A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort Study in Subjects With Female Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 598
- 试验地点
- 66
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to monitor the use of Altis Single Incision Sling (SIS) in a real world population and collect medical data on effectiveness and to monitor safety of Altis SIS at 12 and 36 months post device implantation in women with stress urinary incontinence.
详细描述
This project has been launched after the introduction of Altis in Europe. This study is a multicenter prospective, observational (i.e. naturalistic) post-marketing clinical follow-up of women for who stress urinary incontinence was diagnosed and will be treated with Altis Single Incision Sling System. Therefore these patients will be asked to allow to use their clinical data and answer some questionnaires. The patients'data will be collected in routine clinical practice before, during and after surgery until 12 months. Then, questionnaires will be mailed to the participants annually during 2 additional years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Implanted with Altis Single Incision Sling System
排除标准
- •Refuses to be included in the survey or that their medical data will be used for research purposes
- •Indication for Altis Single Incision Sling System implantation is not for the treatment of female urinary incontinence.
结局指标
主要结局
Adverse events
时间窗: 12 months
Adverse events are any toward medical occurrence, unintended disease or injury or any untoward clinical signs in subjects. Adverse events will be categorized according to relatedness to device or procedure, severity and frequency. At 12-months, The percentage of patients without any device related severe or serious adverse events is measured.
Patient Global Impression of Improvement (PGI-I)
时间窗: 12 months
PGI-I is one of the two outcome measures of the composite primary endpoint. It is a validated question that collects the patients' impression of improvement after the surgery. Among this 7 point-scale ("very much better", "much better", "a little better", "no change", "a little worse", "much worse" and "very much worse"), the patients are asked to check the one number that describes how their urinay tract condition is now, compared with how it's was before the surgery. The percentage of patients who describes "very much better" or "much better" or "little better" and the percentage of patients who describes "very much better" or "much better" were measured.
次要结局
- Incontinence quality of life questionnaire (I-QoL)(Baseline, 8 weeks, 12, 24, 36 months)
- Post-void residual (PVR) volume(Baseline, 8 weeks and 12 months)
- Adverse events(8 weeks, 24, 36 months)
- Subject global satisfaction questionnaire(8 weeks, 12, 24, 36 months)
- Impact on sexual function assessed by the Pelvic organ/urinary incontinence sexual questionnaire (PISQ 12)(Baseline, 8 weeks, 12, 24, 36 months)
- Cough stress test (CST)(Baseline, 8 weeks and 12 months)
- Pad Use(Baseline, 8 weeks, 12, 24 and 36 months)
- International Consultation on Incontinence Questionnaire (ICIQ-UI)(Baseline, 8 weeks, 12, 24 and 36 months)
- Patient Global Impression of Improvement (PGI-I)(8 weeks, 24, 36 months)