Pivotal Study of Subcutaneous Tibial Nerve Stimulation With eCoin for Overactive Bladder (OAB) With Urgency Urinary Incontinence (UUI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 29
- 主要终点
- Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
研究概览
简要总结
This trial is a prospective, multicenter, single-arm study of the safety and effectiveness of eCoinTM tibial nerve stimulation in subjects having overactive bladder (OAB) with urgency urinary incontinence (UUI). The study will evaluate changes from baseline in OAB symptoms as measured by voiding diaries and patient reported-outcomes through 48 weeks of eCoinTM therapy or 52 weeks of implantation.
详细描述
This study enrolled and implanted 133 subjects at 15 sites in the US under the original IDE.
Subjects were given the option to extend out to 3 years post activation, with annual visits at 2 and 3 years post activation (96 and 144 weeks post-activation).
Subjects who are still active in the original IDE study will be offered consecutive enrollment in the post approval study and will be given the option to receive a new implant. Subjects who are no longer active, or have exited the study will be given the option to reenter the study and complete two follow-up visits. Subjects re-entering the study will not have the option to receive a new implant. Post approval follow-up of subjects will occur through the year 5 visit (257 weeks post-activation of their original device). Reimplantation of a new eCoin would not reset their follow-up clock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men between 18 and 80 years old.
- •Diagnosis of overactive bladder with urgency urinary incontinence or mixed urge and stress incontinence with a predominant urgency component (selfreported), for at least 6 months.
- •Individual is without pharmacological treatment of overactive bladder (antimuscarinics and beta-3 agonists).
- •Individual is intolerant of or has an inadequate response to any of anticholinergics, β3-adrenoceptor agonists, onabotulinumtoxinA, or percutaneous tibial nerve stimulation.
排除标准
- •Predominant stress urinary incontinence with more than 1/3 stress urinary incontinent episodes when compared to total urinary incontinent episodes.
- •Clinically significant bladder outlet obstruction.
- •Clinically significant pelvic organ prolapse beyond the hymenal ring.
- •Inadequate skin integrity or any evidence of an infection or inflammation in either lower leg.
结局指标
主要结局
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
时间窗: 48 weeks after device activation.
Responder rate
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.
时间窗: 52 weeks after implantation.
All adverse events will be reported in all patients up to 52 weeks after implantation.
Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.
时间窗: 48 weeks after device activation.
Responder rate
Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.
时间窗: 52 weeks after implantation.
All adverse events will be reported in all patients up to 52 weeks after implantation.
次要结局
- Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events(257 weeks after implantation)
- Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events.(96 weeks after implantation)
- Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events(144 weeks after implantation)
- Moderate-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.(28 weeks after implantation)
- Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary(96 weeks after device activation.)
- Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.(257 weeks after device activation)
- Moderate-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events.(28 weeks after implantation)
- Moderate-term Effectiveness Data. Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.(24 weeks after device activation)
- Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary(96 weeks after device activation.)
- Percentage of Subjects Experiencing 50% or Better Improvement in Urgency Urinary Incontinence Episodes as Measured by a 3-day Voiding Diary.(257 weeks after device activation)
- Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events.(96 weeks after implantation)
- Long-term Safety in All Patients: Percentage of Patients With Device Related Adverse Events(144 weeks after implantation)
- Long-term Safety in All Patients. Percentage of Patients With Device Related Adverse Events(257 weeks after implantation)