Phase 2
N=6
Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections
Neurogenic Bladder · Spinal Cord Injuries
Bottom Line
View on ClinicalTrials.gov: NCT03931408 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Evaluate Bladder Storage Using Urodynamics — 611; 177.67; 662; 452 mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Gentamicin Sulfate (Drug); Placebo instillation (saline alone) (Other); No instillation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Louisville
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evaluate Bladder Storage Using Urodynamics |
611; 177.67; 662; 452; 286.5; 345.5 | — |
| SECONDARY Participants With Symptomatic Urinary Tract Infection |
1; 3; 2; 1; 3; 3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03931408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.