ComfiJ Versus Conventional Double-J Stent for Ureteral Stent Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeni-Suef University
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ComfiJ Ureteral Stent
- Conventional Double-J Ureteral Stent
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov