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Antibiotic
Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections
Phase 2
Waitlist Available
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in baseline bladder capacity to post intervention, an average of 5 months.
Summary
This trial tests if placing an antibiotic solution directly into the bladder can reduce infections in adults with spinal cord injuries who frequently get UTIs. The goal is to see if this method lowers the need for other antibiotics.
Eligible Conditions
- Spinal Cord Injury
- Neurogenic Bladder
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in baseline bladder capacity to post intervention, an average of 5 months.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in baseline bladder capacity to post intervention, an average of 5 months.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Evaluate bladder emptying via measurements of voiding efficiency (%) via Urodynamics assessment or uroflow (if appropriate).
Evaluate bladder storage using Urodynamics
Incidence of urinary tract infections measured with Urinalysis and Culture
+5 moreSide effects data
From 2023 Phase 2 & 3 trial • 23 Patients • NCT0350351363%
Urinary Tract Infection
21%
COVID-19
16%
flu-like symptoms
16%
bladder spasms
11%
Clinically significant labs
11%
GI upset
11%
abdominal stoma issue
11%
heel wound
5%
bowel obstruction
5%
Serratia tissue infection
5%
loose stool
5%
hematuria
5%
inguinal pain
5%
parotitis
5%
vaginitis
5%
muscle strain
5%
Gross hematuria
5%
bladder stone
5%
bone infection
5%
bleeding from catheter site
5%
bladder irritation
5%
conjunctivitis
5%
sweating
5%
pulmonary embolism
5%
Post-COVID 19 pneumonia
5%
cystolitholapaxy
5%
Renal stone removal
5%
air in bladder
5%
upper respiratory infection
5%
pneumonia
5%
nasal discharge
5%
urinary discharge
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gentamicin Sulfate
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: No instillationExperimental Treatment1 Intervention
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.
Group II: GentamicinExperimental Treatment1 Intervention
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).
Group III: Placebo instillation (saline alone)Placebo Group1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gentamicin Sulfate
2018
Completed Phase 3
~4430
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
348 Previous Clinical Trials
77,665 Total Patients Enrolled