9000 URETHRA STUDY: a Prospective, Observational Study About Urethroplasty for Urethral Stricture Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- Failure-free survival
研究概览
简要总结
It has been demonstrated that urethroplasty should be considered the gold standard treatment for urethral stricture disease as it yields higher long-term success rates than endoscopic treatment options such as direct vision internal urethrotomy (DVIU) or dilation. Many data about these procedures exist, although most of the publications about urethroplasty are retrospective and involve a tremendous risk of bias. To address these issues, this study is designed to prospectively gain evidence about this matter in all patient subgroups facing a potential treatment with urethroplasty: native men, native women, transmen, transwomen and children.
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
- 6 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations.
- •Patient age ≥ 6 years.
- •If a patient reaches the age of 18 years, he or she will have to provide a new voluntarily signed written informed consent. All patients reaching the age of 18 years will be contacted by the Principal Investigator or Subinvestigator to provide a new voluntarily signed written informed consent.
排除标准
- •Absence of signed written informed consent and thus a patient unwilling to participate.
结局指标
主要结局
Failure-free survival
时间窗: From date of surgery until the date of stricture recurrence or date of death from any cause, whichever came first, assessed up to 120 months postoperatively
Interval between operation and latest follow-up moment at which the patiënt remains failure-free
次要结局
- Change in urinary continence(From the date of preoperative questionnaire completion until 24 months postoperatively.)
- Change in general quality of life(From the date of preoperative questionnaire completion until 24 months postoperatively.)
- Change in ejaculatory function(From the date of preoperative questionnaire completion until 24 months postoperatively.)
- Change in urinary function(From the date of preoperative questionnaire completion until 24 months postoperatively.)
- Change in quality of life(From the date of preoperative questionnaire completion until 24 months postoperatively.)
- Change in erectile function(From the date of preoperative questionnaire completion until 24 months postoperatively.)