이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

ComfiJ Versus Conventional Double-J Stent for Ureteral Stent Symptoms (COMFIJ-DJS)

2026년 5월 30일 업데이트: Hany Fathy Badawy, MD, Beni-Suef University

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

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

150

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 이집트
      • Minya, 이집트
        • 모병
        • Department of Urology- Minia University Hospitals
        • 수석 연구원:
          • M Abdelmalek, MD
        • 연락하다:
      • Tanta, 이집트
        • 모병
        • Department of Urology- Tanra University Hospitals
        • 수석 연구원:
          • I Elmaadawy, MD
        • 연락하다:
          • I Elmaadawy, MD
          • 전화번호: +201060245430
        • 연락하다:
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, 이집트, 02456
        • 모병
        • Department of Urology- Beni-Suef University Hospitals
        • 연락하다:
        • 수석 연구원:
          • Hany F Badawy, MD

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: ComfiJ Ureteral Stent
Patients randomized to this arm will receive a ComfiJ ureteral stent after unilateral ureteroscopy or retrograde intrarenal surgery when short-term postoperative ureteral stenting is clinically indicated. Planned stent removal will be performed on postoperative day 14 whenever clinically feasible.
장치: 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.
활성 비교기: Conventional Double-J Ureteral Stent
Patients randomized to this arm will receive a conventional double-J ureteral stent after unilateral ureteroscopy or retrograde intrarenal surgery when short-term postoperative ureteral stenting is clinically indicated. Planned stent removal will be performed on postoperative day 14 whenever clinically feasible.
장치: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Ureteral Stent Symptom Questionnaire Urinary Symptoms Domain Score at Postoperative Day 14
기간: Postoperative Day 14 before stent removal
The urinary symptoms domain score of the Arabic linguistically validated Ureteral Stent Symptom Questionnaire (USSQ) will be assessed at postoperative Day 14 before stent removal. The urinary symptoms domain score ranges from 6 to 42, with higher scores indicating worse urinary stent-related symptoms.
Postoperative Day 14 before stent removal

2차 결과 측정

결과 측정
측정값 설명
기간
Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 7
기간: Postoperative Day 7
The total score of the Arabic linguistically validated Ureteral Stent Symptom Questionnaire (USSQ) will be assessed at postoperative Day 7. The USSQ evaluates six domains: urinary symptoms, body pain, general health, work performance, sexual matters, and additional problems. The total score will be calculated as the sum of the six domain scores, with a possible total score range from 27 to 157. Higher scores indicate worse ureteral stent-related symptoms and poorer health-related quality of life.
Postoperative Day 7
Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 14
기간: Postoperative Day 14
The total score of the Arabic linguistically validated Ureteral Stent Symptom Questionnaire (USSQ) will be assessed at postoperative Day 14. The USSQ evaluates six domains: urinary symptoms, body pain, general health, work performance, sexual matters, and additional problems. The total score will be calculated as the sum of the six domain scores, with a possible total score range from 27 to 157. Higher scores indicate worse ureteral stent-related symptoms and poorer health-related quality of life.
Postoperative Day 14
Visual Analogue Scale Pain Score
기간: Postoperative Day 1, postoperative Day 7, and postoperative Day 14
Pain intensity will be assessed using a Visual Analogue Scale. The possible score range is 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.
Postoperative Day 1, postoperative Day 7, and postoperative Day 14
Febrile Urinary Tract Infection
기간: Up to postoperative Day 14
Occurrence of febrile urinary tract infection after ureteral stent insertion, defined as postoperative fever (≥38.0°C) with clinical or laboratory evidence suggestive of urinary tract infection requiring medical evaluation or treatment.
Up to postoperative Day 14
Stent Migration or Displacement
기간: From stent insertion to stent removal on postoperative Day 14
Occurrence of ureteral stent migration or displacement documented clinically, endoscopically, or radiologically during the stent dwelling period.
From stent insertion to stent removal on postoperative Day 14

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Beni-Suef University

수사관

  • 수석 연구원: Hany F Badawy, MD, Faculty of medicine Beni-Suef University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 2일

기본 완료 (추정된)

2027년 4월 1일

연구 완료 (추정된)

2027년 5월 1일

연구 등록 날짜

최초 제출

2026년 5월 30일

QC 기준을 충족하는 최초 제출

2026년 5월 30일

처음 게시됨 (실제)

2026년 6월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 30일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • COMFIJ DJ MRCT 2026

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Individual participant data will not be shared because the study involves individual-level clinical, operative, and patient-reported symptom data from a multicenter interventional trial. Only aggregated, de-identified study results will be reported in publications or presentations. Any future data sharing request will require approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University, and the corresponding ethics committees of the participating centers.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다