The Altis® Single Incision Sling System for Female Stress Urinary Incontinence Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 34
- 主要终点
- Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months
研究概览
简要总结
An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI).
详细描述
An international, multi-center, single arm, prospective clinical study designed to assess the safety and efficacy of the Coloplast Altis single incision sling system for females with stress urinary incontinence (SUI). Primary Objective: Improvement in continence measured by 24 hour pad weight test with at least a 50% reduction in weight from baseline at 6 months. Secondary Objectives: Cough stress test results at 6 months; Subject QoL as measured by validated questionnaires: PGI-I, improvements in UDI-6 and IIQ-7 scores from baseline at 6 months, 3 day voiding diary improvement from baseline at 6 months; Device and procedure related adverse events. Brief Entrance Criteria: Adult female with confirmed SUI through cough stress test or urodynamics; Failed two non-invasive incontinence therapies; No prior surgical SUI treatment; No prolapse POP-Q Stage 2 or higher; No concurrent pelvic floor procedure; No urge predominant incontinence; No incontinence due to neurological disorder/disease; No PVR > 100cc; and, No contraindication to the surgical procedure. Study visits will take place at baseline, implant/hospitalization, 3 months, 6 months, 1 year, and 2 years post operatively. This study will enroll up to 113 subjects at up to 17 investigative sites in the US and Internationally.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is female at least 18 years of age
- •Subject is able and willing to complete all procedures and follow-up visits indicated in this protocol
- •Subject has confirmed stress urinary incontinence (SUI) through cough stress test or urodynamics
- •The subject has failed two non-invasive incontinence therapies (such as Kegel exercise, behavior modification, pad use, biofeedback, etc) for >6 months
排除标准
- •Subject has an active urogenital infection or active skin infection in region of surgery
- •Subject has confirmed Pelvic Organ Prolapse (POP) of Stage 2 or higher as determined by POP-Q prolapse grading
- •Subject is having a concomitant pelvic floor procedure
- •Subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions)
- •Subject had a prior surgical SUI treatment
- •Subject has undergone radiation or brachy therapy to treat pelvic cancer
- •Subject has urge predominant incontinence
- •Subject has an atonic bladder or a post void residual (PVR) consistently about 100cc
- •Subject is pregnant and/or is planning to get pregnant in the future
- •Subject has a contraindication to the surgical procedure or the Altis Instructions For Use (IFU)
- •Subject is enrolled in a concurrent clinical trial of any treatment (drug or device) that could affect continence function without the sponsor's approval
结局指标
主要结局
Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 6 Months
时间窗: 6 months (compared to baseline)
Primary endpoint defined as at least a 50% reduction in 24-hour pad weight from baseline to 6 months (including dry as defined as a pad weight of less than 1.3 grams during the 6-month test), in which the percent of subjects with at least 50% reduction in 24-hour pad weight is compared to a performance goal of 50%.
次要结局
- Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 12 Months(12 months (compared to baseline))
- Percentage of Participants With Negative Cough Stress Test at 12 Months(12 months (compared to baseline))
- Percentage of Participants With Negative Cough Stress Test at 6 Months(6 months)
- Percentage of Participants With at Least 50% Improvement in Incontinence Via 3-Day Voiding Diary From Baseline to 6 Months(6 months (compared to baseline))
- Percentage of Participants With at Least 50% Reduction in 24-hour Pad Weight From Baseline to 12 Months(12 months (compared to baseline))
- Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 12 Months(12 months (compared to baseline))
- Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 12 Months(12 months)
- Percentage of Participants With at Least 50% Improvement in UDI-6 Score From Baseline to 6 Months(6 months (compared to baseline))
- Percentage of Participants With at Least 50% Improvement in IIQ-7 From Baseline to 6 Months(6 months (compared to baseline))
- Percentage of Patients Responding "Very Much Better" or "Much Better" on PGI-I at 6 Months(6 months)