Measuring Pelvic Floor Muscle Fitness Before and After Treatment

Summary

This study is being done to better understand and improve treatment for myofascial pelvic pain, a common cause of long-lasting pelvic pain in women. Myofascial pelvic pain is related to tight or dysfunctional pelvic floor muscles and can cause pain as well as bladder, bowel, and sexual problems. Current clinical evaluations mostly rely on physical examination and patient-reported symptoms and do not fully measure how the pelvic floor muscles are functioning.

The purpose of this study is to measure pelvic floor muscle function using a noninvasive imaging method called near-infrared spectroscopy, or NIRS. This method measures changes in muscle blood flow and oxygen levels during muscle contraction and relaxation. The study will examine whether pelvic floor muscle function improves after different treatments and whether these physiologic changes are associated with improvements in pain and symptoms.

The study will enroll 120 adult women who have had pelvic pain for at least three months and have pelvic floor muscle tenderness on examination. Participants will be randomly assigned to one of three groups: education with relaxation exercises, pelvic floor physical therapy focused on myofascial release, or vaginal medication used to help relax pelvic floor muscles.

Participants will take part in four study visits over a six-month period. During these visits, they will complete questionnaires about pain and pelvic symptoms, undergo pelvic floor examinations, and have pelvic floor muscle imaging using the NIRS device while performing brief muscle contractions and relaxations. Some visits will also include collection of blood, urine, and vaginal samples to measure inflammation.

The information gained from this study may help improve the diagnosis and treatment of myofascial pelvic pain by providing objective measures of pelvic floor muscle function and identifying which treatments are most effective for different patients.

Conditions

• Myofacial Pain
• Pelvic Pain
• Myofascial Pelvic Pain
• Chronic Pelvic Pain

Interventions

DIAGNOSTIC_TEST

Near Infrared Imaging

Near-infrared spectroscopy (NIRS) is a noninvasive imaging technique used in this study to assess pelvic floor muscle physiology. The NIRS device uses near-infrared light to measure changes in oxygenated and deoxygenated hemoglobin within the pelvic floor muscles, providing real-time information about muscle blood flow, oxygenation, and recovery during contraction and relaxation. The device is used transvaginally during a standardized protocol that includes brief, guided pelvic floor muscle contractions and relaxations. NIRS measurements are used for assessment purposes only and are not intended for diagnosis or treatment.

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• University of California, Los Angeles

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2028-09-01

Completion

2029-07-01

FDA Device

Yes

Countries

• United States

Study Locations