Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training

Application of Simultaneous Pelvic Floor Ultrasonography and Electromyography Biofeedback on 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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Floor Muscle Weakness; Pelvic Floor Dysfunction
• Intervention / Treatment: Device: Ultrasound Biofeedback Device; Device: Manometer Biofeedback Device

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li-Chieh Kuo, Ph. D.; Phone Number: 5908 886-62353535; Email: jkkuo@mail.ncku.edu.tw

Study Locations

• Taiwan
  • Taiwan
    • Tainan, Taiwan, Taiwan, 704
      • Recruiting
      • National Cheng-Kung University Hospital
      • Contact: Li-Chieh Kuo, Ph. D.; Phone Number: 5908 886-62353535; Email: jkkuo@mail.ncku.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound group; 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; Application of trans-abdominal ultrasonography as a biofeedback tool during pelvic floor muscle training; Device: Manometer Biofeedback 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.
Active Comparator: Manometry Group; 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; Application of trans-abdominal ultrasonography as a biofeedback tool during pelvic floor muscle training; Device: Manometer Biofeedback 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface Electromyography	Electromyographic signals of pelvic floor muscle contractions will be recorded using the wireless surface EMG system.	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.	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.

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 29, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 4, 2025
• First Submitted That Met QC Criteria: November 19, 2025
• First Posted (Actual): November 21, 2025

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Pelvic floor muscle training; Biofeedback; Pelvic floor dysfunction; Health behavior
• Additional Relevant MeSH Terms: Behavior; Health Behavior
• Other Study ID Numbers: A-ER-112-385

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No