Evaluation of a Non-Implanted Electrical Stimulation Continence Device for Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- OAB-q - Short Form
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 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, 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 years or older with a diagnosis of Overactive Bladder
- •If of reproductive age, must use a reliable form of contraception
排除标准
- •Pregnant, was recently pregnant or is trying to conceive
- •Has a metal pelvic implant or any electrically active implanted medical device
- •Had a previous hysterectomy, pelvic radiation or pelvic cancer
- •Has significant pelvic organ prolapse
- •Had bladder treatment with onabotulinumtoxinA in the previous 12 months
- •Has a significant heart condition
研究组 & 干预措施
Treatment
FemPulse System at one device setting
干预措施: FemPulse System (Device)
Control
FemPulse System at a different device setting
干预措施: FemPulse System (Device)
结局指标
主要结局
OAB-q - Short Form
时间窗: Approximately 11 days in total
OAB bother quality of life questionnaire
Urinary frequency
时间窗: Approximately 11 days in total
Frequency of and intervals between urinary voids (voids per day and time between voids)
All device- and procedure-related adverse events will be collected and tabulated
时间窗: Approximately 11 days in total
Adverse events
OAB Symptom Score
时间窗: Approximately 11 days in total
OAB symptoms quality of life questionnaire
Urinary urgency
时间窗: Approximately 11 days in total
Presence or absence of urgency with each void
Urge urinary incontinence (UUI)
时间窗: Approximately 11 days in total
Presence or absence of UUI with each void
Urogenital Distress Inventory - Short Form
时间窗: Approximately 11 days in total
OAB-related distress quality of life questionnaire
Incontinence Impact Questionnaire - Short Form
时间窗: Approximately 11 days in total
Impact of OAB quality of life questionnaire
次要结局
未报告次要终点