NCT04638348

A Novel Biofeedback for Urinary Incontinence in Women

A Novel Biofeedback Device to Improve Adherence to Pelvic Floor Muscle Training in Women With Urinary Incontinence: A Randomized Controlled Pilot Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: The Hong Kong Polytechnic University · Academic / Other
• Sex: Female
• Age: 35 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

A three-armed randomized pilot trial will be conducted with 51 women having stress urinary incontinence, to evaluate the acceptance and ease of use of the conventional electromyography (EMG) biofeedback via vaginal probe in the treatment of urinary incontinence and that of the newly developed EMG biofeedback with Bluetooth. Women will be randomly allocated to one of two intervention groups (new biofeedback or conventional biofeedback) or the control group (PFMT alone). Women in the intervention groups will perform PFMT either with the new biofeedback or the conventional biofeedback, based on their group allocation. The control group will perform PFMT without a biofeedback device. Study outcome measures include, feasibility measures, International Consultation on Incontinence Questionnaire, and 1-hour pad test.

Detailed description

Objectives: (1) to compare the acceptance and ease of use of the conventional electromyography (EMG) biofeedback via vaginal probe in the treatment of urinary incontinence and that of the newly developed EMG biofeedback with Bluetooth; (2) to investigate the effects of conventional biofeedback, the new biofeedback, and pelvic floor muscle training (PFMT) alone on urinary incontinence and adherence to PFMT. Hypotheses: (1) The new biofeedback will be easier to use and women will more readily accept it than the conventional biofeedback. (2) Women assigned to the new biofeedback group will report better adherence to PFMT and greater improvements in urinary incontinence than women assigned to participate in the conventional biofeedback group. Design and subjects: A three-armed randomized pilot trial will be conducted with 51 women who have stress urinary incontinence. Interventions: Women will be randomly allocated to one of two intervention groups (new biofeedback or conventional biofeedback) or the control group (PFMT alone). Women in the intervention groups will perform PFMT either with the new biofeedback or the conventional biofeedback, based on their group allocation. The control group will perform PFMT without a biofeedback device. Outcome measures: Feasibility measures, International Consultation on Incontinence Questionnaire, and 1-hour pad test. Data analysis and expected results: A one-way between-groups analysis of covariance will be conducted. Adherence to PFMT will be better in the new biofeedback group than in the conventional biofeedback group. New biofeedback will have greater beneficial effects on urinary incontinence than either the conventional biofeedback or PFMT alone.

Conditions

• Stress Urinary Incontinence

Interventions

Type	Name	Description
DEVICE	New Biofeedback	Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.

Timeline

• Start date: 2020-02-01
• Primary completion: 2021-09-29
• Completion: 2021-09-29
• First posted: 2020-11-20
• Last updated: 2024-02-28

Locations

1 site across 1 country: Hong Kong