Therapy Optimisation Study of Adaptive Pudendal Neuromodulation in Women With Urinary Incontinence Implanted With the Amber UI System.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in absolute recharge performance
研究概览
简要总结
AURA-3 study (Augmenting Urinary Reflex Activity Study 3) is a single arm, short-duration (8 month) cohort follow up study of preceding interventional medical device study, AURA-2.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant has exited the AURA-2 clinical investigation.
- •Participant has an implanted Amber UI system.
- •Consents to participation.
排除标准
- •Participant has withdrawn from AURA-2 clinical investigation.
- •Participant is pregnant.
- •A past or current condition that in the opinion of the PI contraindicates enrolment (PI discretion).
研究组 & 干预措施
Amber UI Therapy
Participants will receive optimised recharge accessories and device firmware upgrades
干预措施: Amber UI system (Device)
结局指标
主要结局
Change in absolute recharge performance
时间窗: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months
Change in perceived recharge usability before and after receiving new recharge accessories and training.
Change in relative recharge performance
时间窗: 48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months
Relative (percentage) change in frequency and duration of recharging sessions after receiving new recharge accessories and training compared to baseline.
次要结局
- Change in recharge usability(48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months)
- Fully adaptive mode usability(48 hours; 2 months; 8 months)
- Fully adaptive mode specificity(48 hours; 2 months; 8 months)
- Adverse Device Events(48 hours; 2 weeks; 2 months; 2 months + 1 week; 4 months; 8 months)