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NCT03931408 · ClinicalTrials.gov registry record · Phase 2
Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections
A Phase 2 study, sponsored by University of Louisville.
- Completed
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT03931408: Completed Phase 2 study, sponsored by University of Louisville.
NCT03931408 is a Phase 2 study that has completed, run by University of Louisville. The registered enrollment target is 6 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03931408, a Phase 2 study, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study 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.
Primary Outcome
Assessment of Lower Urinary Tract Function: Urodynamic Bladder Compliance (mL/cm H20) based on Change in Bladder Capacity.
Interventions
- DRUG Gentamicin Sulfate
- OTHER Placebo instillation (saline alone)
- OTHER No instillation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2019-02-19 |
| Est. Completion | 2020-12-30 |
| Phase | Phase 2 |
What the finished NCT03931408 record still lists
NCT03931408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Gentamicin Sulfate is the first listed.
NCT03931408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03931408 about?
NCT03931408 is a clinical study titled "Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections". 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 ar...
What is the current status of trial NCT03931408?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2019-02-19. Estimated completion is 2020-12-30.
What interventions are being tested in trial NCT03931408?
The interventions under investigation include: Gentamicin Sulfate (DRUG), Placebo instillation (saline alone) (OTHER), No instillation (OTHER).
Who is sponsoring clinical trial NCT03931408?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03931408's enrollment target sits among peer trials
6 1996th of 2000 higher than 1 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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