Clinical Study of External Electrical Stimulation for Male Incontinence

NCT ID: NCT06620419

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-15

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Urinary Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Perineal-applied electrical stimulation shaped for males.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment group

Self-applied electrical stimulation for 6 weeks.

Group Type EXPERIMENTAL

Perineal-applied electrical stimulation

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Elidah Elitone Edytone

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Elidah, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gloria Kolb, MS,MBA

Role: PRINCIPAL_INVESTIGATOR

Elidah, Inc.

Locations

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Elidah

Monroe, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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TR-1168

Identifier Type: -

Identifier Source: org_study_id

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