Measuring Pelvic Floor Muscle Fitness Before and After Treatment

NCT07605598 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 25-1502R61AT013008-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

myofascial pelvic pain; chronic pelvic pain; pelvic floor muscle dysfunction; pelvic floor myalgia; pelvic floor hypertonicity; Near-infrared spectroscopy; NIRS imaging; Pelvic floor muscle oxygenation; Pelvic floor muscle blood flow; Pelvic floor muscle fitness; Pelvic floor physical therapy; Myofascial release therapy; Pelvic floor relaxation therapy; Intravaginal diazepam; Intravaginal baclofen; Pelvic floor muscle relaxation medication; Women's pelvic pain; Noninvasive pelvic floor assessment; Pelvic floor imaging

Outcome Measures

Primary Outcomes (1)

• Change in pelvic floor muscle oxygenation with treatment

  Change from baseline in pelvic floor muscle oxygenation response to standardized contraction, measured using near-infrared spectroscopy (NIRS) after treatment interventions designed to alter pelvic floor muscle fitness

  Baseline to 3 months

Secondary Outcomes (12)

• Change in pelvic floor muscle recovery kinetics after pelvic floor therapies

  Baseline to 3 months

• Correlation of change in pelvic pain severity with NIRS metrics

  Baseline to 3 months and 6 months

• Patient Global Impression of Improvement (PGI-I)

  3 months and 6 months

• Change in inflammatory biomarkers

  Baseline to 1-2 weeks after therapy

• Change in the Female Genitouruinary Pain Index

  Baseline to 3 months and 6 months

Other Outcomes (1)

• Prediction of treatment response using NIRS metrics

  Baseline to 6 months

Study Arms (3)

Education

PLACEBO COMPARATOR

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.

Diagnostic Test: Near Infrared Imaging

Pelvic Floor Physical Therapy

ACTIVE COMPARATOR

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.

Diagnostic Test: Near Infrared Imaging

Pharmacological Release

EXPERIMENTAL

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.

Diagnostic Test: Near Infrared Imaging

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.

Also known as: NIRS

Education; Pelvic Floor Physical Therapy; Pharmacological Release

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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®) 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

Sponsors & Collaborators

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

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

Related Publications (8)

• Stone RH, Abousaud M, Abousaud A, Kobak W. A Systematic Review of Intravaginal Diazepam for the Treatment of Pelvic Floor Hypertonic Disorder. J Clin Pharmacol. 2020 Dec;60 Suppl 2:S110-S120. doi: 10.1002/jcph.1775.

  PMID: 33274514 BACKGROUND

• Ross V, Detterman C, Hallisey A. Myofascial Pelvic Pain: An Overlooked and Treatable Cause of Chronic Pelvic Pain. J Midwifery Womens Health. 2021 Mar;66(2):148-160. doi: 10.1111/jmwh.13224. Epub 2021 Mar 31.

  PMID: 33788379 BACKGROUND

• Meister MR, Sutcliffe S, Ghetti C, Chu CM, Spitznagle T, Warren DK, Lowder JL. Development of a standardized, reproducible screening examination for assessment of pelvic floor myofascial pain. Am J Obstet Gynecol. 2019 Mar;220(3):255.e1-255.e9. doi: 10.1016/j.ajog.2018.11.1106. Epub 2018 Dec 7.

  PMID: 30527941 BACKGROUND

• Kapurubandara SC, Lowes B, Sansom-Daly UM, Deans R, Abbott JA. A systematic review of diagnostic tests to detect pelvic floor myofascial pain. Int Urogynecol J. 2022 Sep;33(9):2379-2389. doi: 10.1007/s00192-022-05258-7. Epub 2022 Jul 7.

  PMID: 35796787 BACKGROUND

• Deegan EG, Stothers L, Macnab AJ. Technical Development of a Transvaginal Probe Using Near Infrared Light to Monitor Pelvic Floor Muscle Hemodynamics Bilaterally. J Endourol. 2017;31(S2):A43.

  BACKGROUND

• Bhambhani Y. Application of near Infrared Spectroscopy in Evaluating Cerebral and Muscle Haemodynamics during Exercise and Sport. Journal of Near Infrared Spectroscopy. 2012;20(1):117-39. doi: 10.1255/jnirs.978.

  BACKGROUND

• Bedaiwy MA, Patterson B, Mahajan S. Prevalence of myofascial chronic pelvic pain and the effectiveness of pelvic floor physical therapy. J Reprod Med. 2013 Nov-Dec;58(11-12):504-10.

  PMID: 24568045 BACKGROUND

• Ahangari A. Prevalence of chronic pelvic pain among women: an updated review. Pain Physician. 2014 Mar-Apr;17(2):E141-7.

  PMID: 24658485 BACKGROUND

MeSH Terms

Conditions

Facial Pain; Pelvic Pain; Vaginismus

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Keila S Kimura, B.S.

CONTACT

310-825-8427; kskimura@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Urology at UCLA, Director of Research, Division of Female Pelvic Medicine and Reconstructive Surgery at UCLA

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified individual participant data (IPD) and supporting documents will be available beginning after publication of the primary study results. Data and supporting information will remain available for up to five years following publication, or longer as required by institutional and funding agency data-sharing policies.
• Access Criteria: Access to de-identified individual participant data and supporting information will be provided to qualified researchers upon reasonable request. Researchers must submit a written proposal describing the research question, planned analyses, and data security measures. Requests will be reviewed and approved by the study investigators. Data and documents will be shared only after execution of an appropriate data use agreement and will be provided via secure electronic file transfer. Shared materials will include only de-identified data and redacted documents necessary to support the approved research purpose.

Locations

US (1)