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Recruiting NCT07243028

NCT07243028 Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training

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Clinical Trial Summary
NCT ID NCT07243028
Status Recruiting
Phase
Sponsor National Cheng-Kung University Hospital
Condition Pelvic Floor Dysfunction
Study Type INTERVENTIONAL
Enrollment 70 participants
Start Date 2024-02-29
Primary Completion 2028-12-31

Eligibility & Interventions

Sex Female only
Min Age 21 Years
Max Age N/A
Study Type INTERVENTIONAL
Interventions
Ultrasound Biofeedback DeviceManometer Biofeedback Device

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 70 participants in total. It began in 2024-02-29 with a primary completion date of 2028-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 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.

Contact & Investigator

Central Contact

Li-Chieh Kuo, Ph. D.

✉ jkkuo@mail.ncku.edu.tw

📞 886-62353535

Frequently Asked Questions

Who can join the NCT07243028 clinical trial?

This trial is open to female participants only, aged 21 Years or older, studying Pelvic Floor Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07243028 currently recruiting?

Yes, NCT07243028 is actively recruiting participants. Contact the research team at jkkuo@mail.ncku.edu.tw for enrollment information.

Where is the NCT07243028 trial being conducted?

This trial is being conducted at Tainan, Taiwan.

Who is sponsoring the NCT07243028 clinical trial?

NCT07243028 is sponsored by National Cheng-Kung University Hospital. The trial plans to enroll 70 participants.

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