Efficacy of Holmium Laser Uretherotomy in Combination With Intralesional Steroids in the Treatment of Bulbar Uretheral Stricture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- the maximum flow rate (Qmax) is >15 ml/s at 3 and 6 months after procedure
研究概览
简要总结
the purpose is to evaluate the outcome of visual internal uretherotomy with Holmium laser along with intralesional steroid injection.
详细描述
In this study, the investigator evaluates the efficacy of Holmium laser in combination with intra lesional steroid injection in the treatment of bulbar urethral strictures
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 26 Years 至 69 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Presence of obstructive symptoms,
- •Short segment strictures (stricture length <2 cm) as evident on radiological studies, i.e. retrograde urethrography and micturating cystourethrography.
- •Peak flow rate on uroflowmetry less than 15 ml/s
排除标准
- •Complete obliteration of lumen of urethra on urethroscopy,
- •Balanitis Xerotica Obliterans,
- •Age less than 18 years,
- •Multiple strictures,
- •Active urinary tract infection,
- •Recurrent Strictures.
- •Prior internal uretherotomy
- •Prior urethroplasty
- •Pan-anterior urethral strictures
- •Posterior stenosis
- •Those who lost to follow up
研究组 & 干预措施
Laser uretherotomy
Using Holmium laser uretherotomy only in the treatment of bulbar uretheral stricture
干预措施: Laser uretherotomy (Procedure)
Laser uretherotomy with intralesional steroids
Using holmium laser uretherotomy with injection of 80 mg of triamcinolone (diluted with normal saline to 10 ml) in the treatment of bulbar uretheral stricture
干预措施: Laser uretherotomy with triamcinolone (Procedure)
结局指标
主要结局
the maximum flow rate (Qmax) is >15 ml/s at 3 and 6 months after procedure
时间窗: 3 and 6 months
The procedure will be accepted as successful when the maximum flow rate (Qmax) is \>15 ml/s.
次要结局
未报告次要终点