Posterior Urethral ValvesPhase 2CIRCUP 2NCT07527442
Efficacy and Safety of Circumcision Alone on Risk of Febrile Urinary Tract Infections in Boys With Posterior Urethral Valves: a Prospective Randomized Open-label Multicentric Trial Enriched With Historic Controls.
A Phase 2 study testing Antibiotics strategy and Circumcision in people with Posterior Urethral Valves, run by University Hospital, Bordeaux at 13 sites in France.
Trial summary
Boys with posterior urethral valves (PUV) are at increased risk of developing febrile urinary tract infections (fUTIs). As shown in the CIRCUP trial, circumcision plus antibiotic prophylaxis reduces the risk of FUTIs compared with antibiotic prophylaxis alone. Read more about this study
- Who is it for?
- Ages 1 day to 31 days, men only
- Conditions the study is for
- Posterior Urethral Valves
- What is being tested?
- Antibiotics strategy and Circumcision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 13 sitesFrance
- Study dates
- 13 Apr 2026to 13 Apr 2032
- Phase
- Phase 2
- 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 1 day to 31 days
- Men only
- No healthy volunteers
- Child
- Inclusion Criteria:
For prospective groups:
Male child aged 1 to 31 days Posterior urethral valves diagnosed by cystography within the first 28 days of life Valve resection and circumcision performed before 1 month of life. Adult guardians (>18 years) Parental guardians affiliated with a social security system Parental guardians who have signed an informed consent allowing their child to participate in the study Parental guardians giving consent must be able to understand the trial in its entirety
For retrospective groups from CIRCUP : Parental guardians who are not opposed to their child's participation in the trial
- Exclusion Criteria: Mental state rendering the person giving consent incapable of understanding the trial Parents being a relative of the investigator or a relative of someone from the team directly involved in the trial, including assistant doctors, pharmacists, nurses, and trial coordinators Known contra-indication to all antibiotics used in the study (alfatil, Bactrim, augmentin) Long-term antibiotics use indicated for other reasons than PUV
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
France13 sites
CHU de Besançon
Besançon
Yann Chaussy, MD, 03 81 81 93 33, ychaussy@chu-besancon.fr
CHU de Bordeaux
Bordeaux
Luke HARPER, MD, 05 56 79 98 11, luke.harper@chu-bordeaux.fr
CHU de Limoges
Limoges
Quentin BALLOUHEY, MD, 06 32 85 96 60, quentin.ballouhey@chu-limoges.fr
APHM
Marseille
Alice Faure, MD, 04 91 38 66 82, alice.faure@ap-hm.fr
CHU de Montpellier
Montpellier
Nicolas Kalfa, MD, 04 67 33 87 84, nicolaskalfa@gmail.com
CHU de Nantes
Nantes
Thomas Loubersac, MD, 02 40 08 33 33, thomas.loubersac@chu-nantes.fr
APHP Hôpital Armand Trousseau
Paris, 75012
Pauline Clermidi, MD, 01 71 73 80 05, pauline.clermidi@aphp.fr
APHP Hôpital Necker
Paris, 75015
Thomas Blanc, MD, 01 44 49 41 86, thomas.blanc@aphp.fr
APHP Hôpital Robert Debré
Paris, 75019
Matthieu Peycelon, MD, 01 40 03 36 82, matthieu.peycelon@aphp.fr
CHU de Reims
Reims
Nadia Boudaoud, MD, 03 26 78 36 15, nboudaoud@chu-reims.fr
CHU de Rennes
Rennes
Alexis Arnaud, MD, 02 99 28 43 21, alexis.arnaud@chu-rennes.fr
CHU de la Réunion
Saint-Denis, 97400
Etienne SUPLY, MD, 02 62 90 50 50, etienne.suply@chu-reunion.fr
CHU de Toulouse
Toulouse
Olivier Abbo, MD, 05 34 55 85 99, abbo.o@chu-toulouse.fr
About this study
Boys with posterior urethral valves (PUV) are at increased risk of developing febrile urinary tract infections (fUTIs). As shown in the CIRCUP trial, circumcision plus antibiotic prophylaxis reduces the risk of FUTIs compared with antibiotic prophylaxis alone. This multicenter randomised controlled trial prospectively compares circumcision alone with circumcision plus antibiotic prophylaxis for the prevention of fUTIs in boys with PUV, enriched with external historical data from the CIRCUP trial)
Read the detailed description
Posterior urethral valves (PUV) are the most common cause of Lower Urinary Tract Obstruction (LUTO) in boys. They affect around 1:5000 births, causing increased intravesical pressure during fetal kidney development. They are associated with congenital renal dysplasia, abnormal bladder function and represent the most common obstructive cause of End-Stage Renal Failure in childhood. Postnatal primary valve ablation is the treatment of choice.
Despite optimal postnatal management, these patients present an increased risk of febrile urinary tract infection (fUTI). Febrile urinary tract infections in infants cause morbidity, require intravenous treatment and if they recur, can contribute to renal damage. Long-term prophylactic antibiotic treatment was therefore, until recently, the standard of care.
At the same time, circumcision was also supposed to decrease the rate of fUTI. This is why we conducted, between 2012 and 2017, the CIRCUP randomized controlled trial (PHRC-I) to determine whether circumcision in addition to antibiotic prophylaxis further decreased the risk of fUTI in boys with PUV, within the first two years of life.
