Ureteral Stent-Related SymptomsCOMFIJ-DJSNCT07627828
ComfiJ Versus Conventional Double-J Stent for Ureteral Stent Symptoms
A study testing ComfiJ Ureteral Stent and Conventional Double-J Ureteral Stent in people with Ureteral Stent-Related Symptoms and Ureteral Calculi, run by Beni-Suef University at 3 sites in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteral Stent-Related Symptoms, Ureteral Calculi, Urolithiasis
- What is being tested?
- ComfiJ Ureteral Stent and Conventional Double-J Ureteral Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 3 sitesEgypt
- Study dates
- 2 May 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt3 sites, 3 recruiting
- Recruiting
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate, 02456
Hany F Badawy, MD, +201149525028, HANYFATHY86@GMAIL.COM
Hany F Badawy, MD
- Recruiting
Department of Urology- Minia University Hospitals
Minya
Ahmed M, MD, +20 11 00464753, a.m.abdelmalek@mu.edu.eg
M Abdelmalek, MD
- Recruiting
Department of Urology- Tanra University Hospitals
Tanta
I Elmaadawy, MD, +201060245430
Mohamed.elmaadawy@med.tanta.edu.eg
About this study
Official title: Evaluation of Stent-Related Symptoms After ComfiJ Ureteric Stent Versus Conventional Double-J Ureteric Stent: A Prospective Multicenter Randomized Controlled 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.
Read the detailed description
Ureteral stents are frequently used after ureteroscopy and retrograde intrarenal surgery when temporary postoperative drainage is clinically indicated. However, ureteral stents may cause urinary symptoms, pain, hematuria, impaired daily activity, and reduced quality of life. Stent-related morbidity is therefore an important patient-centered outcome in endourology.
This study will compare a ComfiJ ureteral stent with a conventional double-J ureteral stent in adult patients undergoing unilateral ureteroscopy or retrograde intrarenal surgery for urinary stones. Randomization will be performed only after the surgeon has determined intraoperatively that postoperative stenting is required. Patients will be randomized in a 1:1 ratio to receive either a ComfiJ ureteral stent or a conventional double-J ureteral stent. The planned stent dwell time will be 14 days whenever clinically feasible.
The patient and postoperative outcome assessor will be blinded to treatment allocation. The operating surgeon will not be blinded because the stent type is visible during insertion. Stent-related symptoms will be assessed using the validated Arabic Ureteral Stent Symptom Questionnaire, together with pain scores, analgesic use, emergency visits, complications, stent migration, ease of insertion and removal, and patient satisfaction.
- Being tested
- ComfiJ Ureteral Stent, Conventional Double-J Ureteral Stent
- Keywords
- ComfiJ ureteral stent, Conventional double-J ureteral stent, Ureteral Stent Symptom Questionnaire, Ureteroscopy
- Medical subject headings
- Ureteral Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ComfiJ Ureteral StentDevice
Placement 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 StentDevice
Placement 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.
| Study group | Role | What they receive |
|---|---|---|
| ComfiJ Ureteral Stent | Experimental | Patients randomized to this arm will receive a ComfiJ ureteral stent after unilateral ureteroscopy or retrograde intrarenal surgery when short-term postoperative ureteral stenting is clinically indicated. Planned stent removal will be performed on postoperative day 14 whenever clinically feasible. Receives: Device: ComfiJ Ureteral Stent |
| Conventional Double-J Ureteral Stent | Active comparator | Patients randomized to this arm will receive a conventional double-J ureteral stent after unilateral ureteroscopy or retrograde intrarenal surgery when short-term postoperative ureteral stenting is clinically indicated. Planned stent removal will be performed on postoperative day 14 whenever clinically feasible. Receives: Device: Conventional Double-J Ureteral Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative Day 14 before stent removal
Secondary outcomes (5)
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.
Measured: Postoperative Day 7
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.
Measured: Postoperative Day 14
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.
Measured: Postoperative Day 1, postoperative Day 7, and postoperative Day 14
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.
Measured: Up to postoperative Day 14
Stent Migration or Displacement
Occurrence of ureteral stent migration or displacement documented clinically, endoscopically, or radiologically during the stent dwelling period.
Measured: From stent insertion to stent removal on postoperative Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start2 May 2026
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteral Stent-Related SymptomsStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to receive either a ComfiJ ureteral stent or a conventional double-J ureteral stent after unilateral ureteroscopy or retrograde intrarenal surgery when short-term postoperative ureteral stenting is clinically indicated. The two groups will be followed in parallel using the same postoperative assessment schedule.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Fathy Badawy, MD, Beni-Suef University
- Investigators
- Hany F Badawy, MD, Principal investigator, Faculty of medicine Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627828
- Sponsor's protocol ID
- COMFIJ DJ MRCT 2026
- Acronym
- COMFIJ-DJS
- Status last verified
- May 2026
- First submitted
- 30 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves individual-level clinical, operative, and patient-reported symptom data from a multicenter interventional trial. Only aggregated, de-identified study results will be reported in publications or presentations. Any future data sharing request will require approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University, and the corresponding ethics committees of the participating centers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Stent-Related Symptoms After ComfiJ Ureteric Stent Versus Conventional Double-J Ureteric Stent: A Prospective Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07627828
- Acronym / sponsor ID
- COMFIJ-DJS / COMFIJ DJ MRCT 2026
- Keywords
- ComfiJ ureteral stent, Conventional double-J ureteral stent, Ureteral Stent Symptom Questionnaire, Ureteroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 2 May 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ureteral stents are frequently used after ureteroscopy and retrograde intrarenal surgery when temporary postoperative drainage is clinically indicated. However, ureteral stents may cause urinary symptoms, pain, hematuria, impaired daily activity, and reduced quality of life. Stent-related morbidity is therefore an important patient-centered outcome in endourology.
