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临床试验/NCT05789732
NCT05789732已完成不适用

Efficacy of Silodosin, Tadalafil Alone Versus Silodosin Plus Tadalafil as Medical Expulsive Therapy for Lower Ureteric Stones: A Prospective Randomized Placebo Controlled Study

Benha University1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2022年3月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
168
试验地点
1
主要终点
Stone expulsion rate

研究概览

简要总结

This study will compare the efficacy of silodosin, tadalafil versus silodosin plus tadalafil as Medical Expulsive Therapy (MET) for lower ureteric stones.

详细描述

The global incidence of urolithiasis, a disease with a high recurrence rate, is increasing. Urolithiasis is one of the most common disorders of the urinary tract with a lifetime prevalence of up to 15% with men affected three times more than women.

Urolithiasis causes recurrent stone formers to experience a decline in quality of life, and there is an increasing socioeconomic burden associated with the management of urolithiasis. Improved quality of life may also have increased its prevalence. A significant proportion, about 1/5th of urinary tract stones, is found in the ureter, of which 2/3rd is seen in the distal ureter. Initially, a colicky pain of various grades presents with ureteric stone. It is one of the most common problems that compel a patient to an emergency room.

Methods to manage ureteral stones include conservative treatment, pharmacological treatment (e.g., medical expulsive therapy), shock wave lithotripsy, and surgical treatment. Thus, urologists must select the appropriate treatment for each patient (i.e., non-surgical or surgical). Today, medical expulsive therapy has become the most used modality of treatment for urolithiasis. During this treatment, the ureter smooth muscle is treated via various drugs by different mechanisms.

Blocking alpha-(α-) 1 adrenergic receptor, especially in the distal third decreases basal smooth muscle contraction and causes propulsive antegrade peristalsis helping stone expulsion. By increasing the intraureteral pressure gradient around the stone, alpha-1 adrenergic receptor antagonists eject distal ureteral stones.

Significant pathological changes can occur when ureteric stones are impacted. +is can cause an inflammatory reaction with mucosal edema which could further worsen the ureteric obstruction, increasing the risk of impaction and retention. However, selective alpha-1 blockers, such as tamsulosin and silodosin, have been the treatment of choice, with proven efficacy in multiple clinical trials. Silodosin is a more selective α-1A adrenoceptor blocker with a better stone expulsion rate than tamsulosin.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 168 patients aged >18 years old.
  • Both sexes.
  • Diagnosed with lower ureteric stone from 5mm to 10mm in size.

排除标准

  • Patients with multiple or bilateral ureteric stones
  • single kidney or impairment of renal function
  • Urinary tract infection (UTI)
  • Marked hydronephrosis
  • Patients presenting with severe intractable pain and requiring emergency intervention
  • Any urologic anomalies or history of ureteral surgery
  • Pregnancy
  • Pediatric populations
  • Ischemic heart disease
  • Congestive cardiac failure
  • Complicated hypertension
  • Patients on concomitant treatment with nitrates or calcium channel blockers.

研究组 & 干预措施

Placebo group

Placebo Comparator

Patients in this group will receive placebo treatment once daily.

干预措施: Placebo (Drug)

Silodosin group

Experimental

Patients will receive Silodosin 8 mg once daily.

干预措施: Silodosin (Drug)

Tadalafil group

Experimental

Patients will receive Tadalafil 5 mg once daily.

干预措施: Tadalafil (Drug)

Silodosin and Tadalafil

Experimental

Patients will receive Silodosin 8mg in combination with Tadalafil 5 mg once daily.

干预措施: Silodosin and Tadalafil (Drug)

结局指标

主要结局

Stone expulsion rate

时间窗: Intraoperatively

Stone expulsion rate will be recorded

次要结局

  • Amount of analgesia used(Intraoperatively)
  • Stone expulsion time(Intraoperatively)

研究者

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

Tamer Abd El-Wahab Diab

Lecturer of Urology, Faculty of Medicine, Benha University, Benha, Egypt

Benha University

研究点 (1)

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