Comparison of Ureteral Stent Designs in Children With Kidney Stones

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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 we
• Устройство 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 treatmen

Первичные конечные точки

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

Вторичные конечные точки (3)

• Canadian Endourology Group Stent Symptom Score [Срок оценки: Postoperative Days 1, 3, and 7 after each stent placement, over approximately 8-12 weeks]
• Stent-Related Pain Intensity Measured Using a Visual Analog Scale [Срок оценки: Postoperative Days 1, 3, and 7 after each stent placement, over approximately 8-12 weeks]
• Incidence of Symptomatic Urinary Tract Infection [Срок оценки: During each 4- to 6-week ureteral stent indwelling period]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• SickKids — Toronto

Идентификаторы

NCT: NCT07742358 · 4103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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