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
Bladder CancerTransurethral Resection of the BladderUrinary Tract Infection Bacterial
Investigational drug(s) / intervention(s)
Urine bacterial Culture (UC)No intervention before TURB surgery
Urine bacterial Culture (UC): Performing a systematic UC before the TURB surgery
No intervention before TURB surgery: No Urine Culture before TURB Surgery
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patient aged 18 or over
* Scheduled for TURB surgery for a suspected or confirmed diagnosis of bladder tumor
* Affiliated person or beneficiary of a social security scheme
* Written informed consent obtained from the participant
Exclusion Criteria:
* Patient with active UTI
* Planned combined surgery
* Patient previously included in this research protocol
* People benefiting from enhanced protection, namely minors, people deprived of their liberty by judicial or administrative decision, people staying in a health or social institution, adults under legal protection
* Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation : oral, intravaginal, transdermal; Progestogen-only hormonal contraception associated with inhibition of ovulation : oral, injectable, implantable; Intrauterine device; Intrauterine hormone-releasing system; Bilateral tubal occlusion) or permanent sterilization methods ( hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
Primary outcome measure(s)
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)
Trial sites (15)
Facility
City
Region
Status
Centre Hospitalier Universitaire d'Angers
Angers
France
Not Yet Recruiting
Centre Hospitalier Universitaire de Grenoble Alpes
Grenoble
France
Not Yet Recruiting
Centre Hospitalier de Chartres - Hôpital Louis Pasteur
Le Coudray
France
Not Yet Recruiting
Centre Hospitalier Universitaire de Lille
Lille
France
Not Yet Recruiting
Hospices Civils de Lyon
Lyon
France
Recruiting
Assistance Publique - Hôpitaux de Marseille - Hôpital Nord
Marseille
France
Not Yet Recruiting
Centre Hospitalier Intercommunal de Mont de Marsan et du Pays des Sources
Mont-de-Marsan
France
Recruiting
Centre Hospitalier Universitaire de Nantes - Hotel Dieu
Nantes
France
Not Yet Recruiting
AP-HP - Hôpital Universitaire Pitié-Salpêtrière
Paris
France
Not Yet Recruiting
Hôpital Bichat Claude Bernard-APHP
Paris
France
Not Yet Recruiting
CHU Poitiers - Service de chirurgie urologique
Poitiers
France
Recruiting
Clinique la Croix du Sud
Quint-Fonsegrives
France
Not Yet Recruiting
Centre hospitalier universitaire de Bordeaux
Talence
France
Not Yet Recruiting
Centre Hospitalier Régional et Universitaire de Tours - Bretonneau
Tours
France
Not Yet Recruiting
Centre Hospitalier Régional et Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy
France
Not Yet Recruiting
More Poitiers University Hospital trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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