NIRS for the Diagnosis of Myofascial Pelvic Pain

NCT07181447 | Recruiting DMC FDA Device

• 2 other identifiers: 22-0428R61AT013008-01
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myofascial Pelvic Pain

Keywords

pelvic pain

Outcome Measures

Primary Outcomes (1)

• MPP Diagnosis

  Accurate Diagnosis of Myofascial Pelvic Pain

  1 day

Study Arms (2)

Control Subjects

Women age 18 or older without pelvic pain or other genitourinary complaints

Diagnostic Test: Pelvic Floor Muscle Assessment by Near-Infrared Spectroscopy

Myofascial Pelvic Pain Subjects

Women age 18 or older with pelvic floor muscle pain or tender points

Diagnostic Test: Pelvic Floor Muscle Assessment by Near-Infrared Spectroscopy

Interventions

Pelvic Floor Muscle Assessment by Near-Infrared Spectroscopy DIAGNOSTIC_TEST

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.

Control Subjects; Myofascial Pelvic Pain Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The control subjects (cohort 1) will be adult 18 (\>18 years of age) who lack pelvic pain or other genitourinary symptoms. The MPP cohort (cohort 2) will consist of adult women \>18 years of age with pelvic floor muscle pain or tender points.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

UCLA Center for Women's Pelvic Health

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Keila Kimura

CONTACT

310-794-5910; bladderpainucla@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 18, 2025
• Study Start: January 23, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: After completion of the study, metadata will be shared for a minimum of five years.
• Access Criteria: Deidentified data will be freely available.

Locations

US (1)