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临床试验/NCT02489656
NCT02489656Unknown4 期

Effect of a Silicone Hydrocoated Double Loop Ureteral Stent on Symptoms and Quality of Life in Patients Undergoing F-URS for Kidney Stone; a Comparative Randomized Multicenter Clinical Study.

Coloplast A/S2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
4 期
发起方
Coloplast A/S
入组人数
140
试验地点
2
主要终点
USSQ scale (Ureteral Stent Symptoms Questionnaire)

研究概览

简要总结

This study is a prospective, randomized multicenter study conducted in Europe. It is designed to compare two double loop ureteral stents in terms of the quality of life in patients operated on a kidney stone and requiring the placement of a double loop ureteral stent at the end of the operation.

详细描述

  • The double loop stents are used for both prevention and treatment of ureteral obstruction: They permit the interim internal bypass drainage of urine when obstruction in the ureter especially in cases of lithiasis or after surgical intervention on the upper urinary tract.

  • There are many indications for double loop stent placement and population chosen for this study are adult patients with intra-renal calcium calculi of 7-20 mm in diameter for whom the treatment indication is a flexible ureterorenoscopy.

  • The aims of the use of a double loop stent are to

  • prevent complications (pain, infection) associated with the ureteral obstruction by any residual stone fragments, blood clot or local oedema generated by the intervention.

  • preserve the renal function.

  • facilitate healing process while limiting the risk of stenosis and probably reduce the rate of readmission after patients' discharge.

  • Double loop Stent-related symptoms have a high prevalence and may affect over 80% of patients.

  • Assessment tools are important to determine the symptoms intensity and allow for comparisons at different times. The Urinary Stent Symptom Questionnaire (USSQ) is the most adapted tool designed for this purpose.

  • An ideal ureteral stent is expected to drain well, to be easy to insert and to be comfortable for the patients. The investigators designed a hydro-coated Silicone JJ stent with additional properties for improving patient's comfort.

  • The investigators decided to perform a randomized clinical investigation to evaluate the Coloplast Hydrocoated Silicone JJ in comparison to the Boston Percuflex Plus JJ stent on patients' comfort.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients
  • Aged > 18 years
  • Unilateral renal non-infection stone for whom the treatment indication is a flexible ureterorenoscopy (multiple kidney stones are acceptable provided that only one side is currently symptomatic)
  • Index stone of 5-25 mm (measured on plain abdomen X-Ray KUB or CT)
  • Without any currently implanted JJ stent
  • Patient agreed to participate to the study and having signed the consent form
  • Able to complete self-rated questionnaires.

排除标准

  • Acute ureteric/nephritic colic (residual pain is acceptable)
  • Any type of chronic pain
  • Large stones > 25 mm
  • Infection renal stone already diagnosed and documented
  • Malformation of urinary tract (e.g. Horseshoe kidney, duplicity or, ureterocele, mega ureter)
  • Diverticulum stone
  • Urogenital tumor
  • Any significant neurological disease or injury impacting sensation
  • JJ stents already implanted
  • Patients with long-term indwelling urethral catheter
  • No indication for JJ insertion (e.g. spontaneous stone passage)
  • Untreated urinary tract infection
  • Ureteral obstruction (stenosis, compression, calculi)
  • Neurogenic bladder
  • Overactive bladder
  • Bladder stone
  • Chronic prostatitis
  • BPH treated (recent initiation of 5 alpha-Reductase Inhibitor or Phytotherapeutic agents)
  • Ongoing Alpha-Blocker or Anticholinergic medication
  • Any event discovered during the endoscopy which is not compatible with the study design and objective

结局指标

主要结局

USSQ scale (Ureteral Stent Symptoms Questionnaire)

时间窗: at day 20

次要结局

  • Evaluate impact on quality of life via the USSQ questionnaire assessing 5 other scores and adverse event reporting at all visits.(Day 2, 7 and 35)

研究者

发起方
Coloplast A/S
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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