Comparison of Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LaiKai anti-reflux ureteral stent, LaiKai Ureteral Stent.
- Who it may be relevant to
- Registry conditions: Urolithiasis, Child, Only. Basic parameters: 0 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of the Drainage/Anti-reflux Effect and Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis
Overview
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.
Detailed description
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.
Interventions
- Device LaiKai anti-reflux ureteral stent
Ureteral stents are serving to support the ureter and facilitate urine drainage with an anti-reflux valve. - Device LaiKai Ureteral Stent
Ureteral stents are serving to support the ureter and facilitate urine drainage.
Primary outcome measures
- The effect of stents on body pain [Time frame: Two weeks after stents inserting and two weeks after stents removing]
Secondary outcome measures (5)
- The effect of stents on stone-free rate [Time frame: Two weeks after stents inserting and two weeks after stents removing]
- The effect of stents on urinary symptoms [Time frame: Two weeks after stents inserting and two weeks after stents removing]
- The effect of stents on daily activities and psychological well-being [Time frame: Two weeks after stents inserting and two weeks after stents removing]
- The effect of stents on clinical presentation [Time frame: Two weeks after stents inserting and two weeks after stents removing]
- The effect of the stent on learning [Time frame: Two weeks after stents inserting and two weeks after stents removing]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Children's hospital, Zhejiang University School of Medicine — Hangzhou
Publications
- 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
Identifiers
NCT: NCT06569173 · 2024-IRB-0212-IR-01