Bioengineered Collagen Scaffold Implant as an Alternative to Conventional Buccal Mucosa for Substitution Urethroplasty of Distal Urethral Strictures. - A Pilot Stud
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Urethral patency
研究概览
简要总结
The field of research for this study is tissue engineering and the utilization of a bioengineered collagen implant as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of distal urethral strictures.
详细描述
Urethral stricture is defined as the abnormal narrowing of the urethral lumen in the area of the corpus spongiosum. A stricture is the result of ischemic spongiofibrosis manifesting as scar tissue in the corpus spongiosum. Long-term consequences are chronic fistulation through the skin, recurrent sepsis, bladder stones, obstructive uropathy, obstructive nephropathy, and finally renal failure.
Current available surgical techniques for urethral stricture repair require harvesting of grafts from autologous sites resulting in additional risks of complications at the tissue harvest site and additional pain to the patient.
The hypothesis of this study is that the developed bioengineered collagen implant can be used as an alternative biomaterial to buccal mucosa for substitution urethroplasty in urethral stricture patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Adult males with urethral stricture less than 3 cm (anywhere from penile to bulbar urethra not including the membranous urethra) with existing lumen of at least 6 Fr suitable for augmentation urethroplasty. The stricture may be due to trauma or infection.
排除标准
- •Known bovine collagen allergy
- •Current urinary tract infection
- •Chronic renal failure
- •Neurological diseases
- •Chronic obstructive pulmonary diseases
- •Sleep disturbances
- •Depression
- •Former cancer treatment
- •Recurrent stricture
结局指标
主要结局
Urethral patency
时间窗: four weeks post-surgery
A peri-urethrogram will be performed prior to catheter removal.
次要结局
- Urine flow(two months up-to twenty-four months post-surgery)
- Voiding symptoms(two months up-to twenty-four months post-surgery)