NCT06665698尚未招募不适用
Prospective Study to the Evaluate the Long-term Use of Synthetic I-STOP® Device for Treatment of Stress Urinary Incontinence in Women
DILO Medical0 个研究点目标入组 500 人开始时间: 2024年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- Rate of reintervention
研究概览
简要总结
Evaluate quality of life and rate of reoperation after implantation of the I-STOP sling for stress urinary incontinence
详细描述
This is a prospective, multicenter, non-comparative, interventional post-marketing clinical follow-up study (PMCF) on a population of patients with SUI requiring surgical treatment with implantation of an I-STOP sling to document safety, the performance and effectiveness in the short, medium, and long term of these I-STOP® implants used in their intended purpose.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult woman aged over 18 ;
- •Patient with SUI, having escaped "conservative" medical treatment, with indication for surgical treatment with implantation of an I-STOP® strip via trans-obturator or retropubic route as indicated in the instructions for use of the SUI implant ;
- •Patient affiliated to a social security scheme;
- •Patient capable of completing a self-questionnaire;
- •Patient able to understand the protocol and follow the visit schedule;
- •Patient having signed informed consent.
排除标准
- •Minor patient, pregnant or breastfeeding ;
- •Adult patient subject to a measure of legal protection, guardianship, curatorship or deprived of liberty by judicial or administrative decision ;
- •Patient presenting a contraindication to the use of the implant indicated in the instructions for use of the implant ;
- •Patient with a medical contraindication to surgery and/or anaesthesia.
结局指标
主要结局
Rate of reintervention
时间窗: One year after surgery and after each year during 10 years
Questionnaire sent every year to the patient with question about revision surgery: yes / no
次要结局
- Quality of Life(One year after surgery and after each year during 10 years)
研究者
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