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ComfiJ Versus Conventional Double-J Stent for Ureteral Stent Symptoms (COMFIJ-DJS)

30 maggio 2026 aggiornato da: Hany Fathy Badawy, MD, Beni-Suef University

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

150

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Egitto
      • Minya, Egitto
        • Reclutamento
        • Department of Urology- Minia University Hospitals
        • Investigatore principale:
          • M Abdelmalek, MD
        • Contatto:
      • Tanta, Egitto
        • Reclutamento
        • Department of Urology- Tanra University Hospitals
        • Investigatore principale:
          • I Elmaadawy, MD
        • Contatto:
          • I Elmaadawy, MD
          • Numero di telefono: +201060245430
        • Contatto:
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egitto, 02456
        • Reclutamento
        • Department of Urology- Beni-Suef University Hospitals
        • Contatto:
        • Investigatore principale:
          • Hany F Badawy, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: ComfiJ Ureteral Stent
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.
Dispositivo: ComfiJ 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.
Comparatore attivo: Conventional Double-J Ureteral Stent
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.
Dispositivo: Conventional 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Ureteral Stent Symptom Questionnaire Urinary Symptoms Domain Score at Postoperative Day 14
Lasso di tempo: 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.
Postoperative Day 14 before stent removal

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 7
Lasso di tempo: 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.
Postoperative Day 7
Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 14
Lasso di tempo: 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
Lasso di tempo: 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.
Postoperative Day 1, postoperative Day 7, and postoperative Day 14
Febrile Urinary Tract Infection
Lasso di tempo: 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.
Up to postoperative Day 14
Stent Migration or Displacement
Lasso di tempo: 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.
From stent insertion to stent removal on postoperative Day 14

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Beni-Suef University

Investigatori

  • Investigatore principale: Hany F Badawy, MD, Faculty of medicine Beni-Suef University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 maggio 2026

Completamento primario (Stimato)

1 aprile 2027

Completamento dello studio (Stimato)

1 maggio 2027

Date di iscrizione allo studio

Primo inviato

30 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

30 maggio 2026

Primo Inserito (Effettivo)

4 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

30 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • COMFIJ DJ MRCT 2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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