Clinical Study of External Electrical Stimulation for Male Incontinence
NCT ID: NCT06620419
Last Updated: 2026-01-27
Study Results
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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ACTIVE_NOT_RECRUITING
NA
30 participants
INTERVENTIONAL
2024-05-15
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment group
Self-applied electrical stimulation for 6 weeks.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Read and speak English
* Predominant SUI of at least 1 pad/day
Exclusion Criteria
* 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.
18 Years
80 Years
MALE
No
Sponsors
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Elidah, Inc.
INDUSTRY
Responsible Party
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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
Countries
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Other Identifiers
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TR-1168
Identifier Type: -
Identifier Source: org_study_id
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