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出境医 / 临床实验 / Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections

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

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.

Condition or disease Intervention/treatment Phase
Neurogenic Bladder Spinal Cord Injuries Drug: Gentamicin Sulfate Other: Placebo instillation (saline alone) Other: No instillation Phase 2

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Before the intervention, you will be randomly assigned to one of three groups.
Primary Purpose: Prevention
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
Actual Study Start Date : February 19, 2019
Estimated Primary Completion Date : January 16, 2022
Estimated Study Completion Date : January 16, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Gentamicin
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).
Drug: Gentamicin Sulfate
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.
Other Name: Gentamicin only

Placebo Comparator: Placebo instillation (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).
Other: Placebo instillation (saline alone)
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.
Other Name: Saline only

No instillation
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.
Other: No instillation
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.

Outcome Measures
Primary Outcome Measures :
  1. Incidence of urinary tract infections measured with Urinalysis and Culture [ Time Frame: Change from Baseline urinary tract infections to post intervention, an average of 5 months. ]
    Assessment of symptomatic urinary tract infection

  2. Presence of abnormal ranges of complete cell counts measured by an 8ml blood draw. [ Time Frame: Change from Baseline blood draw values to post intervention, an average of 5 months. ]
    Assessment of complete blood count.

  3. Evaluate bladder storage using Urodynamics [ Time Frame: Change in Baseline bladder capacity to post intervention, an average of 5 months. ]
    Assessment of lower urinary tract function: Change in Baseline bladder capacity (mL) to post intervention

  4. Evaluate bladder emptying via measurements of voiding efficiency (%) via Urodynamics assessment or uroflow (if appropriate). [ Time Frame: Change in Baseline voiding efficiency to post intervention, an average of 5 months. ]
    Assessment of lower urinary tract function.

  5. Presence of bladder and kidney anatomical and morphological changes measured with Ultrasound. [ Time Frame: Change in Baseline ultrasound outcomes to post intervention, an average of 5 months. ]
    Assessment of upper and lower urinary tract

  6. Prevalence of different bladder management techniques, such as medication usage, measured by SCI data set Questionnaires. [ Time Frame: Change in Baseline bladder management to post intervention, an average of 5 months. ]
    Questionnaires to assess bladder management outcomes

  7. Rate of urinary tract infections measured by SCI data set Questionnaires. [ Time Frame: Change in Baseline urinary tract infections to post intervention, an average of 5 months. ]
    Questionnaires to rate of urinary tract infections. (Note there is no scale as a component of this questionnaire.)

  8. Presence of abnormal ranges of metabolic markers measured by an 8ml blood draw for a comprehensive metabolic panel. [ Time Frame: Change from Baseline blood draw values to post intervention, an average of 5 months. ]
    Assessment of metabolic parameters.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Locations
Layout table for location information
United States, Kentucky
Frazier Rehab
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Tracking Information
First Submitted Date  ICMJE March 29, 2019
First Posted Date  ICMJE April 30, 2019
Last Update Posted Date February 8, 2021
Actual Study Start Date  ICMJE February 19, 2019
Estimated Primary Completion Date January 16, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2019)
  • Incidence of urinary tract infections measured with Urinalysis and Culture [ Time Frame: Change from Baseline urinary tract infections to post intervention, an average of 5 months. ]
    Assessment of symptomatic urinary tract infection
  • Presence of abnormal ranges of complete cell counts measured by an 8ml blood draw. [ Time Frame: Change from Baseline blood draw values to post intervention, an average of 5 months. ]
    Assessment of complete blood count.
  • Evaluate bladder storage using Urodynamics [ Time Frame: Change in Baseline bladder capacity to post intervention, an average of 5 months. ]
    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). [ Time Frame: Change in Baseline voiding efficiency to post intervention, an average of 5 months. ]
    Assessment of lower urinary tract function.
  • Presence of bladder and kidney anatomical and morphological changes measured with Ultrasound. [ Time Frame: Change in Baseline ultrasound outcomes to post intervention, an average of 5 months. ]
    Assessment of upper and lower urinary tract
  • Prevalence of different bladder management techniques, such as medication usage, measured by SCI data set Questionnaires. [ Time Frame: Change in Baseline bladder management to post intervention, an average of 5 months. ]
    Questionnaires to assess bladder management outcomes
  • Rate of urinary tract infections measured by SCI data set Questionnaires. [ Time Frame: Change in Baseline urinary tract infections to post intervention, an average of 5 months. ]
    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. [ Time Frame: Change from Baseline blood draw values to post intervention, an average of 5 months. ]
    Assessment of metabolic parameters.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections
Official Title  ICMJE The Evaluation of Antimicrobial Bladder Instillation on the Prevalence of Chronic Urinary Tract Infections and Bladder Dysfunction in Persons With Spinal Cord Injury
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Before the intervention, you will be randomly assigned to one of three groups.
Primary Purpose: Prevention
Condition  ICMJE
  • Neurogenic Bladder
  • Spinal Cord Injuries
Intervention  ICMJE
  • Drug: Gentamicin Sulfate
    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.
    Other Name: Gentamicin only
  • Other: Placebo instillation (saline alone)
    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.
    Other Name: Saline only
  • Other: No instillation
    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.
Study Arms  ICMJE
  • Experimental: Gentamicin
    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).
    Intervention: Drug: Gentamicin Sulfate
  • Placebo Comparator: Placebo instillation (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).
    Intervention: Other: Placebo instillation (saline alone)
  • No instillation
    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: Other: No instillation
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 16, 2022
Estimated Primary Completion Date January 16, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03931408
Other Study ID Numbers  ICMJE 18.0586
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party April Herrity, University of Louisville
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Louisville
Verification Date February 2021

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

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