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

Primary Purpose

Urinary Tract Infections, Spinal Cord Injuries, Spinal Cord Diseases

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gentamicin Sulfate
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infections

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • University of Michigan Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gentamicin sulfate

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of urinary tract infections (UTI)
Number of reported urinary tract infections (UTI) by participants

Secondary Outcome Measures

Change in score of Neurogenic Bladder Symptom Severity scale
Self-reported bladder symptoms on a scale from 0 (no symptoms) to 74 (maximum symptoms)
Change in score of Neurogenic Bowel Dysfunction
Self-reported bowel symptoms on a scale from 0 (very minor) to 14+ (severe)

Full Information

First Posted
April 6, 2018
Last Updated
March 2, 2023
Sponsor
University of Michigan
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT03503513
Brief Title
Gentamicin Bladder Instillations to Prevent Urinary Tract Infections in Patients With Spinal Cord Injury
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 24, 2018 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Department of Health and Human Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Spinal Cord Injuries, Spinal Cord Diseases, Neurogenic Bladder

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gentamicin sulfate
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gentamicin Sulfate
Other Intervention Name(s)
Gent Instillations
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of urinary tract infections (UTI)
Description
Number of reported urinary tract infections (UTI) by participants
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in score of Neurogenic Bladder Symptom Severity scale
Description
Self-reported bladder symptoms on a scale from 0 (no symptoms) to 74 (maximum symptoms)
Time Frame
6 months
Title
Change in score of Neurogenic Bowel Dysfunction
Description
Self-reported bowel symptoms on a scale from 0 (very minor) to 14+ (severe)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise Tate, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne Pelletier-Cameron, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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