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

NCT ID: NCT06569173

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-23
• Study Completion Date: 2025-08-23

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.

Conditions

Urolithiasis; Child, Only

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

LaiKai Anti-Reflux Ureteral Stent (19903)

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

Group Type: EXPERIMENTAL

LaiKai anti-reflux ureteral stent

Intervention Type: DEVICE

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

LaiKai Ureteral Stent (92001024)

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

Group Type: ACTIVE_COMPARATOR

LaiKai Ureteral Stent

Intervention Type: DEVICE

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

Interventions

LaiKai anti-reflux ureteral stent

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

Intervention Type: DEVICE

LaiKai Ureteral Stent

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Children's Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Hongbo Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hongbo Liu

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital, Zhejiang University School of Medicine

Locations

Children's hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Aimei Ma

Role: CONTACT

maaimei@zju.edu.cn

+86 15888864134

Facility Contacts

Hongbo Liu

Role: primary

19329110160@zju.edu.cn

+86 19329110160

Other Identifiers

2024-IRB-0212-IR-01

Identifier Type: -

Identifier Source: org_study_id