An interventional study of Ultrasound Biofeedback Device and Manometer Biofeedback Device in Pelvic Floor Dysfunction and Pelvic Floor Muscle Weakness, sponsored by National Cheng-Kung University Hospital. Recruiting at 1 site in Taiwan. Open to female participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Treatment
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.
228 studies on the registry are indexed under Health Behavior; 95 are open to participants now.
This study's planned enrollment of 70 is below the median of 114 across 196 interventional studies indexed under Health Behavior.
Browse Health Behavior studies →National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in the ultrasound group received ultrasound-based feedback during the first three sessions, followed by manometry-based feedback during the subsequent three sessions.
Device: Ultrasound Biofeedback Device · Device: Manometer Biofeedback Device
Participants in the manometry group received manometry -based feedback during the first three sessions, followed by ultrasound-based feedback during the subsequent three sessions.
Device: Ultrasound Biofeedback Device · Device: Manometer Biofeedback Device
Application of trans-abdominal ultrasonography as a biofeedback tool during pelvic floor muscle training
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.
Bladder base displacement (cm) during pelvic floor muscle contractions measured by transabdominal ultrasound
Transabdominal ultrasound imaging will be employed to provide real-time visualization and quantitative assessment of bladder base displacement during pelvic floor muscle (PFM) contractions. The displacement of the bladder base (in centimeters) will be recorded. Data will be aggregated as mean ± standard deviation.
Time frame: Baseline and at each of the six pelvic floor muscle training sessions (Sessions 1-6). The six training sessions will be completed within approximately one month, and study parameters will be measured at each of these six sessions by the research staff.
Change in bladder base angle (degrees) relative to the horizontal line during pelvic floor muscle contractions measured by transabdominal ultrasound
Transabdominal ultrasound imaging will be used to quantify the angular change of the bladder base relative to a horizontal reference line during pelvic floor muscle (PFM) contractions. The angle (in degrees) at rest and during contraction will be recorded, and the difference will be calculated. Data will be summarized as mean ± standard deviation across participants for each session.
Time frame: Baseline and at each of the six pelvic floor muscle training sessions (Sessions 1-6). The six training sessions will be completed within approximately one month, and study parameters will be measured at each of these six sessions by the research staff.
Survey on Willingness to Use Pelvic Floor Muscle Training Devices
A structured questionnaire designed to assess participants' willingness to use pelvic floor muscle training (PFMT) devices. The survey evaluates multiple domains, including both physical and psychological aspects, providing insights into patient adherence and acceptance of different pelvic floor muscle training (PFMT) assistive tools. The questionnaire is based on a 7-point Likert scale, ranging from 1 ("strongly disagree") to 7 ("strongly agree"). Higher scores indicate greater willingness, acceptance, and positive perception toward the use of pelvic floor muscle training devices.
Time frame: A total of six pelvic floor muscle training sessions will be completed within approximately one month. Questionnaires will be administered at the 3rd session (midpoint of the treatment) and the 6th session (completion of all training sessions)
Surface Electromyography
Electromyographic signals of pelvic floor muscle contractions will be recorded using the wireless surface EMG system.
Time frame: At each of the six pelvic floor muscle training sessions (Sessions 1-6). The six training sessions will be completed within approximately one month, and outcome parameters will be measured at each of these six sessions by the research staff.
Vaginal manometry measurement
A pressure-sensing probe will be inserted vaginally to measure intravaginal pressure (expressed in cmH₂O) generated during pelvic floor muscle contractions.
Time frame: Measurements will be performed during either the 1st to 3rd sessions (approximately days 1-14 after baseline) or the 4th to 6th sessions (approximately days 15-30 after baseline), according to each participant's assigned randomization sequence.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Cheng-Kung University Hospital