Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IU1RD000568-01A2 | Other Grant/Funding Number | VA ORD |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genital Nerve Stimulation | Experimental | Study participants will don the device at the beginning of the experiment session. An initial clinical urodynamics test will be performed to confirm that the participant has neurogenic bladder. The investigators will select stimulation parameters that effectively inhibit reflexive bladder contractions. Serial cystometrograms will then be conducted. Each fill will be conducted either 1) without stimulation (control runs) or 2) with stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Noninvasive electrical stimulation device to improve bladder control | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Bladder Capacity | Change in bladder capacity (in mL) in response to genital nerve stimulation will serve as the primary outcome measure for this study. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Usability Metrics | Study participants will be surveyed regarding device design and usability prior to device usage. | Day 1 |
| Electrical Impedance | 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Device has been developed for male anatomy
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dennis Bourbeau, PhD | Contact | (216) 791-3800 | 4845 | Dennis.Bourbeau@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Dennis Bourbeau, PhD | Louis Stokes VA Medical Center, Cleveland, OH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio | 44106-1702 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| Day 1 |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |