Chronic Electrical Stimulation to Reduce Bladder Hyperreflexia

Completed · Not applicable

Conditions studied: Neurogenic Bladder Dysfunction

In brief

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.

Key facts

Study ID

NCT03472599

Run by

VA Office of Research and Development

People needed

17

Starts

2019-11-01

Expected to finish

2023-09-30

Last updated by the study team

2023-10-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Active sepsis
• Open pressure sores on penis
• Significant trauma, erosion or stricture of the urethra
• Pregnancy
• Individuals who do not speak English.

Where it is running

• Syracuse VA Medical Center, Syracuse, NY — Syracuse, New York, United States
• Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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