MedTrace Logo

Comparison of Ureteral Stent Designs in Children With Kidney Stones

NCT07742358 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-08-03

No results posted yet for this study

Summary

This study will compare two commonly used ureteral stents in children and adolescents undergoing staged treatment for kidney stones. Ureteral stents are small tubes placed between the kidney and bladder to help urine drain after a procedure. Although stents are effective, they can cause bladder spasms, pain, urinary urgency, and other uncomfortable symptoms.

Participants aged 8 to 18 years will receive both a standard Cook double-J ureteral stent and a Polaris Ultra ureteral stent during two planned procedures. The order in which the stents are used will be assigned at random, and participants and caregivers will not be told which stent is in place during each treatment period. Participants will report bladder spasms, pain, urinary symptoms, and quality of life through questionnaires and symptom assessments. The study will determine whether differences in stent design affect comfort, bladder spasms, urinary tract infections, or other stent-related complications. Both stents are approved by Health Canada and are used as part of routine clinical care.

Conditions

  • Pediatric Urolithiasis
  • Ureteral Stent-Related Symptoms

Interventions

DEVICE

Polaris Ultra Ureteral Stent

The Polaris Ultra ureteral stent is a commercially available, Health Canada-approved double-J ureteral stent used for temporary ureteral drainage after ureteroscopic stone treatment. The stent has a dual-durometer polymer design with a firmer proximal segment and a softer distal bladder segment, as well as a hydrophilic coating. In this study, a 6 French stent of a length appropriate for the participant's anatomy will be placed cystoscopically and will remain in place for approximately 4 to 6 weeks during one treatment period.

DEVICE

Cook Double-J Ureteral Stent

The Cook double-J ureteral stent is a commercially available, Health Canada-approved ureteral stent used as the standard-of-care comparator for temporary ureteral drainage after ureteroscopic stone treatment. It is a conventional polyurethane double-J stent with pigtail coils at the renal and bladder ends. In this study, a 6 French stent of a length appropriate for the participant's anatomy will be placed cystoscopically and will remain in place for approximately 4 to 6 weeks during one treatment period.

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-09-01
Completion
2027-09-01

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07742358 on ClinicalTrials.gov