Foot/Hand Neuromodulation for Overactive Bladder (OAB)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Number of Urinary Incontinence Episodes Per Day
研究概览
简要总结
The purpose of this study is to determine if electrical stimulation of the foot is effective in the treatment of overactive bladder conditions.
详细描述
Foot neuromodulation is designed to treat OAB conditions by electrically stimulating the somatic afferent nerves in the foot using skin surface electrodes. The foot stimulation is non-invasive, can be performed at home, and has no adverse effects. Foot neuromodulation therapy will likely be accepted by more patients and have the potential to make a broader impact on the improvement of OAB conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 year old men and women and older
- •Currently having overactive bladder (OAB) symptoms, i.e. urgency, frequency, or incontinence
- •No evidence of neurological disorder or urinary tract infection, i.e. clinically diagnosed as idiopathic OAB
排除标准
- •Pregnant women in their late pregnancy phase will be excluded because the increasing size of the baby/uterus may cause overactive bladder.
- •Patients with implanted electrical stimulators such as pacemaker will be excluded for potential interference with the TENS stimulator.
- •Patients who are allergic to Cipro or Bactrim will be excluded from the CMG study.
结局指标
主要结局
Number of Urinary Incontinence Episodes Per Day
时间窗: Week 1, Week 2, Week 3
Participants kept a daily voiding diary during week 1 (baseline), week 2 (foot stimulation), and week 3 (post foot stimulation). The average number per day urinary incontinence episodes was calculated for week 1 and week 2 for each subject.
次要结局
- Number of Urinary Urgency Episodes Per Day(Week 1, Week 2, Week 3)
研究者
Christopher J Chermansky, MD
Assistant Professor of Urology
University of Pittsburgh