ComfiJ Versus Conventional Double-J Stent for Ureteral Stent Symptoms

NCT07627828 | Recruiting

• 1 other identifier: COMFIJ DJ MRCT 2026
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Ureteral Calculi; Urolithiasis; Ureteral Stent-Related Symptoms

Keywords

ComfiJ ureteral stent; Conventional double-J ureteral stent; Ureteral Stent Symptom Questionnaire; Ureteroscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 7

  Postoperative Day 7

• Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 14

  Postoperative Day 14

• Visual Analogue Scale Pain Score

  Postoperative Day 1, postoperative Day 7, and postoperative Day 14

• Febrile Urinary Tract Infection

  Up to postoperative Day 14

• Stent Migration or Displacement

  From stent insertion to stent removal on postoperative Day 14

Study Arms (2)

ComfiJ Ureteral Stent

EXPERIMENTAL

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

Conventional Double-J Ureteral Stent

ACTIVE COMPARATOR

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

Interventions

ComfiJ Ureteral Stent DEVICE

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.

ComfiJ Ureteral Stent

Conventional Double-J Ureteral Stent DEVICE

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.

Conventional Double-J Ureteral Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (3)

Department of Urology- Beni-Suef University Hospitals

Banī Suwayf, Beni Suweif Governorate, 02456, Egypt

RECRUITING

Department of Urology- Minia University Hospitals

Minya, Egypt

RECRUITING

Department of Urology- Tanra University Hospitals

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Ureteral Calculi; Urolithiasis

Condition Hierarchy (Ancestors)

Ureterolithiasis; Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hany F Badawy, MD

  Faculty of medicine Beni-Suef University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hany F Badawy, MD

CONTACT

+201149525028; HANYFATHY86@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The operating surgeon cannot be blinded because the stent type is visible during insertion. Participants and postoperative outcome assessors will remain blinded to treatment allocation during postoperative symptom assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology, Faculty of Medicine, Beni-Suef University

Model Details: Participants will be randomized in a 1:1 ratio to receive either a ComfiJ ureteral stent or a conventional double-J ureteral stent after unilateral ureteroscopy or retrograde intrarenal surgery when short-term postoperative ureteral stenting is clinically indicated. The two groups will be followed in parallel using the same postoperative assessment schedule.

Study Record Dates

• First Submitted: May 30, 2026
• First Posted: June 4, 2026
• Study Start: May 2, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (3)