NCT03595215已完成不适用
Posterior Tibial Nerve Stimulation's Effectiveness in UI Frequency in Overactive Patients in Home
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in Urge Incontinence Episodes
研究概览
简要总结
This pilot clinical study, which focuses on feasibility and proof-of-principle, will be conducted in 11 female subjects (55-100 years old) with UI. Subjects will use the device three times a week for 8 weeks and complete 3-day "voiding diaries" to record instances of UI episodes and OAB quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •55-100 years old
- •Have an average urinary frequency of ≥ 8 voids per 24 hours (based on a pre-treatment 3-day voiding "training" diary)
- •Have self-reported bladder symptoms of more than 3 months
- •Are ambulatory and able to use the toilet independently
- •Have been off antimuscarinics, anticholinergics or beta-3 agonists for at least 2 weeks prior to enrollment OR on a stable dose for the prior 3 months
- •Patient has urinary urge incontinence of ≥ 8 episodes from a 3-day diary (with incontinence associated at urge level moderate or severe)
- •Able to provide informed consent
- •Capable and willing to follow all study-related procedures
排除标准
- •Have primary complaint of stress urinary incontinence
- •Have a pacemaker or implantable defibrillator
- •Had botox injections in the bladder or pelvic floor muscles in the past 12 months
- •Have a current urinary tract or vaginal infection
- •Have an active implantable SNS device (InterStim & Bion)
- •Have been diagnosed with peripheral neuropathy or nerve damage
- •Currently pregnant
- •Deemed unsuitable for enrollment in study by the investigator based on subjects' history or physical examination
研究组 & 干预措施
TENS Treatment Arm
Experimental
This study is an early feasibility study which will be treating all patients at least 3 times per week, for 8 weeks, using the device.
干预措施: TENS (Device)
结局指标
主要结局
Change in Urge Incontinence Episodes
时间窗: Baseline and 8 weeks
次要结局
- Change in Micturitions Per Day(Baseline and 8 weeks)
- Change in Health-related Quality of Life (HRQL)(Baseline and 8 weeks)
研究者
研究点 (1)
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