Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia
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| ClinicalTrials.gov Identifier: NCT03472599 |
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Recruitment Status :
Recruiting
First Posted : March 21, 2018
Last Update Posted : October 20, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neurogenic Bladder Dysfunction | Other: Genital Nerve Stimulation | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 16 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| 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. |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Long Term Genital Nerve Stimulation to Improve Urinary Continence |
| Actual Study Start Date : | November 1, 2019 |
| Estimated Primary Completion Date : | September 29, 2022 |
| Estimated Study Completion Date : | September 29, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Genital Nerve Stimulation
Study participants in this arm will use take-home genital nerve stimulation for 24+ months in order to assess its effectiveness at decreasing urinary incontinence. In order to set effective genital nerve stimulation parameters, study participants will undergo clinical urodynamics every 6 months in which sensitivity to and tolerance of electrical stimulation are assessed.
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Other: Genital Nerve Stimulation
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. |
- Incontinence [ Time Frame: Collected over 24 months ]The investigators will collect a record of leakage episodes (metric for incontinence) from the specified period.
- Bladder Capacity [ Time Frame: Collected over 24 months ]The investigators will measure bladder capacity in mL during acute urodynamics trials
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03472599
| Contact: Kenneth J Gustafson, PhD | (216) 368-8626 | Kenneth.Gustafson@va.gov | |
| Contact: Seth Meade, BS | (216) 368-8626 | smm214@case.edu |
| United States, New York | |
| Syracuse VA Medical Center, Syracuse, NY | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Steven Brose 315-425-4400 Steven.Brose@va.gov | |
| United States, Ohio | |
| Louis Stokes VA Medical Center, Cleveland, OH | Not yet recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Kenneth J Gustafson, PhD 216-368-8626 Kenneth.Gustafson@va.gov | |
| Principal Investigator: Kenneth J. Gustafson, PhD | |
| Principal Investigator: | Kenneth J. Gustafson, PhD | Louis Stokes VA Medical Center, Cleveland, OH |
Other Publications:
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT03472599 |
| Other Study ID Numbers: |
B2512-R RX002512 ( Other Grant/Funding Number: VA Office of Research and Development ) |
| First Posted: | March 21, 2018 Key Record Dates |
| Last Update Posted: | October 20, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
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Neurogenic bladder dysfunction Genital Nerve Stimulation Electrical Stimulation Urinary Incontinence Spinal cord injury |
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Urinary Bladder, Neurogenic Neurologic Manifestations Nervous System Diseases Urinary Bladder Diseases Urologic Diseases |