Comparison of Ureteral Stent Designs in Children With Kidney Stones | NCT07742358

NCT07742358

Overview

NCT ID: NCT07742358
Lead Sponsor: The Hospital for Sick ChildrenOTHER
Official Title: Randomized Single-Blind Cross-Over Trial Evaluating the Impact of Ureteral Stent Design on Bladder Spasms and Stent-Related Symptoms
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.

Status and Timeline

Status: Recruiting
Last Update Posted: Aug 3, 2026Actual
Start Date: Sep 1, 2026Estimated
Primary Completion Date: Sep 1, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 20Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

Contacts and Locations

Central Contacts: Michael Chua, MDContact
michael.chua@sickkids.ca416-813-7654 ext. 415122

Similar Studies

Participant Group/Arms

Polaris Ultra Followed by Cook Double-JExperimental

Participants assigned to this sequence will receive the Polaris Ultra ureteral stent during the first clinically indicated ureteroscopic procedure. At the subsequent staged procedure, the Polaris Ultra stent will be removed and participants will receive the Cook double-J ureteral stent for the second treatment period. Each stent will remain in place for approximately 4 to 6 weeks. Participants will complete symptom, pain, and quality-of-life assessments during both treatment periods.

Device: Polaris Ultra Ureteral Stent

Device: Cook Double-J Ureteral Stent

Cook Double-J Followed by Polaris UltraExperimental

Participants assigned to this sequence will receive the Cook double-J ureteral stent during the first clinically indicated ureteroscopic procedure. At the subsequent staged procedure, the Cook stent will be removed and participants will receive the Polaris Ultra ureteral stent for the second treatment period. Each stent will remain in place for approximately 4 to 6 weeks. Participants will complete symptom, pain, and quality-of-life assessments during both treatment periods.

Device: Polaris Ultra Ureteral Stent