Clinical trial NCT04638348: A Novel Biofeedback for Urinary Incontinence in Women
Official title: A Novel Biofeedback Device to Improve Adherence to Pelvic Floor Muscle Training in Women With Urinary Incontinence: A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Keywords: Biofeedback
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Kwong Wah Hospital
First posted: 2020-11-20
Enrollment: 51
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Recruitment rate
timeFrame: At the end of recruitment period
measure: Adherence
timeFrame: Post-intervention at 6 months
measure: Retention rate
timeFrame: Post-treatment at 1, 3 and 6 months
Secondary outcomes:
measure: International Consultation on Incontinence Questionnaire-short form
timeFrame: Baseline (pre-intervention), post-treatment at 1, 3 and 6 months
measure: one-hour pad test with stress test
timeFrame: Baseline (pre-intervention), post-treatment at 1, 3 and 6 months
measure: Modified Oxford scale
timeFrame: Baseline (pre-intervention), post-treatment at 1, 3 and 6 months
Other outcomes:
Locations:
city: Kowloon
country: Hong Kong
facility: Kwong Wah Hospital
Study officials:
affiliation: The Hong Kong Polytechnic Unviersity
name: Priya Kannan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kannan P, Cheing GLY, Fung BKY, Li J, Leung WC, Chung RCK, Cheung TW, Lam LF, Lee WY, Wong WC, Wong WH, Tang PYG, Chan PKL. Effectiveness of pelvic floor muscle training alone or combined with either a novel biofeedback device or conventional biofeedback for improving stress urinary incontinence: A randomized controlled pilot trial. Contemp Clin Trials. 2022 Dec;123:106991. doi: 10.1016/j.cct.2022.106991. Epub 2022 Nov 2.