Recruiting

NIRS for MPP

Sponsor:

UCLA

Code:

NCT07181447

Conditions

Myofascial Pelvic Pain

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Pelvic Floor Muscle Assessment by Near-Infrared Spectroscopy

Study Details

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

Study ID

NCT07181447

Start date

Jan 23, 2025

Status verified date

Sep, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

110 participants

Anticipated

Interventions and Outcome Measures

Arms

Control Subjects

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

Myofascial Pelvic Pain Subjects

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

Interventions

Pelvic Floor Muscle Assessment by Near-Infrared Spectroscopy

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.

Primary outcome measure

  • MPP Diagnosis [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Keila Kimura

310-794-5910bladderpainucla@gmail.com

Locations

UCLA Center for Women's Pelvic Health

Recruiting

Los Angeles, California, United States, 90095

Contacts

310-794-5910bladderpainucla@gmail.com

Principal Investigator:

Anne L Ackerman, MD PHD

More Information

Sponsor

University of California, Los Angeles

Last update posted

Aug 4, 2026

Last verified

Sep, 2025

Keywords

  • pelvic pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-08-04.