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NCT03503513 · ClinicalTrials.gov registry record · Phase 2
Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury
A Phase 2 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 2
- Development phase
- 23
- Enrollment target
NCT03503513: Completed Phase 2 study, sponsored by University of Michigan.
NCT03503513 is a Phase 2 study that has completed, run by University of Michigan. The registered enrollment target is 23 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03503513, a Phase 2 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 23 participants
- Enrollment target
Study Summary
A non-randomized study evaluating the efficacy of intravesical gentamicin on the occurrence rate of urinary tract infections and bladder complications in patients after spinal cord injury (SCI), and to assess its effectiveness in promoting overall quality of life (QOL), community living, and participation.
Primary Outcome
Number of reported urinary tract infections (UTI) by participants and documented in medical chart, per person across months pre and post treatment. The number of UTIs over time was determined by establishing a per person-month rate made up of the total number of UTIs pre and during treatment (numerator) for the sample divided by the total number of persons/ 6 months (11 participants over 6 months period = 66) as the denominator. The unit of measure is defined as pre and during treatment number o
Interventions
- DRUG Gentamicin Sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2018-08-24 |
| Est. Completion | 2023-09-30 |
| Phase | Phase 2 |
What the finished NCT03503513 record still lists
NCT03503513 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Gentamicin Sulfate is the first listed.
NCT03503513 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03503513 about?
NCT03503513 is a clinical study titled "Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury". A non-randomized study evaluating the efficacy of intravesical gentamicin on the occurrence rate of urinary tract infections and bladder complications in patients after spinal cord injury (SCI), and to assess its effectiveness in promoting overall quality of life (QOL), community living, and partici...
What is the current status of trial NCT03503513?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 23 participants. The study started on 2018-08-24. Estimated completion is 2023-09-30.
What interventions are being tested in trial NCT03503513?
The interventions under investigation include: Gentamicin Sulfate (DRUG).
Who is sponsoring clinical trial NCT03503513?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03503513's enrollment target sits among peer trials
23 1784th of 2000 higher than 211 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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