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NCT Number: NCT07243028

Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training

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.

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Key information

Conditions

Pelvic Floor Dysfunction Behavior Health Behavior Pelvic Floor Muscle Weakness

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng-Kung University Hospital

Tainan, Taiwan, 704

Location status: Recruiting

Location contact

Li-Chieh Kuo, Ph. D.

CONTACT

[email protected]

886-62353535 ext. 5908

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Individuals planning a future pregnancy.
  • Inability to read, understand, or sign the written consent form prior to participation.

Treatment and study plan

Ultrasound Biofeedback Device

Device

Application of trans-abdominal ultrasonography as a biofeedback tool during pelvic floor muscle training

Manometer Biofeedback Device

Device

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.

Primary outcomes

  1. Bladder base displacement (cm) during pelvic floor muscle contractions measured by transabdominal ultrasound

    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.

    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.

  2. Change in bladder base angle (degrees) relative to the horizontal line during pelvic floor muscle contractions measured by transabdominal ultrasound

    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.

    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.

  3. Survey on Willingness to Use 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)

    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.

Secondary outcomes

  1. Surface Electromyography

    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.

    Electromyographic signals of pelvic floor muscle contractions will be recorded using the wireless surface EMG system.

  2. Vaginal manometry measurement

    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.

    A pressure-sensing probe will be inserted vaginally to measure intravaginal pressure (expressed in cmH₂O) generated during pelvic floor muscle contractions.

Study contacts

Contact information is provided by the study sponsor or research team.

Li-Chieh Kuo, Ph. D.

CONTACT

[email protected]

886-62353535 ext. 5908

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

Application of Simultaneous Pelvic Floor Ultrasonography and Electromyography Biofeedback on Pelvic Floor Muscle Training

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Nov 21, 2025
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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