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

NCT ID: NCT03931408

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-19
• Study Completion Date: 2020-12-30

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.

Conditions

Neurogenic Bladder; Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Gentamicin Sulfate

Intervention Type: DRUG

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.

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).

Group Type: PLACEBO_COMPARATOR

Placebo instillation (saline alone)

Intervention Type: OTHER

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 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.

Group Type: OTHER

No instillation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Gentamicin only; Saline only

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan Harkema, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

Frazier Rehab

Louisville, Kentucky, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18.0586

Identifier Type: -

Identifier Source: org_study_id