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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03503513
• Other study ID #: HUM00137086
• Secondary ID: 90IFRE0002
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: August 24, 2018
• Est. completion date: August 15, 2023

Study information

• Verified date: January 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: August 15, 2023
• Est. primary completion date: August 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Neurogenic Bladder
• Spinal Cord Diseases
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic
• Urinary Tract Infections
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of urinary tract infections (UTI)	Number of reported urinary tract infections (UTI) by participants	6 months
Secondary	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
Secondary	Change in score of Neurogenic Bowel Dysfunction	Self-reported bowel symptoms on a scale from 0 (very minor) to 14+ (severe)	6 months