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

Spinal Cord Injuries Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03931408
• Other study ID #: 18.0586
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: February 19, 2019
• Est. completion date: January 15, 2023

Study information

• Verified date: March 2022
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: January 15, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Neurogenic Bladder
• Spinal Cord Injuries
• Urinary Bladder, Neurogenic
• Urinary Tract Infections
• Wounds and Injuries

Intervention

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:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Frazier Rehab	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of urinary tract infections measured with Urinalysis and Culture	Assessment of symptomatic urinary tract infection	Change from Baseline urinary tract infections to post intervention, an average of 5 months.
Primary	Presence of abnormal ranges of complete cell counts measured by an 8ml blood draw.	Assessment of complete blood count.	Change from Baseline blood draw values to post intervention, an average of 5 months.
Primary	Evaluate bladder storage using Urodynamics	Assessment of lower urinary tract function: Change in Baseline bladder capacity (mL) to post intervention	Change in Baseline bladder capacity to post intervention, an average of 5 months.
Primary	Evaluate bladder emptying via measurements of voiding efficiency (%) via Urodynamics assessment or uroflow (if appropriate).	Assessment of lower urinary tract function.	Change in Baseline voiding efficiency to post intervention, an average of 5 months.
Primary	Presence of bladder and kidney anatomical and morphological changes measured with Ultrasound.	Assessment of upper and lower urinary tract	Change in Baseline ultrasound outcomes to post intervention, an average of 5 months.
Primary	Prevalence of different bladder management techniques, such as medication usage, measured by SCI data set Questionnaires.	Questionnaires to assess bladder management outcomes	Change in Baseline bladder management to post intervention, an average of 5 months.
Primary	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.)	Change in Baseline urinary tract infections to post intervention, an average of 5 months.
Primary	Presence of abnormal ranges of metabolic markers measured by an 8ml blood draw for a comprehensive metabolic panel.	Assessment of metabolic parameters.	Change from Baseline blood draw values to post intervention, an average of 5 months.