Neurogenic Bladder, Spinal Cord Injuries
Conditions
Keywords
bladder, spinal cord injury, urinary tract infection
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.
Interventions
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.
OTHERPlacebo 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.
OTHERNo 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.
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Before the intervention, you will be randomly assigned to one of three groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Bladder Storage Using Urodynamics | 1. Baseline (1 week) 2. Midpoint (2 months) 3. Post (4 months) | Assessment of Lower Urinary Tract Function: Urodynamic Bladder Compliance (mL/cm H20) based on Change in Bladder Capacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Symptomatic Urinary Tract Infection | 1. Baseline (1 week) 2. Midpoint (2 months) 3. Post (4 months) | number of participants with symptomatic urinary tract infection measured by the presence of Leukocyte Esterase level in urine. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
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. | 1 |
| 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).
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. | 3 |
| 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.
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. | 2 |
| Total | 6 |
Baseline characteristics
| Characteristic | Gentamicin | Placebo Instillation (Saline Alone) | No Instillation | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 3 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 2 Participants | 5 Participants |
| Region of Enrollment United States | 1 participants | 3 participants | 2 participants | 6 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 3 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 3 | 0 / 1 |
Outcome results
Primary
Evaluate Bladder Storage Using Urodynamics
Assessment of Lower Urinary Tract Function: Urodynamic Bladder Compliance (mL/cm H20) based on Change in Bladder Capacity.
Time frame: 1. Baseline (1 week) 2. Midpoint (2 months) 3. Post (4 months)
Population: Bladder Compliance
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gentamicin | Evaluate Bladder Storage Using Urodynamics | Baseline (1 week) | 611 mL | — |
| Gentamicin | Evaluate Bladder Storage Using Urodynamics | Midpoint (2 months) | 452 mL | — |
| Placebo Instillation (Saline Alone) | Evaluate Bladder Storage Using Urodynamics | Baseline (1 week) | 177.67 mL | Standard Deviation 124.23 |
| Placebo Instillation (Saline Alone) | Evaluate Bladder Storage Using Urodynamics | Midpoint (2 months) | 286.5 mL | Standard Deviation 226.98 |
| Placebo Instillation (Saline Alone) | Evaluate Bladder Storage Using Urodynamics | Post (4 months) | 345.5 mL | Standard Deviation 313.25 |
| No Instillation | Evaluate Bladder Storage Using Urodynamics | Baseline (1 week) | 662 mL | — |
Secondary
Participants With Symptomatic Urinary Tract Infection
number of participants with symptomatic urinary tract infection measured by the presence of Leukocyte Esterase level in urine.
Time frame: 1. Baseline (1 week) 2. Midpoint (2 months) 3. Post (4 months)
Population: Presence of Leukocyte Esterase in Urine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gentamicin | Participants With Symptomatic Urinary Tract Infection | Baseline (1 week) | 1 participants |
| Gentamicin | Participants With Symptomatic Urinary Tract Infection | Midpoint (2 months) | 1 participants |
| Placebo Instillation (Saline Alone) | Participants With Symptomatic Urinary Tract Infection | Baseline (1 week) | 3 participants |
| Placebo Instillation (Saline Alone) | Participants With Symptomatic Urinary Tract Infection | Midpoint (2 months) | 3 participants |
| Placebo Instillation (Saline Alone) | Participants With Symptomatic Urinary Tract Infection | Post (4 months) | 3 participants |
| No Instillation | Participants With Symptomatic Urinary Tract Infection | Baseline (1 week) | 2 participants |