Assessment of Patient Satisfaction With Transcutaneous Tibial Nerve Stimulation in a County Hospital System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
研究概览
简要总结
The goal of this clinical trial is to study whether transcutaneous tibial nerve stimulation (TTNS) is a feasible and satisfactory treatment for overactive bladder in Urogynecology patients who receive their care at a county hospital.
Researchers will compare outcomes with TTNS to patients who undergo percutaneous tibial nerve stimulation (PTNS).
The main questions it aims to answer are:
- Is TTNS non-inferior to PTNS in terms of OAB symptom severity?
- Are patients as satisfied with TTNS as they are with PTNS?
- Are patients' symptoms improved with TTNS?
Participants will:
- either undergo PTNS or be taught how to do TTNS therapy at home
- complete surveys about their bladder symptoms and satisfaction with treatment
详细描述
Patients who consent to this study will be randomly assigned to either receive PTNS in clinic weekly, or TTNS every other day at home. The severity of their overactive bladder symptoms and satisfaction with treatment will be assessed before starting treatment as well as 6 weeks, 12 weeks and 6 months after starting treatment. The results of these surveys will be compared between groups to determine whether TTNS is non-inferior to PTNS in this particular patient population.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
After randomization, patients and care providers will not be blinded, however investigators will be blinded to the results of the survey instruments.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age between 18 - 90 years old
- •patient of the Urogynecology clinic at Harbor UCLA medical center
- •diagnosis of overactive bladder
- •patient elects non-pharmacologic treatment of overactive bladder
- •English or Spanish speaking
- •able to consent and participate in research
排除标准
- •cognitive impairment or diagnosis of dementia
- •diagnosis of neurogenic bladder
- •prior midurethral sling procedure
- •use of an electronic pacemaker
- •current pregnancy
- •incarcerated persons
研究者
Tajnoos Yazdany, M.D.
Principal Investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center