Restoration of Bladder Function in Spinal Cord Injury

Technology

Bladder health/function

Online since 20 October 2023, updated 298 days ago

About this trial

This trial is enrolling 5-10 individuals with chronic complete spinal cord injuries who have undergone implantation of a Sacral Anterior Root Stimulator (SARS), Finetech Brindley Bladder stimulator, to test the effect of high frequency stimulation on bladder function. SARS is a technique for stimulating nerves that exit at the lowest part of the spinal cord with implanted electrodes. The study will explore new stimulation parameters using a modified external stimulation control unit. If included, participants will receive SARS with high frequency (up to 600Hz), compared with the effect of usual low frequency.

Included participants

Gender

All

Age

≥ 18 years

Injury level

C1 - S5

Severity (AIS)?

AIS-A

AIS-B

Time since injury

All

Healthy volunteers

C1-S5

Additionally, participants must

have undergone implantation of a Finetech Brindley Bladder controller, with or without sacral posterior rhizotomy

NOT have undergone external urethral sphincterotomy

What’s involved

Type

Technology

Details

- Participants will receive high and low frequency stimuli applied to sacral afferent nerves with the already implanted Finetech Brindley bladder stimulator. - Outcome measures will be compared with different frequencies of electrical stimuli and with no electrical stimuli.

Potential benefits

Main benefits

Bladder health/function

Additional benefits

General health

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

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Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

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