Prospective Registry for Patients Undergoing Surgery for Male Stress Urinary Incontinence in Multiple European Centres
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,054
- 试验地点
- 28
- 主要终点
- Cure rate
研究概览
简要总结
This will be a prospective collection of pre-defined parameters on the treatment of male stress urinary incontinence by an artificial urinary sphincter (AUS) and male sling. The data collection will be undertaken from multiple centers in Europe. The participation will be by open invitation to all members of the Female & Functional Section of the EAU (ESFFU) along with other urologists undertaking these procedures. There will be a call via the European Association of urology (EAU) to all European Urologists to register for database entry. There will be no restriction on the number of patients enrolled as long as they are consecutive. The aim is to have a long term collection of the data set from as many centers as possible. An initial assessment for the robustness of the data collection will be undertaken at 3 months by a nominated steering committee. However, the first clinical evaluation of the data collected will commence at 1 year by the steering committee. Thereafter, the evaluations will be performed after every 2 years.
详细描述
STATISTICS
- Number of Participants:
Investigators anticipate to recruit 1000 patients from at least 25-30 European Centers and prospectively collect data from 100 - 200 patients per year. Statistical analysis will be performed on the total number of participants. Based on the available literature, we anticipate an average cure rate of 50% for AUS and for male slings an average cure rate of 65% at the end of study.
With an estimated sample size of 700 patients treated with Artificial Urethral Sphincter (AUS) and 300 patients with a male sling, and taking into account an attrition rate of 10-15%, we will be able to detect a 50% cure rate with 6% on either side of the 95% Confidence Interval for AUS (proportion 0,50 with 95% Confidence Intervals: 0,44-0,56) and a 65% cure rate for patients treated with male slings (proportion 0,65 with 95% Confidence Intervals: 0,57-0,74). 2. Statistical Analysis:
No adjustment procedures or imputations of missing data will take place.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient undergoing surgery for stress incontinence by AUS or male sling.
- •Participant is willing and able to complete the questionnaires and give informed consent for participation in the study.
排除标准
- •Participating center is unable to contribute consecutive patients.
结局指标
主要结局
Cure rate
时间窗: 10 years after surgery
Cure rate will be the main endpoint of the study, and is defined as urinary continence with no need for use of pads or the use of 1 light security pad. The cure rate after 10 years of study follow up will be calculated together with its 95% Confidence Intervals, for the total patient group as well as for each device subtype.
次要结局
未报告次要终点