NCT00481728已完成1 期
Evaluation of Sympathetic Skin Responses and Heart Rate Variability as Objective Measures of Bladder Sensation - a Double Blind Third Party Open Placebo Controlled Randomised Study Using a Single Dose of Tolterodine in Patients With Idiopathic Overactive Bladder and Healthy Volunteers
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Heart rate variability evoked by filling cystometry and intravesical neurostimulation and sympathetic skin response evoked by intravesical neurostimulation in healthy volunteers and OAB patients
研究概览
简要总结
Measuring sympathetic skin response or heart rate variability can provide an objective biomarker of bladder sensation and its modulation by drug with potential to treat overactive bladder.
详细描述
Evaluation of the link between bladder sensation and changes in skin electrical conductance and heart rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female, healthy volunteers or OAB patients 18-65 years old, non pregnant and non lactating
排除标准
- •History of lower urinary tract pathology
- •Excessive alcohol and tobacco consumption
- •Treatment with investigational drug in the last 30 days
- •Abnormal ECG trace
- •Conditions that would contraindicate the use of tolterodine or any other anti muscarinic agent
研究组 & 干预措施
Tolterodine
Experimental
干预措施: Tolterodine (Drug)
Tolterodine
Experimental
干预措施: Filling cystometry (Procedure)
Tolterodine
Experimental
干预措施: Intravesical neurostimulation (Procedure)
结局指标
主要结局
Heart rate variability evoked by filling cystometry and intravesical neurostimulation and sympathetic skin response evoked by intravesical neurostimulation in healthy volunteers and OAB patients
次要结局
- To investigate the correlation between the changes in heart rate variability and sympathetic skin response evoked by filling cystometry and intravesical neurostimulation in OAB patients.(duration of study)
- To determine whether there is a difference in the stimulus response relationship for the evoked changes in HRV and SSR between healthy volunteers and OAB patients.(duration of study)
研究者
研究点 (1)
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