NCT06056856招募中不适用
Anatomical and Functional Outcome of Penile Skin Graft Versus Buccal Mucosal Graft for Urethral Substitution in Long Segment Anterior Urethral Strictures
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The degree of urethral lumen patency.
研究概览
简要总结
This study aims to compare the penile skin graft and buccal mucosal graft for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.
详细描述
Since previous studies were:
- Retrospective and very few were prospective randomized studies
- Some studies were done on lichen sclerosis cases that have an adverse effect on the PSG outcome.
- The follow-up duration was longer for PSG patients.
- Stricture length was usually longer for PSG cases.
This study aims to compare the PSG and BMG for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.
The investigators hypothesize that:
❶ Conducting a well-designed prospective, randomized study can help identify which technique is better than the other.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •The study will include patients with long segment anterior urethral stricture (>2 cm).
排除标准
- •Urethro-cutaneous fistula, urethral abscess or diverticulum.
- •A scarred and unsalvageable urethral plate or scarred perineum.
- •Lichen sclerosis (Balanitis xerotica obliterans).
- •Unhealthy/unavailable buccal mucosa.
结局指标
主要结局
The degree of urethral lumen patency.
时间窗: through study completion, an average of 1 year.
Patent urethra as evidenced by uroflowmetry and retrograde urethrography +/- urethroscopy
次要结局
- Lower urinary tract symptoms improvement(6 months)
- Erectile function assessment(6 months)
研究者
Mohamed Ahmed Anwar
Assistant lecturer
Al-Azhar University
研究点 (2)
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