Clinical Study of External Electrical Stimulation for Male Incontinence

Elidah, Inc.

Status: Active, not recruiting

Conditions: Urinary Incontinence

Treatments: Device: Perineal-applied electrical stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06620419

TR-1168

Details and patient eligibility

About

The purpose of this research is to evaluate the effectiveness of the Elidah neuromuscular stimulation treatment to reduce incontinence in men post-prostatectomy.

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Treatment group

Experimental group

Description:

Self-applied electrical stimulation for 6 weeks.

Treatment:

Device: Perineal-applied electrical stimulation