RecruitingNot ApplicableNCT07243028

Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training

Application of Simultaneous Pelvic Floor Ultrasonography and Electromyography Biofeedback on Pelvic Floor Muscle Training

Sponsor

National Cheng-Kung University Hospital

Enrollment

70 participants

Start Date

Feb 29, 2024

Study Type

INTERVENTIONAL

Conditions

Pelvic Floor Dysfunction Pelvic Floor Muscle Weakness

Summary

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.

Eligibility

Sex: FEMALEMin Age: 21 Years

Inclusion Criteria4

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).
A Pelvic Floor Disability Index (PFDI-20) score greater than 1.
Ability and willingness to provide written informed consent and authorization for the release of personal health information.
Willingness and ability to complete all required questionnaires

Exclusion Criteria2

Individuals planning a future pregnancy.
Inability to read, understand, or sign the written consent form prior to participation.

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Interventions

DEVICEUltrasound Biofeedback Device

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

DEVICEManometer 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.

Locations(1)

National Cheng-Kung University Hospital

Tainan, Taiwan, Taiwan

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NCT07243028

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