A Randomized Trial of Botox for Severe Urge Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Episodes/Day
研究概览
简要总结
The purpose of this study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.
详细描述
The prevalence of urinary incontinence in the US ranges from 3-14% with epidemiologic estimates ranging widely.1 Most urinary incontinence can be categorized into stress urinary incontinence (SUI) or UUI with UUI remaining more common and debilitating than SUI.2 A major cause of UUI is overactive bladder or detrusor instability (DI), and while DI is very common, its etiology remains unknown. DI is often successfully managed with behavioral therapy, physical therapy, medications and surgery with the most effective therapy being anticholinergic medication.2 However, side effects including dry mouth, and constipation often lead to discontinuation of these drugs. In addition, many patients fail anticholinergic medication and have persistent urinary leakage. Women who fail these treatments have limited options.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects must have ALL of the following:
- •Completed a routine evaluation of incontinence (urodynamics, bladder diaries, and pad weights) through the urogynecology clinic at SMH within 3 months of the screening visit
- •Symptoms of urge incontinence associated with leakage on bladder diary
- •24-hour pad weight >100 cc's (volume requiring multiple daily diaper changes)
- •Absence of a bladder infection or other condition that could explain urinary leakage
- •Absence of stress incontinence or a cough leak point pressure > 100 cm H2O on cystometry (this correlates with mild stress incontinence)
- •Failed anticholinergic therapy
- •Willingness and ability to perform intermittent clean catheterization (due to the risk of prolonged urinary retention from Botox)
- •The ability and willingness to return for surveillance evaluations
- •A negative urine pregnancy test if at risk for pregnancy
- •Competent to give signed consent and complete all of the study measures
排除标准
- •Children (< 21 years old), pregnant women and prisoners
- •History of carcinoma of the bladder
- •Absence of a measurable detrusor contraction on a pressure flow micturition study
- •A foreign body in the bladder or other correctable etiology for the UUI
- •Prior documented resistance to Botox
- •Gross fecal incontinence (due to confounding effects on pad weights and counts)
- •Known allergy to lidocaine or related compounds (used for local analgesia)
- •Known allergy to or inability to take both Bactrim DS or Ciprofloxacin (used for urinary tract infection prophylaxis)
- •Current use of an aminoglycoside or preparing for general anesthesia within 1 week (risk of synergetic effects
- •Known neurologic conditions such as Parkinson's disease, myasthenia gravis, multiple sclerosis, autonomic dysfunction, Lambert-Eaton syndrome, Amyotrophic Lateral Sclerosis or other neurologic disorder that may impact urinary function or the effect of Botox.
结局指标
主要结局
Episodes/Day
时间窗: 9 months
number of incontinence episodes/day
次要结局
未报告次要终点
研究者
Michael Flynn
MD
University of Rochester