Evaluation of a Wearable Electrical Incontinence Device in Subjects: A Non-significant Risk Clinical Evaluation of FemPulse Therapy in Women With OAB
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of this clinical trial is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.
详细描述
The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves in the lower abdomen that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females ≥21 yrs with Overactive Bladder
排除标准
- •Is or was recently pregnant
- •Has a metal pelvic implant or any electrically active implanted medical device
- •Has a urinary tract or vaginal infection
- •Had a previous hysterectomy, pelvic radiation or pelvic cancer
- •Has significant pelvic organ prolapse
- •Had bladder treatment with onabotulinumtoxinA in the previous 12 months or Tibial Nerve stimulation within the previous 30 days
- •Has a significant heart condition or a history of vasovagal reaction or low blood pressure
研究组 & 干预措施
Treatment
Active therapy
干预措施: Treament (Device)
Sham Control
Sham Control
干预措施: Sham Control (Device)
结局指标
主要结局
Adverse Events
时间窗: 3 days in total
All device- and procedure-related adverse events will be collected and tabulated
Placeability and comfort of the device
时间窗: 3 days in total
Subjects will be observed for their ability to place, orient and wear the device without discomfort. The outcome is Pass or Fail as determined by the investigator.
次要结局
- Frequency of urinary voids(3 days in total)
- Intervals between urinary voids(3 days in total)
- Urge urinary incontinence (UUI)(3 days in total)