Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training

National Cheng-Kung University

Status: Enrolling

Conditions: Pelvic Floor Muscle Weakness; Pelvic Floor Dysfunction

Treatments: Device: Manometer Biofeedback Device; Device: Ultrasound Biofeedback Device

Study type: Interventional

Funder types: Other

Identifiers

NCT07243028

A-ER-112-385

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Ultrasound group

Active Comparator group

Description:

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

Treatment:

Device: Manometer Biofeedback Device

Device: Ultrasound Biofeedback Device

Manometry Group

Active Comparator group

Description:

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

Treatment:

Device: Manometer Biofeedback Device

Device: Ultrasound Biofeedback Device