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Studies

Interventional Recruiting

NCT07463963 on ClinicalTrials.gov

Relevance of the Urine Bacterial Culture Performed Before TransUrethral Resection of the Bladder for Post-operative Febrile Urinary Tract Infections Prevention: a Non-inferiority Randomized Controlled Trial

  • Sponsor: Centre Hospitalier Universitaire de Poitiers
  • Enrollment: 2600 (Estimated)
  • Study start: 2026-06-29 (Actual)
  • Primary completion: 2030-07-29 (Estimated)
  • Study completion: 2030-08-15 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

The main objective of the study is to demonstrate that not performing a systematic UC before the TURB procedure is non-inferior to performing a systematic UC in terms of the incidence of febrile UTIs during the first 30 postoperative days

Conditions

  • Bladder Cancer
  • Transurethral Resection of the Bladder
  • Urinary Tract Infection Bacterial

Intervention / Treatment

  • Diagnostic Test: Urine bacterial Culture (UC)
  • Other: No intervention before TURB surgery

Primary Outcome Measures

  • Proportion of patients with post-TURB symptomatic febrile Urinary Tract Infection (UTI) (During the 30 days following TURB surgery.)
    The diagnosis of a febrile UTI will be based on clinical, biological and microbiological criteria, as defined by Bilsen et al. based on an international expert consensus (PMID: 38458204)

Countries

France

Locations and Investigators

  • Centre Hospitalier Universitaire d'Angers, Angers, France (Not yet recruiting)
  • Centre Hospitalier Universitaire de Grenoble Alpes, Grenoble, France (Not yet recruiting)
    • Gaelle FIARD, MD
    • Jean-Luc DESCOTES, MD
  • Centre Hospitalier de Chartres - Hôpital Louis Pasteur, Le Coudray, France (Not yet recruiting)
    • Luca LUNELLI, MD
    • Gaétan BADRE, MD
  • Centre Hospitalier Universitaire de Lille, Lille, France (Not yet recruiting)
    • Gautier MARCQ, MD
    • Jean Christophe FANTONI, MD
  • Hospices Civils de Lyon, Lyon, France (Recruiting)
    • Said OURFALI, MD
  • Assistance Publique - Hôpitaux de Marseille - Hôpital Nord, Marseille, France (Not yet recruiting)
    • Michael BABOUDJIAN, MD
  • Centre Hospitalier Intercommunal de Mont de Marsan et du Pays des Sources, Mont-de-Marsan, France (Recruiting)
    • Jean-Jacques PATARD, MD
  • Centre Hospitalier Universitaire de Nantes - Hotel Dieu, Nantes, France (Not yet recruiting)
  • AP-HP - Hôpital Universitaire Pitié-Salpêtrière, Paris, France (Not yet recruiting)
    • Morgan ROUPRET, MD
    • Emmanuel CHARTIER-KASTLER, MD
  • Hôpital Bichat Claude Bernard-APHP, Paris, France (Not yet recruiting)
    • Evanguelos XYLINAS, MD
  • CHU Poitiers - Service de chirurgie urologique, Poitiers, France (Recruiting)
    • Maxime VALLEE, MD
    • Corinne LORRAIN
  • Clinique la Croix du Sud, Quint-Fonsegrives, France (Not yet recruiting)
    • Benjamin PRADERE, MD
    • Marine LESOURD, MD
  • Centre hospitalier universitaire de Bordeaux, Talence, France (Not yet recruiting)
    • Grégoire ROBERT, MD
    • Clément Klein, MD
  • Centre Hospitalier Régional et Universitaire de Tours - Bretonneau, Tours, France (Not yet recruiting)
    • Ali BOURGI, MD
  • Centre Hospitalier Régional et Universitaire de Nancy - Hôpitaux de Brabois, VandÅ“uvre-lès-Nancy, France (Not yet recruiting)
    • Charles MAZEAUD, MD
    • Matthieu SIMONET, MD