A Novel Biofeedback for Urinary Incontinence in Women

Stress Urinary Incontinence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04638348
• Other study ID #: P0033900
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: September 29, 2021

Study information

• Verified date: February 2024
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

Inclusion Criteria:

• women in the age group of 35 to 60 years of age;

• non-pregnant;

• having stress urinary incontinence;

• experiencing mild to moderate urinary incontinence (obtaining a score of = 12 on the short-form of the International Consultation on Incontinence Questionnaire (ICIQ-sf); and

• obtaining a mini-mental state examination (MMSE) score of = 24.

Exclusion Criteria:

• being in the postpartum stage of < 6 months;

• having severe pelvic organ prolapse (stages 3 and 4 on the Baden and Walker grading tool);

• women taking any medications that might cause urine retention;

• women having complicated UI due to radiation to pelvic region;

• obesity with a body mass index = 30;

• women with incontinence secondary to other medical conditions or previous surgeries;

• women with severe psychological problems impairing participation in the study; and

• women having mixed or urge UI.

Related Conditions & MeSH terms

• Enuresis
• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

Intervention

Device:
• New Biofeedback
Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.

Locations

Country	Name	City	State
Hong Kong	Kwong Wah Hospital	Kowloon

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Kwong Wah Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate	Number of participants recruited/screened in a week, the time taken for recruitment of participants, and reasons for declining to participate will be recorded.	At the end of recruitment period
Primary	Adherence	The 0-10-point scale of the reliable tool (Cronbach's a=0.7059) developed to monitor long-term adherence to PFMT in women with UI (that quantifies adherence to home exercise as "low," "moderate," or "high") will be used to evaluate adherence to PFMT with and without the biofeedback device	Post-intervention at 6 months
Primary	Retention rate	This will be calculated as the percentage of participants who completed assessments at 1, 3, and 6 months.	Post-treatment at 1, 3 and 6 months
Secondary	International Consultation on Incontinence Questionnaire-short form	Measures amount of urine loss and intensity. Higher score indicates more sever urinary incontinence.	Baseline (pre-intervention), post-treatment at 1, 3 and 6 months
Secondary	one-hour pad test with stress test	Measure amount of urine leakage. Larger the amount of urine lost in grams, greater is the severity of urinary incontinence.	Baseline (pre-intervention), post-treatment at 1, 3 and 6 months
Secondary	Modified Oxford scale	To grade pelvic floor muscle strength. Lower the score, lower the strength of the pelvic floor muscles.	Baseline (pre-intervention), post-treatment at 1, 3 and 6 months