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

30. mai 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

150

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Egypt
      • Minya, Egypt
        • Rekruttering
        • Department of Urology- Minia University Hospitals
        • Hovedetterforsker:
          • M Abdelmalek, MD
        • Ta kontakt med:
      • Tanta, Egypt
        • Rekruttering
        • Department of Urology- Tanra University Hospitals
        • Hovedetterforsker:
          • I Elmaadawy, MD
        • Ta kontakt med:
          • I Elmaadawy, MD
          • Telefonnummer: +201060245430
        • Ta kontakt med:
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egypt, 02456
        • Rekruttering
        • Department of Urology- Beni-Suef University Hospitals
        • Ta kontakt med:
        • Hovedetterforsker:
          • Hany F Badawy, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: 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.
Aktiv komparator: 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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Ureteral Stent Symptom Questionnaire Urinary Symptoms Domain Score at Postoperative Day 14
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Total Ureteral Stent Symptom Questionnaire Score at Postoperative Day 7
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Beni-Suef University

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

2. mai 2026

Primær fullføring (Antatt)

1. april 2027

Studiet fullført (Antatt)

1. mai 2027

Datoer for studieregistrering

Først innsendt

30. mai 2026

Først innsendt som oppfylte QC-kriteriene

30. mai 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • COMFIJ DJ MRCT 2026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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