Betadine vs Sterile Water for Periurethral Preparation Prior to Straight Catherization in the Clinic Setting: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 4
- 主要终点
- Bacteruria
研究概览
简要总结
The purpose of this study is to determine whether cleaning of the urethra, or external opening to the bladder, with sterile water (water that has been treated to remove bacteria and living organisms) vs Betadine also known as Povidone-Iodine (a medical grade cleaning solution) changes the rates of bacteria in the urine after a temporary catheter, or draining tube, is placed into the bladder. Chemical antiseptics, including Betadine, are the current standard of care. An additional goal of this study is to determine whether cleaning of the urethra, or external opening to the bladder, with sterile water vs betadine changes the amount of discomfort or pain patients experience with placement of a temporary catheter, or draining tube, in the bladder.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patient undergoing in office straight catherization
排除标准
- •History of culture proven recurrent urinary tract infection (2 in any 6-month period or 3 in any 12-month period)
- •Urine Analysis with +Nitrites
- •Catherization for any reason in the last 4 weeks
- •History of Iodine allergy
- •Patients unable to speak English
- •Patient does not have the capacity to consent
- •2-3rd trimester pregnancy
研究组 & 干预措施
Sterile Water
Sterile Water periurethral preparation
干预措施: Sterile water (Drug)
Betadine
Betadine periurethral preparation
干预措施: Povidone-Iodine (Drug)
结局指标
主要结局
Bacteruria
时间窗: Within 2 weeks of the patients procedure date
Bacteruria defined as the presence of bacteria within patient urine evaluated with urinalysis. Bacterial presence will be further characterized by colony forming unit count on urine culture.
Bacteruria
时间窗: Within 2 weeks of the patients procedure date
Bacteruria defined as the presence of bacteria within patient urine evaluated with urinalysis. Bacterial presence will be further characterized by colony forming unit count on urine culture.
次要结局
- Urethral Pain(At the time of catherization)
研究者
Ankita Gupta
Associate Fellowship Director of Urogynecology and Pelvic Reconstructive Surgery
University of Louisville