Randomized Single-Blind Cross-Over Trial Evaluating the Impact of Ureteral Stent Design on Bladder Spasms and Stent-Related Symptoms
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.
• Ability of the participant and/or legally authorized representative to provide written informed consent, with assent obtained from the participant when appropriate, in accordance with institutional policy.
• Age 8 to 18 years at the time of enrollment.
• Undergoing staged ureteroscopic stone management requiring two sequential ureteral stent placements as part of standard clinical care.
• Planned placement of unilateral ureteral stents with an anticipated indwelling duration of approximately 4 to 6 weeks per stent.
• American Society of Anesthesiologists Physical Status Classification I or II at the time of surgery.
• Ability and willingness of the participant and/or caregiver to comply with study procedures, including completion of symptom assessments and questionnaires at specified time points.
• Ability to complete study questionnaires in English, either independently or with caregiver assistance.