L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection: a Double-blind Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Treatment for urinary tract infection after surgery.
研究概览
简要总结
This study will include women who will undergo pelvic reconstructive surgery and/or anti-incontinence sling procedures. Patients will be randomized to the combination of L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract in tablet or placebo twice a day during the seven days before and after surgery (total of 14 days). In this randomized, double-blind study, the investigators will assess treatment of clinically suspected or culture-proven urinary tract infections within 3 weeks of surgery (primary outcome), and risk factors for treatment for postoperative urinary tract infections (secondary outcomes) between the two study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •postoperative transurethral catheterization after surgery for pelvic organ prolapse and/or urinary incontinence
- •patients aged ≥ 18 years
排除标准
- •acute urinary tract infection at the moment of inclusion in the study
- •antibiotic treatment prescribed for any other cause than urinary tract infection
- •pregnancy
- •known allergy to one of the elements of the active compound
- •surgery for mesh excision
- •surgery for urethral diverticulum
- •surgery for fistula repair
- •surgery for sacral neuromodulation
- •any condition precluding the acquisition of written consent
研究组 & 干预措施
L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract
The combination of L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract will be administered in tablet twice a day 7 days before and after surgery
干预措施: L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract (Drug)
Placebo
Placebo tablet twice a day 7 days before and after surgery
干预措施: Placebo (Other)
结局指标
主要结局
Treatment for urinary tract infection after surgery.
时间窗: 3 weeks after surgery.
To assess any treatment received for clinically suspected or culture-proven urinary tract infection within 3 weeks of surgery.
次要结局
未报告次要终点
研究者
Umberto Leone Roberti Maggiore
MD
IRCCS San Raffaele