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

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified April 2024 by University of Michigan
Sponsor
University of Michigan
Information Provided by (Responsible Party)
Denise Tate, PhD
Clinicaltrials.gov Identifier
NCT03503513
Other Study ID Numbers:
HUM00137086
First Submitted
April 5, 2018
First Posted
April 18, 2018
Results First Posted
March 13, 2024
Last Update Posted
June 24, 2024
Last Verified
April 2024

ClinicalTrials.gov processed this data on May 2024. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study 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 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.

Condition or DiseaseIntervention/Treatment
Urinary Tract InfectionsSpinal Cord InjuriesSpinal Cord DiseasesNeurogenic Bladder
Drug: Gentamicin Sulfate

Study Design

Study TypeInterventional
Actual Enrollment23 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposePrevention
Official TitleThe Effect of Gentamicin Intravesical Installations on Decreasing Urinary Tract Infections in Patients With Neurogenic Bladder After Spinal Cord Injury: A Clinical Trial
Study Start DateAugust 23, 2018
Actual Primary Completion DateSeptember 7, 2023
Actual Study Completion DateSeptember 29, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
Gentamicin sulfate
Participants initiate Gentamicin instillations every night for a treatment period of 6 months. Instillations are stopped if they developed a UTI. After receiving treatment for this UTI, they resume the Gentamicin instillations. After baseline screening and being 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 from syringes are to be disposed after each use. Participants use their own catheters. In-dwelling catheters are not allowed.
Drug: Gentamicin Sulfate
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.

Outcome Measures

Primary Outcome Measures
  1. 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.
Secondary Outcome Measures
  1. 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.
  2. 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.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Provision of signed and dated informed consent form and agreement to complete the daily dosing log as instructed by the study coordinator.
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 screening (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; Otological symptoms at baseline (i.e. tinnitus. severe dizziness/vertigo)
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.)

Contacts and Locations

Sponsors and CollaboratorsUniversity of Michigan
Locations
University of Michigan Health System | Ann Arbor Michigan, United States, 48103
Investigators
Principal Investigator: Denise G Tate, PhD, University of MichiganPrincipal Investigator: Anne Pelletier-Cameron, MD, University of Michigan
Study Documents (Full Text)
Documents provided by University of Michigan: Study Protocol  March 8, 2023Documents provided by University of Michigan: Statistical Analysis Plan  June 22, 2023