NCT04248283招募中不适用
A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Uromedica
- 入组人数
- 167
- 试验地点
- 5
- 主要终点
- Provocative pad weight
研究概览
简要总结
A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a clinically relevant improvement in stress urinary incontinence.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female at least 22 years old
- •Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency
- •Provocative pad weight of greater than 11.0 grams
- •Candidate for surgical intervention
- •Negative urinalysis
- •Normal cystourethroscopy
- •Failed at least 6 months of previous treatment(s) for stress urinary incontinence (e.g., exercise regimen, electrical stimulation, surgical procedures, etc). Note: patients may have failed prior anti-incontinence procedures for SUI (e.g., suspension, sling, or urethral bulking agent)
- •Willing and able to sign informed consent and comply with trial follow-up requirements
排除标准
- •Pregnant or lactating
- •Life expectancy of less than 5 years
- •Has uncontrolled diabetes as evidenced by HbA1c over 6.5% and fasting plasma glucose over 130 mg/dL
- •Has auto-immune disease
- •Undergoing radiation therapy
- •Active urinary tract infection
- •Detrusor instability refractory to medication
- •Reduced bladder compliance as defined by a cystometrogram
- •Significant residual volume (greater than 100 ml) after voiding in which detrusor contraction is weak, when the bladder volume is greater than or equal to 250 ml
- •Has, had, or is suspected of having bladder cancer
- •History of bladder stones
- •Urethral stricture evidenced during cystourethroscopy
- •Has a neurogenic bladder that is atonic or has detrusor sphincter dyssynergia
- •Has a diathesis, hemophilia, or a bleeding disorder
- •Has a rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse of grade 3 or higher
- •Had prior pelvic radiotherapy
- •Had a prior artificial urinary sphincter implanted
- •Has a neurogenic condition known to affect bladder/sphincter function
研究组 & 干预措施
Adjustable Continence Therapy for Women
Experimental
Implantation of the Adjustable Continence Therapy for the treatment of female SUI.
干预措施: Adjustable Continence Therapy for Women (ACT) (Device)
结局指标
主要结局
Provocative pad weight
时间窗: 12 months
Change in provocative pad weight from baseline
次要结局
- Urogenital Distress Inventory (UDI)(12 months)
- Incontinence Quality of Life Questionnaire (I-QOL)(12 months)
研究者
研究点 (5)
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