Neurogenic Bladder DysfunctionNCT03472599

Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia

A study testing Genital Nerve Stimulation in people with Neurogenic Bladder Dysfunction, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Neurogenic Bladder Dysfunction
What is being tested?: Genital Nerve Stimulation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 2 sitesUnited States
Study dates: 1 Nov 2019to 30 Sep 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Suprasacral neurogenic bladder following spinal cord injury, stroke, or multiple sclerosis
Neurologically stable
Skeletally mature, over 18 years of age.
Reflex bladder contractions confirmed by cystometrogram
At least six (6) months post spinal cord injury, stroke, or multiple sclerosis diagnosis
Able to understand and comply with study requirements
Able to understand and give informed consent

Who cannot join

Active sepsis
Open pressure sores on penis
Significant trauma, erosion or stricture of the urethra
Pregnancy
Individuals who do not speak English.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
Syracuse VA Medical Center, Syracuse, NY
Syracuse, New York, 13210

Other trials in United States

About this study

Official title: Long Term Genital Nerve Stimulation to Improve Urinary Continence

Bladder spasms after spinal cord injury (SCI) can result in incontinence, urinary tract infections, kidney damage, trigger dangerous increases in blood pressure and decrease independence and quality of life. The investigators' long-term goal is to develop and provide a "bladder pacemaker" able to restore bladder continence for Veterans with SCI. Electrical stimulation of sensory nerves can stop bladder spasms during a doctor visit. However, this approach has not been tested during long term home use. This proposal will 1) determine how well sensory stimulation reduces incontinence and improves quality of life for Veterans with SCI during 1 year of home use, and 2) produce an effective take home system that can be used by more Veterans and other VAs.

Read the detailed description

The clinical problem of neurogenic detrusor overactivity (bladder hyper-reflexia) is among the most serious problems encountered by Veterans with neurologic injuries such as spinal cord injury (SCI). The majority of persons with SCI suffer from neurogenic bladder (73%) and only 17% of persons with traumatic SCI manage their bladders with voluntary micturition. The investigators' long-term goal is to develop and clinically implement a "bladder pacemaker" able to restore bladder continence for Veterans with spinal cord injury (SCI). This proposal will 1) determine the long-term effectiveness of genital nerve stimulation (GNS) to chronically ( 1 year) reduce urinary incontinence and improve quality of life for Veterans with SCI, and 2) develop and produce an effective take home GNS system that can be used by more Veterans, given to Veterans at the end of the study and used in future multi-VA studies.

The rationale for studying chronic GNS is based on the demonstration in humans with SCI that abnormal hyper-reflexive bladder contractions can be acutely inhibited and bladder capacity acutely increased using GNS. The peripheral and easily accessible location of the dorsal genital nerve (DGN) allows surface stimulation and therefore provides the potential for a less complicated surgical intervention than is currently available, increasing the number of individuals who could benefit from bladder control neural prostheses. While GNS has been demonstrated to be effective acutely by multiple groups, relatively few groups have attempted to test this approach for more than a day.

Conditions: Neurogenic Bladder Dysfunction
Being tested: Genital Nerve Stimulation
Keywords: Neurogenic bladder dysfunction, Genital Nerve Stimulation, Electrical Stimulation, Urinary Incontinence, Spinal cord injury
Medical subject headings: Urinary Incontinence, Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Genital Nerve StimulationOther
Genital nerve stimulation activates sensory afferents that travel through the pudendal nerves and enters the spinal cord through the sacral dorsal root ganglia. Inhibitory spinal reflex pathways are activated, causing increased sympathetic outflow through the inferior mesenteric ganglion and hypogastric nerve and also decreased parasympathetic efferent drive through the pelvic nerve, resulting in inhibited bladder contractions.

