Clinical trial NCT06569173: Comparison of Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urolithiasis
Child, Only
Lead sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 108
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The effect of stents on body pain
timeFrame: Two weeks after stents inserting and two weeks after stents removing
Secondary outcomes:
measure: The effect of stents on stone-free rate
timeFrame: Two weeks after stents inserting and two weeks after stents removing
measure: The effect of stents on urinary symptoms
timeFrame: Two weeks after stents inserting and two weeks after stents removing
measure: The effect of stents on daily activities and psychological well-being
timeFrame: Two weeks after stents inserting and two weeks after stents removing
measure: The effect of stents on clinical presentation
timeFrame: Two weeks after stents inserting and two weeks after stents removing
measure: The effect of the stent on learning
timeFrame: Two weeks after stents inserting and two weeks after stents removing
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Children's hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Children's Hospital, Zhejiang University School of Medicine
name: Hongbo Liu
role: PRINCIPAL_INVESTIGATOR
References: