Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/17/2019 |
| Start Date: | April 1, 2019 |
| End Date: | June 1, 2021 |
| Contact: | Kenneth J Gustafson, PhD |
| Email: | kjg@case.edu |
| Phone: | (216) 368-8626 |
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.
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.
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.
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.
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.
We found this trial at
1
site
Cleveland, Ohio 44106
Principal Investigator: Kenneth J. Gustafson, PhD
Phone: 216-368-8626
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