Status:
RECRUITING
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Urinary Urge Incontinence
Stress Urinary Incontinence
Eligibility:
MALE
18-120 years
Phase:
PHASE2
Brief Summary
Background: Men who are treated for prostate cancer often develop urinary leakage (incontinence). An experimental device that uses electrical impulses to stimulate pelvic floor muscles and surroundin...
Detailed Description
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 m...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT06161506
Start Date
February 15 2024
End Date
March 1 2028
Last Update
December 23 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892