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

NCT06569173 | Recruiting

• 1 other identifier: 2024-IRB-0212-IR-01
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis; Child, Only

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The effect of stents on stone-free rate

  Two weeks after stents inserting and two weeks after stents removing

• The effect of stents on urinary symptoms

  Two weeks after stents inserting and two weeks after stents removing

• The effect of stents on daily activities and psychological well-being

  Two weeks after stents inserting and two weeks after stents removing

• The effect of stents on clinical presentation

  Two weeks after stents inserting and two weeks after stents removing

• The effect of the stent on learning

  Two weeks after stents inserting and two weeks after stents removing

Study Arms (2)

LaiKai Anti-Reflux Ureteral Stent (19903)

EXPERIMENTAL

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

Device: LaiKai anti-reflux ureteral stent

LaiKai Ureteral Stent (92001024)

ACTIVE COMPARATOR

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

Device: LaiKai Ureteral Stent

Interventions

LaiKai anti-reflux ureteral stent DEVICE

Ureteral stents are serving to support the ureter and facilitate urine drainage with an anti-reflux valve.

LaiKai Anti-Reflux Ureteral Stent (19903)

LaiKai Ureteral Stent DEVICE

Ureteral stents are serving to support the ureter and facilitate urine drainage.

LaiKai Ureteral Stent (92001024)

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

Children's hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

RECRUITING

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Hongbo Liu

  Children's Hospital, Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aimei Ma

CONTACT

+86 15888864134; maaimei@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: August 23, 2024
• Study Start: August 23, 2024
• Primary Completion: August 23, 2025
• Study Completion: August 23, 2025
• Last Updated: November 12, 2024

Record last verified: 2024-11

Locations

CN (1)