Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer

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.

• 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 use of 1-4 pads 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 with ongoing symptoms
• 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.