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New treatment option for Urinary Urge Incontinence
Official title Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
ClinicalTrials.gov ID: NCT06161506
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 9 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 120, men only
You may be able to join if
- 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...
- urge urinary incontinence, defined as a compelling need to urinate, due to pain or an unpleasant sensation, that is difficult to defer.
You likely can't join if
- 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...
- History of complete denervation of the pelvic floor.
- Severe obesity (body mass index [BMI] \>35).
- Pelvic pain/painful bladder syndrome.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 9 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.