Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Urinary Tract Infections, Spinal Cord Injuries, Spinal Cord Diseases, Neurogenic Bladder

Intervention / Treatment
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* Drug: Gentamicin Sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form. History of traumatic spinal cord injury (SCI) or non-traumatic spinal cord disease, (SCD) with sustained neurological dysfunction At least 6 months post-initial hospital discharge following SCI/SCD onset Neurogenic bladder Ability to perform daily instillation on self or with help of others and willingness to adhere to the study regiment. History of at least 2 documented urinary tract infection (UTI) during the previous 6 months (prior to screening) Have a designated physician or health care provider for routine care Use of clean intermittent catheterization or catheterization through a stoma (i.e. Mitrofanoff) as their primary method of bladder management Exclusion Criteria: Concurrent use of systemic oral or intravesical antibiotic prophylaxis Documented or self-reported history of gentamicin allergy Female patients who are currently pregnant or attempting to become pregnant Patients with a history of 8th cranial nerve disorder Co-morbidities like cancer and chronic disease that could impact patient safety OR significantly affect the rate of UTIs and/or quality of life (QOL) substantially Urological co-morbidities like bladder cancer and history of kidney disease. Current UTI at baseline visit (assessed via urine analysis and culture and symptoms) Concurrent enrollment in a similar clinical trial Concurrent use of contraindicated diuretics (ethacrynic acid, furosemide) Current use of other contraindicated or disallowed concomitant medications or receiving treatments that may influence the results from this study. Known allergy to aminoglycoside antibiotics At the discretion of study team, individuals who are unable or unlikely to comply with procedures and/or for whom study participation is not recommended (e.g. unable to arrange transportation, cognitive and/or behavioral challenges that preclude meaningful participation, poor health, etc.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gentamicin sulfate<br>Participants initiate Gentamicin instillations every night for a period of 6 months. After baseline and consented they are instructed on how to do the instillations through a catheter, once they receive the drug and aid equipment (i.e. syringes) to do installations. Remaining drug is to be disposed after each use. Participants use their own catheters. | Drug: Gentamicin Sulfate<br>* Gentamicin will be compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Participants will do daily instillations of 30 milliliters of solution<br>* Other names: Gent Instillations;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of urinary tract infections (UTI) | Number of reported urinary tract infections (UTI) by participants | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in score of Neurogenic Bladder Symptom Severity scale | Self-reported bladder symptoms on a scale from 0 (no symptoms) to 74 (maximum symptoms) | 6 months | 
| Change in score of Neurogenic Bowel Dysfunction | Self-reported bowel symptoms on a scale from 0 (very minor) to 14+ (severe) | 6 months |