NCT01739946已完成不适用
Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.
Michael Chancellor, MD1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2012年10月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Nerve Growth Factor (NGF) levels
研究概览
简要总结
The goal of this study is to compare protein markers in the urine of patients with and without overactive bladder (OAB) and InterStim®.
详细描述
This study will look for changes in protein markers that might reflect bladder symptoms before and after InterStim® implant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •Clinical symptoms of OAB (urgency and frequency with or without urge incontinence) for at least 3 or the 6 months immediately before the first visit.
- •At least 8 voids/day and an average of 1 nocturnal void over 3 consecutive days on baseline bladder diary.
- •InterStim® treatment naïve or being revised with a new lead
排除标准
- •Pelvic mass, pelvic prolapse, urinary retention, and pelvic malignancies as revealed by physical examination/medical record review
- •Implanted Programmable Generator (IPG) is not implanted/connected to the tined lead (failed Stage I)
- •Revision of only the IPG (without replacement of the tined lead)
- •More than one InterStim® device being placed (undergoing bilateral stimulation)
- •Controls (n=10)
- •Age 18-75 years
- •Deny history of OAB diagnosis or symptoms (urgency and frequency with or without urge incontinence)
- •American Urological Association (AUA) symptom score of ≤4
- •History of pelvic mass, prolapse, urinary retention, or pelvic malignancy within the last year
结局指标
主要结局
Nerve Growth Factor (NGF) levels
时间窗: 4 weeks
pg/ml
次要结局
未报告次要终点
研究者
Michael Chancellor, MD
Principal Investigator
William Beaumont Hospitals
研究点 (1)
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