Outcome of Renal Transplant on a Defunctionalized Bladder. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- improvement of bladder function after recycling
研究概览
简要总结
In this study, investigators will prospectively evaluate the outcome of renal transplantation into a defunctionalized bladder by comparing direct transplantation into this defunctionalized bladder and pre-transplant programmed bladder cycling.
详细描述
Study population:
The study will include patients maintained on hemodialysis for more than 12 months, have oliguria or anuria, reduced bladder capacity, have no history of lower urinary tract dysfunction and have no evidence of urological cause of renal failure. Patients with history of lower urinary tract symptoms before developing renal failure and those with lower urinary tract disease resulting in renal failure will be excluded.
Study design:
It is a randomized controlled trial comparing the outcome of programmed bladder cycling before the time of renal transplantation and direct transplantation without bladder cycling in patients with defunctionalized bladder. Patients, who meet the inclusion criteria, will be randomly allocated into two groups. The first group will undergo renal transplantation on the defunctionalized bladder without bladder recycling. The second group will undergo renal transplantation after bladder recycling.
Measurements:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients maintained on hemodialysis for more than 12 months
- •have oliguria or anuria
- •reduced bladder capacity
- •have no history of lower urinary tract dysfunction and have no evidence of urological cause of renal failure.
排除标准
- •Patients with history of lower urinary tract symptoms before developing renal failure and
- •those with lower urinary tract disease resulting in renal failure will be excluded
结局指标
主要结局
improvement of bladder function after recycling
时间窗: 3 months
to evaluate whether bladder recycling is efficient to restore bladder function prior to renal transplantation by urodynamic evaluation and ascending cystogram to measure the bladder capacity in cm
次要结局
- voiding function after renal transplantation(3 months after renal transplantation)
- graft function(1 year)
研究者
Mohamed Hassan Zahran
Assistant lecturer of urology and renal transplantation
Mansoura University