Device for Bladder Control for Men With SCI

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
VA Office of Research and Development
Study ID
NCT07668063
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Neurogenic Bladder

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Noninvasive electrical stimulation device to improve bladder control — DEVICE
    Genital nerve stimulation (GNS) will be applied using a wearable, transcutaneous neurostimulator and sleeve electrode that targets the genital nerve reflex pathway for the treatment of neurogenic bladder associated with spinal cord injury.

Study Details

Urinary incontinence, bladder frequency, and bladder urgency are significant medical problems for people with overactive bladder (OAB) or neurogenic bladder overactivity (NDO). Affected individuals typically experience reflex bladder contractions in response to bladder filling at low volumes, resulting in urinary incontinence and decreased bladder capacity. This project will advance a new device for administering noninvasive electrical stimulation in order to improve bladder control.

Key Dates

Start date
Jun 1, 2028
Status verified
Jun 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Genital Nerve Stimulation
    Study participants will don the device at the beginning of the experiment session. An initial clinical urodynamics test will be performed to confirm that the participant has neurogenic bladder. The investigators will select stimulation parameters that effectively inhibit reflexive bladder contractions. Serial cystometrograms will then be conducted. Each fill will be conducted either 1) without stimulation (control runs) or 2) with stimulation.

Primary Outcome Measure

Bladder Capacity [ Time Frame: Day 1 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Louis Stokes VA Medical Center, Cleveland, OHClevelandOhio44106-1702
Curtis J Donskey, MD
[email protected]
(216) 791-3800
Dennis Bourbeau, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Louis Stokes VA Medical Center, Cleveland, OH· Cleveland, OH

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