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.
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.
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;
Parallel
LaiKai anti-reflux ureteral stent
DeviceUreteral stents are serving to support the ureter and facilitate urine drainage with an anti-reflux valve.
LaiKai Ureteral Stent
DeviceUreteral stents are serving to support the ureter and facilitate urine drainage.
The effect of stents on body pain
Inquire whether the child has experienced body pain, especially lumbar pain after the insert or removal of the stent. If yes, assign a value of 1; if no, assign a value of 0. The higher the score, the worse the stent is in terms of relieving lumbar pain.
The effect of stents on stone-free rate
Calculate the stone clearance rate for children three months and half a year after surgery. The higher the stone clearance rate, the better the stent's effectiveness.
The effect of stents on urinary symptoms
Use a self-administered questionnaire to understand the children's daytime urination intervals, times getting up at night, number of urge urinary incontinence episodes, number of genuine urinary incontinence episodes, times of incomplete urination, times of burning sensation during urination, number of hematuria episodes, degree of hematuria, and overall impact of urinary tract symptoms. Scores are assigned from 1 to 3 or 1 to 5 for different questions, with higher scores indicating poorer stent effectiveness in the corresponding dimension.
The effect of stents on daily activities and psychological well-being
Based on the questions in the self-administered questionnaire, including "Does the stent affect daily activities?", "Does the stent affect the child's social interactions?", and "Does the stent cause the child to have feelings of inferiority?", we understand the impact of the stent on the child's daily life and psychological well-being. The results are categorized as "No impact", "Slight impact", and "Significant impact", with corresponding scores of "1-3 points". The higher the score, the greater the adverse effect of the stent on the child.
The effect of stents on clinical presentation
Understand the impact of the stent on children's urinary tract infections, antibiotic use, and emergency department visits through a questionnaire. The results are scored as "0-1" or "1-5", with higher scores indicating a greater adverse effect of the stent.
Click on the lead sponsor to view all of their trials.
