Multicentric Study on Infections of the Urinary Tract After Stent Removal (MINUS-trial).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- number of participants demonstrating a post-stent removal urinary tract infection
研究概览
简要总结
The MINUS-trial is a multicentric prospective observational study in which consecutive patients, 18 years of age and older who receive a ureteral stent during any endoscopic procedure will be approached to participate. Their stent will be removed in outpatient office or by string extraction at home with or without antibiotic prophylaxis (depending on the standard of care of the participating center). A urine sample will be taken before stent removal and patients will be asked to complete a questionnaire to assess symptoms of urinary tract infection (UTI) after stent removal. If the patient experiences symptoms of UTI (urgency, frequency, dysuria or haematuria) that exceed the usually experienced post-cystoscopy symptoms, they have to provide a urine sample.
The purpose of this study is to provide multi-institutional, multinational, observational data on the incidence of UTI after stent removal with or without antibiotic prophylaxis in the outpatient setting in patients with a sterile urine culture prior to the intervention of stent placement and no demonstrated infection during the stent has been in situ.
The primary outcome is the presence of a febrile or non-febrile urinary tract infection after stent removal.
Secondary objectives are to identify risk factors for post-stent removal UTI and identify differences in UTI incidence between cystoscopic stent removal in the outpatient setting versus string-removal by the patient in the home environment.
详细描述
Given the high morbidity, cost and loss of quality of life of stent related infections, there is a need for practical strategies for decreasing stent associated UTI's and sepsis. One of these strategies may be to provide targeted antibiotic prophylaxis. On the other hand, the widespread growing bacterial resistance due to the overuse of antibiotics is of growing concern.
To date, no clear guidelines regarding antibiotic prophylaxis prior to ureteral stent removal are available. The European Association of Urology (EAU) does not recommend antibiotic prophylaxis before cystoscopy, but there is no specific recommendation regarding stent removal. This is mainly due to the lack of good and robust data.
The MINUS-trial is a multicentric prospective observational study with the aim of providing multi-institutional, multinational, observational data on the incidence of UTI after stent removal with or without antibiotic prophylaxis in the outpatient setting in patients with a sterile urine culture prior to the intervention of stent placement and no demonstrated infection during the stent has been in situ.
The primary outcome is the presence of a febrile or non-febrile urinary tract infection after stent removal.
Secondary objectives are to identify risk factors for post-stent removal UTI and identify differences in UTI incidence between cystoscopic stent removal in the outpatient setting versus string-removal by the patient in the home environment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient aged 18 years or above
- •Stent placed during endoscopic procedure
- •A negative urine culture (UC) pre-operatively with a single dose of antibiotic prophylaxis peri-operatively
- •Stent removal is planned in outpatient setting of by the patient by using a string.
- •Able and willing to provide consent
排除标准
- •Permanent indwelling catheter (transurethral catheter, suprapubic catheter, nephrostomy tubes)
- •Pregnant patients
- •Patient performing clean intermittent (self-)catheterization
- •Recent history (<3 months) of demonstrated UTI
结局指标
主要结局
number of participants demonstrating a post-stent removal urinary tract infection
时间窗: 30 days after removal
For this outcome measure, a urinary tract infection is defined as a urine sample demonstrating an identified uropathogen with at least 10.000 colony forming units in a patient demonstrating symptoms of a urinary tract infection after removal of a ureteral stent. Asymptomatic bacteriuria will not be considered a positive outcome.
次要结局
未报告次要终点