Comparison of Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis

Официальное название

Comparison of the Drainage/Anti-reflux Effect and Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis

Обзор

The aim of this study is to investigate the effectiveness and related complications of anti-reflux stents used in pediatric urolithiasis surgery at the Children's Hospital affiliated with Zhejiang University School of Medicine, by comparing them with conventional stents.

Подробное описание

Ureteral stents are crucial adjunctive devices following urolithiasis surgery, serving to support the ureter and facilitate urine drainage. However, the application of these stents can lead to complications such as urinary tract infections, lumbar pain, and bladder irritative symptoms, which significantly impact the quality of life in pediatric patients. Novel designs, such as anti-reflux stents equipped with valves, have been optimized to enhance unidirectional urine flow while effectively preventing retrograde urine flow. It is anticipated that these designs could alleviate symptoms of lumbar pain and urinary tract infections, thereby improving the postoperative recovery quality in children. Current adult studies suggest that anti-reflux stents might reduce urine reflux but may also be associated with significantly stronger urinary symptoms. To date, there have been no pediatric studies reported on the efficacy of anti-reflux stents. The aim of this study is to investigate the effectiveness and related complications of anti-reflux stents used in pediatric urolithiasis surgery at the Children's Hospital affiliated with Zhejiang University School of Medicine, by comparing them with conventional stents.

Вмешательства

• Устройство LaiKai anti-reflux ureteral stent
  Ureteral stents are serving to support the ureter and facilitate urine drainage with an anti-reflux valve.
• Устройство LaiKai Ureteral Stent
  Ureteral stents are serving to support the ureter and facilitate urine drainage.

Первичные конечные точки

• The effect of stents on body pain [Срок оценки: Two weeks after stents inserting and two weeks after stents removing]

Вторичные конечные точки (5)

• The effect of stents on stone-free rate [Срок оценки: Two weeks after stents inserting and two weeks after stents removing]
• The effect of stents on urinary symptoms [Срок оценки: Two weeks after stents inserting and two weeks after stents removing]
• The effect of stents on daily activities and psychological well-being [Срок оценки: Two weeks after stents inserting and two weeks after stents removing]
• The effect of stents on clinical presentation [Срок оценки: Two weeks after stents inserting and two weeks after stents removing]
• The effect of the stent on learning [Срок оценки: Two weeks after stents inserting and two weeks after stents removing]

Критерии участия

Критерии включения

• A definitive diagnosis of urinary tract stones by CT scan, with indications for ureteroscopic lithotripsy (URL), percutaneous nephrolithotomy (PCNL), laparoscopic/open stone extraction with or without robotic assistance, or combined endoscopic lithotripsy, and no contraindications;
• Age is less than 18 years old;
• For preschool children, the informed consent form is signed by the parents; for school-age children, the informed consent form is signed by both the parents and the child themselves.

Критерии исключения

• A history of recurrent bladder irritative symptoms or urinary tract infections;
• Severe renal insufficiency, anatomical or functional solitary kidney, and other significant comorbidities that render the child unsuitable for participation in the study;
• Stent placement surgery within the past 3 months;
• Recent use of medications that may interfere with the study results, such as solifenacin;
• Stent removal surgery performed at an external medical facility.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Children's hospital, Zhejiang University School of Medicine — Ханчжоу

Публикации

• Hu Q, Liu H, Ru W, Xu Z, Hu L, Yan X. Does an anti-reflux ureteral stent offer real benefits for children after endoscopic surgery for upper urinary tract stones? A single-center randomized controlled trial. World J Urol. 2026 Jun 6;44(1):412. doi: 10.1007/s00345-026-06525-8. PMID 42249895

Идентификаторы

NCT: NCT06569173 · 2024-IRB-0212-IR-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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