Clinical Study of External Electrical Stimulation for Male Incontinence

NCT06620419 | Active Not Recruiting DMC FDA Device

• 1 other identifier: TR-1168
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Incontinence

Keywords

male; men; prostatetectomy; incontinence; electrical stimulation

Outcome Measures

Primary Outcomes (1)

• Reduction in Leakage by Pad weight

  24-hr pad weight

  6 weeks

Secondary Outcomes (6)

• Safety measured by no Adverse events

  6 weeks

• Quality of Life Improvement

  6 weeks

• Quality of Life Improvement

  6 weeks

• Reduction in leakage

  6 weeks

• Reduction in leakage at Night

  6 weeks

Study Arms (1)

Treatment group

EXPERIMENTAL

Self-applied electrical stimulation for 6 weeks.

Device: Perineal-applied electrical stimulation

Interventions

Perineal-applied electrical stimulation DEVICE

Small controller that outputs stimulation for stress incontinence and OAB, attached to a male-anatomy thin GelPad placed in the perineal area.

Also known as: Elidah, Elitone, Edytone

Treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for robotic-assisted laparoscopic prostatectomy
• Read and speak English
• Predominant SUI of at least 1 pad/day

You may not qualify if:

• 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.

Sponsors & Collaborators

• Elidah, Inc.: lead

Study Sites (1)

Elidah

Monroe, Connecticut, 06468, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Gloria Kolb, MS,MBA

  Elidah, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Perineal-applied electrical stimulation shaped for males.

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: October 1, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 27, 2026

Record last verified: 2025-10

Locations

US (1)