Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women

Study Overview
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Brief Summary
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The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence. The aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence.

Detailed Description
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The purpose of this research is to evaluate the effectiveness of the ELITONE-UUI electrical muscle stimulation device on treating urge incontinence in women. The aim of the device is to stimulate the pelvic floor muscles and surrounding structures to improve urinary incontinence. This is a randomized prospective controlled study of two active groups with a stimulation frequency difference between the groups.

Official Title
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Clinical Study to Evaluate the Efficacy of Surface Electrical Stimulation for Urge Urinary Incontinence in Women

Conditions
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Urge Incontinence

Intervention / Treatment
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* Device: ELITONE UUI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Predominant urge urinary incontinence as determined by responses to a series of three standard questions from the King's Health Questionnaire; specifically: An affirmative response to Is it very difficult to control when you have a strong urge to urinate?, An affirmative or negative response to Do you lose urine with physical activities such as coughing, sneezing, running?, And, if an affirmative response to the second question, an affirmative response to Are more of your incontinence episodes due to a strong urge to urinate than to abdominal pressure such as sneezing? Mild-moderate incontinence symptoms as determined by self-reported typical number of accidents of 1 or more per 24 hours. Symptom severity is later verified with data from the Daily Log (See 5.4) Exclusion Criteria: Less than 1 incontinence accident (leak) per day* Severe incontinence as determined by self-reported >5 accidents per day Currently pregnant, may be pregnant, attempting to become pregnant, or delivery within previous 6 weeks Vaginal or pelvic surgery within previous 6 months Severe Obesity as defined by BMI >= 35 Change in incontinence medication type or dosing within the last 3 months. History or symptoms of urinary retention, extra-urethral incontinence, overflow incontinence Pelvic pain/painful bladder syndrome Active urinary tract infection (UTI) or history of recurrent UTIs (more than three in a year), or recurrent vaginitis (bacterial/fungal) Tissues protruding outside the vagina at rest Presence of incontinence-associated dermatitis or other perineal skin disorders or lesions, Complete denervation of the pelvic floor Conductive inter-uterine devise (IUD/Coil) or metal implants in the abdominal or pelvic area, including the hip and lumbar spine, Chronic coughing Previous use of Interstim device or Botox for UI Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems. Cancer, epilepsy or cognitive dysfunction Underlying neurologic/neuromuscular disorder Impaired decision making, suicidal thoughts, or drug/alcohol dependence Lacks capacity to consent for themselves.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 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
Interventional Model Description: Randomized between two active groups
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Group A<br>Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region, with stimulation group A. | Device: ELITONE UUI<br>* External electrical stimulation<br>* Other names: ELITONE muscle stimulator;|
| Active Comparator: Active Group B<br>Electrical muscle stimulator and surface applied electrode shaped to fit the perineal region with stimulation group B. | Device: ELITONE UUI<br>* External electrical stimulation<br>* Other names: ELITONE muscle stimulator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy assessed by average number of urinary incontinence episodes per day |  | 6 weeks | 
| Safety assessed by number of serious adverse events |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy assessed by change in Incontinence quality of life questionnaire (I-QOL) |  | 6 weeks | 
| Efficacy assessed by reduction in average Pads used per day |  | 6 weeks | 
| Efficacy assessed by reduction in average bathroom visits | Day and night distinction | 6 weeks | 
| Efficacy assessed by reduction in average urge incontinence episodes | Distinction with and without leaking | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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incontinence, bladder, urge, urgency, stimulation