ComfiJ Versus Conventional Double-J Stent for Ureteral Stent Symptoms
Recruiting now · Not applicable
Conditions studied: Ureteral Stent-Related Symptoms, Ureteral Calculi, Urolithiasis
In brief
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.
Key facts
- Study ID
- NCT07627828
- Run by
- Beni-Suef University
- People needed
- 150
- Starts
- 2026-05-02
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Department of Urology- Beni-Suef University Hospitals — Banī Suwayf, Beni Suweif Governorate, Egypt (enrolling)
- Department of Urology- Minia University Hospitals — Minya, Egypt (enrolling)
- Department of Urology- Tanra University Hospitals — Tanta, Egypt (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.