Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections
Neurogenic Bladder, Spinal Cord Injuries
About this trial
This is an interventional prevention trial for Neurogenic Bladder focused on measuring bladder, spinal cord injury, urinary tract infection
Eligibility 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.
Sites / Locations
- Frazier Rehab
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Other
Gentamicin
Placebo instillation (saline alone)
No instillation
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).
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).
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.