ComfiJ Versus Conventional Double-J Stent for Ureteral Stent Symptoms

Официальное название

Evaluation of Stent-Related Symptoms After ComfiJ Ureteric Stent Versus Conventional Double-J Ureteric Stent: A Prospective Multicenter Randomized Controlled Trial

Обзор

This prospective multicenter randomized controlled trial will compare stent-related symptoms after placement of a ComfiJ ureteral stent versus a conventional double-J ureteral stent in adult patients undergoing unilateral ureteroscopy or retrograde intrarenal surgery for urinary stones when short-term postoperative ureteral stenting is clinically indicated. Eligible patients will be randomized intraoperatively after the operating surgeon confirms the need for postoperative stenting. The primary outcome will be the Ureteral Stent Symptom Questionnaire urinary symptoms domain score on postoperative day 14 before planned stent removal.

Подробное описание

Ureteral stents are frequently used after ureteroscopy and retrograde intrarenal surgery when temporary postoperative drainage is clinically indicated. However, ureteral stents may cause urinary symptoms, pain, hematuria, impaired daily activity, and reduced quality of life. Stent-related morbidity is therefore an important patient-centered outcome in endourology.

This study will compare a ComfiJ ureteral stent with a conventional double-J ureteral stent in adult patients undergoing unilateral ureteroscopy or retrograde intrarenal surgery for urinary stones. Randomization will be performed only after the surgeon has determined intraoperatively that postoperative stenting is required. Patients will be randomized in a 1:1 ratio to receive either a ComfiJ ureteral stent or a conventional double-J ureteral stent. The planned stent dwell time will be 14 days whenever clinically feasible.

The patient and postoperative outcome assessor will be blinded to treatment allocation. The operating surgeon will not be blinded because the stent type is visible during insertion. Stent-related symptoms will be assessed using the validated Arabic Ureteral Stent Symptom Questionnaire, together with pain scores, analgesic use, emergency visits, complications, stent migration, ease of insertion and removal, and patient satisfaction.

Вмешательства

• Устройство ComfiJ Ureteral Stent
  Placement of a ComfiJ ureteral stent after unilateral ureteroscopy or retrograde intrarenal surgery for urinary stones when short-term postoperative ureteral stenting is clinically indicated.
• Устройство Conventional Double-J Ureteral Stent
  Placement of a conventional double-J ureteral stent after unilateral ureteroscopy or retrograde intrarenal surgery for urinary stones when short-term postoperative ureteral stenting is clinically indicated.

Первичные конечные точки

• Ureteral Stent Symptom Questionnaire Urinary Symptoms Domain Score at Postoperative Day 14 [Срок оценки: Postoperative Day 14 before stent removal]

Вторичные конечные точки (5)

• Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 7 [Срок оценки: Postoperative Day 7]
• Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 14 [Срок оценки: Postoperative Day 14]
• Visual Analogue Scale Pain Score [Срок оценки: Postoperative Day 1, postoperative Day 7, and postoperative Day 14]
• Febrile Urinary Tract Infection [Срок оценки: Up to postoperative Day 14]
• Stent Migration or Displacement [Срок оценки: From stent insertion to stent removal on postoperative Day 14]

Критерии участия

Критерии включения

• Age 18 to 80 years.
• Adult patients undergoing unilateral ureteroscopy or retrograde intrarenal surgery for ureteric or renal stones.
• Intraoperative confirmation that short-term postoperative ureteric stenting for approximately 2 weeks is clinically indicated.
• Indications for postoperative stenting may include ureteric edema, minor ureteric mucosal trauma, need for ureteric dilatation, ureteral access sheath use with expected postoperative edema, impacted stone, residual dust or fragments requiring temporary drainage, or prolonged procedure.
• Ability to understand and complete the Arabic Ureteral Stent Symptom Questionnaire.
• Ability to provide written informed consent.

Критерии исключения

• Cases in which no postoperative ureteric stent is clinically indicated.
• Cases requiring prolonged urinary drainage or major reconstructive decision-making.
• Bilateral ureteroscopy or retrograde intrarenal surgery.
• Solitary kidney.
• Major ureteric injury or ureteric perforation.
• Preoperative febrile urinary tract infection or sepsis.
• Pregnancy or breastfeeding.
• Neurogenic bladder.
• Overactive bladder syndrome.
• Major neurological disease or psychiatric disease affecting symptom reporting.
• History of major bladder, prostate, or pelvic surgery likely to confound stent-related symptoms.
• Concomitant use of alpha-blockers, anticholinergics, chronic analgesics, or other medications likely to alter symptom evaluation.
• Other acute medical conditions that might influence the Ureteral Stent Symptom Questionnaire pain score, including acute pancreatitis, acute gastroenteritis, or musculoskeletal disorders.
• Known allergy to any study-related medication or device material.
• Inability to comply with the follow-up schedule.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 3 центра

• Department of Urology- Beni-Suef University Hospitals — Banī Suwayf
• Department of Urology- Minia University Hospitals — Minya
• Department of Urology- Tanra University Hospitals — Tanta

Идентификаторы

NCT: NCT07627828 · COMFIJ DJ MRCT 2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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