Myofacial PainNCT07605598
Measuring Pelvic Floor Muscle Fitness Before and After Treatment
A study testing Near Infrared Imaging in people with Myofacial Pain and Pelvic Pain, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Myofacial Pain, Pelvic Pain, Myofascial Pelvic Pain
- What is being tested?
- Near Infrared Imaging
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UCLA
Los Angeles, California, 90095
A Lenore Ackerman, MD, PhD, 310-794-7700, aackerman@mednet.ucla.edu
Keila S Kimura, B.S., 310-825-8427, kskimura@mednet.ucla.edu
About this study
Official title: Quantitative Assessment of Pelvic Floor Muscle Fitness in Myofascial Pelvic Pain Before and After Myofascially-Directed Therapies
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Near Infrared Imaging
- 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
- Medical subject headings
- Facial Pain, Pelvic Pain, Vaginismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared ImagingDiagnostic test
Also called NIRS
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: Near Infrared Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 3 months
Secondary outcomes (12)
Change in pelvic floor muscle recovery kinetics after pelvic floor therapies
Change from baseline in pelvic floor muscle oxygenation recovery time following contraction, measured using NIRS, with pelvic floor-directed therapies
Measured: Baseline to 3 months
Correlation of change in pelvic pain severity with NIRS metrics
Change from baseline in average pelvic pain intensity measured using a numeric rating scale (0-10) as correlated with metrics of pelvic floor muscle oxygenation
Measured: Baseline to 3 months and 6 months
Patient Global Impression of Improvement (PGI-I)
Participant-reported overall improvement in pelvic symptoms using the Patient Global Impression of Improvement (PGI-I) scale after pelvic-floor directed therapies. The PGI-I is a single-question, patient-reported scale used to measure perceived treatment response compared to a baseline, which is rated on a seven-point scale from 1 (Very much better) to 7 (Very much worse).
Measured: 3 months and 6 months
Change in inflammatory biomarkers
Change from baseline in systemic and local inflammatory biomarkers measured from blood, urine, and vaginal samples after pelvic-floor directed therapies. This exploratory aim will examine a wide-range of inflammatory mediators in each biological sample, including: EGF, Eotaxin/CCL11, G-CSF, GM-CSF, IFNα2, IFNγ, IL-1α, IL-1β, IL-1RA, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8/CXCL8, IL-10, IL-12 (p40), IL-12(p70), IL-13, IL-15, IL-17A/CTLA8, IL-17E/IL-25, IL-17F, IL-18, IL-22, IP-10/CXCL10, MCP-1/CCL2, M-CSF, MIG/CXCL9, MIP-1α/CCL3, MIP-1β/CCL4, PDGF-AA, PDGF-AB/BB, RANTES/CCL5, TNFα, TNFβ/LTA, VEGF-A. While the primary analysis will examine IL-6, IL-8, and TNF-β levels before and after treatment (measure in pg/mL), as these have been implicated previously in other myofascial pain conditions, the additional biomarkers may serve to provide additional insight into disease pathophysiology.
Measured: Baseline to 1-2 weeks after therapy
Change in the Female Genitouruinary Pain Index
Change from baseline in patient-reported pelvic floor-related symptoms, including urinary, pain- and health-related quality of life will be measured using the validated female Genitourinary Pain Index (fGUPI) (scored 0-45, with higher numbers indicated worse pain and quality-of-life).
Measured: Baseline to 3 months and 6 months
Change in Colorectal Functional Outcome questionnaire (COREFO)
Change from baseline in patient-reported pelvic floor-related and bowel symptoms will be measured using the Colorectal Functional Outcome questionnaire (COREFO) (scored 0-100, where 100 indicates the worst possible bowel function)
Measured: Baseline to 3 months and 6 months
Change in International Consultation on Incontinence Questionnaire-female Lower Urinary Tract Symptoms (ICIQ-fLUTS)
Change from baseline in patient-reported pelvic floor-related and urinary symptoms, will be measured using the International Consultation on Incontinence Questionnaire-female Lower Urinary Tract Symptoms (ICIQ-fLUTS) (scored 0-48, where higher scores indicate more severe urinary symptoms )
Measured: Baseline to 3 months and 6 months
Change in Pelvic Floor Distress Index (PFDI-20)
Change from baseline in patient-reported pelvic floor-related, urinary, bowel, and pain symptoms will be measured using the validated Pelvic Floor Distress Index (PFDI-20) (scored 0-300, where higher scores indicate more severe symptoms).
Measured: Baseline to 3 months and 6 months
Change in Female Sexual Functional Index (FSFI)
Change from baseline in patient-reported sexual symptoms will be measured using validated questionnaires:Female Sexual Functional Index (FSFI) (scored 2-36, where higher scores indicate better sexual function)
Measured: Baseline to 3 months and 6 months
Change in the Hospital Anxiety and Depression Scale (HADS)
Change from baseline in patient-reported anxiety and depression symptoms will be measured using the validated Hospital Anxiety and Depression Scale (HADS) (scored 0-42, with higher scores indicating higher severity symptoms).
