Comparison of Ureteral Stent Designs in Children With Kidney Stones
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-18
SponsorThe Hospital for Sick Children
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
American Society of Anesthesiologists Physical Status Classification III or higher at the time of surgery.
Active urinary tract infection, defined as clinical symptoms consistent with infection and a positive urine culture, at the time of screening or before stent placement.
Significant baseline bladder dysfunction, including neurogenic bladder, overactive bladder requiring chronic anticholinergic therapy, or prior bladder augmentation, that could confound assessment of stent-related symptoms.
Requirement for bilateral ureteral stent placement or planned bilateral ureteroscopic procedures.
Trial design
Design model
Crossover
Treatments tested in this trial
Polaris Ultra Ureteral Stent
DeviceThe 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.
Cook Double-J Ureteral Stent
DeviceThe 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Polaris Ultra Followed by Cook Double-JExperimental treatment 2 interventions
Group B: Cook Double-J Followed by Polaris UltraExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Frequency of Bladder Spasm Episodes
Time frame
Postoperative Days 1, 3, and 7 during each of two stent treatment periodsSecondary outcomes
1
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 weeks2
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 weeks3
Incidence of Symptomatic Urinary Tract Infection
Time frame
During each 4- to 6-week ureteral stent indwelling periodOther outcomes
1
Validity and Responsiveness of the Canadian Endourology Group Stent Symptom Score
Convergent validity will be assessed using the correlation between the Canadian Endourology Group Stent Symptom Score and the Ureteric Stent Symptoms Questionnaire, with correlation coefficients ranging from -1 to 1; values farther from 0 indicate a stronger relationship. Responsiveness will be assessed using the within-participant change in Canadian Endourology Group Stent Symptom Score between the two stent periods, summarized as the mean or median paired difference with a 95% confidence interval; a larger absolute change indicates greater responsiveness. The USSQ includes urinary symptoms generally scored 1-5 with one quality-of-life item scored 1-7, pain intensity scored 0-10 with related items generally scored 1-5, and general health, work, sexual, and additional-problem domains using mainly 1-5 scales or counts of days; higher scores generally indicate worse symptoms or impairment.
Time frame
From baseline through completion of both treatment periods, approximately 8-12 weeksSponsors and contacts
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Source ClinicalTrials.gov