CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 23 enrolled
Drug / intervention
Gentamicin Sulfatedrug
Likely dose
Gentamicin Sulfate 480 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03503513
NCT03503513Phase 3Completed
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The Effect of Gentamicin Intravesical Installations on Decreasing Urinary Tract Infections in Patients With Neurogenic Bladder After Spinal Cord Injury: A Clinical Trial

University of Michigan·interventional·Posted Apr 19, 2018·Updated Jun 25, 2024

In Brief

A Phase 3 clinical trial evaluating Gentamicin Sulfate for Urinary Tract Infections and 3 related conditions. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Tract Infections, Spinal Cord Injuries, Spinal Cord Diseases, Neurogenic Bladder
CountriesUnited States
CollaboratorsDepartment of Health and Human Services

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedApr 19, 2018
Enrollment StartAug 24, 2018
Primary CompletionSep 8, 2023
Study CompletionSep 30, 2023
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 8.2 years ago

Interventions

Gentamicin Sulfatedrug

Gentamicin is compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Pharmacy mails participants treatment drug. Once received, participants will do daily instillations of 30 milliliters of solution after catheterizing their bladder at night.