CompletedNot Applicable

Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia

United States17 participantsStarted 2019-11-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incontinence

Timeframe: Collected over 24 months

Trial details

NCT IDNCT03472599

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2023-09-30

View on ClinicalTrials.gov More Neurogenic Bladder Dysfunction trials