Device for Bladder Control for Men With SCI

Noninvasive Electrical Stimulation Device to Improve Bladder Control for Men With Spinal Core Injury

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurogenic Bladder
• Intervention / Treatment: Device: Noninvasive electrical stimulation device to improve bladder control

Detailed Description

Urinary incontinence, bladder frequency, and bladder urgency are significant medical problems for people with overactive bladder (OAB) or neurogenic bladder overactivity (NDO). Restoring bladder control is considered a high priority, but remains a critically unmet need requiring further development. The long-term goal is to develop and clinically implement a "bladder pacemaker" able to restore bladder control for individuals with OAB or NDO. Electrical stimulation of the genital nerves inhibits the spinal neural circuits involved in hyper-reflexive bladder spasms.

Genital nerve stimulation (GNS) has been used by multiple groups to inhibit reflexive OAB and neurogenic bladder contractions during acute (1 visit) urodynamic testing and limited chronic take-home testing. The investigators have recently demonstrated that surface GNS inhibits reflexive bladder contractions and reduces incontinence in individuals with SCI during one month of home use using a limited stimulation system. Participant feedback from these studies identified a number of stimulation system issues that created nontrivial inconveniences, which affected activities of daily living and prevented some participants from participating in the study. Required improvements include, but are not limited to better electrode interface, elimination of wired connections, and a smaller device.

The purposes of this proposal are to 1) develop and prototype a device for bladder control for men using GNS and 2) determine the acute effect of GNS on bladder capacity using this new prototype device. This work is building on previous success prototyping a similar device for women with OAB or NDO, which is being developed in other projects. The success of this study will be used to conduct a multi-site study of GNS and lead to clinical implementation.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Dennis Bourbeau, PhD; Phone Number: 4845 (216) 791-3800; Email: Dennis.Bourbeau@va.gov

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-1702
      • Louis Stokes VA Medical Center, Cleveland, OH
      • Principal Investigator: Dennis Bourbeau, PhD
      • Contact: Curtis J Donskey, MD; Phone Number: 4788 (216) 791-3800; Email: curtis.donskey@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Suprasacral SCI
• Neurologically stable
• Skeletally mature
• Presence of reflex bladder contractions
• At least 12 months post SCI

Exclusion Criteria:

• Active sepsis
• Open pressure sores on or around pelvis
• Bleeding diathesis
• Significant urethral trauma, erosion, or stricture
• Indwelling catheter for over 1 year AND bladder capacity less than 100 mL
• Significant history of autonomic dysreflexia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder Capacity	Change in bladder capacity (in mL) in response to genital nerve stimulation will serve as the primary outcome measure for this study.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability Metrics	Study participants will be surveyed regarding device design and usability prior to device usage.	Day 1
Electrical Impedance	The Gravata's electrode to skin contact will be assessed through measuring electrical impedance of the device to confirm adherence to out benchmark (less than 4 kOhms)	Day 1

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Dennis Bourbeau, PhD, Louis Stokes VA Medical Center, Cleveland, OH

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2028
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 25, 2026

Study Record Updates

• Last Update Posted (Actual): June 25, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Spinal cord injury; Neurogenic detrusor overactivity; Genital nerve stimulation
• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Trauma, Nervous System; Urinary Bladder Diseases; Spinal Cord Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Spinal Cord Injuries; Urinary Bladder, Neurogenic
• Other Study ID Numbers: RRD5-001-25W; IU1RD000568-01A2 (Other Grant/Funding Number: VA ORD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No