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: Active, not recruiting
• 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 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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Martin Forchheimer, MPP; Phone Number: (734) 936-7949; Email: forchm@med.umich.edu
• Study Contact Backup: Name: Denise Tate, PhD; Phone Number: (734) 936-7949; Email: dgtate@umich.edu

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
• Genders Eligible for Study: All

Description

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.)

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 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; 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; Other Names: Gent Instillations

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Department of Health and Human Services

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2018
• Primary Completion (Anticipated): August 15, 2023
• Study Completion (Anticipated): August 15, 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 (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: January 1, 2023

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; 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