Intralesional Injection of Mitomycin C Following Visual Internal Urethrotomy for Recurrent Urethral Stricture
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Urethral stricture recurrence
研究概览
简要总结
To evaluate the effectiveness of administering mitomycin C through intralesional injection after performing visual internal urethrotomy (VIU) for the treatment of recurring urethral stricture.
详细描述
Numerous studies have investigated the impact of intralesional administration of antifibrotic drugs on urethral strictures following visual internal urethrotomy (VIU). These drugs include mitomycin C, botulinum toxin A, somatostatin analog, and glucocorticoids. Mitomycin C (MMC) is known for its potent chemotherapeutic and antibiotic properties. It effectively hinders mitosis and fibroblast proliferation, playing a crucial role in tissue healing and scar formation by reducing the release of matrix proteins through the inhibition of proliferative fibroblasts. With its anti-proliferative and anti-scarring characteristics, MMC proves to be a suitable option for treating recurrent urethral strictures.
thus we conduct a randomized controlled trial to evaluate the safety and efficacy of Mitomycin in decrease urethral stricture recurrence.
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, Outcomes Assessor)
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
- •All adult male patients aged above 18 years with a single bulbar urethral stricture measuring less than ( 1.5 cm), and had failed at least one prior intervention for urethral stricture(urethral dilation & VIU) were included in our study
排除标准
- •Patients with urethral strictures more than (1.5 cm), multiple urethral strictures, complex stricture, complicated by a fistula or abscess, completely occluded urethral strictures and previous urethroplasty were excluded
研究组 & 干预措施
25 Patients with recurrent urethral stricture undergoing visual internal urethrotomy only.
Standard procedure of visual internal urethrotomy only for urethral stricture
干预措施: Mitomycin c (Drug)
25 Patients with recurrent urethral stricture undergoing visual internal urethrotomy with intralesio
intralesional injection of mitomycin-c following the standard visual internal urethrotomy
干预措施: Mitomycin c (Drug)
结局指标
主要结局
Urethral stricture recurrence
时间窗: 1 year
is defined as recurrence of LUTS during follow-up visits starting at 3 months till 12 months with difficulty of passing urine and confirmed by a voiding cystourethrogram.
次要结局
- urinary tract infection(1 month)
- uroflowmetery(1 year)
研究者
Ahmed Maher Gamil Ahmed Higazy
principle investigator
Ain Shams University