Posterior Tibial Nerve Stimulation vs. Sham
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The objective of this study is to determine the efficacy of a sham for posterior tibial nerve stimulation (PTNS).
研究概览
简要总结
The overall goal of this research is to determine the efficacy of a sham for posterior tibial nerve stimulation (PTNS). This novel design is needed in order to have a sham treatment that is similar to the actual treatment. The PTNS is used to treat urgency and frequency in people with overactive bladder (OAB). Until research is done using a sham component, we are unable to ascertain if the current use of PTNS is due to a placebo effect.
详细描述
Subjects will be healthy volunteers who are recruited by word of mouth. At their office visit with the Nurse Practitioner (NP), the subject's history and medication list will be reviewed.
The NP will randomize subjects into groups: one group with the PTNS on the right and sham on the left; the other group with the PTNS on the left and sham on the right. There will be a maximum of 30 subjects tested, and up to 50 people screened. The subjects will have 1 session for the testing of the PTNS vs sham that will include 15 minutes of stimulation as noted below. All participants will be blinded to the therapy they receive as described below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects >18 years of age
- •Female subjects will be menopausal, or have had a tubal ligation or hysterectomy.
- •Capable of giving informed consent
- •Capable and willing to follow study related procedures
排除标准
- •Pregnancy
- •InterStim
- •The subject is deemed unsuitable for enrollment in this study by the investigators based on their history or physical examination (including bleeding disorders)
结局指标
主要结局
The objective of this study is to determine the efficacy of a sham for posterior tibial nerve stimulation (PTNS).
时间窗: Prospective
次要结局
未报告次要终点