NCT05678413招募中不适用
Role of Paclitaxel in Prevention of Stricture Recurrence After Direct Visual Internal Urethrotomy (DVIU); Prospective Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Success of treatment
研究概览
简要总结
Stricture urethra is a common disease and has various causing factors. The most common performed procedure is direct visual internal urethrotomy (DVIU), but unfortunately has a high recurrence rates. Multiple trial were performed to improve the outcomes of DVIU. Various intralesional injections were used. in this trial we will evaluate intralesional paclitaxel injection following DVIU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Anterior urethral stricture
- •Short strictures (less than 2 cm)
- •International Prostate Symptom Score less than 11 and maximum flow rate < 15 ml per second.
- •No previous treatment for stricture disease
排除标准
- •Recurrent cases
- •Prior pelvic radiation
- •Associated other pathology or unresolved confounding etiologies (e.g. bladder neck contracture, neurogenic bladder, benign prostatic hyperplasia) were excluded.
结局指标
主要结局
Success of treatment
时间窗: 1 year
Treatment free rates (Freedom from repeat intervention e.g., repeat dilation, DVIU or urethroplasty).
次要结局
未报告次要终点
研究者
Mohamed Fawzy Abd Elfattah Salman
Director
Al-Azhar University
研究点 (1)
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