Neurogenic BladderPhase 1/2NCT07668063
Device for Bladder Control for Men With SCI
A Phase 1/2 study of Neurogenic Bladder, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Neurogenic Bladder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2028to 31 Dec 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suprasacral SCI
- Neurologically stable
- Skeletally mature
- Presence of reflex bladder contractions
- At least 12 months post SCI
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
Curtis J Donskey, MD, (216) 791-3800 ext. 4788, curtis.donskey@va.gov
Dennis Bourbeau, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Neurogenic Bladder
- Being tested
- Noninvasive electrical stimulation device to improve bladder control
- Keywords
- Neurogenic detrusor overactivity, Spinal cord injury, Genital nerve stimulation
- Medical subject headings
- Urinary Bladder, Neurogenic, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive electrical stimulation device to improve bladder controlDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Genital Nerve Stimulation | Experimental | 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. Receives: Device: Noninvasive electrical stimulation device to improve bladder control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bladder Capacity
Change in bladder capacity (in mL) in response to genital nerve stimulation will serve as the primary outcome measure for this study.
Measured: Day 1
Secondary outcomes (2)
Usability Metrics
Study participants will be surveyed regarding device design and usability prior to device usage.
Measured: 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)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start1 Jun 2028 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pilot study to evaluate the efficacy of a prototype device to improve bladder control in persons with spinal cord injury and neurogenic bladder dysfunction. Each participant will serve as their own control.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Dennis Bourbeau, PhD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668063
- Sponsor's protocol ID
- RRD5-001-25W
- Other IDs
- IU1RD000568-01A2
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Electrical Stimulation Device to Improve Bladder Control for Men With Spinal Core Injury
- ClinicalTrials.gov ID
- NCT07668063
- Acronym / sponsor ID
- RRD5-001-25W
- Conditions
- Neurogenic Bladder
- Keywords
- Neurogenic detrusor overactivity, Spinal cord injury, Genital nerve stimulation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2028 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pilot study to evaluate the efficacy of a prototype device to improve bladder control in persons with spinal cord injury and neurogenic bladder dysfunction. Each participant will serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| Genital Nerve Stimulation | Experimental | Device: Noninvasive electrical stimulation device to improve bladder controlStudy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Suprasacral SCI
- Neurologically stable
- Skeletally mature
- Presence of reflex bladder contractions
- At least 12 months post SCI
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Noninvasive electrical stimulation device to improve bladder controlGenital 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. | Device | Genital Nerve Stimulation |
Primary outcome
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.
2 secondary outcomes
Usability Metrics
Time frame: Day 1
Electrical Impedance
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Neurogenic Bladder
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
Active, not recruitingObservational study
Pediatric Locomotor Training Bladder Study
Spinal Cord Injuries, Neurogenic Bladder
RecruitingEarly Phase 1
Concomitant Renal and Urinary Bladder Allograft Transplantation
Chronic Kidney Diseases, Bladder Dysfunction
Active, not recruitingObservational study
Qualitative Assessment of the Impact of TTNS on QOL and Participation
Neurogenic Bladder, Urinary Retention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dennis Bourbeau, PhD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Neurogenic Bladder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dennis Bourbeau, PhD ((216) 791-3800 ext. 4845, Dennis.Bourbeau@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder Capacity (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.