Prospective Registry for Patients Undergoing Artificial Urinary Sphincter (AUS) Surgery for Female Stress Urinary Incontinence (SUI) Due to Intrinsic Sphincter Deficiency (ISD)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
- 试验地点
- 21
- 主要终点
- Cure rate
研究概览
简要总结
Prospective collection of pre-defined parameters of AUS Surgery for Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency
详细描述
This will be a prospective non-controlled cohort study evaluating the outcomes of artificial urinary sphincter (AUS) implantation surgery (Robot-assisted, Laparoscopic, Open or other) in female patients. The data collection will be undertaken from multiple centres in Europe. The participation will be by open invitation from the Urologists from the European Society of Female & Functional Urology Section of the European Association of Urology (ESFFU) to all its members along with other surgeons undertaking these procedures. The aim is to recruit a total of 150 patients in 2 years whereafter patients will be followed until the end of Registry which is 5 years after inclusion of the first patient. 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 dataset from as many centres as possible.
An initial assessment for the robustness of the data collection and first clinical evaluation of the data collected will be performed after 1 year by a nominated steering committee. Thereafter, the evaluations will be performed after every year until end of Registry.
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
- •Patient should be Female and aged over 18 years.
- •The patient will undergo an initial AUS implantation surgery (Robot-assisted, Laparoscopic, Open or other) for treatment of stress urinary incontinence due to intrinsic sphincter deficiency.
- •Participant is willing and able to give informed consent for participation in the Registry
- •Patient is able to complete the questionnaires.
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: Up to 5 years post surgery
Cure rate is defined as urinary continence with no pads used or use of 1 light security pad.The cure rate after 5 years of study follow up will be calculated together with its 95% Confidence Intervals, for the total patient group as well as for each of the AUS implantation surgery procedures (Robot-assisted, Laparoscopic, Open, or other).
次要结局
- Maximum free urinary flow(At baseline, week 6, week 12 after surgery)
- Urodynamic parameter Maximum cystometric capacity(At baseline, week 12 after surgery)
- Urodynamic parameter Maximum urinary flow during pressure-flow study(At baseline, week 12 after surgery)
- Revision-free rate(At 1, 2, 3, 4, 5 years of Registry follow-up)
- ICIQ-Urinary Incontinence-Short Form Questionnaire (ICIQ-UI-SF)(At each of the evaluation points up to 5 years post surgery)
- 24-hour pad tests(At each of the evaluation points up to 5 years post surgery)
- ICIQ-Female Sexual Matters Associated with Lower Urinary Tract Symptoms (ICIQ-FLUTSsex)(At each of the evaluation points up to 5 years post surgery)
- Urodynamic parameter Detrusor overactivity(At baseline, week 12 after surgery)
- Main conclusion of Urodynamic investigations(At baseline, week 12 after surgery)
- Time being incontinence-free(Up to 5 years post surgery)
- Urodynamic parameter Maximum detrusor pressure during pressure-flow study(At baseline, week 12 after surgery)
- Post void Residual Volume(At baseline, week 6, week 12 after surgery)
- ICIQ- Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol)(At each of the evaluation points up to 5 years post surgery)
- Urodynamic parameter Volume at leakage(At baseline, week 12 after surgery)
- Urodynamic parameter Detrusor pressure at Max flow during pressure-flow study(At baseline, week 12 after surgery)
- Urodynamic parameter Retrograde leak point pressure(At baseline, week 12 after surgery)
- Number of patients with complications(During surgery and up to 5 years after surgery)
- Time being revision-free(Up to 5 years post-surgery)