Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Measuring Pelvic Floor Muscle Fitness Before and After Treatment

21 maja 2026 zaktualizowane przez: Anne Lenore Ackerman, University of California, Los Angeles

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.

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

120

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Stany Zjednoczone
    • California
      • Los Angeles, California, Stany Zjednoczone, 90095
        • UCLA
        • Kontakt:
        • Kontakt:
        • Główny śledczy:
          • A Lenore Ackerman, MD, PhD
        • Pod-śledczy:
          • Michelle Tororsis, MD
        • Pod-śledczy:
          • Jeffery Chiang, PhD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Diagnostyczny
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: 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.
Test diagnostyczny: 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.
Inne nazwy:
  • NIRS
Aktywny komparator: 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.
Test diagnostyczny: 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.
Inne nazwy:
  • NIRS
Eksperymentalny: 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.
Test diagnostyczny: 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.
Inne nazwy:
  • NIRS

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in pelvic floor muscle oxygenation with treatment
Ramy czasowe: 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
Baseline to 3 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in pelvic floor muscle recovery kinetics after pelvic floor therapies
Ramy czasowe: Baseline to 3 months
Change from baseline in pelvic floor muscle oxygenation recovery time following contraction, measured using NIRS, with pelvic floor-directed therapies
Baseline to 3 months
Correlation of change in pelvic pain severity with NIRS metrics
Ramy czasowe: Baseline to 3 months and 6 months
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
Baseline to 3 months and 6 months
Patient Global Impression of Improvement (PGI-I)
Ramy czasowe: 3 months and 6 months
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).
3 months and 6 months
Change in inflammatory biomarkers
Ramy czasowe: Baseline to 1-2 weeks after therapy
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.
Baseline to 1-2 weeks after therapy
Change in the Female Genitouruinary Pain Index
Ramy czasowe: Baseline to 3 months and 6 months
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).
Baseline to 3 months and 6 months
Change in Colorectal Functional Outcome questionnaire (COREFO)
Ramy czasowe: Baseline to 3 months and 6 months
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)
Baseline to 3 months and 6 months
Change in International Consultation on Incontinence Questionnaire-female Lower Urinary Tract Symptoms (ICIQ-fLUTS)
Ramy czasowe: Baseline to 3 months and 6 months
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 )
Baseline to 3 months and 6 months
Change in Pelvic Floor Distress Index (PFDI-20)
Ramy czasowe: Baseline to 3 months and 6 months
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).
Baseline to 3 months and 6 months
Change in Female Sexual Functional Index (FSFI)
Ramy czasowe: Baseline to 3 months and 6 months
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)
Baseline to 3 months and 6 months
Change in the Hospital Anxiety and Depression Scale (HADS)
Ramy czasowe: Baseline to 3 months and 6 months
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).
Baseline to 3 months and 6 months
Change in the Short Form 12 (SF-12)
Ramy czasowe: Baseline to 3 months and 6 months
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.
Baseline to 3 months and 6 months
Change in Whole Person Health Index (WPHI)
Ramy czasowe: Baseline to 3 months and 6 months
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.
Baseline to 3 months and 6 months

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Prediction of treatment response using NIRS metrics
Ramy czasowe: Baseline to 6 months
The Near InfraRed Spectroscopic (NIRS) pelvic floor muscle measurements are obtained vaginally during a series of pelvic floor muscle contractions, both short- and long-duration. Features abstracted from the resulting NIRS waveforms [change in oxygenated hemoglobin (measure in nM) from baseline to during MVC, the sustainable duration of SMVC (sec), and the decrease in the change in oxygenated hemoglobin with MVC over a series of contractions (measured in nM, indicative of muscle fatigue)] will be combined using generalized linear models to create a single, unitless predictive score that will be correlated with treatment responses. The magnitude of the clinical treatment response will be measured as a decrease in pain scores expressed as a continuous variable using the Numeric Rating Scale (NRS), a validated 11-point, patient-reported tool.
Baseline to 6 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of California, Los Angeles

Współpracownicy

National Center for Complementary and Integrative Health (NCCIH)

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 września 2028

Ukończenie studiów (Szacowany)

1 lipca 2029

Daty rejestracji na studia

Pierwszy przesłany

6 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 maja 2026

Pierwszy wysłany (Rzeczywisty)

26 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

26 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

21 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 25-1502
  • R61AT013008-01 (Grant/umowa NIH USA)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Ramy czasowe udostępniania IPD

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.

Kryteria dostępu do udostępniania IPD

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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • ANALITYCZNY_KOD

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

produkt wyprodukowany i wyeksportowany z USA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj