Can COX-2 Inhibitor Decrease Stricture Recurrence After Direct Vision Internal Urethrotomy?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- Urethral stricture recurrence
研究概览
简要总结
To evaluate the efficacy and safety of nonsteroidal anti-inflammatory drugs (NSAIDs) in preventing urethral stricture recurrence after direct visual internal urethrotomy.
详细描述
The most common aetiology of urethral strictures is idiopathic, followed by iatrogenic causes, including transurethral resection, urethral catheterization, prostate cancer treatments, and previous hypospadias surgery.
The recurrence rates are higher with previously treated, long and multiple strictures, penile compared with bulbar strictures, and those with perioperative infection.
It has been reported that post-transurethral resection of the prostate (TURP) to receive or not receive a COX-2 inhibitor (rofecoxib 25 mg/day) for 20 days. At 1 year of follow-up, a urethral stricture had been diagnosed in 17 and 0 % of cases without and with COX-2 treatment, respectively
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
- Single (Participant)
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
- •Age ≥ 18 years
- •American Society of Anesthesiologists (ASA) score ≤
- •Urethral stricture length ≤ 1.5 cm
排除标准
- •Recurrent urethral stricture ≥ 2 times.
- •Pelvic fracture urethral distraction defect (PFUDD).
研究组 & 干预措施
Nonsteroidal anti-inflammatory drugs
Patients will undergo direct vision internal urethrotomy (DVIU) plus nonsteroidal anti-inflammatory drugs (NSAID) for 3 weeks.
干预措施: Nonsteroidal anti-inflammatory drugs (Drug)
Control group
Patients will undergo direct vision internal urethrotomy (DVIU) plus a placebo for 3 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Urethral stricture recurrence
时间窗: 90 days postoperative
Urethral stricture recurrence is defined as the need for a secondary procedure, including dilation, internal urethrotomy, and urethroplasty, considered as treatment failure.
次要结局
- International Prostate Symptom Score (IPSS)(90 days postoperative)
- Quality of life (QOL)(90 days postoperative)
- Maximum flow rate(90 days postoperative)
- Incidence of complications(90 days postoperative)
研究者
Waheed Fawzy Abdelrasol
Lecturer of Urology, Faculty of medicine, New Vally University, New Vally, Egypt
New Valley University