Ureteral Calculi, Ureteral Stent-Related Symptoms, Urolithiasis
Conditions
Keywords
ComfiJ ureteral stent, Conventional double-J ureteral stent, Ureteral Stent Symptom Questionnaire, Ureteroscopy
Brief 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 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.
Interventions
DEVICEComfiJ Ureteral Stent
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.
DEVICEConventional Double-J Ureteral Stent
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.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ureteral Stent Symptom Questionnaire Urinary Symptoms Domain Score at Postoperative Day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 7 | 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. |
| Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 14 | 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. |
| Visual Analogue Scale Pain Score | Postoperative Day 1, postoperative Day 7, and postoperative Day 14 | 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. |
| Febrile Urinary Tract Infection | Up to postoperative Day 14 | 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. |
| Stent Migration or Displacement | From stent insertion to stent removal on postoperative Day 14 | Occurrence of ureteral stent migration or displacement documented clinically, endoscopically, or radiologically during the stent dwelling period. |
Countries
Egypt
Contacts
CONTACTHany F Badawy, MD
PRINCIPAL_INVESTIGATORHany F Badawy, MD
Faculty of medicine Beni-Suef University
Outcome results
None listed