Neurogenic Bladder
Conditions
Keywords
Neurogenic detrusor overactivity, Spinal cord injury, Genital nerve stimulation
Brief summary
Urinary incontinence, bladder frequency, and bladder urgency are significant medical problems for people with overactive bladder (OAB) or neurogenic bladder overactivity (NDO). Affected individuals typically experience reflex bladder contractions in response to bladder filling at low volumes, resulting in urinary incontinence and decreased bladder capacity. This project will advance a new device for administering noninvasive electrical stimulation in order to improve bladder control.
Detailed description
Urinary incontinence, bladder frequency, and bladder urgency are significant medical problems for people with overactive bladder (OAB) or neurogenic bladder overactivity (NDO). Restoring bladder control is considered a high priority, but remains a critically unmet need requiring further development. The long-term goal is to develop and clinically implement a "bladder pacemaker" able to restore bladder control for individuals with OAB or NDO. Electrical stimulation of the genital nerves inhibits the spinal neural circuits involved in hyper-reflexive bladder spasms. Genital nerve stimulation (GNS) has been used by multiple groups to inhibit reflexive OAB and neurogenic bladder contractions during acute (1 visit) urodynamic testing and limited chronic take-home testing. The investigators have recently demonstrated that surface GNS inhibits reflexive bladder contractions and reduces incontinence in individuals with SCI during one month of home use using a limited stimulation system. Participant feedback from these studies identified a number of stimulation system issues that created nontrivial inconveniences, which affected activities of daily living and prevented some participants from participating in the study. Required improvements include, but are not limited to better electrode interface, elimination of wired connections, and a smaller device. The purposes of this proposal are to 1) develop and prototype a device for bladder control for men using GNS and 2) determine the acute effect of GNS on bladder capacity using this new prototype device. This work is building on previous success prototyping a similar device for women with OAB or NDO, which is being developed in other projects. The success of this study will be used to conduct a multi-site study of GNS and lead to clinical implementation.
Interventions
DEVICENoninvasive electrical stimulation device to improve bladder control
Genital nerve stimulation (GNS) will be applied using a wearable, transcutaneous neurostimulator and sleeve electrode that targets the genital nerve reflex pathway for the treatment of neurogenic bladder associated with spinal cord injury.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a pilot study to evaluate the efficacy of a prototype device to improve bladder control in persons with spinal cord injury and neurogenic bladder dysfunction. Each participant will serve as their own control.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Suprasacral SCI * Neurologically stable * Skeletally mature * Presence of reflex bladder contractions * At least 12 months post SCI
Exclusion criteria
* Active sepsis * Open pressure sores on or around pelvis * Bleeding diathesis * Significant urethral trauma, erosion, or stricture * Indwelling catheter for over 1 year AND bladder capacity less than 100 mL * Significant history of autonomic dysreflexia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bladder Capacity | Day 1 | Change in bladder capacity (in mL) in response to genital nerve stimulation will serve as the primary outcome measure for this study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability Metrics | Day 1 | Study participants will be surveyed regarding device design and usability prior to device usage. |
| Electrical Impedance | Day 1 | The Gravata's electrode to skin contact will be assessed through measuring electrical impedance of the device to confirm adherence to out benchmark (less than 4 kOhms) |
Countries
United States
Contacts
CONTACTDennis Bourbeau, PhD
PRINCIPAL_INVESTIGATORDennis Bourbeau, PhD
Louis Stokes VA Medical Center, Cleveland, OH
Outcome results
None listed