NCT03785262终止不适用
Low Energy Surface Waves to Prevent Urinary Infections and Catheter Associated Symptoms Among Patients With Neurogenic Bladder Dysfunction
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Bacteriuria
研究概览
简要总结
The Uroshield device is a commercially available device with two parts: a disposable actuator which attaches to the external portion of the catheter and a portable battery. The device sends out low-frequency ultrasound waves which run along the surfaces of the catheter. These acoustic waves prevent bacteria from adhering to the catheter and prevent the formation of biofilm. Our objective is to conduct a pilot study to determine if the UroShield device can reduce bacteriuria and catheter biofilm formation among neurogenic bladder patients with an indwelling catheter, as well as improve urinary quality of life and symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •>18 years of age
- •Spinal cord injury (>1 year), multiple sclerosis (>1 year), spina bifida, parkinsons (>1 year)
- •Indwelling catheter (urethral or suprapubic) for >3 months, and used as primary bladder management mechanism
- •>1 urinary tract infection in the last 12 months
排除标准
- •Intravesical botox in the last 6 months
- •Chronic antibiotic suppressive therapy
- •Active symptomatic UTI on day of randomization
- •Unable to understand written and spoken English
- •Prior/current utilization of the Uroshield device
结局指标
主要结局
Bacteriuria
时间窗: 30 days
Proportion with bacteriuria \>10\^5 cfu at day 30
次要结局
- Scanning electron microscopy of biofilms(30 days)
- Total bacterial cell counts(30 days)
- Neurogenic bladder symptom score (NBSS)(30 days)
- Patient subjective rating of amount of sediment/debris at the end of the 30 days(30 days)
- Microbiome comparison of biofilms(30 days)
研究者
研究点 (2)
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