Urinary Incontinence
Conditions
Keywords
male, men, prostatetectomy, incontinence, electrical stimulation
Brief summary
The purpose of this research is to evaluate the effectiveness of the Elidah neuromuscular stimulation treatment to reduce incontinence in men post-prostatectomy.
Interventions
DEVICEPerineal-applied electrical stimulation
Small controller that outputs stimulation for stress incontinence and OAB, attached to a male-anatomy thin GelPad placed in the perineal area.
Sponsors
Elidah, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Perineal-applied electrical stimulation shaped for males.
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Leakage by Pad weight | 6 weeks | 24-hr pad weight |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety measured by no Adverse events | 6 weeks | No adverse events |
| Quality of Life Improvement | 6 weeks | Incontinence I-QoL survey |
| Reduction in leakage | 6 weeks | As measured by Pads per day |
| Reduction in leakage at Night | 6 weeks | As measured by Nocturia episode |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGloria Kolb, MS,MBA
Elidah, Inc.
Outcome results
None listed