This study will compare a ComfiJ ureteral stent with a conventional double-J ureteral stent in adult patients undergoing unilateral ureteroscopy or retrograde intrarenal surgery for urinary stones. Randomization will be performed only after the surgeon has determined intraoperatively that postoperative stenting is required. Patients will be randomized in a 1:1 ratio to receive either a ComfiJ ureteral stent or a conventional double-J ureteral stent. The planned stent dwell time will be 14 days whenever clinically feasible.
The patient and postoperative outcome assessor will be blinded to treatment allocation. The operating surgeon will not be blinded because the stent type is visible during insertion. Stent-related symptoms will be assessed using the validated Arabic Ureteral Stent Symptom Questionnaire, together with pain scores, analgesic use, emergency visits, complications, stent migration, ease of insertion and removal, and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to receive either a ComfiJ ureteral stent or a conventional double-J ureteral stent after unilateral ureteroscopy or retrograde intrarenal surgery when short-term postoperative ureteral stenting is clinically indicated. The two groups will be followed in parallel using the same postoperative assessment schedule.
| Arm | Type | Receives |
|---|---|---|
| ComfiJ Ureteral Stent | Experimental | Device: ComfiJ Ureteral StentPatients randomized to this arm will receive a ComfiJ ureteral stent after unilateral ureteroscopy or retrograde intrarenal surgery when short-term postoperative ureteral stenting is clinically indicated. Planned stent removal will be performed on postoperative day 14 whenever clinically feasible. |
| Conventional Double-J Ureteral Stent | Active comparator | Device: Conventional Double-J Ureteral StentPatients randomized to this arm will receive a conventional double-J ureteral stent after unilateral ureteroscopy or retrograde intrarenal surgery when short-term postoperative ureteral stenting is clinically indicated. Planned stent removal will be performed on postoperative day 14 whenever clinically feasible. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ComfiJ Ureteral StentPlacement of a ComfiJ ureteral stent after unilateral ureteroscopy or retrograde intrarenal surgery for urinary stones when short-term postoperative ureteral stenting is clinically indicated. | Device | ComfiJ Ureteral Stent |
| Conventional Double-J Ureteral StentPlacement 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. | Device | Conventional Double-J Ureteral Stent |
Primary outcome
Ureteral Stent Symptom Questionnaire Urinary Symptoms Domain Score at Postoperative Day 14
Time frame: Postoperative Day 14 before stent removal
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.
5 secondary outcomes
Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 7
Time frame: Postoperative Day 7
Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 14
Time frame: Postoperative Day 14
Visual Analogue Scale Pain Score
Time frame: Postoperative Day 1, postoperative Day 7, and postoperative Day 14
Febrile Urinary Tract Infection
Time frame: Up to postoperative Day 14
Stent Migration or Displacement
Time frame: From stent insertion to stent removal on postoperative Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves individual-level clinical, operative, and patient-reported symptom data from a multicenter interventional trial. Only aggregated, de-identified study results will be reported in publications or presentations. Any future data sharing request will require approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University, and the corresponding ethics committees of the participating centers.
Related trials for Ureteral Stent-Related Symptoms
RecruitingPhase 1/2
Dexamethasone for Ureteral STent Symptoms (DUSTS)
Ureteral Stent-Related Symptom
Enrolling by invitation
Impact of Ureteral Stent and Sheaths Size on Post-Operative Pain
Ureteral Stent-Related Symptom, Retrograde Intra-renal Surgery
Not yet recruitingPhase 3
Assessing Suzetrigine for Pain Reduction Following Ureteroscopic Surgery
Opioid Consumption, Postoperative, Multimodal Analgesia
Active, not recruiting
Optimal Stent Duration After Ureteroscopy
Ureteral Stent
RecruitingObservational study
Clinical Evaluation of the Pelvic Floor Fatigue Index (PFFI)
Urolithiasis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hany F Badawy, MD principal investigator
Faculty of medicine Beni-Suef University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ComfiJ Ureteral Stent and Conventional Double-J Ureteral Stent in people with Ureteral Stent-Related Symptoms and Ureteral Calculi, run by Beni-Suef University at 3 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hany F Badawy, MD (+201149525028, HANYFATHY86@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ureteral Stent Symptom Questionnaire Urinary Symptoms Domain Score at Postoperative Day 14 (time frame: Postoperative Day 14 before stent removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.