Pediatric Urolithiasis, Ureteral Stent-Related Symptoms
Conditions
Brief 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.
Interventions
DEVICEPolaris 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.
DEVICECook 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
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants and their caregivers will be blinded to the ureteral stent type used during each treatment period. The operating surgeon and clinical study team involved in device placement will not be blinded because of visible and technical differences between the stents. Surgeons will not collect the patient-reported outcome measures. Unblinding may occur when knowledge of the stent type is medically necessary for participant management.
Intervention model description
Participants will be randomized in a 1:1 ratio to one of two treatment sequences. One sequence will receive the Polaris Ultra ureteral stent during the first treatment period followed by the Cook double-J ureteral stent during the second period. The other sequence will receive the stents in the reverse order. Each participant will therefore receive both interventions and serve as their own control.
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * Known hypersensitivity or allergy to materials used in either ureteral stent included in the study. * Pregnancy or lactation, as determined by clinical assessment and/or institutional testing requirements, where applicable. * Use of chronic opioid therapy, chronic anticholinergic medications, or other medications that, in the investigator's opinion, would substantially interfere with assessment of stent-related pain or urinary symptoms. * Participation in another interventional clinical trial that could interfere with the objectives or outcome assessments of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of Bladder Spasm Episodes | Postoperative Days 1, 3, and 7 during each of two stent treatment periods |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Canadian Endourology Group Stent Symptom Score | Postoperative Days 1, 3, and 7 after each stent placement, over approximately 8-12 weeks | 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. |
| Stent-Related Pain Intensity Measured Using a Visual Analog Scale | Postoperative Days 1, 3, and 7 after each stent placement, over approximately 8-12 weeks | 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. |
| Incidence of Symptomatic Urinary Tract Infection | During each 4- to 6-week ureteral stent indwelling period | — |
Countries
Canada
Contacts
CONTACTMichael Chua, MD
Outcome results
None listed