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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07668063 on ClinicalTrials.gov