Comparing Two Ureteral Stent Designs in Children with Kidney Stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares two ureteral stents—Polaris Ultra and Cook Double-J—in children and adolescents aged 8 to 18 who require two sequential stent placements as part of staged stone management. Each participant receives both stents in random order during two planned procedures, with blinding of the patient and caregiver to which stent is in place. Outcomes are reported through patient and caregiver questionnaires and symptom assessments focusing on bladder spasms, pain, urinary symptoms, and quality of life. The goal is to see if stent design influences stent-related discomfort, infections, or other complications. The study is conducted at SickKids in Toronto and is led by The Hospital for Sick Children.

Why it matters

Who can join: the full rules

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.

Where it's running

• SickKids
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Michael Chua, MD
• Email: michael.chua@sickkids.ca
• Phone: 416-813-7654

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ComfiJ vs. standard double-J stent after ureteroscopy or RIRS

  This trial tests whether a ComfiJ ureteral stent causes fewer urinary symptoms than a conventional double-J stent in adults needing short-term stenting after ureteroscopy or RIRS for stones.

  Recruiting at 3 sites Beni-Suef University · Banī Suwayf, Beni Suweif Governorate and 2 other locations · NCT07627828

• Dusting vs Fragmentation Laser Cystolithotripsy for Pediatric Bladder Stones

  This study tests two laser strategies during bladder-stone surgery in children to see which method finishes faster and leaves the bladder stone-free with fewer complications.

  Recruiting Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07623980

• Melatonin and Solifenacin for stent-related symptoms after ureteroscopy

  This study tests whether solifenacin, melatonin, or both can reduce stent-related urinary symptoms and improve sleep after ureteroscopic stone treatment.

  Recruiting Phase 2 Beni-Suef University · Banī Suwayf, BeniSuef · NCT07617922

• Intravesical aminophylline to aid ureteroscopic access in children with distal ureteral stones

  This study tests whether putting aminophylline in the bladder helps some kids get a semi-rigid ureteroscope to pass into the ureter during treatment for distal ureteral stones.

  Recruiting Phase 2 Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07617896

• Vacuum-assisted Mini-percutaneous vs Transurethral Cystolithotripsy for Pediatric Bladder Stones

  This study tests whether a suction-assisted mini-percutaneous approach is as safe and effective as the standard transurethral method for removing bladder stones in children aged 2 to 14.

  Recruiting Beni-Suef University · Banī Suwayf, Beni Suweif Governorate · NCT07614880

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.