Study groups in NCT03472599
Study group	Role	What they receive
Genital Nerve Stimulation	Experimental	Study participants in this arm will use take-home genital nerve stimulation for 24+ months in order to assess its effectiveness at decreasing urinary incontinence. In order to set effective genital nerve stimulation parameters, study participants will undergo clinical urodynamics every 6 months in which sensitivity to and tolerance of electrical stimulation are assessed. Receives: Other: Genital Nerve Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Incontinence
Leakage episodes (metric for incontinence) collected over the initial month of testing.
Measured: Collected over 1 month
Urgency
Urgency episodes collected over the initial month of testing.
Measured: Collected over 1 month

Secondary outcomes (1)

Bladder Capacity
The investigators will measure bladder capacity in mL during acute urodynamics trials
Measured: Collected over 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201930 Sep 2023

First posted21 Mar 2018
Study start1 Nov 2019
Primary completion30 Sep 2023
Study completion30 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Neurogenic Bladder DysfunctionStudies 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: All subjects will take home skin surface electrodes and a simple one-channel electrical stimulators appropriate for extended use set to the stimulus parameters found effective during an initial urodynamics test. Genital nerve stimulation will be applied either continuously or on-demand when individuals turn stimulation on when they feel the onset of bladder leaking.
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03472599
Sponsor's protocol ID: B2512-R
Other IDs: RX002512
Status last verified: Jul 2026
First submitted: 5 Mar 2018
Last updated: 20 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bourbeau DJ, Creasey GH, Sidik S, Brose SW, Gustafson KJ. Genital nerve stimulation increases bladder capacity after SCI: A meta-analysis. J Spinal Cord Med. 2018 Jul;41(4):426-434. doi: 10.1080/10790268.2017.1281372. Epub 2017 Feb 15.
PubMed 28198657
Bourbeau DJ, Gustafson KJ, Brose SW. At-home genital nerve stimulation for individuals with SCI and neurogenic detrusor overactivity: A pilot feasibility study. J Spinal Cord Med. 2019 May;42(3):360-370. doi: 10.1080/10790268.2017.1422881. Epub 2018 Jan 15.
PubMed 29334338

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
RecruitingEarly Phase 1
Concomitant Renal and Urinary Bladder Allograft Transplantation
Chronic Kidney Diseases, Bladder Dysfunction
Not yet recruiting
Rapid UTI Diagnostics in Lower Urinary Tract Dysfunction Among Catheter Users
Neurogenic Bladder Disorder, Lower Urinary Tract Disorder
Not yet recruitingEarly Phase 1
Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD
Spinal Cord Injury, Neurogenic Bladder (NB)
Not yet recruiting
Radio-frequency (RF) Bladder Monitor
Spinal Cord Injuries (SCI), Neurogenic Lower Urinary Tract Dysfunction

All Neurogenic Bladder Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long Term Genital Nerve Stimulation to Improve Urinary Continence
ClinicalTrials.gov ID: NCT03472599
Acronym / sponsor ID: B2512-R
Conditions: Neurogenic Bladder Dysfunction
Keywords: Neurogenic bladder dysfunction, Genital Nerve Stimulation, Electrical Stimulation, Urinary Incontinence, Spinal cord injury
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: Syracuse VA Medical Center
Study start: 1 Nov 2019 (actual)
Primary completion: 30 Sep 2023 (actual)
Study completion: 30 Sep 2023 (actual)
First posted: 21 Mar 2018 (actual)
Results: Posted 20 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: All subjects will take home skin surface electrodes and a simple one-channel electrical stimulators appropriate for extended use set to the stimulus parameters found effective during an initial urodynamics test. Genital nerve stimulation will be applied either continuously or on-demand when individuals turn stimulation on when they feel the onset of bladder leaking.

Arm	Type	Receives
Genital Nerve Stimulation	Experimental	Other: Genital Nerve StimulationStudy participants in this arm will use take-home genital nerve stimulation for 24+ months in order to assess its effectiveness at decreasing urinary incontinence. In order to set effective genital nerve stimulation parameters, study participants will undergo clinical urodynamics every 6 months in which sensitivity to and tolerance of electrical stimulation are assessed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Suprasacral neurogenic bladder following spinal cord injury, stroke, or multiple sclerosis
Neurologically stable
Skeletally mature, over 18 years of age.
Reflex bladder contractions confirmed by cystometrogram
At least six (6) months post spinal cord injury, stroke, or multiple sclerosis diagnosis

Key exclusion criteria (5 listed)

Active sepsis
Open pressure sores on penis
Significant trauma, erosion or stricture of the urethra
Pregnancy
Individuals who do not speak English.

