Measuring Pelvic Floor Muscle Fitness Before and After Treatment

STUDY OVERVIEW This is a prospective, randomized, controlled clinical study designed to objectively measure pelvic floor muscle (PFM) physiology and inflammatory changes in women with myofascial pelvic pain (MPP). The study uses a novel, transvaginal near-infrared spectroscopy (NIRS) system to assess pelvic floor muscle oxygenation, hemodynamics, and recovery during standardized contraction and relaxation tasks. The overarching goal is to improve objective diagnosis, phenotyping, and personalized treatment of MPP.

Scientific Rationale Myofascial pelvic pain is a common contributor to chronic pelvic pain in women and is characterized by pelvic floor muscle hypertonicity, impaired muscle perfusion, local acidosis, and accumulation of inflammatory mediators. These physiologic abnormalities contribute to pain as well as bladder, bowel, and sexual dysfunction. Current clinical evaluation relies largely on subjective examination and patient-reported symptoms, which limits precision in diagnosis and treatment selection.

Preliminary work has demonstrated that pelvic floor NIRS imaging can reliably distinguish women with MPP from asymptomatic controls and can identify physiologic impairments such as reduced muscle oxygenation and delayed recovery following contraction. This study evaluates whether targeted myofascial therapies improve these objective physiologic measures and whether changes in muscle physiology correlate with symptom improvement and inflammatory biomarkers.

STUDY OBJECTIVES

Primary Objective To determine whether pelvic floor muscle fitness, measured using NIRS-derived oxygenation parameters, improves following myofascial-directed treatments in women with MPP.

Secondary Objectives To characterize NIRS-derived physiologic patterns associated with symptom severity and pelvic floor dysfunction.

To assess relationships between NIRS measures and systemic and local inflammatory biomarkers.

To identify physiologic predictors of treatment response using machine-learning-based analytic approaches.

STUDY DESIGN

Design: Prospective, randomized, controlled trial

Sample size: 120 adult women with myofascial pelvic pain

Randomization: 1:1:1 allocation

Treatment arms:

Education and generalized relaxation (control) Myofascially-directed pelvic floor physical therapy Pharmacologic pelvic floor muscle relaxation

Study duration: Six months per participant

Study visits: Baseline, 1-2 weeks, 3 months, and 6 months

Total participant time: Approximately four hours across all visits

STUDY PROCEDURES

Baseline Visit After informed consent, participants complete validated questionnaires assessing pelvic pain, urinary, bowel, sexual function, psychological symptoms, and quality of life. Participants also complete two 24-hour bladder and bowel diaries.

Clinical assessments include urinalysis and post-void residual if not recently documented, standardized pelvic examination with grading of muscle strength and myofascial tenderness, perineometry, surface electromyography, and bulbospongiosus reflex testing. Pelvic floor NIRS imaging is performed transvaginally during a guided 10-minute protocol involving repeated contraction and relaxation exercises, capturing real-time oxygenated and deoxygenated hemoglobin data across multiple circumferential channels.

Biologic specimens, including blood, urine, and vaginal samples, are collected for inflammatory biomarker analysis.

Follow-Up Assessments Participants return at 1-2 weeks, 3 months, and 6 months to repeat symptom questionnaires, bladder and bowel diaries, pelvic floor examination, and NIRS imaging. Participants also complete a patient global impression of improvement assessment at all visits after treatment. Biologic specimen collection is repeated at the early post-treatment visit.

DATA MANAGEMENT AND SAFETY

All study data are collected and managed using secure, HIPAA-compliant electronic data capture systems. Data are de-identified at the time of entry. An independent monitoring process oversees recruitment, protocol adherence, and adverse events. All study procedures are considered minimal risk and consistent with standard gynecologic and pelvic floor physical therapy care.

Inclusion criteria

Women over 18 years of age

Pelvic Pain for more than 3 months

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 treatment 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®) in the past 6 months

Active UTI or vaginal infection

Pregnancy or childbirth in the past 12 months, currently planning a pregnancy

Illicit Drug addiction/regular use of controlled substances (including marijuana use in the past 2 weeks or during the study period)

Pelvic floor physical therapy in the past 3 months

Malignancy or other serious medical condition (e.g., poorly controlled diabetes [HgA1c > 8], chronic renal disease [GFR <30], neurologic or rheumatic disease)

Diagnosed with an alternate cause of pelvic pain (e.g., ulcerative interstitial cystitis, vestibulodynia, vulvar dermatoses, dysmenorrhea)

Urinary retention with a PVR >150 mL

Greater than stage 3 pelvic organ prolapse

Indwelling vaginal devices (e.g., pessary, contraceptive ring. Not including Mirena IUD) that cannot be removed for the study

Inability to sign an informed consent, fill out questionnaires, or complete study interviews