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)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Bladder Cancer; Urinary Tract Infection Bacterial; Transurethral Resection of the Bladder
• Intervention / Treatment: Other: No intervention before TURB surgery; Diagnostic test: Urine bacterial Culture (UC)

Detailed Description

Transurethral resection of the bladder (TURB) is a routinely performed surgery in urology (65,000/y in France). Its primary indication is the management of bladder cancer for diagnostic, prognostic, and therapeutic purposes. Currently, both French and European guidelines recommend screening for asymptomatic bacteriuria (ABU) using a urine culture (UC) before TURB. If the UC is positive, antibiotic treatment must be initiated 48 hours before surgery and continued for a maximum of 7 days after the procedure. Theoretically, the purpose of preoperative ABU screening before TURB is to reduce the rate of post-operative urinary tract infections (UTIs). However, there is currently a lack of high-level studies justifying this approach, despite its being a recommended practice. The literature estimates the rate of post-TURB UTIs to be between 2% and 3.7%. In a recent French multicentre retrospective study, the rate of postoperative febrile UTI was 2.3%. This study did not find a significant association between positive pre-operative UC and a post-operative febrile UTI. Moreover, these post-TURB infections are generally of moderate severity (Grade 2 of Clavien-Dindo classification) and do not progress to sepsis. The rate of severe infections is estimated between 0.3% and 0.74%, and no study has yet demonstrated the link between the presence of a positive preoperative UC and an increased risk of postoperative infection. The causality between preoperative UC and postoperative UTIs remains unestablished. According to the TOCUS study, approximately one-third of patients exhibit ABU before undergoing urological surgery, translating to approximately 20,000 patients annually in France. Despite the relatively low rate of post-TURB UTIs and their mild severity, guidelines mandate antibiotic treatment for these patients. Antibiotic resistance is now a daily concern for clinicians and countries alike. A prominent 2014 WHO report emphasized the consequences of antibiotic resistance, including its impact on morbidity, mortality, and societal costs. The risk of entering a post-antibiotic era by 2050 could become a reality if strong measures are not taken immediately. Therefore, we propose a non- inferiority randomized controlled trial to investigate the impact of not performing pre-operative UC before TURB on the incidence of post-TURB febrile UTIs.

• Study Type: Interventional
• Enrollment (Estimated): 2600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maxime VALLEE, MD; Phone Number: +33 5 16 60 42 22; Email: maxime.vallee@chu-poitiers.fr

