Actively Recruiting
Application of Simultaneous Pelvic Floor Ultrasonography and Electromyography Biofeedback on Pelvic Floor Muscle Training
Led by National Cheng-Kung University Hospital · Updated on 2025-11-21
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying women with pelvic floor dysfunction to understand how different feedback methods affect their adherence to pelvic floor muscle training (PFMT). The study compares non-invasive ultrasound imaging feedback with invasive manometry combined with electromyography (EMG) feedback. By collecting both subjective adherence information and objective performance data, the research aims to develop personalized treatment strategies that may improve therapy effectiveness, patient satisfaction, and ongoing engagement with PFMT. Participants are randomly assigned to one of two groups. One group receives ultrasound-based feedback during the first three training sessions followed by manometry-based feedback in the next three sessions. The other group starts with manometry-based feedback for three sessions, then switches to ultrasound feedback for the remaining three. Each participant completes six pelvic floor muscle training sessions over about one month. During each session, researchers measure bladder base movement and angle using transabdominal ultrasound, and assess muscle activity with surface electromyography. Vaginal manometry measurements are also taken according to the participant's assigned schedule. Surveys about willingness to use PFMT devices are completed midway and at the end of the training. The study carefully tracks these outcomes at every session to evaluate treatment responses and adherence.
CONDITIONS
Brief Title
Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 21 years or older diagnosed with pelvic floor muscle dysfunction requiring pelvic floor muscle training
- Pelvic Floor Disability Index (PFDI-20) score greater than 1
- Ability and willingness to provide written informed consent and authorize release of personal health information
- Willingness and ability to complete all required questionnaires
You will not qualify if you...
- Planning a future pregnancy
- Inability to read, understand, or sign the written consent form prior to participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 1 month
Participants undergo pelvic floor muscle training using either ultrasound biofeedback or manometry biofeedback devices in a crossover design.
6 training sessions within approximately one month
Trial Site Locations
Total: 1 location
1
National Cheng-Kung University Hospital
Tainan, Taiwan, Taiwan, 704
Actively Recruiting
Research Team
L
Li-Chieh Kuo, Ph. D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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