PROSPECTIVE STUDY EVALUATING THE SAFETY AND EFFECTIVENESS OF ADJUSTABLE CONTINENCE THERAPY (ACT) BALLOONS FOR THE MANAGEMENT OF URINARY INCONTINENCE IN CHILDREN WITH BLADDER EXSTROPHY OR INCONTINENT EPISPADIAS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Evaluation of the clinical impact of ACT balloon on urinary continence with pad weight
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of a minimally invasive surgical procedure with ACT (Adjustable Continence Therapy) balloons implantation for the treatment of urinary incontinence in children with bladder exstrophy or isolated epispadias.
The ACT therapy consists of two small adjustable silicone balloons connected with a tubing to a port, surgically placed around the bladder neck, one on each side of the urethra.
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
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boys and girls > 5 years with bladder exstrophy or isolated epispadias;
- •sphincteric incontinence (leak point pressure < 45 cm d'H20, open bladder neck during filling, stress urinary incontinence);
- •normal renal function (eGFR > 90ml/min);
- •no (or stable) upper urinary tract dilatation in ultrasound.
排除标准
- •under 5 years or more than 18 years old;
- •renal insufficiency (acute or chronic);
- •evolutive deterioration of the upper urinary tract (hydronephrosis);
- •unmanageable detrusor instability;
- •residual volume greater than 100 ml after voiding;
- •bleeding disorders.
研究组 & 干预措施
Study Arm 1
Children with bladder exstrophy or isolated epispadias
干预措施: ACT (Device)
结局指标
主要结局
Evaluation of the clinical impact of ACT balloon on urinary continence with pad weight
时间窗: 24 months
Therapeutic success will be based on whether patients demonstrate at least a 50% reduction in 24 hour Pad weight at 6, 12 and 24 months follow-up compared to the pad weight results at baseline.
次要结局
- Number of pads per day (voiding diary)(6, 12 and 24 months)
- Number of incontinence episodes per day (voiding diary)(6, 12 and 24 months)
- PIN-Q questionnaire(6, 12 and 24 months)
- Incidence of urethral stricture and device erosion after ACT implantation(6, 12 and 24 months)