Using ultrasound or manometer+EMG biofeedback to support pelvic floor muscle training
Official title: Application of Simultaneous Pelvic Floor Ultrasonography and Electromyography Biofeedback on Pelvic Floor Muscle Training
Run by National Cheng-Kung University Hospital · NCT07243028 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 21 Years and up |
| Sex | Women only |
| Enrollment | 70 (estimated) |
| Sponsor | National Cheng-Kung University Hospital Academic / other |
| Locations | 1 site (Tainan, Taiwan) |
| Status | Recruiting |
| Started | February 29, 2024 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | November 21, 2025 |
| Trial ID | NCT07243028 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
National Cheng-Kung University Hospital
Tainan, Taiwan, Taiwan Recruiting
Study contacts
- Study coordinator: Li-Chieh Kuo, Ph. D.
- Email: jkkuo@mail.ncku.edu.tw
- Phone: 886-62353535
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.