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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03503513
Recruitment Status : Active, not recruiting
First Posted : April 19, 2018
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Denise Tate, PhD, University of Michigan

Brief Summary:
A cross over 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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infections Spinal Cord Injuries Spinal Cord Diseases Neurogenic Bladder Drug: Gentamicin Sulfate Drug: Saline Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : August 24, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gentamicin sulfate followed by saline 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

Drug: Saline
Normal saline only, patients will instill 30 milliliters daily.

Experimental: Saline followed gentamicin sulfate 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

Drug: Saline
Normal saline only, patients will instill 30 milliliters daily.




Primary Outcome Measures :
  1. Number of urinary tract infections (UTI) [ Time Frame: 12 months ]
    Number of reported urinary tract infections (UTI) by participants


Secondary Outcome Measures :
  1. Change in score of Neurogenic Bladder Symptom Severity scale [ Time Frame: 12 months ]
    Self-reported bladder symptoms on a scale from 0 (no symptoms) to 74 (maximum symptoms)

  2. Change in score of Neurogenic Bowel Dysfunction [ Time Frame: 12 months ]
    Self-reported bowel symptoms on a scale from 0 (very minor) to 14+ (severe)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503513


Locations
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United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48103
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Denise Tate, PhD University of Michigan
Principal Investigator: Anne Pelletier-Cameron, MD University of Michigan

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Responsible Party: Denise Tate, PhD, Professor of Physical Medicine and Rehabilitation, University of Michigan
ClinicalTrials.gov Identifier: NCT03503513     History of Changes
Other Study ID Numbers: HUM00137086
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Wounds and Injuries
Spinal Cord Injuries
Urinary Tract Infections
Urinary Bladder, Neurogenic
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Urologic Diseases
Neurologic Manifestations
Urinary Bladder Diseases
Signs and Symptoms
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action