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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03503513
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
Denise Tate, PhD, University of Michigan

Tracking Information
First Submitted Date  ICMJE April 6, 2018
First Posted Date  ICMJE April 19, 2018
Last Update Posted Date August 17, 2021
Actual Study Start Date  ICMJE August 24, 2018
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2021)
Number of urinary tract infections (UTI) [ Time Frame: 6 months ]
Number of reported urinary tract infections (UTI) by participants
Original Primary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
Number of urinary tract infections (UTI) [ Time Frame: 12 months ]
Number of reported urinary tract infections (UTI) by participants
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2021)
  • Change in score of Neurogenic Bladder Symptom Severity scale [ Time Frame: 6 months ]
    Self-reported bladder symptoms on a scale from 0 (no symptoms) to 74 (maximum symptoms)
  • Change in score of Neurogenic Bowel Dysfunction [ Time Frame: 6 months ]
    Self-reported bowel symptoms on a scale from 0 (very minor) to 14+ (severe)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2018)
  • 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)
  • 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury
Official Title  ICMJE The Effect of Gentamicin Intravesical Installations on Decreasing Urinary Tract Infections in Patients With Neurogenic Bladder After Spinal Cord Injury: A Clinical Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Urinary Tract Infections
  • Spinal Cord Injuries
  • Spinal Cord Diseases
  • Neurogenic Bladder
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Gentamicin sulfate
Intervention: Drug: Gentamicin Sulfate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2021)
25
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2018)
40
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Adrienne Roth, BA (734) 936-7949 adbpo@med.umich.edu
Contact: Martin Forchheimer, MPP (734) 936-7949 forchm@med.umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03503513
Other Study ID Numbers  ICMJE HUM00137086
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Denise Tate, PhD, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Denise Tate, PhD University of Michigan
Principal Investigator: Anne Pelletier-Cameron, MD University of Michigan
PRS Account University of Michigan
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP