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Pelvic Floor Myofascial PainNCT03885791

Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

A study testing vaginal cryotherapy in people with Pelvic Floor Myofascial Pain and Pelvic Pain, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
vaginal cryotherapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
165 participants
Where
1 siteUnited States
Study dates
22 Mar 2019to 24 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    St Louis, Missouri, 63110

Other trials in United States

About this study

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.

Being tested
vaginal cryotherapy
Medical subject headings
Pelvic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vaginal cryotherapyDevice

    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.

Study groups in NCT03885791
Study groupRoleWhat they receive
Vaginal cryotherapy - interventionExperimentalThe 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.
Receives: Device: vaginal cryotherapy
Vaginal cryotherapy - controlPlacebo comparatorThe 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.
Receives: Device: vaginal cryotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in myofascial pain score

    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.

    Measured: 10-15 minutes (Pre- to post-treatment)

Secondary outcomes (5)

  1. Pelvic Floor Distress Inventory-20

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

    Measured: 2 weeks

  2. Pelvic Floor Impact Questionnaire-7

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

    Measured: 2 weeks

  3. Prolapse and Incontinence Sexual Questionnaire

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

    Measured: 2 weeks

  4. Urogenital Distress Inventory

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

    Measured: 2 weeks

  5. Lower Urinary Tract Symptoms (LUTS) Tool

    Validated questionnaire to assess lower urinary tract symptoms

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2019
  2. Study start22 Mar 2019
  3. Primary completion24 Jul 2024
  4. Study completion24 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03885791
Sponsor's protocol ID
201901209
Status last verified
Feb 2026
First submitted
15 Mar 2019
Last updated
24 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sexton CC, Coyne KS, Kopp ZS, Irwin DE, Milsom I, Aiyer LP, Tubaro A, Chapple CR, Wein AJ; EpiLUTS Team. The overlap of storage, voiding and postmicturition symptoms and implications for treatment seeking in the USA, UK and Sweden: EpiLUTS. BJU Int. 2009 Apr;103 Suppl 3:12-23. doi: 10.1111/j.1464-410X.2009.08369.x.

    PubMed 19302498

  • Adams K, Gregory WT, Osmundsen B, Clark A. Levator myalgia: why bother? Int Urogynecol J. 2013 Oct;24(10):1687-93. doi: 10.1007/s00192-013-2089-8. Epub 2013 Apr 11.

    PubMed 23575699

  • Pastore EA, Katzman WB. Recognizing myofascial pelvic pain in the female patient with chronic pelvic pain. J Obstet Gynecol Neonatal Nurs. 2012 Sep-Oct;41(5):680-91. doi: 10.1111/j.1552-6909.2012.01404.x. Epub 2012 Aug 3.

    PubMed 22862153

  • Spitznagle TM, Robinson CM. Myofascial pelvic pain. Obstet Gynecol Clin North Am. 2014 Sep;41(3):409-32. doi: 10.1016/j.ogc.2014.04.003. Epub 2014 Jul 9.

    PubMed 25155122

  • Borg-Stein J, Iaccarino MA. Myofascial pain syndrome treatments. Phys Med Rehabil Clin N Am. 2014 May;25(2):357-74. doi: 10.1016/j.pmr.2014.01.012. Epub 2014 Mar 17.

    PubMed 24787338

  • Bedaiwy MA, Patterson B, Mahajan S. Prevalence of myofascial chronic pelvic pain and the effectiveness of pelvic floor physical therapy. J Reprod Med. 2013 Nov-Dec;58(11-12):504-10.

    PubMed 24568045

  • Nadler SF, Weingand K, Kruse RJ. The physiologic basis and clinical applications of cryotherapy and thermotherapy for the pain practitioner. Pain Physician. 2004 Jul;7(3):395-9.

    PubMed 16858479

  • Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.

    PubMed 11857671

  • Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp Z, Herschorn S, Coyne K, Kelleher C, Hampel C, Artibani W, Abrams P. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006 Dec;50(6):1306-14; discussion 1314-5. doi: 10.1016/j.eururo.2006.09.019. Epub 2006 Oct 2.

    PubMed 17049716

  • Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 2011 Oct;108(7):1132-8. doi: 10.1111/j.1464-410X.2010.09993.x. Epub 2011 Jan 13.

    PubMed 21231991

  • Kalder M, Pantazis K, Dinas K, Albert US, Heilmaier C, Kostev K. Discontinuation of treatment using anticholinergic medications in patients with urinary incontinence. Obstet Gynecol. 2014 Oct;124(4):794-800. doi: 10.1097/AOG.0000000000000468.

    PubMed 25198276

  • Latthe P, Latthe M, Say L, Gulmezoglu M, Khan KS. WHO systematic review of prevalence of chronic pelvic pain: a neglected reproductive health morbidity. BMC Public Health. 2006 Jul 6;6:177. doi: 10.1186/1471-2458-6-177.

    PubMed 16824213

  • Sedighimehr N, Manshadi FD, Shokouhi N, Baghban AA. Pelvic musculoskeletal dysfunctions in women with and without chronic pelvic pain. J Bodyw Mov Ther. 2018 Jan;22(1):92-96. doi: 10.1016/j.jbmt.2017.05.001. Epub 2017 May 3.

    PubMed 29332764

  • Peters KM, Carrico DJ. Frequency, urgency, and pelvic pain: treating the pelvic floor versus the epithelium. Curr Urol Rep. 2006 Nov;7(6):450-5. doi: 10.1007/s11934-006-0053-6.

    PubMed 17052440

  • Moldwin RM, Fariello JY. Myofascial trigger points of the pelvic floor: associations with urological pain syndromes and treatment strategies including injection therapy. Curr Urol Rep. 2013 Oct;14(5):409-17. doi: 10.1007/s11934-013-0360-7.

    PubMed 23943509

Questions about this trial

What is this clinical trial studying?

A study testing vaginal cryotherapy in people with Pelvic Floor Myofascial Pain and Pelvic Pain, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in myofascial pain score (time frame: 10-15 minutes (Pre- to post-treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03885791, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.

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