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

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A cross over study evaluating the efficacy of intravesical gentamicin on the occurrence rate of urinary tract infections and bladder complications in patients after spinal cord injury (SCI), and to assess its effectiveness in promoting overall quality of life (QOL), community living, and participation.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Treatments: Gentamicins

Criteria

Inclusion Criteria:

• Provision of signed and dated informed consent form.

• 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 willingness to adhere to the study regiment.

• History of at least 2 documented urinary tract infection (UTI) during the previous 6 months (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 OR significantly 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 baseline visit (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 or receiving treatments that may influence the results from this study.

• Known allergy to aminoglycoside antibiotics

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