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Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections

Primary Purpose

Neurogenic Bladder, Spinal Cord Injuries

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gentamicin Sulfate
Placebo instillation (saline alone)
No instillation
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neurogenic Bladder focused on measuring bladder, spinal cord injury, urinary tract infection

Eligibility Criteria

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

Inclusion Criteria:

  • At least 18 years of age;
  • Non-progressive spinal cord injury;
  • Stable medical condition;
  • Bladder dysfunction as a result of spinal cord injury
  • History of recurrent UTIs (defined as 3 or more within the past year or 2 or more within the past 6 months).

Exclusion Criteria:

  • Signs or symptoms of serious UTI that requires the use of systemic antibiotics;
  • Use of any urine-acidifying agent, bladder irrigant, or systemic antibiotic within the previous 2 weeks;
  • Participants colonized with gentamicin-resistant bacteria on baseline urine culture or a gentamicin allergy/sensitivity;
  • Participants with known hearing loss and/or renal disease;
  • Pregnant at the time of enrollment or planning to become pregnant during the time course of the study.

Sites / Locations

  • Frazier Rehab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Gentamicin

Placebo instillation (saline alone)

No instillation

Arm Description

Participants will be randomized into one of three groups. In this arm, participants will perform bladder instillations using a 50ml solution of gentamicin mixed with saline, 2 times per day. A formulation derived from 480 mg gentamicin sulfate diluted in 1 L normal saline will be used for instillation. Participants will be blinded during the study and will not know if they are receiving gentamicin or placebo (saline alone).

Participants will be randomized into one of three groups. In this arm, participants will perform bladder instillations using a 50ml solution of saline alone. Participants will be blinded during the study and will not know if they are receiving gentamicin or placebo (saline alone).

Participants will be randomized into one of three groups. In this arm participants will not receive an instillation of gentamicin or saline alone, but instead will continue standard of care. Participants will be assessed at the pre-, mid- and post-intervention time points.

