RECRUITING

NIRS for the Diagnosis of Myofascial Pelvic Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Myofascial Pelvic Pain (MPP) is an often-misdiagnosed condition affecting up to 26% of women during their lives and imposing enormous costs on national health care systems. It frequently involves comorbidities such as bladder, bowel, and sexual dysfunction. There are no quantitative measures that adequately guide the physician and accurate diagnosis typically requires an internal examination by a tertiary specialist. This study will develop and test an instrument to establish a normal range for near infrared spectroscopy (NIRS) optical changes associate with pelvic floor exercise in adult women based on the test-to test (intra-day) reliability of oxygen kinetics related to contraction of the pelvic floor muscle. We will establish the relationship between the quantitative NIRS data, the condition of Myofascial pelvic musculature and the symptomatology of MPP and related comorbidities. We will also evaluate prospectively the effectiveness of these data in predicting effective treatment modalities. Finally, we will optimize a training regime for non-specialists to allow this technique to be used in a variety of settings. The development of this device and validation of its relevance to diagnosis and treatment of MPP will provide effective care sooner and at a lower cost than current procedures. It will also reduce inequities in the availability of care to underserved populations by providing an inexpensive, reliable and easily available method for a variety of providers to address MPP.

Official Title

Quantitative Assessment of Pelvic Floor Muscle Fitness in Myofascial Pelvic Pain

Quick Facts

Study Start:2025-01-23
Study Completion:2026-09-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07181447

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women between 18 and 100 years of age
  2. * Pelvic pain for more than 6 months duration
  3. * Report an average daily pain intensity score of at least 4 (on a 0 to 10 scale)
  4. * Palpable trigger/tender points in internal pelvic floor muscles on standardized myofascial pelvic floor exam
  5. * Willing to refrain from new clinical treatments that may affect pain during the study period
  1. * Inability to participate in clinic visits
  2. * Prior invasive pelvic procedures for pain (e.g., prior pelvic surgery, sacral neuromodulation, intradetrusor Botox®)
  3. * Active UTI or vaginal infection
  4. * Pregnancy, childbirth during the previous 12 months, currently planning pregnancy
  5. * Illicit Drug addiction/regular use of controlled substances
  6. * Malignancy or other serious medical condition (e.g., poorly controlled diabetes \[HgA1c \> 8\], neurologic or rheumatic disease)
  7. * Diagnosed with an alternate cause of pelvic pain (e.g., interstitial cystitis, vestibulodynia, vulvar dermatoses dysmenorrhea)
  8. * Urinary retention
  9. * Greater than stage 3 pelvic organ prolapse
  10. * Indwelling vaginal devices (e.g., pessary, contraceptive ring)
  11. * Inability to sign an informed consent, fill out questionnaires, or complete study interviews

Contacts and Locations

Study Contact

Keila Kimura
CONTACT
310-794-5910
bladderpainucla@gmail.com

Study Locations (Sites)

UCLA Center for Women's Pelvic Health
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-23
Study Completion Date2026-09-01

Study Record Updates

Study Start Date2025-01-23
Study Completion Date2026-09-01

Terms related to this study

Keywords Provided by Researchers

  • pelvic pain

Additional Relevant MeSH Terms

  • Myofascial Pelvic Pain