跳至主要内容
临床试验/NCT00427648
NCT00427648终止3 期

Intravesical Alkalized Lidocaine for the Treatment of Overactive Bladder (OAB), a Randomized, Double-blinded Controlled Trial

Frank Tu1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

1

Active Comparator

xylocaine

干预措施: alkalinized xylocaine (Drug)

2

Placebo Comparator

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

发起方
Frank Tu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Frank Tu

Division Director, Gynecological Pain and Minimally Invasive Surgery, Department of Obstetrics and Gynecology

NorthShore University HealthSystem

研究点 (1)

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