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NCT Number: NCT07742358

Comparison of Ureteral Stent Designs in Children With Kidney Stones

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.

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Key information

Conditions

Pediatric Urolithiasis Ureteral Stent-Related Symptoms

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SickKids

Toronto, Ontario, M5G 1E8, Canada

Location status: Recruiting

Location contact

Michael Chua

CONTACT

[email protected]

416-813-7654 ext. 415122

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polaris Ultra Ureteral Stent

Device

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

Device

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 outcomes

  1. Frequency of Bladder Spasm Episodes

    Time frame: Postoperative Days 1, 3, and 7 during each of two stent treatment periods

Secondary outcomes

  1. Canadian Endourology Group Stent Symptom Score

    Time frame: 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.

  2. Stent-Related Pain Intensity Measured Using a Visual Analog Scale

    Time frame: 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.

  3. Incidence of Symptomatic Urinary Tract Infection

    Time frame: During each 4- to 6-week ureteral stent indwelling period

Other outcomes

  1. Validity and Responsiveness of the Canadian Endourology Group Stent Symptom Score

    Time frame: From baseline through completion of both treatment periods, approximately 8-12 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael Chua, MD

CONTACT

[email protected]

416-813-7654 ext. 415122

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Randomized Single-Blind Cross-Over Trial Evaluating the Impact of Ureteral Stent Design on Bladder Spasms and Stent-Related Symptoms

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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