💬In plain words
What the trial is, and whether it could suit you
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 surrounding tissues may help.
Objective:
To see if the Elidah device can reduce urinary incontinence after prostate treatment.
Eligibility:
Men aged 18 years and older who have had moderate urinary incontinence for at least 6 months after treatment for prostate cancer.
Design:
Participants will be in the study for about 9 weeks. They will be screened. They will have a physical exam with urine tests.
The Elidah device consists of a Controller and a GelPad. The Controller sets the strength of electrical impulses. The GelPad is placed against the skin under the pelvis.
Participants will be given an Elidah device and taught how to use it at home.
They will use the device once a day for 20 minutes
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
* 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.
National Institutes of Health Clinical Center
Bethesda, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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