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The Evaluation of Antimicrobial Bladder Instillation on the Prevalence of Chronic Urinary Tract Infections and Bladder Dysfunction in Persons With Spinal Cord Injury
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.
The purpose of this study is to determine if twice daily bladder flushing with an antibiotic solution will decrease the rate of UTIs and the use of oral medications used to treat UTIs. The occurrence of UTIs in the SCI population is high, with a rate of about 2.5 episodes per year. The inability to effectively empty the bladder increases the risk of UTIs, which are the most common medical complication after SCI. This study will help us understand the effectiveness of a local bladder therapy on preventing UTIs and improving bladder function in individuals with SCI.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Frazier Rehab
Louisville, Kentucky, United States
Start Date
February 19, 2019
Primary Completion Date
July 14, 2020
Completion Date
December 30, 2020
Last Updated
January 29, 2025
6
ACTUAL participants
Gentamicin Sulfate
DRUG
Placebo instillation (saline alone)
OTHER
No instillation
OTHER
Lead Sponsor
University of Louisville
NCT06521723
NCT05563103
NCT06588010
Data Source & Attribution
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