跳至主要内容
临床试验/NCT07841340
NCT07841340已完成不适用

The Efficacy and Safety of Adjunctive Alpha-blocker Therapy Before Flexible Ureteroscopy in the Management of Upper Ureteric Stones in Pediatrics Group

Ain Shams University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年9月4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
80
试验地点
1
主要终点
Number of Participants with Successful Flexible Ureteroscope Negotiation Through the Ureteral Orifice in tamsulosin group versus non tamsulosin group

研究概览

简要总结

A unique aspect of pediatric URS is the smaller ureteral diameter, which often results in failure to access the ureter during an initial URS attempt.

Ureteral orifice navigation is often limited at the level of the ureteral orifice or intramural ureter. α1 adrenergic receptors are densely located at this level, and α-antagonists can reduce the tension of the intramural segment The purpose of this study was to evaluate if preoperative treatment with tamsulosin is associated with an increased rate of successful first-time ureteral orifice navigation in a school-age pediatric population, defined as patients 5-18 years old.

详细描述

The incidence of pediatric urolithiasis has risen dramatically over the past few decades, with a reported rate of 4% per year .There is controversy regarding the practice of routine prestenting and balloon dilation to gain ureteral access in children. The AUA guidelines recommend against the routine use of prestenting. Balloon dilation of the ureteral orifice carries the risk of ureteral perforation and ureteral stricture, due to tissue ischemia .There are three subtypes of alpha- 1 adrenoceptors (ARs) in the ureteric wall: alpha-1A, alpha-1B and alpha-1D. In the proximal ureter, the distribution of ARs was alpha-1D ≥alpha-1B >alpha-1A. In the distal and middle ureters, the distribution of ARs was alpha-1D > alpha-1A > alpha-1B . Tamsulosin acts on α1A and α1D receptors causing the relaxation of the ureteric wall, which consequently increases the urine bolus and intra-ureteral pressure above the stone and lowers intra-ureteral pressure below the stone by decreasing peristalsis in association with the decrease in basal and micturition pressure, even at the bladder neck; thus, it increases the chance of stone expulsion .The management of ureteric stones consists of observation, medical expulsive therapy (MET), shockwave lithotripsy (SWL), ureteroscopy, percutaneous nephrolithotomy or open and laparoscopic stone surgery, depending on the clinical situation .The presumed mechanism of action of alphablockers is the inhibition of smooth muscle contraction in the ureter, causing relaxation of the ureter smooth muscle and reducing the strength and frequency of peristalsis .Flexible ureteroscopy (FURS) has been applied in recent years to the treatment of urinary stones. FURS presents overt advantages over other techniques, including improved resolution and increased optical field, high stone-free rate, reduced risk of bleeding, limited surgical injury, good repeatability, and speedy recovery; in addition, further miniaturization is possible. In children and infants, who have a relatively high stone recurrence rate, FURS could be performed repeatedly. FURS and holmium laser lithotripsy in treating infants and children has been previously assessed in the literature; however, most reports were limited in sample size.

Aim of the study:To evaluate efficacy adjunctive alpha-blocker therapy before Flexible ureteroscopy in the management of Upper ureteric stones in children as regard facilitating ureteric orifice navigation, Ureteral Dilatation, intraoperative and postoperative Complication, patient satisfaction and stone free rate.

PATIENTS AND METHODS This was a prospective randomized control study that was conducted at tertiary care hospital between September 2022 till September 2024. The study was approved by the Research Ethics Committee (REC) of Ain Shams University Faculty of Medicine. A detailed written informed consent was secured from patients' parents included in the study before enrollment after explaining the benefits and risks of the medication and procedure.

Eligibility criteria We included all children aged between 5 and 18 years with upper ureteric stones. Patients excluded from the analysis were children with active urosepsis, ureteral stricture, bilateral ureteral stones, children with already stented ureter, Children with congenital anomalies e.g. solitary kidney, duplex system, ureterocele, Those with hypersensitivity to α-blockers and Known hypotensive or bradycardic patients.

Participants and group allocation A total of 80 patients were included and randomly allocated into two groups depending on simple one to one randomization utilizing a sealed envelope prepared by an independent third party to ensure unbiased distribution. Outcome assessors, and statisticians were blinded to the treatment to minimize bias.. Group A: 40 Children received Tamsulosin 0.4 mg capsule for 5 days prior to Flexible uretroscopy. Group B: 40 Children didn't receive Tamsulosin 0.4 mg capsule prior to Flexible uretroscopy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 5:18 years
  • •Children with upper ureteric stones

排除标准

  • •Children with active urosepsis.
  • •Children with ureteral stricture
  • •Children with past history of ureteric endoscopy or stent application.
  • •Children with bilateral ureteral stones.
  • •Children with congenital anomalies e.g. solitary kidney, duplex system, ureterocele.
  • •Those with hypersensitivity to α-blockers.
  • •Known hypotensive or bradycardic patients.

研究组 & 干预措施

interventional

Experimental

Children with ureteric stones with age between 5:18 years will receive Tamsulosin 0.4 mg capsule for 5 days prior to Flexible uretroscopy

干预措施: Tamsulosin (Drug)

control

No Intervention

Children with ureteric stones with age between 5:18 years will not receive Tamsulosin 0.4 mg capsule prior to Flexible uretroscopy

结局指标

主要结局

Number of Participants with Successful Flexible Ureteroscope Negotiation Through the Ureteral Orifice in tamsulosin group versus non tamsulosin group

时间窗: Intraoperative, during flexible ureteroscopy

Successful negotiation is defined as advancement of the flexible ureteroscope through the ureteral orifice and into the ureter sufficiently to allow performance of the intended ureteroscopic procedure. The outcome will be recorded as the number and percentage of participants with successful negotiation in each treatment group

次要结局

  • Number of Participants with Intraoperative or Postoperative Complications Following Flexible Ureteroscopy(From the beginning of flexible ureteroscopy until 1 month postoperatively)
  • Number of Participants with Tamsulosin-Related Adverse Events Following Preoperative Tamsulosin Administration.(From initiation of tamsulosin until the day of surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验