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

PHASE2CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

February 19, 2019

Primary Completion Date

July 14, 2020

Study Completion Date

December 30, 2020

Conditions
Neurogenic BladderSpinal Cord Injuries
Interventions
DRUG

Gentamicin Sulfate

Gentamicin will be compounded for immediate use in single-dose, disposable BD 50ml Luer-Lok tip syringes. The container closure system for the diluted gentamicin sulfate solution and saline solution will be sterile and processed with depyrogenation. The solution will be slowly infused into the bladder after drainage of urine is complete. While monitoring blood pressure, the solution will remain in the participant's bladder for a least 30 minutes (unless the participant is experiencing autonomic dysreflexia, and in that case, immediately drained) with the goal of attaining 2 hours.

OTHER

Placebo instillation (saline alone)

Saline will be compounded for immediate use in single-dose, disposable BD 50ml Luer-Lok tip syringes. The container closure system for the diluted gentamicin sulfate solution and saline solution will be sterile and processed with depyrogenation. The solution will be slowly infused into the bladder after drainage of urine is complete. While monitoring blood pressure, the solution will remain in the participant's bladder for a least 30 minutes (unless the participant is experiencing autonomic dysreflexia, and in that case, immediately drained) with the goal of attaining 2 hours.

OTHER

No instillation

Participants will not receive an instillation of gentamicin or saline alone, but instead will continue standard of care. Participants will be assessed at the pre-, mid- and post-intervention time points.

Trial Locations (1)

40202

Frazier Rehab, Louisville

All Listed Sponsors
lead

University of Louisville

OTHER

NCT03931408 - Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections | Biotech Hunter | Biotech Hunter