RecruitingNot Applicable

NIRS for the Diagnosis of Myofascial Pelvic Pain

United States110 participantsStarted 2025-01-23

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

MPP Diagnosis

Timeframe: 1 day

Trial details

NCT IDNCT07181447

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07-01

Contact for this trial

Keila Kimura

310-794-5910 bladderpainucla@gmail.com

View on ClinicalTrials.gov More Myofascial Pelvic Pain trials