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Clinical Trial 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.


Clinical Trial Description

Intervention: Participants number of UTIs during the six-month treatment period will be compared to the number they incurred during the six months prior to treatment. Participants complete a baseline visit which consists of medical history, informed consent, urinalysis/culture indicating no active UTIs, metabolic panel, and questionnaires. Similar information is collected at the end of treatment and at a 3-month follow up visit. Participants begin active treatment using gentamicin plus saline solution after they have completed all requirements. Instillations of treatment solution occur nightly after the participant's last evening catheterization. Bi-weekly calls are conducted to ensure compliance and document adverse events. Participants will stop the trial if they develop an UTI. After receiving treatment for the UTI by their physician, they will go into a washout period of a week before resuming the trial with Gentamicin instillations. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03503513
Study type Interventional
Source University of Michigan
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date August 24, 2018
Completion date August 15, 2023

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