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

Sponsor

University of Louisville (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03931408

Collaborator

(none)

Enrollment

Location

Arms

46.9

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

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

Anticipated 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 :

Feb 19, 2019

Anticipated Primary Completion Date :

Jan 15, 2023

Anticipated Study Completion Date :

Jan 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 Names: 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 Names: Saline only
Other: 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.

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 Names:

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 Names:

Saline only

Other: 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

Incidence of urinary tract infections measured with Urinalysis and Culture [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. [Change from Baseline blood draw values to post intervention, an average of 5 months.]
Assessment of complete blood count.
Evaluate bladder storage using Urodynamics [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). [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. [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. [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. [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. [Change from Baseline blood draw values to post intervention, an average of 5 months.]
Assessment of metabolic parameters.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.