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临床试验/NCT02519153
NCT02519153Unknown4 期

Role of Phosphodiesterase 5 Inhibitors (PDE5i) (Sildenafil) in Management of Distal Ureteral Stone

Mansoura University0 个研究点目标入组 100 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
100
主要终点
the percentage of passage of lower ureteric stones.

研究概览

简要总结

Urolithiasis is one of the most common urological diseases. The risk of urolithiasis is estimated to be between 5% and 12% all over the world with increased incidence in male rather than female (2:1) respectively . Ureteral stones account for 20% from all urinary tract stones, more than 70% of the ureteral stones found in the lower third of the ureter . The incidence of urinary stones has been increasing day by day. Medical expulsive therapy (MET) of ureteral stones is the investigators' concern in this study. Stone location, size, number, ureteral spasm, mucosal edema or inflammation and ureteral anatomy are the factors affecting passage of the ureteral stones. So, MET is based on mechanism that stone passage is facilitated by the relaxation of ureteral smooth muscle , increasing hydrostatic pressure proximal to the stone and decreasing exciting edema . There are many oral medication could be used as MET such as adrenergic blockers, calcium channel blockers, prostaglandin synthesis inhibitors, glyceryl trinitrate and steroid treatment . Calcium-channel blockers and adrenergic α-antagonists are the main that has been proposed to enhance stone passage as expulsive medical therapy. Cyclic nucleotides are degraded by phosphodiesterases enzymes (PDEs). So using of PDE inhibtors may play role in relaxation of smooth muscle of the ureter. A study was done for evaluation of three PDE5 inhibtors, sildenafil , vardenafil and tadalafil, they found that PDE5 inhibitors can reverse the tension of isolated human ureteral smooth muscle via cGMP-mediated pathways.

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 70 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male Patient aged from 18-65 years.
  • Lower third ureteric stones at or below sacro-iliac joint .
  • Stone size rang from 5- 10 mm.
  • Unilateral ureteric stone

排除标准

  • Patients who had recurrent fever.
  • Patient underwent ESWL.
  • Patient with rising serum creatinine > 2mg/dl.
  • Patient with history of uretero-vesical reimplantation.
  • Stone larger than 10 mm

研究组 & 干预措施

control

Placebo Comparator

patient receive placebo for 4 weeks and followed for passage of stone distal ureter

干预措施: Sildenafil (Drug)

sildenafil

Active Comparator

patient receive sildenafil 50 mg for 4 weeks once per day and followed for passage of stone distal ureter

干预措施: Sildenafil (Drug)

结局指标

主要结局

the percentage of passage of lower ureteric stones.

时间窗: one year

次要结局

  • number of patient need for analgesic treatment during their medical expulsive tharpy(one year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

mohamed awad tharwat

Urology & Nephrology Center

Mansoura University

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