Measuring Pelvic Floor Muscle Fitness Before and After Treatment

Conditions

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

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Near Infrared Imaging — DIAGNOSTIC_TEST
  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.

Study Details

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.

Key Dates

Start date

Sep 1, 2026

Status verified

May 2026

Primary completion

Sep 1, 2028

Completion

Jul 1, 2029

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Placebo Comparator: Education
  Education and Generalized Relaxation. Patients are educated about myofascial pelvic pain and given a home course of non-specific relaxation exercises administered via a virtual intervention of five 5-10 min videos.
• Active Comparator: Pelvic Floor Physical Therapy
  Pelvic floor physical therapy with myofascial release will be performed by a designated female physical therapist who is a Board-Certified Clinical Specialist in Women's Health Physical Therapy. The methods and approaches used will be at the discretion of the therapist, based on an individual assessment of symptoms and detailed pelvic floor assessment.
• Experimental: Pharmacological Release
  Compounded intravaginal diazepam 0.5% and baclofen 0.4% ointment. Participants receive a compounded intravaginal ointment containing diazepam (0.5%) and baclofen (0.4%) to promote pelvic floor muscle relaxation. Medication is initiated nightly and may be titrated up to three times daily based on symptom response and tolerability.

Primary Outcome Measure

Change in pelvic floor muscle oxygenation with treatment [ Time Frame: Baseline to 3 months ]

Central Contacts

• Keila S Kimura, B.S.
  310-825-8427
  [email protected]

Locations (1)

Find similar trials in Los Angeles, CA

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