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Measuring Pelvic Floor Muscle Fitness Before and After Treatment

2026年5月21日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

120

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • California
      • Los Angeles、California、アメリカ、90095
        • UCLA
        • コンタクト：
        • コンタクト：
        • 主任研究者：
          • A Lenore Ackerman, MD, PhD
        • 副調査官：
          • Michelle Tororsis, MD
        • 副調査官：
          • Jeffery Chiang, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：診断
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
プラセボコンパレーター：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.
診断テスト：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.
他の名前：
  • 放医研
アクティブコンパレータ：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.
診断テスト：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.
他の名前：
  • 放医研
実験的：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.
診断テスト：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.
他の名前：
  • 放医研

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in pelvic floor muscle oxygenation with treatment
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in pelvic floor muscle recovery kinetics after pelvic floor therapies
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Prediction of treatment response using NIRS metrics
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

University of California, Los Angeles

協力者

National Center for Complementary and Integrative Health (NCCIH)

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2028年9月1日

研究の完了 (推定)

2029年7月1日

試験登録日

最初に提出

2026年5月6日

QC基準を満たした最初の提出物

2026年5月21日

最初の投稿 (実際)

2026年5月26日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月26日

QC基準を満たした最後の更新が送信されました

2026年5月21日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 25-1502
  • R61AT013008-01 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

IPD 共有時間枠

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.

IPD 共有アクセス基準

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.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

はい

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