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
RUPTURE
2 other identifiers
interventional
2,600
1 country
15
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2026
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2026
CompletedFirst Posted
Study publicly available on registry
March 11, 2026
CompletedStudy Start
First participant enrolled
June 29, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 15, 2030
September 4, 2026
September 1, 2026
4.1 years
February 24, 2026
September 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with post-TURB symptomatic febrile Urinary Tract Infection (UTI)
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)
During the 30 days following TURB surgery.
Secondary Outcomes (10)
Proportion of patients with postponed TURB surgery
Between the pre-operative consultation and date of TURB surgery, up to 60 days
Time to surgery
Between the pre-operative consultation and the date of TURB surgery, up to 60 days
The hospital length of stay
Between TURB surgery and day 30 after TURB surgery
Proportion of patients with hospital readmission or postoperative complications
Within 30 days following the TURB surgery
Proportion of patients with hospital readmission linked to the urinary surgical procedure
Within 30 days following the TURB surgery
- +5 more secondary outcomes
Study Arms (2)
No Urine Bacterial Culture performed before TransUrethral Resection of the Bladder (TURB)
EXPERIMENTALUrine Bacterial Culture performed 4 to 10 days before TURB
ACTIVE COMPARATORInterventions
Performing a systematic UC before the TURB surgery
No Urine Culture before TURB Surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Centre Hospitalier Universitaire d'Angers
Angers, 49100, France
Centre Hospitalier Universitaire de Grenoble Alpes
Grenoble, 38043, France
Centre Hospitalier de Chartres - Hôpital Louis Pasteur
Le Coudray, 28630, France
Centre Hospitalier Universitaire de Lille
Lille, 59037, France
Hospices Civils de Lyon
Lyon, 69229, France
Assistance Publique - Hôpitaux de Marseille - Hôpital Nord
Marseille, 13354, France
Centre Hospitalier Intercommunal de Mont de Marsan et du Pays des Sources
Mont-de-Marsan, 40024, France
Centre Hospitalier Universitaire de Nantes - Hotel Dieu
Nantes, 44093, France
AP-HP - Hôpital Universitaire Pitié-Salpêtrière
Paris, 75013, France
Hôpital Bichat Claude Bernard-APHP
Paris, 75018, France
CHU Poitiers - Service de chirurgie urologique
Poitiers, 86000, France
Clinique la Croix du Sud
Quint-Fonsegrives, 31130, France
Centre hospitalier universitaire de Bordeaux
Talence, 33404, France
Centre Hospitalier Régional et Universitaire de Tours - Bretonneau
Tours, 37044, France
Centre Hospitalier Régional et Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54500, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 24, 2026
First Posted
March 11, 2026
Study Start
June 29, 2026
Primary Completion (Estimated)
July 29, 2030
Study Completion (Estimated)
August 15, 2030
Last Updated
September 4, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share