Comparison of Ureteral Stent Designs in Children With Kidney Stones
Randomized Single-Blind Cross-Over Trial Evaluating the Impact of Ureteral Stent Design on Bladder Spasms and Stent-Related Symptoms
The Hospital for Sick Children
20 participants
Sep 1, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07742358