Bladder CancerRUPTURENCT07463963
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
A study testing Urine bacterial Culture (UC) in people with Bladder Cancer and Transurethral Resection of the Bladder, run by Poitiers University Hospital at 15 sites in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Transurethral Resection of the Bladder, Urinary Tract Infection Bacterial
- What is being tested?
- Urine bacterial Culture (UC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,600 participants
- Where
- 15 sitesFrance
- Study dates
- 29 Jun 2026to 15 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
France15 sites, 15 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire d'Angers
Angers, 49100
Pierre BIGOT, MD, +332 41 35 61 96, PiBigot@chu-angers.fr
SOUHIL Lebdai, MD, +332.41.35.35.16, SoLebdai@chu-angers.fr
- Not yet recruiting
Centre Hospitalier Universitaire de Grenoble Alpes
Grenoble, 38043
Gaelle FIARD, MD, +334 76 76 55 71, GFiard@chu-grenoble.fr
Jean-Luc DESCOTES, MD, +335 56 79 55 47, JLDescotes@chu-grenoble.fr
- Not yet recruiting
Centre Hospitalier de Chartres - Hôpital Louis Pasteur
Le Coudray, 28630
Luca LUNELLI, MD, +332.37.30.31.58, urc.multi@ch-chartres.fr
Gaétan BADRE, MD, +332.37.30.31.58, gbadre@ch-chartres.fr
- Not yet recruiting
Centre Hospitalier Universitaire de Lille
Lille, 59037
Gautier MARCQ, MD, +333 20 44 43 98, gautier.marcq@chu-lille.fr
Jean Christophe FANTONI, MD, jeanchristophe.FANTONI@chu-lille.fr
- Recruiting
Hospices Civils de Lyon
Lyon, 69229
Said OURFALI, MD, +334 78 86 28 26, said.ourfali@chu-lyon.fr
- Not yet recruiting
Assistance Publique - Hôpitaux de Marseille - Hôpital Nord
Marseille, 13354
Michael BABOUDJIAN, MD, +336 25 31 40 29, michael.baboudjian@ap-hm.fr
- Recruiting
Centre Hospitalier Intercommunal de Mont de Marsan et du Pays des Sources
Mont-de-Marsan, 40024
Jean-Jacques PATARD, MD, +335.58.05.11.30, jean-jacques.patard@ch-mdm.fr
- Not yet recruiting
Centre Hospitalier Universitaire de Nantes - Hotel Dieu
Nantes, 44093
Benoit MESNARD, MD, +332.40.08.39.10, benoit.mesnard@chu-nantes.fr
Stephane DEVERGIE, MD, stephane.devergie@chu-nantes.fr
- Not yet recruiting
AP-HP - Hôpital Universitaire Pitié-Salpêtrière
Paris, 75013
Morgan ROUPRET, MD, +331 42 17 72 97, morgan.roupret@aphp.fr
Emmanuel CHARTIER-KASTLER, MD, +336.32.93.44.69, emmanuel.chartier-kastler@aphp.fr
- Not yet recruiting
Hôpital Bichat Claude Bernard-APHP
Paris, 75018
Evanguelos XYLINAS, MD, +331.40.25.71.02, evanguelos.xylinas@aphp.fr
- Recruiting
CHU Poitiers - Service de chirurgie urologique
Poitiers, 86000
Maxime VALLEE, MD, +335 16 60 42 22, maxime.vallee@chu-poitiers.fr
Corinne LORRAIN, +335 49 44 39 30, Corinne.LORRAIN@chu-poitiers.fr
- Not yet recruiting
Clinique la Croix du Sud
Quint-Fonsegrives, 31130
Benjamin PRADERE, MD, +33 6.61.40.44.18, benjaminpradere@gmail.com
Marine LESOURD, MD, +33 6.68.38.45.55, drmarinelesourd@gmail.com
- Not yet recruiting
Centre hospitalier universitaire de Bordeaux
Talence, 33404
Grégoire ROBERT, MD, +335 57 82 12 15, gregoire.robert@chu-bordeaux.fr
Clément Klein, MD, +335 56 79 55 47, clement.klein@chu-bordeaux.fr
- Not yet recruiting
Centre Hospitalier Régional et Universitaire de Tours - Bretonneau
Tours, 37044
Ali BOURGI, MD, +336.66.39.81.79, ali.bourgi@univ-tours.fr
- Not yet recruiting
Centre Hospitalier Régional et Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, 54500
Charles MAZEAUD, MD, +336.69.57.04.49, c.mazeaud@chru-nancy.fr
Matthieu SIMONET, MD, m.simonet@chru-nancy.fr
About this study
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
Read the 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.
