NCT03082118已完成不适用
Vesair Continued Access Trial: Use of the Vesair® Bladder Control System in the Treatment of Post-Menopausal Female Subjects With Stress Urinary Incontinence
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 14
- 主要终点
- Improvement on patient-reported outcomes
研究概览
简要总结
Single arm study of the Vesair Balloon in postmenopausal women.
详细描述
All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually.
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
- •Post-menopausal women with SUI or stress predominant mixed incontinence
- •Maximum score on IQOL of 60
- •Positive cough test for leakage
- •Willing to undergo procedures
- •Free from infection
- •Have previously tried (and failed) noninvasive treatment for SUI
排除标准
- •SUI due to SUI
- •Urge-predominant mixed incontinence
- •Incontinence of neurogenic etiology
- •2 or more UTIs in past year and 1 in past 3 months
- •Surgery for SUI in the past 6 months
- •taking medication that can be used to treat SUI
- •taking medication that affects urinary symptoms for less than 3 months
- •undergoing biofeedback
- •Grade 3 or worse cystocele
- •last menstrual period within 12 months
- •oral progesterone or estrogen in the past 12 months
- •BMI > 40
- •involuntary detrusor contractions or discomfort during bladder filling
- •previous stage III or worse cancer
- •previous cancer of the urinary tract
- •previous symptoms for early stage cancer in the past 2 years
- •anticoagulation therapy other than aspirin
- •history of prosthetic heart valve
- •neurological or connective tissue condition or disease affecting bladder function
- •known allergy to device components
研究组 & 干预措施
Vesair Arm
Experimental
Subjects treated with the Vesair Bladder Control System at enrollment.
干预措施: Vesair Bladder Control System (Device)
结局指标
主要结局
Improvement on patient-reported outcomes
时间窗: 3-12 months
Improvement reported on questionnaires
次要结局
- Reduction in leakage events(3-12 months)
研究者
研究点 (14)
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