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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
ComfiJ Ureteral Stent
DevicePlacement of a ComfiJ 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
DevicePlacement 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: ComfiJ Ureteral StentExperimental treatment 1 intervention
Group B: Conventional Double-J Ureteral StentActive comparator 1 intervention
Trial outcomes
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.
Time frame
Postoperative Day 14 before stent removalSecondary outcomes
1
Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 7
The total score of the Arabic linguistically validated Ureteral Stent Symptom Questionnaire (USSQ) will be assessed at postoperative Day 7. The USSQ evaluates six domains: urinary symptoms, body pain, general health, work performance, sexual matters, and additional problems. The total score will be calculated as the sum of the six domain scores, with a possible total score range from 27 to 157. Higher scores indicate worse ureteral stent-related symptoms and poorer health-related quality of life.
Time frame
Postoperative Day 72
Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 14
The total score of the Arabic linguistically validated Ureteral Stent Symptom Questionnaire (USSQ) will be assessed at postoperative Day 14. The USSQ evaluates six domains: urinary symptoms, body pain, general health, work performance, sexual matters, and additional problems. The total score will be calculated as the sum of the six domain scores, with a possible total score range from 27 to 157. Higher scores indicate worse ureteral stent-related symptoms and poorer health-related quality of life.
Time frame
Postoperative Day 143
Visual Analogue Scale Pain Score
Pain intensity will be assessed using a Visual Analogue Scale. The possible score range is 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.
Time frame
Postoperative Day 1, postoperative Day 7, and postoperative Day 144
Febrile Urinary Tract Infection
Occurrence of febrile urinary tract infection after ureteral stent insertion, defined as postoperative fever (≥38.0°C) with clinical or laboratory evidence suggestive of urinary tract infection requiring medical evaluation or treatment.
Time frame
Up to postoperative Day 14Sponsors and contacts
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Source ClinicalTrials.gov