Biofilms on Short-term Indwelling Ureteral Stents: Influence on Associated Symptoms and Complications; Prediction by Urine Analysis; Current Bacterial Spectrum and Antibiotic Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)
研究概览
简要总结
This study is performed to analyze various aspects of biofilms on ureteral stents.
详细描述
The study is performed to provide a better understanding of the influence of biofilms on ureteral stents on the entire spectrum of stent-associated morbidity.
Moreover, it could provide more detailed knowledge about the correlation of the occurrence of biofilms on ureteral stents and findings in urinary analysis, which could serve as a decision support whether patients with ureteral stents undergoing further interventions (for example ESWL or simple secondary URS) should receive antibiotic prophylaxis.
Correlation of results of urinary bacteriologies (assessed pre- and intraoperatively) and biofilm analysis on stents could provide information if "targeted antibiotic treatment" based on urinary bacteriology only is possible at all.
Correlation of urinary analysis and conventional urinary bacteriology could provide a valuable contribution regarding the prediction of bacteriuria and the necessity of postponing operations.
Additionally, the study is intended to provide an overview over the recent bacterial species that are involved into biofilms on ureteral stents and their resistance to antibiotics. This could provide valuable information about the choice of antibiotics in cases were treatment has to be performed empirically.
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
- •Patients temporarily undergoing ureteral stenting
- •Informed consent
排除标准
- •Bilateral stenting
- •Ureteral obstruction due to malignancies
- •Additionally performed procedures/operations during stent indwelling time -Cognitively impaired patients
- •UTI at the time of stent insertion (>10 to the power of 2 cfu/ml)
结局指标
主要结局
Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)
时间窗: Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion)
Total biofilm mass on ureteral stents.
时间窗: Time of stent removal: Four weeks (range 2-6 weeks) after stent insertion
次要结局
- Urinary analysis (pH, nitrite, leucocyturia, hematuria).(Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion))
- Number of bacteria on stent surface (cell count as estimated by scanning electron microscopy)(Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion)
- Next generation sequencing of biofilms(Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion)
- Assessment of morbidity using the Ureteral Stent Symptom Questionnaire (USSQ)(One week after stent insertion; Four weeks (range 2-6 weeks) after stent removal.)
- Rapid immunoassay test for bacteriuria(Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion))
- Number of bacteria on stent surface (determined via quantitative PCR)(Day of stent removal: Four weeks (range 2-6 weeks) after stent insertion)
- Urine Culture(Before study inclusion; Day before stent removal (i.e. 4 weeks (range 2-6 weeks) after insertion); Intraoperatively (during stent removal))
研究者
Dominik Abt
Dr. med.
Cantonal Hospital of St. Gallen