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

• ClinicalTrials.gov Identifier: NCT03931408
• Recruitment Status: Active, not recruiting
• First Posted: April 30, 2019
• Last Update Posted: March 3, 2022
• Sponsor: University of Louisville
• Information provided by (Responsible Party): April Herrity, University of Louisville

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

• 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 15, 2023
• Estimated Study Completion Date: January 15, 2023

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

• 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

United States, Kentucky

Frazier Rehab

Louisville, Kentucky, United States, 40202

Sponsors and Collaborators

University of Louisville

More Information

• Responsible Party: April Herrity, Assistant Professor, University of Louisville
• ClinicalTrials.gov Identifier: NCT03931408
• Other Study ID Numbers: 18.0586
• First Posted: April 30, 2019
• Last Update Posted: March 3, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by April Herrity, University of Louisville:

bladder; spinal cord injury; urinary tract infection

Additional relevant MeSH terms:

Infections; Urinary Tract Infections; Spinal Cord Injuries; Urinary Bladder, Neurogenic; Wounds and Injuries; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Urologic Diseases; Neurologic Manifestations; Urinary Bladder Diseases; Gentamicins; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action