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.
Trial summary
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. Read more about this study
- 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
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Syracuse VA Medical Center
- Responsible party
- Sponsor
- Investigators
- Kenneth J. Gustafson, PhD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
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 28198657Bourbeau 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