and locations

Locations

  • Center for Outpatient Health/Washington University in St. Louis

    St Louis, Missouri, 63110, United States

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