Shock therapy for leaky bladders: new device aims to dry up prostate cancer aftermath
NCT ID NCT06161506
First seen Jun 27, 2026 · Last updated Jul 24, 2026 · Updated 5 times
Summary
This study tests a device that sends mild electrical pulses to the pelvic floor muscles to help men who have bladder leakage after prostate cancer treatment. About 41 men with moderate leakage for at least 6 months will use the device at home for 20 minutes a day, 5 days a week, for 6 weeks. The main goal is to see if the device reduces the amount of urine leaked, measured by weighing pads before and after treatment.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 41 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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Other studies related to the condition(s) this trial covers.
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