ComfiJ vs. standard double-J stent after ureteroscopy or RIRS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized study compares two types of ureteral stents in adults undergoing unilateral ureteroscopy or retrograde intrarenal surgery for stones. Participants are randomized intraoperatively to receive either a ComfiJ stent or a conventional double-J stent, with stents typically left in for about 14 days. The primary endpoint is the urinary symptoms domain of the Ureteral Stent Symptom Questionnaire on postoperative day 14. Outcomes will also include pain scores, analgesic use, healthcare visits, complications, stent-related issues, and patient satisfaction, with blinding of patients and outcome assessors. The trial aims to determine if the ComfiJ stent improves patient comfort and reduces stent-related morbidity compared with the conventional stent.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Urology- Beni-Suef University Hospitals
  Banī Suwayf, Beni Suweif Governorate, Egypt Recruiting
• Department of Urology- Minia University Hospitals
  Minya, Egypt Recruiting
• Department of Urology- Tanra University Hospitals
  Tanta, Egypt Recruiting

Study contacts

• Principal investigator: Hany F Badawy, MD — Faculty of medicine Beni-Suef University
• Study coordinator: Hany F Badawy, MD
• Email: HANYFATHY86@GMAIL.COM
• Phone: +201149525028

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.