Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03885791
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Pelvic Floor Myofascial Pain Pelvic Pain Myofascial Pain Device: vaginal cryotherapy Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain
Actual Study Start Date : March 22, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Vaginal cryotherapy - 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.
 Device: vaginal cryotherapy

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.
Placebo Comparator: Vaginal cryotherapy - control
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.
 Device: vaginal cryotherapy

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03885791


Contacts
Layout table for location contacts
Contact: Jerry Lowder, MD 3147471402 lowderj@wustl.edu
Contact: Haidy Morsy, MD 314-273-1905 h.morsy@wustl.edu

Locations
Layout table for location information
United States, Missouri
Center for Outpatient Health/Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jerry Lowder, MD    314-747-1402    lowderj@wustl.edu   
Contact: Haidy Morsy, MD    314-273-1905    h.morsy@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
  Study Documents (Full-Text)

Documents provided by Washington University School of Medicine:
Study Protocol and Statistical Analysis Plan  [PDF] March 15, 2019

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03885791    
Other Study ID Numbers: 201901209
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Myofascial Pain Syndromes
Pelvic Pain
Pain
 Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases