Prospective Long-term Single Center Cohort Study Assessing Functional Outcome of Urethral Reconstructive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 1
- 主要终点
- Quality Of Life: change from baseline (=preoperative value)
研究概览
简要总结
The analysis of the long-term outcomes and quality-of-life parameters after urethral reconstruction surgery.
详细描述
Urethroplasty is the surgical repair of a urethral stricture. Depending on the location, severity and length of the stricture, various techniques can be performed.
The first procedure consists of the excision of the stenotic segment and end-to-end anastomosis. Other procedures consist of widening the urethra with buccal mucosa as free graft or with vascularized (genital) skin flaps. The results of these techniques have been described in prospective cohort studies, but to date there is little good data about the functional outcome and quality-of-life with longer follow-up after this surgery.
The purpose of this study is to prospectively follow patients for functional outcome parameters and quality-of-life to obtain long-term information concerning these surgeries.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •urethral stricture surgery
- •informed consent
排除标准
- •loss of follow-up
- •not willing to participate
结局指标
主要结局
Quality Of Life: change from baseline (=preoperative value)
时间窗: 6m, 1y, 2y, 3y, 4y
Validated questionnaires (patient reported outcome measures) concerning general discomfort, micturition problems, erections, and the impact of those problems on their social life. * International Prostate Symptom Score - Quality of Life questionnaire (IPSS-QOL) * International Consultation of Incontinence - Lower Urinary Tract Symptoms Quality of Life questionnaire (ICIQ-LUTSQoL)
次要结局
- Functional outcomes: micturition: change from baseline (=preoperative value)(6m, 1y, 2y, 3y, 4y)
- Functional outcomes: erection: change from baseline (=preoperative value)(6m, 1y, 2y, 3y, 4y)