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NCT Number: NCT07668063

Device for Bladder Control for Men With SCI

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.

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Key information

Conditions

Neurogenic Bladder Central Nervous System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location contact

Curtis J Donskey, MD

CONTACT

[email protected]

(216) 791-3800 ext. 4788

Dennis Bourbeau, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Bladder Capacity

    Time frame: Day 1

    Change in bladder capacity (in mL) in response to genital nerve stimulation will serve as the primary outcome measure for this study.

Secondary outcomes

  1. Usability Metrics

    Time frame: Day 1

    Study participants will be surveyed regarding device design and usability prior to device usage.

  2. Electrical Impedance

    Time frame: Day 1

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Dennis Bourbeau, PhD

CONTACT

[email protected]

(216) 791-3800 ext. 4845

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Important dates

Study start
2028
Primary completion
2029
Study completion
2029
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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