Outcomes

Primary Outcome Measures

Incidence of urinary tract infections measured with Urinalysis and Culture
Assessment of symptomatic urinary tract infection
Presence of abnormal ranges of complete cell counts measured by an 8ml blood draw.
Assessment of complete blood count.
Evaluate bladder storage using Urodynamics
Assessment of lower urinary tract function: Change in Baseline bladder capacity (mL) to post intervention
Evaluate bladder emptying via measurements of voiding efficiency (%) via Urodynamics assessment or uroflow (if appropriate).
Assessment of lower urinary tract function.
Presence of bladder and kidney anatomical and morphological changes measured with Ultrasound.
Assessment of upper and lower urinary tract
Prevalence of different bladder management techniques, such as medication usage, measured by SCI data set Questionnaires.
Questionnaires to assess bladder management outcomes
Rate of urinary tract infections measured by SCI data set Questionnaires.
Questionnaires to rate of urinary tract infections. (Note there is no scale as a component of this questionnaire.)
Presence of abnormal ranges of metabolic markers measured by an 8ml blood draw for a comprehensive metabolic panel.
Assessment of metabolic parameters.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2019
Last Updated
March 1, 2022
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT03931408
Brief Title
Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections
Official Title
The Evaluation of Antimicrobial Bladder Instillation on the Prevalence of Chronic Urinary Tract Infections and Bladder Dysfunction in Persons With Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 19, 2019 (Actual)
Primary Completion Date
January 15, 2023 (Anticipated)
Study Completion Date
January 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Participants will undergo daily gentamicin bladder instillations to determine if its use will reduce the rate of symptomatic urinary tract infections (UTIs) as well as the use of oral and intravenous antibiotics in adults with chronic spinal cord injury (SCI) who have recurrent UTIs. Participants are randomized into one of three groups: 1) Gentamicin and saline instillation 2) Saline only instillation 3) Standard of care, no instillation.
Detailed Description
The purpose of this study is to determine if twice daily bladder flushing with an antibiotic solution will decrease the rate of UTIs and the use of oral medications used to treat UTIs. The occurrence of UTIs in the SCI population is high, with a rate of about 2.5 episodes per year. The inability to effectively empty the bladder increases the risk of UTIs, which are the most common medical complication after SCI. This study will help us understand the effectiveness of a local bladder therapy on preventing UTIs and improving bladder function in individuals with SCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bladder, Spinal Cord Injuries
Keywords
bladder, spinal cord injury, urinary tract infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Before the intervention, you will be randomly assigned to one of three groups.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gentamicin
Arm Type
Experimental
Arm Description
Participants will be randomized into one of three groups. In this arm, participants will perform bladder instillations using a 50ml solution of gentamicin mixed with saline, 2 times per day. A formulation derived from 480 mg gentamicin sulfate diluted in 1 L normal saline will be used for instillation. Participants will be blinded during the study and will not know if they are receiving gentamicin or placebo (saline alone).
Arm Title
Placebo instillation (saline alone)
Arm Type
Placebo Comparator
Arm Description
Participants will be randomized into one of three groups. In this arm, participants will perform bladder instillations using a 50ml solution of saline alone. Participants will be blinded during the study and will not know if they are receiving gentamicin or placebo (saline alone).
Arm Title
No instillation
Arm Type
Other
Arm Description
Participants will be randomized into one of three groups. In this arm participants will not receive an instillation of gentamicin or saline alone, but instead will continue standard of care. Participants will be assessed at the pre-, mid- and post-intervention time points.
Intervention Type
Drug
Intervention Name(s)
Gentamicin Sulfate
Other Intervention Name(s)
Gentamicin only
Intervention Description
Gentamicin will be compounded for immediate use in single-dose, disposable BD 50ml Luer-Lok tip syringes. The container closure system for the diluted gentamicin sulfate solution and saline solution will be sterile and processed with depyrogenation. The solution will be slowly infused into the bladder after drainage of urine is complete. While monitoring blood pressure, the solution will remain in the participant's bladder for a least 30 minutes (unless the participant is experiencing autonomic dysreflexia, and in that case, immediately drained) with the goal of attaining 2 hours.
Intervention Type
Other
Intervention Name(s)
Placebo instillation (saline alone)
Other Intervention Name(s)
Saline only
Intervention Description
Saline will be compounded for immediate use in single-dose, disposable BD 50ml Luer-Lok tip syringes. The container closure system for the diluted gentamicin sulfate solution and saline solution will be sterile and processed with depyrogenation. The solution will be slowly infused into the bladder after drainage of urine is complete. While monitoring blood pressure, the solution will remain in the participant's bladder for a least 30 minutes (unless the participant is experiencing autonomic dysreflexia, and in that case, immediately drained) with the goal of attaining 2 hours.
Intervention Type
Other
Intervention Name(s)
No instillation
Intervention Description
Participants will not receive an instillation of gentamicin or saline alone, but instead will continue standard of care. Participants will be assessed at the pre-, mid- and post-intervention time points.
Primary Outcome Measure Information:
Title
Incidence of urinary tract infections measured with Urinalysis and Culture
Description
Assessment of symptomatic urinary tract infection
Time Frame
Change from Baseline urinary tract infections to post intervention, an average of 5 months.
Title
Presence of abnormal ranges of complete cell counts measured by an 8ml blood draw.
Description
Assessment of complete blood count.
Time Frame
Change from Baseline blood draw values to post intervention, an average of 5 months.
Title
Evaluate bladder storage using Urodynamics
Description
Assessment of lower urinary tract function: Change in Baseline bladder capacity (mL) to post intervention
Time Frame
Change in Baseline bladder capacity to post intervention, an average of 5 months.
Title
Evaluate bladder emptying via measurements of voiding efficiency (%) via Urodynamics assessment or uroflow (if appropriate).
Description
Assessment of lower urinary tract function.
Time Frame
Change in Baseline voiding efficiency to post intervention, an average of 5 months.
Title
Presence of bladder and kidney anatomical and morphological changes measured with Ultrasound.
Description
Assessment of upper and lower urinary tract
Time Frame
Change in Baseline ultrasound outcomes to post intervention, an average of 5 months.
Title
Prevalence of different bladder management techniques, such as medication usage, measured by SCI data set Questionnaires.
Description
Questionnaires to assess bladder management outcomes
Time Frame
Change in Baseline bladder management to post intervention, an average of 5 months.
Title
Rate of urinary tract infections measured by SCI data set Questionnaires.
Description
Questionnaires to rate of urinary tract infections. (Note there is no scale as a component of this questionnaire.)
Time Frame
Change in Baseline urinary tract infections to post intervention, an average of 5 months.
Title
Presence of abnormal ranges of metabolic markers measured by an 8ml blood draw for a comprehensive metabolic panel.
Description
Assessment of metabolic parameters.
Time Frame
Change from Baseline blood draw values to post intervention, an average of 5 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age; Non-progressive spinal cord injury; Stable medical condition; Bladder dysfunction as a result of spinal cord injury History of recurrent UTIs (defined as 3 or more within the past year or 2 or more within the past 6 months). Exclusion Criteria: Signs or symptoms of serious UTI that requires the use of systemic antibiotics; Use of any urine-acidifying agent, bladder irrigant, or systemic antibiotic within the previous 2 weeks; Participants colonized with gentamicin-resistant bacteria on baseline urine culture or a gentamicin allergy/sensitivity; Participants with known hearing loss and/or renal disease; Pregnant at the time of enrollment or planning to become pregnant during the time course of the study.
Facility Information:
Facility Name
Frazier Rehab
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections

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