Axonics SacRal NeuromodulaTIon System for Urinary Urgency Incontinence TreatmeNt (ARTISAN-SNM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 6
- 主要终点
- Proportion of Responders
研究概览
简要总结
The ARTISAN-SNM study is designed to evaluate the safety and effectiveness of the Axonics Sacral Neuromodulation System as an aid in the treatment of the symptoms of urinary urgency incontinence (UUI) in patients who have failed or could not tolerate more conservative treatments.
详细描述
The ARTISAN-SNM Trial which was a single-arm, prospective study that included 29 centers and enrolled 129 participants. The primary aim of the study was to evaluate the safety and efficacy of the Axonics SNM System for the treatment of UUI symptoms. Primary outcome was improvement in UUI episodes on a 3-day bladder diary. Secondary outcomes included quality of life using the ICIQ-OABqol questionnaire, patient satisfaction, and bowel symptoms captured using the Cleveland Clinic Florida Fecal Incontinence Score (CCF-FIS). Participants were followed out to 2 years and data was reported at 6 months, 1 year and 2 years
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of UUI demonstrated on a 72-hour voiding diary defined as a minimum of four (4) leaking episodes associated with urgency, at least 50% of all leaking episodes associated with urgency, and at least one leaking episode each 24-hour period.
- •Greater than or equal to 6 months' history of UUI diagnosis
- •For male subjects only: Peak flow rate > 15 cc/s as verified by uroflowmetry within 6 months prior to enrollment; Residual bladder volume < 150 cc tested within 6 months prior to enrollment
- •21 years of age and older
- •Willing and capable of providing informed consent
- •Capable of participating in all testing associated with this clinical investigation
排除标准
- •Stress incontinence or mixed incontinence.
- •Current urinary tract mechanical obstruction (e.g. benign prostatic enlargement or urethral stricture)
- •Interstitial cystitis or bladder pain syndrome as defined by either American Urological Association (AUA) or European Association of Urology (EAU) guidelines
- •A female who is breastfeeding
- •A female with a positive urine pregnancy test
研究组 & 干预措施
Treatment group
Urinary Urgency Incontinence
干预措施: Axonics Sacral Neuromodulation System (SNM) System (Device)
结局指标
主要结局
Proportion of Responders
时间窗: 2 years
Responders are defined as patients with greater than or equal to 50% reduction in symptoms
次要结局
- ICIQ-OAB-qol(2 years)
- Daily Number of Urgency Leaks(2 years)
- Voids(2 years)