Intravesical Gentamicin to Prevent Recurrent UTI
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Assess feasibility of trial recruitment
研究概览
简要总结
Feasibility assessment of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day) to prevent recurrent urinary tract infections (UTI)
详细描述
The overall goal of this project is to assess the feasibility of a larger trial investigating the use of intravesical gentamicin instillation (putting antibiotics directly into the bladder) versus the current standard of care of oral nitrofurantoin prophylaxis (taking a low dose of antibiotics by mouth every day). Investigators plan to gain patient perspective regarding preferences for study design and assess associations between the treatments with changes in the postmenopausal urinary microbiome (urobiome).
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Postmenopausal
- •2 UTIs in 6 months
- •desire to start antibiotic prophylaxis to prevent UTIs
排除标准
- •Parkinsons disease
- •myasthenia gravis
- •renal failure
- •liver failure
- •bladder pain syndrome
- •multiple negative urine cultures associated with UTI symptoms (>/= 3)
- •bladder Botox treatments in the past
- •treatment planned for UI and prolapse
- •unevaluated microscopic hematuria
- •history of kidney stones
- •no antibiotics within 4 weeks
- •most recent weight <40kg (88.18lbs)
- •surgically altered urinary tract (urinary diversion, phalloplasty, etc)
- •allergy or hypersensitivity to either of the study medications or medications in the same family including but not limited to: amikacin, kanamycin, neomycin, paromomycin, streptomycin, tobramycin.
研究组 & 干预措施
Standard of Care
Standard of care
干预措施: Nitrofurantoin (Drug)
Experimental
Gentamicin
干预措施: Gentamicin (Drug)
结局指标
主要结局
Assess feasibility of trial recruitment
时间窗: 3 months
measure screening ratio (number of people screened versus number enrolled)
Examine treatment compliance
时间窗: 3 months
compare medication compliance between groups, as measured by weekly self-reported number of doses taken in the oral medication group and attendance at installation visits in the intravesical gentamicin group
Examine trial retention
时间窗: 3 months
compare the proportion of participants retained in each group
次要结局
- Patient reported outcome measures(6 weeks, 3 months)
- culture-proven UTIs(3 months)