Clinical Study of External Electrical Stimulation for Male Incontinence (NCT06620419) | Clinical Trial Compass
Active ā Not RecruitingNot Applicable
Clinical Study of External Electrical Stimulation for Male Incontinence
United States30 participantsStarted 2024-05-15
Plain-language summary
The purpose of this research is to evaluate the effectiveness of the Elidah neuromuscular stimulation treatment to reduce incontinence in men post-prostatectomy.
Who can participate
Age range18 Years ā 80 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Scheduled for robotic-assisted laparoscopic prostatectomy
* Read and speak English
* Predominant SUI of at least 1 pad/day
Exclusion Criteria:
* History or symptoms of urinary incontinence, urinary retention, extra-urethral incontinence, overflow incontinence
* Complete denervation of the pelvic floor
* Severe Obesity as defined by BMI \>= 40
* Has undergone pre-op pelvic floor exercise strengthening
* Pelvic pain/painful bladder syndrome
* Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems.
* History of epilepsy
* Underlying neurologic/neuromuscular disorder
* Metal implants in the abdomen or pelvic area
* Chronic coughing
* Impaired decision making, suicidal thoughts, or drug/alcohol dependence
* Uncontrolled intercurrent illness that would limit compliance with study requirements
* Lacks capacity to adhere with study requirements
* Lacks capacity to consent for themselves.