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

Launched by UNIVERSITY OF MICHIGAN · Apr 11, 2018

Keywords

ClinConnect Summary

Intervention: Participants' number of UTIs during the six-month treatment period will be compared to the number they incurred during the six months prior to treatment. Participants complete a baseline visit which consists of medical history, informed consent, urinalysis/culture indicating no active UTIs, metabolic panel, and self-reported measures about complications, symptoms, community participation and quality of life. Similar information is collected at the end of treatment. At a 3-month follow up visit, all available data is obtained through phone interviews and/or medical chart review...

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Eligibility criteria

• Inclusion Criteria:
• • Provision of signed and dated informed consent form and agreement to complete the daily 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 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 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 or receiving 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 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.)