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

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

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 Overview

• Status: Completed
• Conditions: Spinal Cord Diseases; Urinary Tract Infections; Spinal Cord Injuries; Neurogenic Bladder
• Intervention / Treatment: Drug: Gentamicin Sulfate

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • University of Michigan Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.; Other Names: Gent Instillations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months prior to treatment and 6 months during treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Department of Health and Human Services
• Investigators: Principal Investigator: Denise G Tate, PhD, University of Michigan; Principal Investigator: Anne Pelletier-Cameron, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2018
• Primary Completion (Actual): September 8, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: April 6, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 19, 2018

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Central Nervous System Diseases; Nervous System Diseases; Urologic Diseases; Urinary Bladder Diseases; Neurologic Manifestations; Disease Attributes; Trauma, Nervous System; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Communicable Diseases; Wounds and Injuries; Urinary Tract Infections; Spinal Cord Diseases; Spinal Cord Injuries; Urinary Bladder, Neurogenic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Gentamicins
• Other Study ID Numbers: HUM00137086; 90IFRE0002 (Other Grant/Funding Number: NIDRR/ACL/HHS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No