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临床试验/NCT04325880
NCT04325880Unknown3 期

Efficacy of Mirabegron Versus Tamsulosin Versus Solifenacin for Treatment of Ureteral Stents-Related Symptoms: a Randomized Controlled Trial

Mansoura University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
入组人数
240
试验地点
1
主要终点
Improvement in stent related symptoms using ureteral stent symptoms questionnaire (USSQ)

研究概览

简要总结

The primary objective of this prospective, single-centre randomized controlled trial is to assess the efficacy of three different drugs in treatment of ureteral stents related symptoms (Beta 3 adrenergic receptor agonist; Mirabegron 50mg) vs. (Alpha 1 adrenergic receptor antagonist; Tamsulosin 0.4mg) vs. (Anticholinergic; Solifenacin 10 mg) using validated symptoms questionnaires.

In addition, adverse events of the utilized medications will be monitored during study period as a secondary objective.

详细描述

Indwelling ureteral stents are specialized catheters designed to alleviate obstruction by maintaining the patency of the ureteral lumen and to splint the ureter by acting as a scaffold to promote organized tissue healing. (1)

Common issues associated with contemporary ureteral stents include stent-related pain, hematuria, dysuria, urgency, infection, and encrustation (2). Majority of patients (80%) reported one or more urinary symptoms with over 80% of patients experience stent-related pain that affects daily activities, 58% report reduced work capacity, and 32%report sexual dysfunction (2). In addition, as many as 32% of patients had ureteral stents removed sooner than anticipated because of these complications (3).

Considering this high prevalence of ureteral stent related symptoms (uSRS) among patients and its potential impact on quality of life (QoL), adequate management of these bothering symptoms was the point of research over the last decades (4).

The exact mechanism involved in uSRS is not yet known; however, many authors report that such symptoms are associated with ureteral spasms, urinary reflux attributable to ureteral stent, or trigonal irritation (5).

Different novel types of stents have been developed and evaluated to reduce uSRS; however, there is still controversy regarding their clinical application (6). Conversely, pharmacological therapy, including anticholinergics and alpha-blockers, remains the most effective option to manage uSRS (7).

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
Double (Participant, Care Provider)

入排标准

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

入选标准

  • Adult patients (aged 19-80 years)
  • Undergo unilateral uncomplicated retrograde rigid ureteroscopy (URS) or retrograde intrarenal surgery (RIRS) with planned ureteral stent insertion.

排除标准

  • Patients with neurogenic bladder, OAB syndrome, and neurological and psychiatric diseases
  • Residual ureteral or renal stones after the procedure
  • Preoperative febrile UTI
  • pregnancy or breastfeeding
  • Bilateral ureteroscopic surgery
  • Single kidney
  • Chronic kidney disease
  • Cardiovascular or cerebrovascular disease
  • Hepatic dysfunction
  • History of pelvic surgery or irradiation
  • History of bladder or prostate surgery
  • Other acute medical conditions as acute gastroenteritis, osetoarthritis that might influence the patient QoL
  • Preoperative indwelling of ureteral stent for relief of stone-related pain or sepsis

研究组 & 干预措施

Placebo arm

Placebo Comparator

Patients in this arm will receive a placebo formula

干预措施: Placebo oral tablet (Drug)

Mirabegron arm

Active Comparator

Patients in this arm will receive Mirabegrone 50 mg once daily

干预措施: Mirabegron 50 MG (Drug)

Tamsulosin arm

Active Comparator

Patients in this arm will receive tamsulosin o.4 mg once daily

干预措施: Tamsulosin (Drug)

Solifenacin arm

Active Comparator

Patients in this arm will receive solifenacin 10 mg once daily

干预措施: Solifenacin Succinate 10 MG (Drug)

结局指标

主要结局

Improvement in stent related symptoms using ureteral stent symptoms questionnaire (USSQ)

时间窗: 4 weeks

The effect of the assigned treatment on improvement of stent related symptoms will be assessed at the time of stent removal using ureteral stent symptoms questionnaire (USSQ)

次要结局

  • Adverse event of medications(4 weeks)

研究者

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

Amr Abdel-Lateif El-Sawy

Principal Investigator

Mansoura University

研究点 (1)

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