- Being tested
- Urine bacterial Culture (UC), No intervention before TURB surgery
- Keywords
- Urine Culture
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine bacterial Culture (UC)Diagnostic test
Performing a systematic UC before the TURB surgery
No intervention before TURB surgeryOther
No Urine Culture before TURB Surgery
| Study group | Role | What they receive |
|---|---|---|
| No Urine Bacterial Culture performed before TransUrethral Resection of the Bladder (TURB) | Experimental | Not described Receives: Other: No intervention before TURB surgery |
| Urine Bacterial Culture performed 4 to 10 days before TURB | Active comparator | Not described Receives: Diagnostic Test: Urine bacterial Culture (UC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During the 30 days following TURB surgery.
Secondary outcomes (10)
Proportion of patients with postponed TURB surgery
Measured: Between the pre-operative consultation and date of TURB surgery, up to 60 days
Time to surgery
time to surgery (in days) is defined as the number of days between the pre-operative consultation and the date of TURB surgery
Measured: 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
Measured: Between TURB surgery and day 30 after TURB surgery
Proportion of patients with hospital readmission or postoperative complications
Measured: Within 30 days following the TURB surgery
Proportion of patients with hospital readmission linked to the urinary surgical procedure
Measured: Within 30 days following the TURB surgery
Proportion of patients with systemic UTI among patients with hospital readmission
Systemic UTI is defined as UTI complicated by sepsis (corresponding to a qSOFA > 1)
Measured: Within 30 days following the TURB surgery
Proportion of patients with pre-operative antibiotic prescription for preoperative colonization before the TURB surgery
Measured: Between Visit 0 (pre-operative consultation) and Visit 1(TURB surgery)
Proportion of patients with post-operative antibiotic prescription
Measured: 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)
Measured: 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).
Measured: Between TURB surgery and the date of death (censored at day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start29 Jun 2026
- Primary completion29 Jul 2030 (estimated)
- Study completion15 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463963
- Sponsor's protocol ID
- RUPTURE
- Other IDs
- 2025-A01451-48
- Acronym
- RUPTURE
- Status last verified
- Sep 2026
- First submitted
- 24 Feb 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07463963
- Acronym / sponsor ID
- RUPTURE / RUPTURE
- Keywords
- Urine Culture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 29 Jul 2030 (estimated)
- Study completion
- 15 Aug 2030 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Urine Bacterial Culture performed before TransUrethral Resection of the Bladder (TURB) | Experimental | Other: No intervention before TURB surgery |
| Urine Bacterial Culture performed 4 to 10 days before TURB | Active comparator | Diagnostic Test: Urine bacterial Culture (UC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine bacterial Culture (UC)Performing a systematic UC before the TURB surgery | Diagnostic test | Urine Bacterial Culture performed 4 to 10 days before TURB |
| No intervention before TURB surgeryNo Urine Culture before TURB Surgery | Other | No Urine Bacterial Culture performed before TransUrethral Resection of the Bladder (TURB) |
Primary outcome
Proportion of patients with post-TURB symptomatic febrile Urinary Tract Infection (UTI)
Time frame: 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)
10 secondary outcomes
Proportion of patients with postponed TURB surgery
Time frame: Between the pre-operative consultation and date of TURB surgery, up to 60 days
Time to surgery
Time frame: Between the pre-operative consultation and the date of TURB surgery, up to 60 days
The hospital length of stay
Time frame: Between TURB surgery and day 30 after TURB surgery
Proportion of patients with hospital readmission or postoperative complications
Time frame: Within 30 days following the TURB surgery
Proportion of patients with hospital readmission linked to the urinary surgical procedure
Time frame: Within 30 days following the TURB surgery
Proportion of patients with systemic UTI among patients with hospital readmission
Time frame: Within 30 days following the TURB surgery
Proportion of patients with pre-operative antibiotic prescription for preoperative colonization before the TURB surgery
Time frame: Between Visit 0 (pre-operative consultation) and Visit 1(TURB surgery)
Proportion of patients with post-operative antibiotic prescription
Time frame: Within 30 days following the TURB surgery
Time to post-TURB infection diagnosis
Time frame: Between the TURB surgery and the infection diagnosis date (truncated at day 30)
Overall survival time
Time frame: Between TURB surgery and the date of death (censored at day 30)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine bacterial Culture (UC) in people with Bladder Cancer and Transurethral Resection of the Bladder, run by Poitiers University Hospital at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maxime VALLEE, MD (+33 5 16 60 42 22, maxime.vallee@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with post-TURB symptomatic febrile Urinary Tract Infection (UTI) (time frame: During the 30 days following TURB surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.