Transcutaneous Electrical Nerve Stimulation Analgesia During Outpatient Operative Cystoscopy for Overactive Bladder: A Randomized Control Trial (TENSOB Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Mean pain measured by Visual Analog Scale (VAS)
研究概览
简要总结
This will be a double blind randomized control trial in men and women with urinary urge incontinence that are undergoing outpatient operative cystoscopy for Onabotulinumtoxin A chemo denervation as third line therapy for overactive bladder (OAB) or urinary urge incontinence (UUI). Subjects will be identified by the University of Rochester Urologists and Urogynecologists participating in the study who currently oversee urinary urge incontinence care. Subjects will be randomized into two groups. One group will be undergoing the cystoscopy with transcutaneous electrical nerve stimulation (TENS) for analgesia and the second group will have cystoscopy with placebo TENS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Men and Women, Age ≥18 years
- •Diagnosis of OAB/UUI,
- •Scheduled to undergo intravesical Botox injections in the office
- •Able to read/write English
- •Exclusion criteria:
- •Currently undergoing Sacral Neuromodulation
- •Cutaneous damage such as ulcers or broken skin on target treatment area
- •Currently implanted cardiac pacemaker or defibrillator
- •Pre-procedural use of opioids for pain management, less than 8 hours from last dose
- •Participants with altered sensation below the umbilicus
排除标准
- 未提供
结局指标
主要结局
Mean pain measured by Visual Analog Scale (VAS)
时间窗: within 10 minutes after procedure
The VAS for pain consists of a 100-mm-long horizontal line where 0-mm equals no pain and 100-mm equals worst possible pain.
次要结局
- Mean pain measured by Likert scale(within 10 minutes after procedure)
- Number of participants with side effects(within 10 minutes after procedure)
- Mean satisfaction with the procedure(within 10 minutes after procedure)
- Number of participants who guessed correctly whether they were given the active TENS or placebo TENS(within 10 minutes after procedure)
研究者
Paula Doyle
Professor
University of Rochester