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

  • STATUS
    Recruiting
  • days left to enroll
    73
  • participants needed
    25
  • sponsor
    University of Michigan
Updated on 10 May 2022
urinary tract infection
spinal cord
spinal cord disorder
spinal disease
neurogenic bladder
incomplete spinal cord injury
intermittent catheterization
bladder instillations

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.

Details
Condition Urinary Tract Infections, Spinal Cord Injuries, Spinal Cord Diseases, Neurogenic Bladder
Treatment Saline, Gentamicin Sulfate
Clinical Study IdentifierNCT03503513
SponsorUniversity of Michigan
Last Modified on10 May 2022

Eligibility

Yes No Not Sure

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.)
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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