Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training

NCT ID: NCT07243028

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-29

Study Completion Date

2028-12-31

Brief Summary

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This study aims to investigate the factors influencing adherence to pelvic floor muscle training (PFMT) devices among patients with pelvic floor dysfunction (PFD) through structured questionnaires, while simultaneously comparing the effectiveness of different feedback modalities, including non-invasive ultrasound imaging and invasive manometry with electromyography (EMG). By integrating subjective adherence data with objective performance outcomes, the project seeks to evaluate the potential of system-level integration for personalized therapeutic strategies, ultimately enhancing treatment efficacy, improving patient satisfaction, and promoting sustained engagement in PFMT.

Detailed Description

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Conditions

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Pelvic Floor Dysfunction Pelvic Floor Muscle Weakness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ultrasound group

Participants in the ultrasound group received ultrasound-based feedback during the first three sessions, followed by manometry-based feedback during the subsequent three sessions.

Group Type ACTIVE_COMPARATOR

Ultrasound Biofeedback Device

Intervention Type DEVICE

Application of trans-abdominal ultrasonography as a biofeedback tool during pelvic floor muscle training

Manometer Biofeedback Device

Intervention Type DEVICE

Application of manometry as a biofeedback tool during pelvic floor muscle training. The manometer is a routinely used clinical device in hospital-based pelvic floor rehabilitation programs to provide quantitative intravaginal pressure feedback and guide patients in performing correct pelvic floor muscle contractions.

Manometry Group

Participants in the manometry group received manometry -based feedback during the first three sessions, followed by ultrasound-based feedback during the subsequent three sessions.

Group Type ACTIVE_COMPARATOR

Ultrasound Biofeedback Device

Intervention Type DEVICE

Application of trans-abdominal ultrasonography as a biofeedback tool during pelvic floor muscle training

Manometer Biofeedback Device

Intervention Type DEVICE

Application of manometry as a biofeedback tool during pelvic floor muscle training. The manometer is a routinely used clinical device in hospital-based pelvic floor rehabilitation programs to provide quantitative intravaginal pressure feedback and guide patients in performing correct pelvic floor muscle contractions.

Interventions

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Ultrasound Biofeedback Device

Application of trans-abdominal ultrasonography as a biofeedback tool during pelvic floor muscle training

Intervention Type DEVICE

Manometer Biofeedback Device

Application of manometry as a biofeedback tool during pelvic floor muscle training. The manometer is a routinely used clinical device in hospital-based pelvic floor rehabilitation programs to provide quantitative intravaginal pressure feedback and guide patients in performing correct pelvic floor muscle contractions.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Women aged 21 years or older diagnosed with pelvic floor muscle dysfunction and requiring pelvic floor muscle training (e.g., for symptomatic pelvic organ prolapse, stress urinary incontinence, or dysfunctional voiding).
2. A Pelvic Floor Disability Index (PFDI-20) score greater than 1.
3. Ability and willingness to provide written informed consent and authorization for the release of personal health information.
4. Willingness and ability to complete all required questionnaires

Exclusion Criteria

1. Individuals planning a future pregnancy.
2. Inability to read, understand, or sign the written consent form prior to participation.
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Cheng-Kung University Hospital

Tainan, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Li-Chieh Kuo, Ph. D.

Role: CONTACT

886-62353535 ext. 5908

Facility Contacts

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Li-Chieh Kuo, Ph. D.

Role: primary

886-62353535 ext. 5908

Other Identifiers

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A-ER-112-385

Identifier Type: -

Identifier Source: org_study_id

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