Cycling Study With the Axonics System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 6
- 主要终点
- To evaluate the efficacy of daily cyclic stimulation of 2 hours "on" and 22 hours "off" in reducing UUI episodes by > 50% in newly implanted participants, or maintenance of efficacy in currently implanted participants with an implanted Axonics System
研究概览
简要总结
A prospective, multi-center, study comparing continuous sacral neuromodulation (SNM) stimulation to daily cyclic stimulation of 2 hours "on" and 22 hours "off" using the Axonics System.
详细描述
After consent is provided, the required visits are at Baseline, Day 0, 1-Month, and 3-Month. At the follow-up visits, a bladder diary is reviewed, symptoms are assessed, the PGI-I questionnaire is completed, and cyclic stimulation hours may be changed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants who are ≥ 21 years at the time of consent
- •Has a primary indication of UUI (participants with a secondary indication of UF or FI may also be enrolled)
- •Has a diagnosis of UUI for greater than or equal to 6 months prior to the date of consent
- •UUI episodes:
- •For currently implanted participants (Group A), they must be considered therapy responders with a >50% reduction in UUI episodes (based on their original baseline diaries) and satisfied with their SNM therapy
- •For de novo candidates (Group B), they must have completed a successful PNE documented with a >50% reduction in UUI episodes on a 3-day diary (a diary must exist within a medical record or equivalent)
- •Willing and capable of providing informed consent
- •Agrees to return to the site for all study visits
- •Fluent (able to speak and read) in English
排除标准
- •Any participant that the study Investigator deems to be a poor candidate who is unable to complete a 72-hour bladder diary or will be non-compliant for study visits
- •Diagnosis of urinary retention
- •Surgical treatment for stress incontinence (e.g. sling, Burch), and/or pelvic organ prolapse in the past 3 months or recommended or planned within 3 months from the time of consent
- •Changes to current regimen of medications that could impact bladder function within 4 weeks prior to consent
- •Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)
- •Current symptomatic urinary tract infection (UTI)
- •A patient who early discontinued from the ARTISTRY registry
- •A female with a positive urine pregnancy test
- •A female who is breastfeeding
结局指标
主要结局
To evaluate the efficacy of daily cyclic stimulation of 2 hours "on" and 22 hours "off" in reducing UUI episodes by > 50% in newly implanted participants, or maintenance of efficacy in currently implanted participants with an implanted Axonics System
时间窗: 3 months
Comparison of UUI episodes on a 3-day bladder diary at 3 months as compared to baseline UUI episodes
次要结局
- To evaluate patient satisfaction with cyclic stimulation(3 months)