Device for Bladder Control for Men With SCI
NCT07668063 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2026-06-25
Summary
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.
Conditions
- Neurogenic Bladder
Interventions
- DEVICE
-
Noninvasive electrical stimulation device to improve bladder control
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.
Sponsors & Collaborators
-
VA Office of Research and Development
lead FED
Principal Investigators
-
Dennis Bourbeau, PhD · Louis Stokes VA Medical Center, Cleveland, OH
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2028-06-01
- Primary Completion
- 2029-12-31
- Completion
- 2029-12-31
Countries
- United States
Study Locations
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