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
Genital Nerve StimulationGenital nerve stimulation activates sensory afferents that travel through the pudendal nerves and enters the spinal cord through the sacral dorsal root ganglia. Inhibitory spinal reflex pathways are activated, causing increased sympathetic outflow through the inferior mesenteric ganglion and hypogastric nerve and also decreased parasympathetic efferent drive through the pelvic nerve, resulting in inhibited bladder contractions.	Other	Genital Nerve Stimulation

Primary outcome

Incontinence
Time frame: Collected over 1 month
Leakage episodes (metric for incontinence) collected over the initial month of testing.
Urgency
Time frame: Collected over 1 month
Urgency episodes collected over the initial month of testing.

1 secondary outcome

Bladder Capacity
Time frame: Collected over 1 month

Results and safety

Results posted to the registry on 20 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Genital Nerve Stimulation	17	2

Primary outcome: Incontinence

Time frame: Collected over 1 month. Mean (Standard Deviation). Unit: Events

Measure	Genital Nerve Stimulation n = 3
Control	2.08 (1.92)
Stimulation	0.88 (0.33)

Population analysed: Diary problems for 2 subjects

Primary outcome: Urgency

Time frame: Collected over 1 month. Mean (Standard Deviation). Unit: Events

Measure	Genital Nerve Stimulation n = 4
Control	7.95 (3.76)
Stimulation	7.04 (3.24)

Population analysed: Diary problems for 2 subjects

1 secondary outcome is reported in the full results.

Adverse events

Time frame: from enrollment until end of follow up - up to 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Genital Nerve Stimulation	0 of 17 (0%)	0 of 17 (0%)	0 of 17

Limitations and caveats (from the sponsor): COVID and New York related restrictions limited subject recruitment and testing sessions. Subject diary-related issues and missing diary data were major limitations. Device handling and maintenance limited subject participation.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28198657Bourbeau DJ, Creasey GH, Sidik S, Brose SW, Gustafson KJ. Genital nerve stimulation increases bladder capacity after SCI: A meta-analysis. J Spinal Cord Med. 2018 Jul;41(4):426-434. doi: 10.1080/10790268.2017.1281372. Epub 2017 Feb 15.
Results publication: PubMed 29334338Bourbeau DJ, Gustafson KJ, Brose SW. At-home genital nerve stimulation for individuals with SCI and neurogenic detrusor overactivity: A pilot feasibility study. J Spinal Cord Med. 2019 May;42(3):360-370. doi: 10.1080/10790268.2017.1422881. Epub 2018 Jan 15.
Individual participant dataSharing planned: No

Related trials for Neurogenic Bladder Dysfunction

Recruiting
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
Neurogenic Dysfunction of the Urinary Bladder, Multiple Sclerosis
RecruitingEarly Phase 1
Concomitant Renal and Urinary Bladder Allograft Transplantation
Chronic Kidney Diseases, Bladder Dysfunction
Not yet recruiting
Rapid UTI Diagnostics in Lower Urinary Tract Dysfunction Among Catheter Users
Neurogenic Bladder Disorder, Lower Urinary Tract Disorder
Not yet recruitingEarly Phase 1
Coupled Gentamicin-Lactobacillus Rhamnosus in NLUTD
Spinal Cord Injury, Neurogenic Bladder (NB)
Not yet recruiting
Radio-frequency (RF) Bladder Monitor
Spinal Cord Injuries (SCI), Neurogenic Lower Urinary Tract Dysfunction

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. This study is not recruiting at the moment.

Kenneth J. Gustafson, PhD principal investigator

Louis Stokes VA Medical Center, Cleveland, OH

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Genital Nerve Stimulation in people with Neurogenic Bladder Dysfunction, run by VA Office of Research and Development at 2 sites 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incontinence (time frame: Collected over 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03472599, which also lists 2 linked publications.

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 20 Aug 2026.