NCT05211193已完成不适用
Open Label, Multi Center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I (Tesla Medical) in the Treatment of Overactive Bladder (OAB).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of severe urgency episodes
研究概览
简要总结
Open label Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder.
详细描述
Open label, Multi center Study to Evaluate the Efficacy of the Home Based Electrical Transcutaneous NeuroModulation (eTNM) Treatment Via Nerve Stimulator URIS I in the Treatment of Overactive Bladder (OAB).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years or older, inclusive
- •Diagnosis of OAB or mixed incontinence with the predominance of OAB symptoms
- •Dissatisfaction with any current or previous pharmacotherapy treatment of OAB for any reason within the past 12 months
- •Treatment Satisfaction VAS <50
- •Ability to understand and sign ICF
- •Subject agreed to attend all follow up evaluations and was willing to completely and accurately fill out voiding diaries and questionnaires, and was willing to complete required exams and tests
- •Subject agreed not to participate in another research study from the time of screening until the final study visit
- •Subject agreed not to use a pharmacotherapy treatment for OAB from the time of screening until the final study visit
排除标准
- •Prior treatment with botulotoxin for OAB
- •Previous pharmacotherapy for OAB if >12 months ago
- •Urinary retention with post void residual > 150ml
- •Neurological disease affecting urinary bladder function, including but not limited to Parkinson's disease, multiple sclerosis, stroke, spinal cord injury and nerves of lower limbs
- •History or presence of stress incontinence, or mixed incontinence where stress incontinence was predominant
结局指标
主要结局
Change of severe urgency episodes
时间窗: baseline and end of study (6weeks treatment)
The proportion of subjects with ≥ 50% change in severe urgency episodes (Grade 3 or 4) will be summarized by visit and for the full treatment period using the last observation.
次要结局
未报告次要终点
研究者
研究点 (1)
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