NCT04026347终止不适用
An Evaluation of the Vesair® Bladder Control System for the Treatment of Stress Urinary Incontinence in Post-Menopausal Women
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 158
- 试验地点
- 25
- 主要终点
- Composite Endpoint
研究概览
简要总结
Single-blind, multicenter, randomized clinical trial of the Vesair Balloon in the treatment of Stress Urinary Incontinence in post-menopausal women
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Subject and assessor blinded to randomization result
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 for at least 12 months
- •Average of at least one leak per day
- •Failed non-invasive treatment
- •Willing to undergo cystoscopy and a minimum of 5 visits over one year
排除标准
- •BMI > 40.0
- •Last menstrual period within 12 months of enrollment
- •On birth control and/or oral hormone replacement therapy
- •Urge-predominant mixed incontinence
- •SUI due to intrinsic sphincter deficiency
- •Prior treatment with the Vesair Balloon
- •Prior medical, surgical or non-surgical treatment for SUI within 6 months of enrollment
- •Recurrent or recent (within the past 5 years) kidney stones
- •Recurrent or recent (within the past 3 months) Urinary Tract Infection
- •Stage 3 or higher cystocele (POP-Q)
- •Interstitial or follicular cystitis / painful bladder syndrome
- •Local genital infection
- •Artificial sphincter
- •Anatomic abnormalities which would interfere with device placement.
- •Visible blood in the urine
- •Uncontrolled bladder contractions / discomfort with bladder filling up to 300cc
- •History of cancer of the urinary tract
- •History of any cancer within the past two years (excluding non-melanoma skin cancers)
- •History of any cancer not (yet) treated with curable intent (excluding non-melanoma skin cancers)
- •Immunologically suppressed or immunocompromised
- •Undergoing pelvic radiation, pelvic fibrosis from previous pelvic radiation
- •Non ambulatory / unable to do simple pad weight testing exercises
- •On anticoagulation therapy with the exception of aspirin
- •History of mental illness requiring inpatient treatment
- •Neurological disease such as Parkinson's or multiple sclerosis
- •Uncontrolled diabetes (A1C > 9%)
- •Recent alcohol or drug abuse requiring treatment in the past year
- •Autoimmune or connective tissue disorders such as Marfan syndrome, Ehlers-Danlos or Myasthenia Gravis
- •Allergy to polyurethane or perfluorocarbons
研究组 & 干预措施
Vesair
Experimental
Subjects are treated with Vesair Balloon at enrollment (day 0)
干预措施: Vesair Balloon (Device)
Sham
Sham Comparator
Subjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit.
干预措施: Vesair Balloon (Device)
Sham
Sham Comparator
Subjects are treated with sham at enrollment (day 0) and treated with balloon (if desired) after six month visit.
干预措施: Sham balloon placement (Other)
结局指标
主要结局
Composite Endpoint
时间窗: 6 months
Pad weight + I-QOL
次要结局
- Episode Frequency(6 months)
- Pad Weight(6 months)
- I-QOL(6 months)
- Patient Global Impression of Improvement (PGI-I)(6 months)
研究者
研究点 (25)
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