Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections

• Status: Active, not recruiting
• Trial end date: 2022-01-16
• Target enrollment: 0
• Participant gender: All

Summary

Participants will undergo daily gentamicin bladder instillations to determine if its use will reduce the rate of symptomatic urinary tract infections (UTIs) as well as the use of oral and intravenous antibiotics in adults with chronic spinal cord injury (SCI) who have recurrent UTIs. Participants are randomized into one of three groups: 1) Gentamicin and saline instillation 2) Saline only instillation 3) Standard of care, no instillation.

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

Details

• Lead Sponsor: University of Louisville
• Treatments: Gentamicins; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• At least 18 years of age;

• Non-progressive spinal cord injury;

• Stable medical condition;

• Bladder dysfunction as a result of spinal cord injury

• History of recurrent UTIs (defined as 3 or more within the past year or 2 or more within the past 6 months).

Exclusion Criteria:

• Signs or symptoms of serious UTI that requires the use of systemic antibiotics;

• Use of any urine-acidifying agent, bladder irrigant, or systemic antibiotic within the previous 2 weeks;

• Participants colonized with gentamicin-resistant bacteria on baseline urine culture or a gentamicin allergy/sensitivity;

• Participants with known hearing loss and/or renal disease;

• Pregnant at the time of enrollment or planning to become pregnant during the time course of the study.