UVASC Urethral Vascularization and Urodynamics
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Color histogram index (Vascularity Index)
研究概览
简要总结
The urethra plays a crucial role in maintaining urinary continence. Its complex blood supply is still not well understood. Particularly in the context of urethral pressure. Urethral pressure can be measured by bladder and urethral pressure studies (urodynamic).
This study aims to use advanced imaging techniques to analyse the blood supply of the urethra and correlate it to urethral pressure measurements.
Elucidating these relationships will improve our understanding of urethral function and malfunction, and ultimately optimise diagnosis and treatment of stress urinary incontinence. A total of 35 participants with stress urinary incontinence and 35 without stress urinary incontinence will be asked to participate in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Urodynamic examination
- •Written informed consent
- •Understanding of the German language
- •Indicated urodynamic assessment
- •Endovaginal and perineal ultrasound feasible
排除标准
- •Urinary tract infections
- •Transgender Population
- •Pregnancy
- •History of incontinence or prolapse surgery
- •Pelvic prolapse higher than second degree
- •Prior pelvic radiotherapy
- •Prior history of gynecologic tumor
研究组 & 干预措施
Stress urinary incontinence
participants with stress urinary incontinence
干预措施: 3D Ultrasound (Diagnostic Test)
NO Stress Urinary Incontinence
Participants referred to urodynamics without stress urinary incontinence
干预措施: 3D Ultrasound (Diagnostic Test)
结局指标
主要结局
Color histogram index (Vascularity Index)
时间窗: Enrollment by the urodynamic examination until the ultrasound measurement (VOCAL) up to 4 weeks
Doppler Indices (Vascularity Index) generated by Virtual Organ Computer-aided AnaLysis (VOCAL)
次要结局
未报告次要终点
研究者
Diana Höhn
MD
Insel Gruppe AG, University Hospital Bern