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Recruiting NCT07243028

Ultrasound and Electromyography Biofeedback for Pelvic Floor Muscle Training

No phase Interventional Pelvic Floor Dysfunction Pelvic Floor Muscle Weakness

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound Biofeedback Device, Manometer Biofeedback Device.
Who it may be relevant to
Registry conditions: Pelvic Floor Dysfunction, Pelvic Floor Muscle Weakness. Basic parameters: from 21 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • 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.]
  • 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.]
  • 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)]
Secondary outcome measures (2)
  • 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.]
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Cheng-Kung University Hospital — Tainan

Publications

  • Chao YH, Chiang CJ, Tsai CH, Cheng YM, Kuo LC, Su FC. Adherence and continuance intention of biofeedback-assisted pelvic floor muscle training: a theory-driven study among women with pelvic floor disorders. BMC Womens Health. 2026 Jul 18. doi: 10.1186/s12905-026-04711-9. Online ahead of print. PMID 42471707

Identifiers

NCT: NCT07243028 · A-ER-112-385

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