Clinical trial NCT03472599: Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia
Official title: Long Term Genital Nerve Stimulation to Improve Urinary Continence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurogenic Bladder Dysfunction
Keywords: Neurogenic bladder dysfunction
Genital Nerve Stimulation
Electrical Stimulation
Urinary Incontinence
Spinal cord injury
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Syracuse VA Medical Center
First posted: 2018-03-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Incontinence
timeFrame: Collected over 24 months
Secondary outcomes:
measure: Bladder Capacity
timeFrame: Collected over 24 months
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Syracuse VA Medical Center, Syracuse, NY
state: New York
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
Study officials:
affiliation: Louis Stokes VA Medical Center, Cleveland, OH
name: Kenneth J. Gustafson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.