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

Zhejiang University

Status: Enrolling

Conditions: Child, Only; Urolithiasis

Treatments: Device: LaiKai anti-reflux ureteral stent; Device: LaiKai Ureteral Stent

Study type: Interventional

Funder types: Other

Identifiers

NCT06569173

2024-IRB-0212-IR-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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108 participants in 2 patient groups

LaiKai Anti-Reflux Ureteral Stent (19903)

Experimental group

Description:

LaiKai Anti-Reflux Ureteral Stent (19903) arm received anti-reflux stent.

Treatment:

Device: LaiKai anti-reflux ureteral stent

LaiKai Ureteral Stent (92001024)

Active Comparator group

Description:

LaiKai Ureteral Stent (92001024) arm received regular ureteral stent.

Treatment:

Device: LaiKai Ureteral Stent