A 3 Years Naturalistic Cohort Survey Of Virtue® Male Sling System For Male Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort in Subjects With Male Stress Urinary Incontinence
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 13
- 主要终点
- Patient Global Impression of Improvement (PGI-I)
研究概览
简要总结
The purpose of this study is to monitor the use of Virtue® Male Sling in a real world population and collect medical data on effectiveness and to monitor safety of Virtue® at 12 and 36 months post device implantation in men with post-prostatectomy urinary incontinence.
详细描述
This project will be launched after the first introduction of Virtue® Male Sling in Europe. This study is a multicenter prospective, non-interventional (i.e. naturalistic) post-marketing clinical follow up of men with urinary incontinence implanted with Virtue® Male Sling System by urologists who are experienced in the device. The patient will be followed for 12 months in routine real world clinical practice except for administration of subject questionnaire(s). Routine visits will be performed approximately at baseline (preoperative and implantation period), between 1 and 3 months (immediate post-operative period) and 12 months. Then questionnaires will be mailed 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
- Male
- 接受健康志愿者
- 否
入选标准
- •Implanted with the Virtue® Male 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 the Virtue® Male Sling System implantation is not for the treatment of male urinary incontinence
结局指标
主要结局
Patient Global Impression of Improvement (PGI-I)
时间窗: 12 months
PGI-I is a validated questionnaire that collects the patient's 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), we ask the patients to check the one number that best decribes how their urinary tract condition is now, compared with how it's was before the surgery. Patients who score little or much or very much better will be considered a treatment success. We measure the percentage of patient who describe the treatment success
Adverse events
时间窗: 12 months
Adverse events are any untoward 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, we measure the percentage of patients without any device related severe or serious adverse events.
次要结局
- Post-void residual (PVR) volume(Baseline, 8 weeks, 12 months)
- Uroflowmetry(Baseline, 8 weeks, 12 months)
- International Consultation on Incontinence Questionnaire (ICIQ-UI)(Baseline, 8 weeks, 12, 24, 36 months)
- Subject global satisfaction questionnaire(8 weeks, 12, 24, 36 months)
- Pad weight testing(Baseline, 8 weeks and 12 months)
- Pad Use(Baseline, 8 weeks, 12, 24, 36 months)
- Incontinence quality of life questionnaire (I-QoL)(Baseline, 8 weeks, 12, 24, 36 months)