Clinical Study of External Electrical Stimulation for Male Incontinence

January 26, 2026 updated by: Elidah, Inc.

Clinical Evaluation of Perineal Electrical Stimulation for Urinary Incontinence in Men

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Monroe, Connecticut, United States, 06468
        • Elidah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Self-applied electrical stimulation for 6 weeks.
Device: Perineal-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.
Other Names:
  • Elitone
  • Elidah
  • Edytone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Leakage by Pad weight
Time Frame: 6 weeks
24-hr pad weight
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety measured by no Adverse events
Time Frame: 6 weeks
No adverse events
6 weeks
Quality of Life Improvement
Time Frame: 6 weeks
Incontinence I-QoL survey
6 weeks
Quality of Life Improvement
Time Frame: 6 weeks
Sexual Health SHIM survey
6 weeks
Reduction in leakage
Time Frame: 6 weeks
As measured by Pads per day
6 weeks
Reduction in leakage at Night
Time Frame: 6 weeks
As measured by Nocturia episode
6 weeks
Reduction in leakage
Time Frame: 6 weeks
As measured by daytime leaking episodes
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elidah, Inc.

Investigators

  • Principal Investigator: Gloria Kolb, MS,MBA, Elidah, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 26, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TR-1168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe