Cold vs. Laser Internal Urethrotomy Treatment of Urethral Strictures
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- post operative clinical & imaging signs of urinary outflow obstruction or partial obstruction
研究概览
简要总结
The purpose of this study is to determine whether laser internal urethrotomy (IU) is as efficient as cold knife internal urethrotomy for treatment of anterior urethral strictures regarding post operative urination outflow, stricture recurrence rate and possible post- operative complications
详细描述
The current surgical treatment for anterior urethral stricture includes internal urethrotomy (IU) by cold knife. Recurrence rate after such procedure is quoted as 35-70% in 2 to 5 years follow-up. Possible surgical alternative procedures include: open surgical urethral re-construction, urethral stents usage & laser IU. According to existing data (Nd-YAG laser- retrospective) the recurrence rate after laser IU is far better comparing to cold knife urethrotomy. The current research intends to address this question using prospective randomized methods.
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
- •Men over 18 years old with urethral stricture
排除标准
- •S/P urethral reconstruction
- •Posterior urethral strictures
结局指标
主要结局
post operative clinical & imaging signs of urinary outflow obstruction or partial obstruction
时间窗: up to 2 years
Urethral stricture \& urinary flow will be assessed by physical examination, urethrography, cystoscopy, sonographic bladder scan for urine rest, urine flowmetry \& clinical questionnaire (IPSS).
次要结局
- post operative complications(up to 2 years)