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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ComfiJ Ureteral Stent | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Postoperative Day 14 before stent removal |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hany F Badawy, MD | Contact | +201149525028 | HANYFATHY86@GMAIL.COM |
| Name | Affiliation | Role |
|---|---|---|
| Hany F Badawy, MD | Faculty of medicine Beni-Suef University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology- Beni-Suef University Hospitals | Recruiting | Banī Suwayf | Beni Suweif Governorate | 02456 | Egypt |
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.
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| ID | Term |
|---|---|
| D014514 | Ureteral Calculi |
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D053039 | Ureterolithiasis |
| D014515 | Ureteral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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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.
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The operating surgeon cannot be blinded because the stent type is visible during insertion. Participants and postoperative outcome assessors will remain blinded to treatment allocation during postoperative symptom assessment.
| Conventional Double-J Ureteral Stent | Device | 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. |
|
| 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. | 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. | 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. | 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. | From stent insertion to stent removal on postoperative Day 14 |
| Department of Urology- Minia University Hospitals | Recruiting | Minya | Egypt |
|
| Department of Urology- Tanra University Hospitals | Recruiting | Tanta | Egypt |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |