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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
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.
SickKids
Toronto, Ontario, Canada
RECRUITINGFrequency of Bladder Spasm Episodes
Time frame: Postoperative Days 1, 3, and 7 during each of two stent treatment periods
Canadian Endourology Group Stent Symptom Score
The Canadian Endourology Group Stent Symptom Score includes several subdomains rather than one clearly stated total range: urinary symptom items generally use 5 response levels, pain intensity uses a 0-10 scale, healthcare-use items are Yes/No, and quality-of-life interference items use 0-10 scales. Across domains, higher values or more severe responses indicate worse symptoms or greater impairment.
Time frame: Postoperative Days 1, 3, and 7 after each stent placement, over approximately 8-12 weeks
Stent-Related Pain Intensity Measured Using a Visual Analog Scale
Stent-related pain intensity will be measured using a 0-10 Visual Analog Scale, where 0 means no pain and 10 means the worst pain imaginable; higher scores indicate worse pain.
Time frame: Postoperative Days 1, 3, and 7 after each stent placement, over approximately 8-12 weeks
Incidence of Symptomatic Urinary Tract Infection
Time frame: During each 4- to 6-week ureteral stent indwelling period
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