Recruiting

Cook Double-J & Polaris Ultra

Sponsor:

The Hospital for Sick Children

Code:

NCT07742358

Conditions

Pediatric Urolithiasis

Ureteral Stent-Related Symptoms

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

Interventions

Polaris Ultra Ureteral Stent

Cook Double-J Ureteral Stent

Study Details

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.

Conditions

Pediatric Urolithiasis

Ureteral Stent-Related Symptoms

Study ID

NCT07742358

Start date

Sep 1, 2026

Status verified date

Jul, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Polaris Ultra Followed by Cook Double-J

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.

experimental: Cook Double-J Followed by Polaris Ultra

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.

Interventions

Polaris 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.

Cook 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.

Primary outcome measure

  • Frequency of Bladder Spasm Episodes [ Time Frame: Postoperative Days 1, 3, and 7 during each of two stent treatment periods ]

Central Contacts and Locations

Central contacts

Michael Chua, MD

416-813-7654michael.chua@sickkids.ca

Locations

SickKids

Recruiting

Toronto, Ontario, Canada, M5G 1E8

Contacts

Michael Chua

416-813-7654michael.chua@sickkids.ca

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2026-08-03.