Clinical Study of External Electrical Stimulation for Male Incontinence

Not Applicable

Recruiting

• Conditions: Urinary Incontinence
• Interventions: Device: Perineal-applied electrical stimulation

• Registration Number: NCT06620419
• Lead Sponsor: Elidah, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-15
• Study First Submitted: 2024-05-16
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-27
• Last Update Submitted: 2024-09-27
• Study First Posted: 2024-10-01
• Last Update Posted: 2024-10-01
• Primary Completion: 2025-01
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Perineal-applied electrical stimulation	Self-applied electrical stimulation for 6 weeks.

Primary Outcome Measures

Name	Time	Method
Reduction in Leakage by Pad weight	6 weeks	24-hr pad weight

Secondary Outcome Measures

Name	Time	Method
Safety measured by no Adverse events	6 weeks	No adverse events
Quality of Life Improvement	6 weeks	Sexual Health SHIM survey
Reduction in leakage	6 weeks	As measured by daytime leaking episodes
Reduction in leakage at Night	6 weeks	As measured by Nocturia episode

Trial Locations

Locations (1)

Elidah; 🇺🇸 Monroe, Connecticut, United States