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.
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 self-reported measures about complications, symptoms, community participation and quality of life. Similar information is collected at the end of treatment. At a 3-month follow up visit, all available data is obtained through phone interviews and/or medical chart reviews except for self-report measures. 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, answer questions 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
23
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.
University of Michigan Health System
Ann Arbor, Michigan, United States
Number of Urinary Tract Infections (UTI) Over Time
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 of UTI events per person months. These appear below under outcome measure data table.
Time frame: 6 months prior to treatment and 6 months during treatment
Change in Score of Neurogenic Bladder Symptom Severity (NBSS) Scale
Self-reported bladder symptoms on a scale from 0 (no symptoms) to 74 (maximum symptoms). The NBSS is a patient reported 22 item scale designed to assess symptoms and bladder related consequences among persons with neurogenic bladder dysfunction. NBSS scores are calculated across three domains with higher scores being worse and reflecting more symptoms or complications. Incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23). An additional question of happiness (points) was not used for this outcome.
Time frame: Baseline to 6 months
Change in Score of Neurogenic Bowel Dysfunction (NBD)
Self-reported bowel symptoms on a scale from 0 (very minor) to 14+ (severe). The NBD is a 10 item validated measure that assesses frequency of defecation and methods of bowel management and complications. Thus negative numbers in "score change" represent decrease in symptom severity.
Time frame: Baseline to 6 months
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