Clinical Investigation of an Adjustable Continence Therapy (ACT) Periurethral Prosthetic System for Treatment of Female Stress Urinary Incontinence With or Without Hypermobility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Uromedica
- 入组人数
- 221
- 试验地点
- 14
- 主要终点
- Change of Stamey Grade From Baseline to 12 Months.
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of a minimally invasive surgical procedure in up to 160 implanted female patients in which two adjustable balloons (one on each side of the urethra) are implanted to treat urinary stress incontinence.
The results will be analyzed to demonstrate the effects of the device as well as its associated risks. Therapeutic success will be based on whether the patients demonstrate at least a one-grade (mean) reduction in the Stamey score at 12 months.
详细描述
This is a multi-center, prospective, non randomized clinical trial comparing baseline data to the 12 month data. Urodynamic testing, pad weights and a direct visual stress test will be used to determine success along with the Stamey score.
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
- 是
入选标准
- •18 years or older
- •Diagnosed with stress urinary incontinence with or without urethral hypermobility
- •Willing to sign informed consent
- •Candidates for surgical intervention for stress incontinence
- •Negative urinalysis or urine culture within 2 weeks of implantation
- •Normal cystourethroscopy
- •Failed at least 6 months of previous treatments for stress urinary incontinence (e.g., exercise regimen, electrical stimulation, surgical procedures, etc.)
- •May have failed suspension or sling procedures
排除标准
- •Pregnant or lactating
- •Life expectancy of less than one year
- •Insulin dependant diabetic
- •Auto-immune disease
- •Undergoing radiation therapy
- •Active urinary tract infection
- •Detrusor instability refractory to meds
- •Reduced bladder compliance
- •Significant bladder residual >100mls
- •Bladder cancer
- •Unsuccessfully treated bladder stones
- •Current urethral stricture preventing the passage of a 24 French endoscope
- •Neurogenic bladder
- •Uncorrected rectocele, cystocele, urethrocele, enterocele or pelvic prolapse of Grade 3 or higher
- •Prior pelvic radiotherapy
- •Artificial urinary sphincter implanted
研究组 & 干预措施
Experimental
Open Label Study, ACT (Adjustable Continence Therapy)
干预措施: ACT (Adjustable Continence Therapy) (Device)
结局指标
主要结局
Change of Stamey Grade From Baseline to 12 Months.
时间窗: Baseline to 12 months
The Stamey grade classifies the severity of stress incontinence in four possible grades from 0-3. Grade 0: no leaking, Grade 1: loss of urine with sudden increases of abdominal pressure: e.g. coughing, sneezing or laughing, Grade 2: loss of urine with lesser degrees of stress: e.g. walking or standing up, and Grade 3: loss of urine without any relation to physical activity or position, e.g. while lying in bed. The primary end point at 12 months is a mean change in Stamey Grade from baseline of greater than or equal to -1.
次要结局
- Incontinence Impact Questionnaire (IIQ-7)(Baseline to 12 months)
- Incontinence Quality of Life (IQoL) Questionnaire(Baseline to 12 months)
- Number of Incontinence Episodes Per Day (Voiding Diary)(Baseline to 12 months)
- Urinary Distress Inventory (UDI-6)(Baseline to 12 months)
- Number of Pads Changed Per Day (Voiding Diary)(Baseline to 12 months)
- Provocative Pad Weight(Baseline to 12 months)