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

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.

Study Overview

• Status: Recruiting
• Conditions: Urolithiasis; Ureteral Calculi; Ureteral Stent-Related Symptoms
• Intervention / Treatment: Device: ComfiJ Ureteral Stent; Device: Conventional Double-J Ureteral Stent

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hany F Badawy, MD; Phone Number: +201149525028; Email: Hanyfathy86@gmail.com

Study Locations

• Egypt
  • Minya, Egypt
    • Recruiting
    • Department of Urology- Minia University Hospitals
    • Principal Investigator: M Abdelmalek, MD
    • Contact: Ahmed M, MD; Phone Number: +20 11 00464753; Email: a.m.abdelmalek@mu.edu.eg
  • Tanta, Egypt
    • Recruiting
    • Department of Urology- Tanra University Hospitals
    • Principal Investigator: I Elmaadawy, MD
    • Contact: I Elmaadawy, MD; Phone Number: +201060245430
    • Contact: Email: Mohamed.elmaadawy@med.tanta.edu.eg
  • Beni Suweif Governorate
    • Banī Suwayf, Beni Suweif Governorate, Egypt, 02456
      • Recruiting
      • Department of Urology- Beni-Suef University Hospitals
      • Contact: Hany F Badawy, MD; Phone Number: +201149525028; Email: Hanyfathy86@gmail.com
      • Principal Investigator: Hany F Badawy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ureteral Stent Symptom Questionnaire Urinary Symptoms Domain Score at Postoperative Day 14	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Ureteral Stent Symptom Questionnaire Score at 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	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	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	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	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

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Hany F Badawy, MD, Faculty of medicine Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: May 30, 2026
• First Submitted That Met QC Criteria: May 30, 2026
• First Posted (Actual): June 4, 2026

Study Record Updates

• Last Update Posted (Actual): June 4, 2026
• Last Update Submitted That Met QC Criteria: May 30, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Ureteroscopy; Ureteral Stent Symptom Questionnaire; ComfiJ ureteral stent; Conventional double-J ureteral stent
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Calculi; Ureteral Diseases; Pathological Conditions, Signs and Symptoms; Ureterolithiasis; Ureteral Calculi; Urolithiasis
• Other Study ID Numbers: COMFIJ DJ MRCT 2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No