A Novel Biofeedback for Urinary Incontinence in Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Device: New Biofeedback


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: New Biofeedback<br>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. | Device: New Biofeedback<br>* Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.<br>* Other names: Conventional Biofeedback;|
| Active Comparator: Conventional Biofeedback<br>Women allocated to the conventional biofeedback group will undergo pelvic floor muscle training with the conventional biofeedback probe inserted in the vagina | Device: New Biofeedback<br>* Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.<br>* Other names: Conventional Biofeedback;|
| Active Comparator: Control group<br>The control group will perform pelvic floor muscle training without any biofeedback device. | Device: New Biofeedback<br>* Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.<br>* Other names: Conventional Biofeedback;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Adherence | The 0-10-point scale of the reliable tool (Cronbach's α=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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biofeedback