NCT07627828 ComfiJ Versus Conventional Double-J Stent for Ureteral Stent Symptoms
| NCT ID | NCT07627828 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beni-Suef University |
| Condition | Ureteral Stent-Related Symptoms |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-05-02 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2026-05-02 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Hany F Badawy, MD
PRINCIPAL INVESTIGATOR
Faculty of medicine Beni-Suef University
Frequently Asked Questions
Who can join the NCT07627828 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ureteral Stent-Related Symptoms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07627828 currently recruiting?
Yes, NCT07627828 is actively recruiting participants. Contact the research team at HANYFATHY86@GMAIL.COM for enrollment information.
Where is the NCT07627828 trial being conducted?
This trial is being conducted at Banī Suwayf, Egypt, Minya, Egypt, Tanta, Egypt.
Who is sponsoring the NCT07627828 clinical trial?
NCT07627828 is sponsored by Beni-Suef University. The principal investigator is Hany F Badawy, MD at Faculty of medicine Beni-Suef University. The trial plans to enroll 150 participants.