Neurogenic Bladder Dysfunction
Conditions
Keywords
Neurogenic bladder dysfunction, Genital Nerve Stimulation, Electrical Stimulation, Urinary Incontinence, Spinal cord injury
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.
Interventions
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.
Sponsors
VA Office of Research and Development
Syracuse VA Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incontinence | Collected over 1 month | Leakage episodes (metric for incontinence) collected over the initial month of testing. |
| Urgency | Collected over 1 month | Urgency episodes collected over the initial month of testing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bladder Capacity | Collected over 1 month | The investigators will measure bladder capacity in mL during acute urodynamics trials |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKenneth J. Gustafson, PhD
Louis Stokes VA Medical Center, Cleveland, OH
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62 years |
| Injury Multiple Sclerosis | 6 Participants |
| Injury Other | 3 Participants |
| Injury Spinal Cord Injury | 8 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
None listed