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

University of Louisville (UOFL)

Status and phase: Completed; Phase 2

Conditions: Spinal Cord Injuries; Neurogenic Bladder

Treatments: Other: Placebo instillation (saline alone); Other: No instillation; Drug: Gentamicin Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT03931408

18.0586

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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6 participants in 3 patient groups, including a placebo group

Gentamicin

Experimental group

Description:

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).

Treatment:

Drug: Gentamicin Sulfate

Placebo instillation (saline alone)

Placebo Comparator group

Description:

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).

Treatment:

Other: Placebo instillation (saline alone)

No instillation

Other group

Description:

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.

Treatment:

Other: No instillation