Randomised Comparative Prospective Study of the Treatment of Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency : ACT™ Balloon Versus Artificial Urinary Sphincter ( AMS800™)
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Social continence defined by the use of 0-1 adult protective pads per day
研究概览
简要总结
The main objective is to compare the efficacy of AMS800 ™ and ACT ™ devices for the Treatment of Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency on "social continence" at 6 months.
Continence is defined by the average number of pads used per day. The social continence is defined by (0-1) pad per day
详细描述
Prospective multicenter randomized controlled trial comparing two parallel arms: the implantation of an adjustable balloon (experimental arm) versus implantation of an artificial urinary sphincter AMS800 ™ (control arm), for the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).
This research will focus on the assessment of improved continence, quality of life, and Cost-Effectiveness Analysis.
The tested device ACT ™ device is a prosthesis used to support the bladder neck and proximal urethra increasing the urethral coaptation and supporting to the bladder neck to prevent urine leakage at stress.
The medical device AMS 800 ™(control arm) is an implantable device made of silicone elastomer filled with saline/X-Ray fluid, used in the treatment of stress urinary incontinence related to ISD. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by closing the urethra and allowing the patient to void according to the patient's will and opening of the device (sub-cutaneous pump).
An inclusion visit will take place between 3 months and 1 month before the date of the surgery to explain the purpose of the study, the benefits and risks for patients, and describe the comparative medical devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patients suffering from stress urinary incontinence due to ISD.
- •Patients with maximum urethral closure pressure(PCUM) < 50 cm H2O or bladder leakage pressure < 100 cm H2O
- •Patient who accepted surgery
- •Patient with normal urethra-cystoscopy (no foreign body nor calculus)
- •Patient with effort leaks on clinical examination
- •Patient who never had SUA or ACT ™ balloon
- •Affiliation to health insurance
- •Written informed consent
排除标准
- •Patient pregnant or breastfeeding
- •Patient with a life expectancy of less than 2 years
- •Patient with overactive bladder uncontrolled and considered an against-indication for surgery
- •Patient with reduced bladder compliance
- •Patient with significant post-void residual volume according to the judgment of the Investigator
- •Patient with a history of pelvic radiotherapy
研究组 & 干预措施
ACT™ device
Patients randomized to receive the Adjustable Continence Therapy device ACT™
干预措施: ACT™ device (Device)
AMS 800 ™ device
Patients randomized to receive the artificial urinary sphincter AMS 800 ™
干预措施: AMS 800 ™ device (Device)
结局指标
主要结局
Social continence defined by the use of 0-1 adult protective pads per day
时间窗: 6 months
次要结局
- Assessment of incontinence (number and type of protective pads used per day)(12 months)
- impact on quality of life assessed by EQ-5D Health Questionnaire.(12 months)
- assessment of the urinary flow using ICIQ-FLUTS questionnaire(12 months)
- Assessment of Urinary Profile Symptoms using UPS questionnaire(12 months)