Using ultrasound or manometer+EMG biofeedback to support pelvic floor muscle training

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

This project will test whether ultrasound imaging or a manometer with EMG feedback helps women with pelvic floor dysfunction stay with and get better results from pelvic floor muscle training.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 21 Years and up
• Sex: Female
• Sponsor: National Cheng-Kung University Hospital (other)
• Locations: 1 site (Tainan, Taiwan)
• Trial ID: NCT07243028 on ClinicalTrials.gov

What this trial studies

This interventional project compares two biofeedback methods—non‑invasive ultrasound imaging and invasive manometry paired with electromyography (EMG)—for guiding pelvic floor muscle training in women with pelvic floor dysfunction. Participants complete structured questionnaires about adherence and satisfaction while their objective performance on PFMT is measured with the assigned device. The study integrates subjective adherence data with device-measured outcomes to explore which feedback modality best supports effective, sustained training. Results will inform whether combining patient-reported adherence with objective feedback could enable more personalized PFMT strategies.

Who should consider this trial

Good fit: Women age 21 or older with pelvic floor muscle dysfunction who need pelvic floor muscle training, have a PFDI-20 score >1, can give written consent, and can complete required questionnaires are ideal candidates.

Not a fit: People planning pregnancy or those unable to read/complete consent and questionnaires (or unable/unwilling to use the assigned biofeedback devices) are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the approach could improve pelvic floor muscle training effectiveness, increase patient satisfaction, and help people maintain exercise habits over time.

How similar studies have performed: Previous research has shown that various biofeedback approaches can help adherence and outcomes for pelvic floor training, though direct head-to-head comparisons of ultrasound versus manometry+EMG are limited.

Eligibility criteria

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.

Where this trial is running

Tainan, Taiwan

• National Cheng-Kung University Hospital — Tainan, Taiwan, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Li-Chieh Kuo, Ph. D.

Conditions: Pelvic Floor Dysfunction, Pelvic Floor Muscle Weakness, Pelvic floor dysfunction, Pelvic floor muscle training, Health behavior, Biofeedback