Intravesical Alkalized Lidocaine for the Treatment of Overactive Bladder (OAB), a Randomized, Double-blinded Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks.
研究概览
简要总结
The purpose of this study is to determine whether alkalized lidocaine instilled into the bladder is effective in the treatment of overactive bladder (OAB).
详细描述
Existing first-line treatments for overactive bladder are limited by requirements for chronic dosing and associated systemic side effects. Small case series suggest that bladder instillation of lidocaine may be effective in downregulating the afferent neuronal activity of a sensitized bladder, leading to elevation of the urge sensory threshold and decreasing detrusor activity. However, neither the effectiveness over placebo nor the durability of the response has been previously investigated.
Comparison(s): We propose a randomized, prospective double-blinded controlled trial to determine if a three-week trial of intravesical alkalized lidocaine instillation decreases symptoms of overactive bladder more than instillation of normal saline using a validated outcome instrument, the OAB-q.
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 100 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
xylocaine
干预措施: alkalinized xylocaine (Drug)
2
normal saline
干预措施: placebo (Drug)
结局指标
主要结局
Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks.
时间窗: 6 weeks
次要结局
- OAB-q (Symptom Scale) at 6 Weeks(6 weeks)
- Cystometric Assessment of Maximal Bladder Capacity at 6 Weeks Only.(6 weeks)
- Median Number of Daily Voiding Episodes at 12 Months.(12 months)
- SF-12 Physical at 6 Weeks(6 weeks)
- Global Assessment of Change - Frequency at 6 Weeks(6 weeks)
- Average Weekly NRS for Frequency at 6 Weeks(6 weeks)
研究者
Frank Tu
Division Director, Gynecological Pain and Minimally Invasive Surgery, Department of Obstetrics and Gynecology
NorthShore University HealthSystem