Study Locations

• France
  • Angers, France, 49100
    • Centre Hospitalier Universitaire d'Angers
    • Contact: Pierre BIGOT, MD; Phone Number: +332 41 35 61 96; Email: PiBigot@chu-angers.fr
    • Contact: SOUHIL Lebdai, MD; Phone Number: +332.41.35.35.16; Email: SoLebdai@chu-angers.fr
  • Grenoble, France, 38043
    • Centre Hospitalier Universitaire de Grenoble Alpes
    • Contact: Gaelle FIARD, MD; Phone Number: +334 76 76 55 71; Email: GFiard@chu-grenoble.fr
    • Contact: Jean-Luc DESCOTES, MD; Phone Number: +335 56 79 55 47; Email: JLDescotes@chu-grenoble.fr
  • Le Coudray, France, 28630
    • Centre Hospitalier de Chartres - Hôpital Louis Pasteur
    • Contact: Luca LUNELLI, MD; Phone Number: +332.37.30.31.58; Email: urc.multi@ch-chartres.fr
    • Contact: Gaétan BADRE, MD; Phone Number: +332.37.30.31.58; Email: gbadre@ch-chartres.fr
  • Lille, France, 59037
    • Centre Hospitalier Universitaire De Lille
    • Contact: Gautier MARCQ, MD; Phone Number: +333 20 44 43 98; Email: gautier.marcq@chu-lille.fr
    • Contact: Jean Christophe FANTONI, MD; Email: jeanchristophe.FANTONI@chu-lille.fr
  • Lyon, France, 69229
    • Hospices Civils de Lyon
    • Contact: Said OURFALI, MD; Phone Number: +334 78 86 28 26; Email: said.ourfali@chu-lyon.fr
  • Marseille, France, 13354
    • Assistance Publique - Hopitaux de Marseille - Hopital Nord
    • Contact: Michael BABOUDJIAN, MD; Phone Number: +336 25 31 40 29; Email: michael.baboudjian@ap-hm.fr
  • Mont-de-Marsan, France, 40024
    • Centre Hospitalier Intercommunal de Mont de Marsan et du Pays des Sources
    • Contact: Jean-Jacques PATARD, MD; Phone Number: +335.58.05.11.30; Email: jean-jacques.patard@ch-mdm.fr
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire de Nantes - Hotel Dieu
    • Contact: Benoit MESNARD, MD; Phone Number: +332.40.08.39.10; Email: benoit.mesnard@chu-nantes.fr
    • Contact: Stephane DEVERGIE, MD; Email: stephane.devergie@chu-nantes.fr
  • Paris, France, 75013
    • AP-HP - Hôpital Universitaire Pitié-Salpêtrière
    • Contact: Morgan ROUPRET, MD; Phone Number: +331 42 17 72 97; Email: morgan.roupret@aphp.fr
    • Contact: Emmanuel CHARTIER-KASTLER, MD; Phone Number: +336.32.93.44.69; Email: emmanuel.chartier-kastler@aphp.fr
  • Paris, France, 75018
    • Hôpital Bichat Claude Bernard-APHP
    • Contact: Evanguelos XYLINAS, MD; Phone Number: +331.40.25.71.02; Email: evanguelos.xylinas@aphp.fr
  • Poitiers, France, 86000
    • CHU Poitiers - Service de chirurgie urologique
    • Contact: Maxime VALLEE, MD; Phone Number: +335 16 60 42 22; Email: maxime.vallee@chu-poitiers.fr
    • Contact: Corinne LORRAIN; Phone Number: +335 49 44 39 30; Email: Corinne.LORRAIN@chu-poitiers.fr
  • Quint-Fonsegrives, France, 31130
    • Clinique La Croix Du Sud
    • Contact: Benjamin PRADERE, MD; Phone Number: +33 6.61.40.44.18; Email: benjaminpradere@gmail.com
    • Contact: Marine LESOURD, MD; Phone Number: +33 6.68.38.45.55; Email: drmarinelesourd@gmail.com
  • Talence, France, 33404
    • Centre hospitalier Universitaire de Bordeaux
    • Contact: Grégoire ROBERT, MD; Phone Number: +335 57 82 12 15; Email: gregoire.robert@chu-bordeaux.fr
    • Contact: Clément Klein, MD; Phone Number: +335 56 79 55 47; Email: clement.klein@chu-bordeaux.fr
  • Tours, France, 37044
    • Centre Hospitalier Régional et Universitaire de Tours - Bretonneau
    • Contact: Ali BOURGI, MD; Phone Number: +336.66.39.81.79; Email: ali.bourgi@univ-tours.fr
  • Vandœuvre-lès-Nancy, France, 54500
    • Centre Hospitalier Régional et Universitaire de Nancy - Hôpitaux de Brabois
    • Contact: Charles MAZEAUD, MD; Phone Number: +336.69.57.04.49; Email: c.mazeaud@chru-nancy.fr
    • Contact: Matthieu SIMONET, MD; Email: m.simonet@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: No Urine Bacterial Culture performed before TransUrethral Resection of the Bladder (TURB)	Other: No intervention before TURB surgery; No Urine Culture before TURB Surgery
Active Comparator: Urine Bacterial Culture performed 4 to 10 days before TURB	Diagnostic test: Urine bacterial Culture (UC); Performing a systematic UC before the TURB surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	During the 30 days following TURB surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with postponed TURB surgery		Between the pre-operative consultation and date of TURB surgery, up to 60 days
Time to surgery (in days), defined by the number of days between the pre-operative consultation and the date of TURB surgery		Between the pre-operative consultation and the date of TURB surgery, up to 60 days
The hospital length of stay	The hospital length of stay , defined by the number of days between surgery and discharge from the hospital	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
Proportion of patients with systemic UTI among patients with hospital readmission	Proportion of patients with systemic UTI among patients with hospital readmission, defined as UTI complicated by sepsis (corresponding to a qSOFA > 1)	Within 30 days following the TURB surgery
Proportion of patients with pre-operative antibiotic prescription for preoperative colonization before the TURB surgery		Between Visit 0 (pre-operative consultation) and Visit 1(TURB surgery)
Proportion of patients with post-operative antibiotic prescription		Within 30 days following the TURB surgery
Time to post-TURB infection diagnosis	Time to post-TURB infection diagnosis (in days), defined by the time between TURB surgery and the infection diagnosis date (truncated at day 30)	Between the TURB surgery and the infection diagnosis date (truncated at day 30)
Overall survival time	Overall survival time (in days), defined by the time between TURB surgery and the date of death (censored at day 30).	Between TURB surgery and the date of death (censored at day 30)

Collaborators and Investigators

• Sponsor: Poitiers University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): June 15, 2030
• Study Completion (Estimated): August 15, 2030

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Urine Culture
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 2025-A01451-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No