Electrical Stimulation Device for Neurogenic Bladder

DB
Overseen ByDennis Bourbeau, PhD
Age: 18+
Sex: Male
Trial Phase: Phase 1 & 2
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

DB

Dennis Bourbeau, PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Are You a Good Fit for This Trial?

This trial is for men who have bladder control problems due to spinal cord injury (SCI) or neurogenic bladder. Participants should be adults with symptoms like frequent urination, urgency, or incontinence caused by nerve-related bladder issues.

Inclusion Criteria

Skeletally mature
My neurological condition is stable.
Suprasacral SCI
See 2 more

Exclusion Criteria

I have a condition that makes me bleed easily.
I currently have an active infection in my body (sepsis).
I have had serious injury or narrowing of my urethra.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Noninvasive electrical stimulation device to improve bladder control

Trial Overview

The study is testing a new noninvasive device that uses electrical stimulation on the body to help improve bladder control in men with SCI or neurogenic bladder. The goal is to reduce urinary accidents and increase how much the bladder can hold.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Genital Nerve StimulationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
1,691
Recruited
3,759,000+