NCT05408533已完成不适用
Silver-coated Catheter Versus Standard Catheter for UTI Prevention in a Short-term Transurethral Indwelling Catheter Population After Pelvic Reconstructive Surgery: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 4
- 主要终点
- Incidence of UTIs requiring treatment
研究概览
简要总结
Primary Aim: To determine whether silver-coated transurethral catheter decreases the incidence of culture-confirmed urinary tract infection for women with catheter-managed urinary retention after pelvic reconstructive surgery
Secondary Aims:
To assess difference in bacterial uropathogens isolated in urine cultures Adverse symptoms possibly caused by silver-coated catheter
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo major or minor pelvic organ prolapse surgery of any compartment, or urinary incontinence surgery that are diagnosed with POUR via failed retrograde voiding trial and require an indwelling transurethral catheter upon hospital discharge. Sacral neuromodulation procedures and intradetrusor onabotulinumtoxinA (Botox) injections are excluded.
排除标准
- •Unwilling or unable to participate in the study.
- •Unwilling or unable to do a catheter self-removal at home.
- •Inability to understand English.
- •Pregnant women
- •Patient personal history of urogenital anomaly, neurogenic bladder, use of chronic self-intermittent catheterization or suprapubic tubes, ureteral stents or other genitourinary indwelling devices, immunosuppressed state or chronic use of steroids.
- •Currently (prior 3 months) undergoing medical management for recurrent UTI or interstitial cystitis
- •Active urinary tract infection.
- •Intraoperative bladder injury or cystotomy
- •Physical or mental impairment that would affect the subject's ability to perceive urinary tract infection symptoms
- •Reported allergy to silver metal
结局指标
主要结局
Incidence of UTIs requiring treatment
时间窗: approximately 4 weeks
Post-operative UTI rate
次要结局
- Adverse symptoms possibly causes by silver-coated catheter(approximately 4 weeks)
- Assess the types of bacterial uropathogens isolated from the urine cultures(approximately 4 weeks)
研究者
研究点 (4)
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