Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury

Inclusion Criteria:

• Provision of signed and dated informed consent form and agreement to complete thedaily dosing log as instructed by the study coordinator.

• History of traumatic spinal cord injury (SCI) or non-traumatic spinal cord disease, (SCD) with sustained neurological dysfunction

• At least 6 months post-initial hospital discharge following SCI/SCD onset

• Neurogenic bladder

• Ability to perform daily instillation on self or with help of others and willingnessto adhere to the study regiment.

• History of at least 2 documented urinary tract infection (UTI) during the previous 6months (prior to screening)

• Have a designated physician or health care provider for routine care

• Use of clean intermittent catheterization or catheterization through a stoma (i.e.Mitrofanoff) as their primary method of bladder management

Exclusion Criteria:

• Concurrent use of systemic oral or intravesical antibiotic prophylaxis

• Documented or self-reported history of gentamicin allergy

• Female patients who are currently pregnant or attempting to become pregnant

• Patients with a history of 8th cranial nerve disorder

• Co-morbidities like cancer and chronic disease that could impact patient safety ORsignificantly affect the rate of UTIs and/or quality of life (QOL) substantially

• Urological co-morbidities like bladder cancer and history of kidney disease.

• Current UTI at screening (assessed via urine analysis and culture and symptoms)

• Concurrent enrollment in a similar clinical trial

• Concurrent use of contraindicated diuretics (ethacrynic acid, furosemide)

• Current use of other contraindicated or disallowed concomitant medications orreceiving treatments that may influence the results from this study.

• Known allergy to aminoglycoside antibiotics; Otological symptoms at baseline (i.e.tinnitus. severe dizziness/vertigo)

• At the discretion of study team, individuals who are unable or unlikely to complywith procedures and/or for whom study participation is not recommended (e.g. unableto arrange transportation, cognitive and/or behavioral challenges that precludemeaningful participation, poor health, etc.)