A Study of Transcutaneous Electrical Nerve Stimulation for Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of incontinence episodes per day
研究概览
简要总结
The purpose of the study is to compare patient centered- outcomes between Transcutaneous Electrical Nerve Stimulation (TENS) at three locations to treat urinary urge incontinence. One of these locations will be along the tibial nerve, which is traditionally accessed near the medial malleolus. The second site will be on the sacral nerve which is accessed over the sacrum. The third site will be a sham site on the shoulder. This study will evaluate the feasibility of transcutaneous electrical stimulation in the treatment of overactive bladder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients who are clinically diagnosed with urge incontinence, defined as urinary leakage associated with a sudden, strong desire to pass urine that is difficult to defer.
- •Patients with urge predominant mixed incontinence.
- •Patients will need to have answered at "Yes" to "leakage related to feeling urgency" on the UDI 6 questionnaire.
- •Over 18 years of age.
- •English speaking who are able to give informed consent to participate in the study.
- •Patients who have four urinary incontinence episodes.
排除标准
- •Stress incontinence desiring surgical management.
- •Previous treatment of refractory urge incontinence such as PTNS, SNS, or Intradetrusor onabotulinumtoxin A injections.
- •Neurological conditions affecting continence such as multiple sclerosis, a history of spinal shock within the past year, or neurologic impairment requiring a wheelchair.
- •Urethral diverticulum.
- •Daily catheterization due to urinary retention.
- •The use of anticholinergic medications for less than 6 weeks.
- •Patients who have pacemakers in place.
- •Patients with limited mobility requiring a wheelchair.
- •Elevated PVR > 200 cc
- •Untreated urinary tract infection, defined as symptoms and a urine culture with greater than 100,000 cfu/ ml within the last 1 month prior to treatment.
- •Uncorrected Stage 3 prolapse.
研究组 & 干预措施
Tibial Nerve
Transcutaneous electrical stimulation will be placed on the posterior tibial nerve.
干预措施: Transcutaneous Electrical Nerve Stimulation (Device)
Parasacral
Transcutaneous electrical stimulation will be placed on the lower back near the s3 foramina.
干预措施: Transcutaneous Electrical Nerve Stimulation (Device)
Shoulder
Transcutaneous electrical stimulation will be placed on the shoulder.
干预措施: Transcutaneous Electrical Nerve Stimulation (Device)
结局指标
主要结局
Number of incontinence episodes per day
时间窗: 6 weeks
Patients will self-report the number of incontinence episodes.
次要结局
- Number of bladder voids per day(6 weeks)