Condition or disease | Intervention/treatment | Phase |
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Neurogenic Bladder Spinal Cord Injuries | Drug: Gentamicin Sulfate Other: Placebo instillation (saline alone) Other: No instillation | Phase 2 |
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 |
Arm | Intervention/treatment |
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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).
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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
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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).
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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
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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.
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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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Kentucky | |
Frazier Rehab | |
Louisville, Kentucky, United States, 40202 |
Tracking Information | |||||||
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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 |
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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
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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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 |