A Novel Biofeedback for Urinary Incontinence in Women

The Hong Kong Polytechnic University

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: New Biofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04638348

P0033900

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: Female

Ages: 35 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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51 participants in 3 patient groups

New Biofeedback

Experimental group

Description:

Women allocated to the new biofeedback group will be instructed to attach the biofeedback device to their underpants and then perform pelvic floor muscle training.

Treatment:

Device: New Biofeedback

Conventional Biofeedback

Active Comparator group

Description:

Women allocated to the conventional biofeedback group will undergo pelvic floor muscle training with the conventional biofeedback probe inserted in the vagina

Treatment:

Device: New Biofeedback

Control group

Active Comparator group

Description:

The control group will perform pelvic floor muscle training without any biofeedback device.

Treatment:

Device: New Biofeedback