Comparison of Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis
NCT Number: NCT06569173
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Urolithiasis|Child, Only
Interventions: DEVICE: LaiKai anti-reflux ureteral stent|DEVICE: LaiKai Ureteral Stent
Sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sex: ALL
Age: CHILD, ADULT
Enrollment: 108
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-01
Completion Date: 2025-09-01

Summary:
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.

Primary Outcome Measures: 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., Two weeks after stents inserting and two weeks after stents removing
Secondary Outcome Measures: 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., Two weeks after stents inserting and two weeks after stents removing|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., Two weeks after stents inserting and two weeks after stents removing|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., Two weeks after stents inserting and two weeks after stents removing|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., Two weeks after stents inserting and two weeks after stents removing|The effect of the stent on learning, Understand the impact of the stent on the child's learning situation through a questionnaire, with the results scored on a scale of "0-1". The higher the score, the greater the adverse impact of the stent on learning., Two weeks after stents inserting and two weeks after stents removing