Comparing anti-reflux stents and standard stents in children with kidney stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness and complications of anti-reflux stents versus conventional stents in pediatric patients undergoing surgery for urolithiasis. Ureteral stents are essential for supporting the ureter and facilitating urine drainage post-surgery, but they can cause complications like urinary tract infections and lumbar pain. The study aims to determine if anti-reflux stents, designed to prevent urine reflux, can reduce these symptoms and improve recovery quality in children. This is the first pediatric study to evaluate the efficacy of anti-reflux stents in this context.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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;
2. Age is less than 18 years old;
3. 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.

Exclusion Criteria:

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

Where it's running

• Children's hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Hongbo Liu — The Children's Hospital of Zhejiang University School of Medicine
• Study coordinator: Aimei Ma
• Email: maaimei@zju.edu.cn
• Phone: +86 15888864134

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.