Risk Factors and Clinical Implications of Double-J Ureteral Stent Bacterial Colonization: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Bacterial colonization of the Double-J ureteral stent
研究概览
简要总结
This prospective cohort study will evaluate the risk factors associated with bacterial colonization of Double-J ureteral stents and examine its clinical implications. Adult patients undergoing temporary ureteral stent insertion for routine urological indications will be followed until stent removal, when urine and stent cultures will be obtained. The study will assess the association between colonization and factors such as indwelling time, diabetes mellitus, chronic kidney disease, prior urinary tract infection, prior antibiotic exposure, and stent-related symptoms.
详细描述
This prospective observational cohort study will enroll adult patients undergoing temporary Double-J ureteral stent insertion at Al-Azhar University hospitals in Cairo, Egypt. Participants will be followed from stent insertion until removal. Baseline demographic, clinical, and laboratory data will be collected, together with stent-related variables such as stent side, size, material, and indwelling time. Midstream urine culture will be obtained when feasible before insertion and again at removal, and the stent will be cultured under sterile conditions at removal.
The primary outcome is bacterial colonization of the Double-J stent, defined as positive growth on stent culture at removal. Secondary outcomes include positive urine culture, febrile urinary tract infection, concordance between urine and stent cultures, antimicrobial resistance patterns, stent-related symptom burden, and need for hospitalization or additional treatment. Risk factors for colonization will be analyzed using multivariable logistic regression.
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
- •Age 18 years or older.
- •Temporary Double-J stent insertion.
- •Standard urological indication.
- •Planned stent removal during follow-up.
- •Ability to attend follow-up and provide specimens.
- •Written informed consent.
排除标准
- •Active urosepsis at insertion.
- •Permanent or intended long-term stenting.
- •Concomitant nephrostomy tube or urinary diversion.
- •Severe immunosuppression or neutropenia.
- •Incomplete baseline data.
- •Loss to follow-up or failure to retrieve the stent.
- •Refusal to participate.
结局指标
主要结局
Bacterial colonization of the Double-J ureteral stent
时间窗: At the time of stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.
Positive growth on stent culture at removal.
次要结局
- Antimicrobial resistance profile(At stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.)
- Positive urine culture(From stent insertion until stent removal, assessed up to 52 weeks after insertion.)
- Number of Participants With Febrile Urinary Tract Infection(From stent insertion until stent removal, assessed up to 52 weeks after insertion.)
- Agreement between urine culture and stent culture(At stent removal, assessed from 2 weeks up to 52 weeks after stent insertion.)
- Stent-related symptom burden(From stent insertion until stent removal, assessed up to 52 weeks after insertion.)
- Hospitalization or additional intervention(From stent insertion until stent removal, assessed up to 52 weeks after insertion.)
研究者
Abul-fotouh Ahmed
Professor of Urology
Al-Azhar University