Randomized Single-Blind Cross-Over Trial Evaluating the Impact of Ureteral Stent Design on Bladder Spasms and Stent-Related Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Frequency of Bladder Spasm Episodes
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and their caregivers will be blinded to the ureteral stent type used during each treatment period. The operating surgeon and clinical study team involved in device placement will not be blinded because of visible and technical differences between the stents. Surgeons will not collect the patient-reported outcome measures. Unblinding may occur when knowledge of the stent type is medically necessary for participant management.
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Frequency of Bladder Spasm Episodes
时间窗: Postoperative Days 1, 3, and 7 during each of two stent treatment periods
次要结局
- Canadian Endourology Group Stent Symptom Score(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(Postoperative Days 1, 3, and 7 after each stent placement, over approximately 8-12 weeks)
- Incidence of Symptomatic Urinary Tract Infection(During each 4- to 6-week ureteral stent indwelling period)
研究者
Michael Chua
Staff Urologist
The Hospital for Sick Children