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

Phase 2

Completed

Interventions: Drug: Gentamicin Sulfate
Other: Placebo instillation (saline alone)
Other: No instillation

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Gentamicin	Gentamicin Sulfate	Participants will be randomized into one of three groups. In this arm, participants will perform bladder instillations using a 50ml solution of gentamicin mixed with saline, 2 times per day. A formulation derived from 480 mg gentamicin sulfate diluted in 1 L normal saline will be used for instillation. Participants will be blinded during the study and will not know if they are receiving gentamicin or placebo (saline alone).
Placebo instillation (saline alone)	Placebo instillation (saline alone)	Participants will be randomized into one of three groups. In this arm, participants will perform bladder instillations using a 50ml solution of saline alone. Participants will be blinded during the study and will not know if they are receiving gentamicin or placebo (saline alone).
No instillation	No instillation	Participants will be randomized into one of three groups. In this arm 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.

Primary Outcome Measures

Name	Time	Method
Evaluate Bladder Storage Using Urodynamics	1. Baseline (1 week) 2. Midpoint (2 months) 3. Post (4 months)	Assessment of Lower Urinary Tract Function: Urodynamic Bladder Compliance (mL/cm H20) based on Change in Bladder Capacity.

Secondary Outcome Measures

Name	Time	Method
Participants With Symptomatic Urinary Tract Infection	1. Baseline (1 week) 2. Midpoint (2 months) 3. Post (4 months)	number of participants with symptomatic urinary tract infection measured by the presence of Leukocyte Esterase level in urine.