Measured: Baseline to 3 months and 6 months
Change in the Short Form 12 (SF-12)
Change from baseline in patient-reported health-related quality of life will be measured using the validated Short Form 12 (SF-12), which includes the Physical Component Summary (PCS) and Mental Component Summary (MCS), both weighted assessments measured such that 50 is the median score for the population, meaning that scores below 50 suggest below-average perceived health.
Measured: Baseline to 3 months and 6 months
Change in Whole Person Health Index (WPHI)
Change from baseline in patient-reported overall health, will be measured using the validated Whole Person Health Index (WPHI), which includes 9 items, each of which is measured on a 5-point Likert scale in which higher scores indicate better self-perceived health.
Measured: Baseline to 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Myofacial PainStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Anne Lenore Ackerman, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605598
- Sponsor's protocol ID
- 25-1502
- Other IDs
- R61AT013008-01
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying published results will be shared with qualified researchers upon reasonable request. Data will be de-identified in accordance with applicable privacy regulations and institutional policies. Requests for data access must include a brief description of the proposed research, planned analyses, and data protection measures, and will be reviewed by the study investigators. Data will be shared through a secure data transfer mechanism following execution of an appropriate data use agreement. Data will be available beginning after publication of the primary study results and will remain available for a defined period consistent with institutional and funding agency requirements.
Publications
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.
PubMed 33274514Ross 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.
PubMed 33788379Meister 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.
PubMed 30527941Kapurubandara 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.
PubMed 35796787Deegan 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.
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.
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.
PubMed 24568045Ahangari A. Prevalence of chronic pelvic pain among women: an updated review. Pain Physician. 2014 Mar-Apr;17(2):E141-7.
PubMed 24658485
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment of Pelvic Floor Muscle Fitness in Myofascial Pelvic Pain Before and After Myofascially-Directed Therapies
- ClinicalTrials.gov ID
- NCT07605598
- Acronym / sponsor ID
- 25-1502
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education | Placebo comparator | Diagnostic Test: Near Infrared ImagingEducation 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. |
| Pelvic Floor Physical Therapy | Active comparator | Diagnostic Test: Near Infrared ImagingPelvic 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. |
| Pharmacological Release | Experimental | Diagnostic Test: Near Infrared ImagingCompounded 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Infrared ImagingAlso: NIRSNear-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. | Diagnostic test | Education, Pelvic Floor Physical Therapy, Pharmacological Release |
Primary outcome
Change in pelvic floor muscle oxygenation with treatment
Time frame: Baseline to 3 months
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
12 secondary outcomes
Change in pelvic floor muscle recovery kinetics after pelvic floor therapies
Time frame: Baseline to 3 months
Correlation of change in pelvic pain severity with NIRS metrics
Time frame: Baseline to 3 months and 6 months
Patient Global Impression of Improvement (PGI-I)
Time frame: 3 months and 6 months
Change in inflammatory biomarkers
Time frame: Baseline to 1-2 weeks after therapy
Change in the Female Genitouruinary Pain Index
Time frame: Baseline to 3 months and 6 months
Change in Colorectal Functional Outcome questionnaire (COREFO)
Time frame: Baseline to 3 months and 6 months
Change in International Consultation on Incontinence Questionnaire-female Lower Urinary Tract Symptoms (ICIQ-fLUTS)
Time frame: Baseline to 3 months and 6 months
Change in Pelvic Floor Distress Index (PFDI-20)
Time frame: Baseline to 3 months and 6 months
Change in Female Sexual Functional Index (FSFI)
Time frame: Baseline to 3 months and 6 months
Change in the Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline to 3 months and 6 months
Change in the Short Form 12 (SF-12)
Time frame: Baseline to 3 months and 6 months
Change in Whole Person Health Index (WPHI)
Time frame: Baseline to 3 months and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Background: PubMed 33274514Stone 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.
- Background: PubMed 33788379Ross 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.
- Background: PubMed 30527941Meister 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.
- Background: PubMed 35796787Kapurubandara 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.
- BackgroundDeegan 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.
- BackgroundBhambhani 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: PubMed 24568045Bedaiwy 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.
- Background: PubMed 24658485Ahangari A. Prevalence of chronic pelvic pain among women: an updated review. Pain Physician. 2014 Mar-Apr;17(2):E141-7.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying published results will be shared with qualified researchers upon reasonable request. Data will be de-identified in accordance with applicable privacy regulations and institutional policies. Requests for data access must include a brief description of the proposed research, planned analyses, and data protection measures, and will be reviewed by the study investigators. Data will be shared through a secure data transfer mechanism following execution of an appropriate data use agreement. Data will be available beginning after publication of the primary study results and will remain available for a defined period consistent with institutional and funding agency requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near Infrared Imaging in people with Myofacial Pain and Pelvic Pain, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keila S Kimura, B.S. (310-825-8427, kskimura@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pelvic floor muscle oxygenation with treatment (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07605598, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.