Electrical stimulation to reduce urinary incontinence in men after prostate cancer treatment
A Phase II Trial of Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
This study tests if using a device that sends electrical impulses can help men who have had prostate cancer treatment reduce urinary incontinence.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 41 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | Male |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06161506 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the Elidah device, which uses electrical impulses to stimulate pelvic floor muscles, in reducing urinary incontinence in men who have undergone treatment for prostate cancer. Participants will use the device at home for 20 minutes a day, five days a week, over a period of six weeks. The study aims to assess the device's impact on urinary leakage, which is a common side effect of prostate cancer therapy. Participants will be monitored through daily logs and physical exams to track their progress.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older who have experienced moderate urinary incontinence for at least six months following prostate cancer treatment.
Not a fit: Patients who do not have a history of urinary incontinence or those who are planning a change in prostate cancer therapy during the study may not benefit.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life for men suffering from urinary incontinence after prostate cancer treatment.
How similar studies have performed: While the Elidah device has been previously cleared for use in women, this application for men is novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Deborah E Citrin, M.D. — National Cancer Institute (NCI)
- Study coordinator: Theresa C Cooley Zgela, R.N.
- Email: theresa.cooleyzgela@nih.gov
- Phone: (301) 451-8905
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.