A Phase II Trial of Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer

Study Overview
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Brief Summary
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Background: Urinary incontinence is a common side effect of prostate cancer therapy that can negatively impact the quality of life. Standard treatment includes an initial course of pelvic floor muscle exercises followed by surgical therapy if urinary incontinence persists. Although pelvic floor muscle exercises can be successful in reducing urinary incontinence, compliance with exercises is poor. The Elitone (registered trademark) device was recently cleared by the Food and Drug Administration (FDA) for use in women with stress urinary incontinence. This device provides a surface electrical muscle stimulation device designed to contract the pelvic floor muscles and has been shown to reduce incontinence in women using the product. Recently, the electrode component (GelPad) of the device has been adapted for use in men by the manufacturing company, Elidah. The male version of the device is named the Elidah device. Objective: -To describe the efficacy of the Elidah device on male urinary incontinence Eligibility: Participants must be male. Participants must have a history of urinary incontinence for at least 6 months after prostate cancer treatment. Participants must have at least one of the following types of urinary incontinence: stress urinary incontinence, defined as involuntary loss of urine on effort or physical exertion (e.g., sporting activities), or on sneezing or coughing; urge urinary incontinence, defined as a compelling need to urinate, due to pain or an unpleasant sensation, that is difficult to defer. Design: This is a phase II trial testing the efficacy of the Elidah device in people treated for prostate cancer with stress and/or urge urinary incontinence. Prior to treatment, participants will undergo baseline assessments including 24-hour pad weight testing and questionnaires relating to incontinence and quality of life. Participants will self-administer the Elidah device treatment for 20 minutes per day, 5 days per week during a 6-week period in the at-home environment. Participants will maintain a Daily Log to record usage of the Elidah device, urinary leaks, and use of pads during each week of treatment. Following 6 weeks of therapy, participants will undergo re-evaluation of symptoms and urinary incontinence via questionnaires and testing with the 24-hour pad weight test.

Detailed Description
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Background: Urinary incontinence is a common side effect of prostate cancer therapy that can negatively impact the quality of life. Standard treatment includes an initial course of pelvic floor muscle exercises followed by surgical therapy if urinary incontinence persists. Although pelvic floor muscle exercises can be successful in reducing urinary incontinence, compliance with exercises is poor. The Elitone (registered trademark) device was recently cleared by the Food and Drug Administration (FDA) for use in women with stress urinary incontinence. This device provides a surface electrical muscle stimulation device designed to contract the pelvic floor muscles and has been shown to reduce incontinence in women using the product. Recently, the electrode component (GelPad) of the device has been adapted for use in men by the manufacturing company, Elidah. The male version of the device is named the Elidah device. Objective: -To describe the efficacy of the Elidah device on male urinary incontinence Eligibility: Participants must be male. Participants must have a history of urinary incontinence for at least 6 months after prostate cancer treatment. Participants must have at least one of the following types of urinary incontinence: stress urinary incontinence, defined as involuntary loss of urine on effort or physical exertion (e.g., sporting activities), or on sneezing or coughing; urge urinary incontinence, defined as a compelling need to urinate, due to pain or an unpleasant sensation, that is difficult to defer. Design: This is a phase II trial testing the efficacy of the Elidah device in people treated for prostate cancer with stress and/or urge urinary incontinence. Prior to treatment, participants will undergo baseline assessments including 24-hour pad weight testing and questionnaires relating to incontinence and quality of life. Participants will self-administer the Elidah device treatment for 20 minutes per day, 5 days per week during a 6-week period in the at-home environment. Participants will maintain a Daily Log to record usage of the Elidah device, urinary leaks, and use of pads during each week of treatment. Following 6 weeks of therapy, participants will undergo re-evaluation of symptoms and urinary incontinence via questionnaires and testing with the 24-hour pad weight test.

Official Title
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A Phase II Trial of Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer

Conditions
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Urinary Urge Incontinence, Stress Urinary Incontinence, Prostatic Hyperplasia

Intervention / Treatment
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* Device: Elidah Device


Participation Criteria
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Eligibility Criteria
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INCLUSION CRITERIA: Participants must be male. Participants must have a history of urinary incontinence for at least 6 months after local prostate cancer treatment. Participants must have at least one of the following types of urinary incontinence: stress urinary incontinence, defined as involuntary loss of urine on effort or physical exertion (e.g., sporting activities) or on sneezing or coughing urge urinary incontinence, defined as a compelling need to urinate, due to pain or an unpleasant sensation, that is difficult to defer. Participants must have moderate urinary incontinence defined as 1-5 leaks per day and use at least 1 pad per day by self-report at screening. Participants must be able to read and write in English. Age >= 18 years. Eastern Cooperative Oncology Group (ECOG) performance status <= 2. Ability to understand and the willingness to sign a written informed consent document. EXCLUSION CRITERIA: Change of therapy for prostate cancer planned during the study intervention. History or symptoms of urinary retention (not an exclusion if this occurred before prostatectomy), extra-urethral incontinence, overflow incontinence. Active urinary tract infection (UTI) at screening or history of recurrent urinary tract infections (>= 4 UTIs within the 12 months prior to the study treatment initiation). History of complete denervation of the pelvic floor. Severe obesity (body mass index [BMI] >35). Pelvic pain/painful bladder syndrome. Metal implant in the abdominal or pelvic area. History of chronic cough. An implanted cardiac device, history of untreated cardiac arrhythmia, or history of other heart problems. History of epilepsy. History of underlying neurologic/neuromuscular disorder that could contribute to urinary incontinence. Change in medications prescribed for urinary incontinence within 2 weeks prior to the study treatment initiation. Uncontrolled intercurrent illness evaluated by medical history and physical examination or social situations that would limit compliance with study requirements.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1/Elidah Device<br>Elidah device application. | Device: Elidah Device<br>* The Elidah device is a modified version of the FDA approved ELITONE device cleared for use in the treatment of female stress urinary incontinence. For the current study, only minor modifications have been implemented with respect to the shape of the electrode component, providing a contour better suited to fit the male anatomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the efficacy of the Elidah device treatment on male urinary incontinence | Percent decrease in 24-hour pad weight after treatment with the Elidah device. | Baseline and within 2 weeks after completing treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of the Elidah device in men with urinary incontinence | Frequency of adverse events among treated participants and reporting the results, by maximum grade of event and type of toxicity noted. | 3 week visit and end of treatment visit | 
| To assess alternative measures of efficacy of Elidah device on male urinary incontinence and bother | Evaluated by the number of pads and number of leaks before and after treatment. The mean of the percent reduction in the number of pads used per day following treatment will be computed along with 95% confidence intervals. | Baseline and at end of treatment visit | 
| To assess participant-reported outcomes of Elidah device use for male urinary incontinence | The proportion of participants for which the I-QoL score improves by 2.5 points or more following six weeks of Elidah device use will be estimated. 95% confidence intervals for this proportion will be constructed. | Baseline and at end of treatment visit | 
| To assess treatment compliance with the Elidah device | A test of binomial proportions will be performed to assess whether the treatment noncompliance rate is above the unacceptability threshold. | 3 week visit and end of treatment visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elidah Device, Urinary Incontinence, Prostate Cancer