Pilot Study to Evaluate the Efficacy of Antiseptic Bladder Lavage Versus Pulsatile Lavage With Physiologic Serum in Catheterized Patients With Asymptomatic Bacteriuria With Uropathogens.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- urinary culture
研究概览
简要总结
In patients with advanced multiple sclerosis, permanent urinary catheters are often used to manage the urinary incontinence and bladder emptying problems. These catheters will lead to urinary tract infection, blocking of the catheter etc.. Especially infections with certain bacteria such as proteus, enterobacteriaceae and ESBL producing enterobacteriaceae and pseudomonas can pose a problem for the hospital infection control and for the patient.
This study wants to evaluate the potential role of regular bladder lavage with saline, a solution of betadine, an acid solution of acetic acid and of URotainer Twin Suby G ( Braun)in the decontamination of these bladders and the prevention of clinically relevant urinary tract infections.
详细描述
PAtients will be selected from the catheterised patient population of the National MS Center in Belgium for this prospective randomised comparative pilot studyon bladder lavage.
The potential benefit for the patient is a reduction in number of clinical urinary tract infections and a reduction of antibiotic use.
According to the type of bacteria that is cultured from the urine, patients will be allocated to one of 4 subgroups:
- 30 patients will recieve bladder lavage with a Isobetadine Dermicum Solution
- 20 patients will revieve bladder lavage with acetic acid solutions
- 10 patients will recieve bladder lavage with saline
- 10 patients will receive bladder lavage with Urotainer Suby G
The effect will be measured by two repeat urine cultures after the bladder lavage( 2days and 5 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with an indwelling catheter
- •catheter associated bacteriuria with proteus, enterobacteriaceae or pseudomonas
- •willing and able to give informed consent to the study
排除标准
- •patients with a clinically relevant UTI ( fever, pain or cloudy urine)
- •cognitively impaired patients
- •patients not able or willing to give informed consent
- •patients with allergies for ISobetadine dermicum or other substances used in the protocol
- •patients who only have a catheter for less than 1 month
- •patients taking systemic antibiotics during the last 48h
研究组 & 干预措施
lavage Isobetadine Dermicum solution
Patient will receive 1 bladder lavage daily with a solution of 5ml Isobetadine Dermicum in 100cc saline
干预措施: bladder lavage (Procedure)
lavage Acetic Acid solution
Patients will receive a daily bladder lavage during 5 consecutive days with a solution of 0.5% acetic acid in 100cc of saline
干预措施: bladder lavage (Procedure)
lavage with saline
patients will receive during 5 consecutive days a bladder lavage with 100cc saline
干预措施: bladder lavage (Procedure)
lavage Urotainer Suby G
patients will receive during 5 consecutive days a bladder lavage with 100cc of Urotainer Suby G
干预措施: bladder lavage (Procedure)
结局指标
主要结局
urinary culture
时间窗: day 2 and day 5 after last bladder lavage
After 5 consecutive days of bladder lavage, a urine culture will be taken at day 2 and 5. A count of \<100.000 CFU/ml and is considered a positive result. The outcome will be considered positive if this positive result is found in more than 30% of subjects.
次要结局
- pyuria(day 2 and day 5 after the last bladder lavage)
研究者
Daphne Kos
Scientific Research
National Multiple Sclerosis Center