Safety and Performance of the BlueWind System for the Treatment of Patients With Overactive Bladder (OAB) Amended to Allow Extended Follow up of the Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- Incidence of serious adverse events
研究概览
简要总结
BlueWind system safety and performance in treatment of patients diagnosed with overactive bladder (OAB)
详细描述
BlueWind Medical system safety and performance in treatment of patients diagnosed with overactive bladder (OAB)
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
- 是
入选标准
- •Signed written informed consent.
- •Male or female aged 18 -
- •Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out voiding diaries and questionnaires, and is willing to complete required exams and tests.
- •Patients with overactive bladder symptoms:
- •Urinary frequency greater than 8 times/24 hours AND/OR Urinary urgency leaks of at least 2 leaks on 3 day voiding diary
- •Patient who has failed conservative treatment after at least 6 months of treatment
- •Patients with normally functioning upper urinary tract.
- •Patients with no clinical evidence of a neurological S2-S4 motor sensory deficit.
- •Prior PTNS Group: Patients who have had successful PTNS treatment (successful treatment is defined as ≥50% reduction in urinary frequency, and/or ≥50% fewer incontinence episodes, or a return to normal voiding frequency [<8 voids/day], based on retrospective diary review).
- •De novo Patient Group: Patient who passes the BlueWind compatibility test.
排除标准
- •Any metal implant in the area of BlueWind Medical implantation site.
- •Patients who have not had stable OAB medications for at least 30 days.
- •Patients who have received botulinum toxin injections within the past 6 months.
- •Previous urinary incontinence surgery or implantation of artificial graft material within the last 6 months.
- •Any spinal or genitourinary surgery within the last 6 months. Pelvic pain disorders
- •Obvious clinically demonstrated genuine stress incontinence.
- •Any neurological disease or disorder including neuropathy or injury resulting in neuropathy.
- •Current urinary tract infection, presence of urinary stone and/or urinary tract malignancy (i.e. tumor, vesicourethral reflux, etc.)
- •Pelvic radiotherapy and chemotherapy.
- •Severe uncontrolled diabetes.
- •Patients anticipating magnetic resonance imaging (MRI) exams.
- •Presence of cystocele, enterocele or rectocele of grade 3 or
- •Prior PTNS Group: Patients who are receiving concomitant nerve stimulation therapies for OAB treatment, except for PTNS maintenance therapy.
- •De novo Patient Group: Patients who have received or are receiving nerve stimulation therapies for OAB treatment, including PTNS.
研究组 & 干预措施
OAB
Patients with overactive bladder (OAB) with or without urge incontinence.
Two patient populations will be enrolled in the study:
Patients with no previous treatment with percutaneous tibial nerve stimulation (PTNS) [de novo patient group] and Patients with a documented success on PTNS therapy [prior-PTNS group]. Documented success on PTNS is defined by a ≥50% reduction in urinary frequency, and/or ≥50% fewer incontinence episodes, or a return to normal voiding frequency [<8 voids/day], based on retrospective diary review.
All patients will be treated with BlueWind Medical System.
干预措施: BlueWind Medical system (Device)
结局指标
主要结局
Incidence of serious adverse events
时间窗: 6 months
Incidence of serious adverse events system and or procedure related
Incidence of serious adverse events (amended)
时间窗: 36 months
Incidence of serious adverse events system and or procedure related (amended)
次要结局
未报告次要终点