Electrical stimulation treatment for male urinary incontinence after prostate surgery
Clinical Evaluation of Perineal Electrical Stimulation for Urinary Incontinence in Men
This study is testing a new electrical stimulation treatment to see if it can help men with urinary incontinence after prostate surgery feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Elidah, Inc. Industry-sponsored |
| Locations | 1 site (Monroe, Connecticut) |
| Trial ID | NCT06620419 on ClinicalTrials.gov |
What this trial studies
This clinical study evaluates the effectiveness of Elidah's neuromuscular stimulation treatment aimed at reducing urinary incontinence in men who have undergone robotic-assisted laparoscopic prostatectomy. Participants will receive perineal-applied electrical stimulation to assess its impact on their incontinence symptoms. The study focuses on men experiencing predominant stress urinary incontinence, with the goal of improving their quality of life post-surgery.
Who should consider this trial
Good fit: Ideal candidates are men scheduled for robotic-assisted laparoscopic prostatectomy who experience predominant stress urinary incontinence.
Not a fit: Patients with a history of urinary incontinence, severe obesity, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce urinary incontinence in men after prostate surgery, enhancing their quality of life.
How similar studies have performed: While similar approaches have been explored, this specific application of electrical stimulation for post-prostatectomy incontinence is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scheduled for robotic-assisted laparoscopic prostatectomy * Read and speak English * Predominant SUI of at least 1 pad/day Exclusion Criteria: * History or symptoms of urinary incontinence, urinary retention, extra-urethral incontinence, overflow incontinence * Complete denervation of the pelvic floor * Severe Obesity as defined by BMI \>= 40 * Has undergone pre-op pelvic floor exercise strengthening * Pelvic pain/painful bladder syndrome * Implanted cardiac device, untreated cardiac arrhythmia or suffer from other heart problems. * History of epilepsy * Underlying neurologic/neuromuscular disorder * Metal implants in the abdomen or pelvic area * Chronic coughing * Impaired decision making, suicidal thoughts, or drug/alcohol dependence * Uncontrolled intercurrent illness that would limit compliance with study requirements * Lacks capacity to adhere with study requirements * Lacks capacity to consent for themselves.
Where this trial is running
Monroe, Connecticut
- Elidah — Monroe, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Gloria Kolb, MS,MBA — Elidah, Inc.
- Study coordinator: Gloria Kolb, MS MBA
- Email: elidahstudy@gmail.com
- Phone: 978-435-4324
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.