Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21+
SponsorNational Cheng-Kung University Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
A Pelvic Floor Disability Index (PFDI-20) score greater than 1.
Ability and willingness to provide written informed consent and authorization for the release of personal health information.
Willingness and ability to complete all required questionnaires
Disqualifiers
Individuals planning a future pregnancy.
Inability to read, understand, or sign the written consent form prior to participation.
Trial design
Design model
Crossover
Treatments tested in this trial
Ultrasound Biofeedback Device
DeviceApplication of trans-abdominal ultrasonography as a biofeedback tool during pelvic floor muscle training
Manometer Biofeedback Device
DeviceApplication 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Ultrasound groupActive comparator 2 interventions
Group B: Manometry GroupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.2
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.3
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)Secondary outcomes
1
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.2
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.Sponsors and contacts
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Source ClinicalTrials.gov