Actively Recruiting
Evaluation of Stent-Related Symptoms After ComfiJ Ureteric Stent Versus Conventional Double-J Ureteric Stent: A Prospective Multicenter Randomized Controlled Trial
Led by Beni-Suef University · Updated on 2026-06-04
150
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating ureteral stent-related symptoms in adults who need temporary stenting after unilateral ureteroscopy or retrograde intrarenal surgery for urinary stones. The study compares a newer ComfiJ ureteral stent with a conventional double-J ureteral stent to understand which stent causes fewer urinary symptoms and related issues. The trial is randomized and multicenter, focusing on patient comfort and quality of life after surgery. Participants will be randomly assigned during surgery to receive either a ComfiJ or conventional double-J ureteral stent if short-term postoperative stenting is needed. The stents are planned to remain in place for about 14 days before removal. The study uses a double-blind design where patients and outcome assessors do not know which stent was used, while surgeons are aware during insertion. Throughout the study, participants will complete the Arabic Ureteral Stent Symptom Questionnaire to assess urinary symptoms, along with pain scores and records of analgesic use, emergency visits, and complications. Researchers will also monitor stent migration, ease of insertion and removal, and patient satisfaction. The main outcome is the urinary symptoms score on day 14 before stent removal. Follow-up assessments occur up to postoperative day 14, and the study is scheduled to end in May 2027.
CONDITIONS
Brief Title
ComfiJ Versus Conventional Double-J Stent for Ureteral Stent Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
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Your Study Journey: What to Expect
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 14 days or until stent removal
Participants receive placement of either a ComfiJ ureteral stent or 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.
1 stent insertion visit and 1 stent removal visit on postoperative day 14
Duration - Up to 14 days post-implantation
Participants are monitored for stent-related symptoms, pain, complications, and satisfaction during the stent dwell time.
Visits on postoperative days 1, 7, and 14 for symptom assessments
Trial Site Locations
Total: 3 locations
1
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate, Egypt, 02456
Actively Recruiting
2
Department of Urology- Minia University Hospitals
Minya, Egypt
Actively Recruiting
3
Department of Urology- Tanra University Hospitals
Tanta, Egypt
Actively Recruiting
Research Team
H
Hany F Badawy, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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