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Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain

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ClinicalTrials.gov Identifier: NCT03885791
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE March 15, 2019
First Posted Date  ICMJE March 22, 2019
Last Update Posted Date December 4, 2020
Actual Study Start Date  ICMJE March 22, 2019
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
  • 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
  • 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
  • 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
  • Urogenital Distress Inventory [ Time Frame: 2 weeks ]
    Validated questionnaire to assess presence and degree of bother of lower urinary tract symptoms
  • Lower Urinary Tract Symptoms (LUTS) Tool [ Time Frame: 2 weeks ]
    Validated questionnaire to assess lower urinary tract symptoms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain
Official Title  ICMJE Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pelvic Floor Myofascial Pain
  • Pelvic Pain
  • Myofascial Pain
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.
    Intervention: Device: vaginal cryotherapy
  • 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.
    Intervention: Device: vaginal cryotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2019)
132
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date April 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jerry Lowder, MD 3147471402 lowderj@wustl.edu
Contact: Haidy Morsy, MD 314-273-1905 h.morsy@wustl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03885791
Other Study ID Numbers  ICMJE 201901209
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Washington University School of Medicine
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP