Comparison of outcome of augmentation urethroplasty versus incision urethrotomy in females with urethral stricture disease – A randomized controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Evaluate and compare the outcomes of augmentation urethroplasty and incision urethrotomy in resolving urethral stricture in females. This includes assessing improvement in urinary symptoms (AUA symptom score betterment), restoration of normal urinary flow (Qmax more than 15 ml/sec) and reduction in PVR (to less than 100ml)
研究概览
简要总结
My thesis is to compare outcomes of augmentation urethroplasty with incision urethrotomy in females with urethral stricture. I will be including female patients in the age group of 18 years to 75 years, who were diagnosed with urethral strictutre clinically and radiologically. Patients will be randomely allotted into two groups by block randomization method, one group will undergo augmentation urethroplasty and other will undergo incision urethrotomy. I will be comparing the outcomes of both above mentioned procedures at 3 months and 6 months like symptomatic improvement and recurrence of stricture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- Female
入选标准
- •Those who belong to above mentioned age group and having urethral stricture proven either by clinical or radiological evidence, who are ready to give consent.
排除标准
- •Age not belonging to inclusion criteria, those who are not giving consent for surgery, patients with neurogenic bladder, genital prolapse and previous surgeries for urethral stricture will be excluded.
结局指标
主要结局
Evaluate and compare the outcomes of augmentation urethroplasty and incision urethrotomy in resolving urethral stricture in females. This includes assessing improvement in urinary symptoms (AUA symptom score betterment), restoration of normal urinary flow (Qmax more than 15 ml/sec) and reduction in PVR (to less than 100ml)
时间窗: At 3 months and 6 months postoperatively
次要结局
- To compare short term recurrence (6 months) of urethral stricture after augmentation urethroplasty and incision urethrotomy(6 months)
研究者
Dr Bibin Sunny
AIIMS Patna