The Evaluation of Antimicrobial Bladder Instillation on the Prevalence of Chronic Urinary Tract Infections and Bladder Dysfunction in Persons With Spinal Cord Injury
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Evaluate Bladder Storage Using Urodynamics
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Before the intervention, you will be randomly assigned to one of three groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Gentamicin Sulfate (Drug)
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).
干预措施: Placebo instillation (saline alone) (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.
干预措施: No instillation (Other)
结局指标
主要结局
Evaluate Bladder Storage Using Urodynamics
时间窗: 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.
次要结局
- Participants With Symptomatic Urinary Tract Infection(1. Baseline (1 week) 2. Midpoint (2 months) 3. Post (4 months))