We chose boys with PUV as they were undergoing surgery for their valve resection in any case, and the circumcision did not require an additional anaesthesia.
The results of the CIRCUP study were clear. The risk of fUTI was 3% in the Circumcision and antibiotic prophylaxis group vs 20% in the antibiotic prophylaxis alone group (RR: 10.3 (95% CI: 1.3 - 82.5)) (Circumcision and risk of febrile urinary tract infection in boys with posterior urethral valves. Harper L et al. 2022. Eur Urol (5), Annex 1).
The results from this study brought us, as well as several other teams (who either contacted us directly or as comments to our published study) to question the utility of antibiotic prophylaxis in circumcised boys with PUV (antibiotic prophylaxis has potential deleterious effects, both individually, and in terms of public health perspective). Circumcision alone could be a legitimate prophylactic strategy, in terms of balance between efficacy and risk of promoting antibiotic resistance.
We therefore aim to conduct a new clinical trial in boys with PUV to assess the effects of circumcision alone (without antibiotic prophylaxis) on the risk of fUTI using an efficient randomized trial design in this pediatric rare disease setting by incorporating data from the previous CIRCUP trial. This would allow us the identify risk of presenting a febrile UTI in circumcised boys with PUV and no antibiotic prophylaxis. This would help us determine the optimal strategy for UTI prevention in this population and discuss options with the parents.
- Conditions
- Posterior Urethral Valves
- Being tested
- Antibiotics strategy, Circumcision
- Keywords
- Posterior urethral valves, Febrile Urinary Infection, Circumcision, Antibiotic prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotics strategyDrug
daily antibiotic prophylaxis up to two years
CircumcisionProcedure or surgery
Circumcision performed at the time of valve resection
| Study group | Role | What they receive |
|---|---|---|
| Research strategy | Experimental | Prospective strategy administered to participants of CIRCUP 2: Antibiotics-sparing strategy: Circumcision alone, performed at the time of valve resection Receives: Procedure: Circumcision |
| Reference strategy 1 | Active comparator | Circumcision, performed at the time of valve resection, plus daily antibiotic prophylaxis up to two years Prospective strategy administered to participants of CIRCUP 2 + Use of data from historical controls from CIRCUP Receives: Drug: Antibiotics strategy; Procedure: Circumcision |
| Reference strategy 2 | Active comparator | Daily antibiotic prophylaxis up to two years Use of data from historical controls from CIRCUP Receives: Drug: Antibiotics strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first febrile urinary tract infections (fUTI) between baseline and 2 years
The diagnosis of fUTI is defined as fever (>38.5° Celsius) with evidence of pyuria and culture-proven infection on urinalysis, obtained by urethral catheterization or suprapubic aspiration, as well as biological signs of inflammation.
Measured: between baseline and 2 years
Secondary outcomes (5)
Median number of fUTIs
Median number of fUTIs at 2 years in children with at least 1 fUTI during follow-up
Measured: at 2 years
The proportion of children with worsening renal scans (defined as an increase in heterogeneity and number of cortical defects)
The proportion of children with worsening renal scans (defined as an increase in heterogeneity and number of cortical defects) between baseline and 2-years
Measured: between baseline and 2-years
Absolute risk difference of first fUTI with circumcision alone versus circumcision and antibiotic prophylaxis
Absolute risk difference of first fUTI with circumcision alone versus circumcision and antibiotic prophylaxis
Measured: at 2 years
Absolute risk difference of first fUTI with circumcision alone versus antibiotic prophylaxis alone
Absolute risk difference of first fUTI with circumcision alone versus antibiotic prophylaxis alone
Measured: at 2 years
Absolute risk difference of first fUTI with circumcision and antibiotic prophylaxis versus antibiotic prophylaxis alone
Absolute risk difference of first fUTI with circumcision and antibiotic prophylaxis versus antibiotic prophylaxis alone
Measured: at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start13 Apr 2026 (estimated)
- Primary completion13 Apr 2032 (estimated)
- Study completion13 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posterior Urethral ValvesStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luke HARPER, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527442
- Sponsor's protocol ID
- CHUBX 2023/52
- Other IDs
- 2024-519166-48-01
- Acronym
- CIRCUP 2
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harper L, Blanc T, Peycelon M, Michel JL, Leclair MD, Garnier S, Flaum V, Arnaud AP, Merrot T, Dobremez E, Faure A, Fourcade L, Poli-Merol ML, Chaussy Y, Dunand O, Collin F, Huiart L, Ferdynus C, Sauvat F. Circumcision and Risk of Febrile Urinary Tract Infection in Boys with Posterior Urethral Valves: Result of the CIRCUP Randomized Trial. Eur Urol. 2022 Jan;81(1):64-72. doi: 10.1016/j.eururo.2021.08.024. Epub 2021 Sep 22.
PubMed 34563412
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Circumcision Alone on Risk of Febrile Urinary Tract Infections in Boys With Posterior Urethral Valves: a Prospective Randomized Open-label Multicentric Trial Enriched With Historic Controls.
- ClinicalTrials.gov ID
- NCT07527442
- Acronym / sponsor ID
- CIRCUP 2 / CHUBX 2023/52
- Conditions
- Posterior Urethral Valves
- Keywords
- Posterior urethral valves, Febrile Urinary Infection, Circumcision, Antibiotic prophylaxis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 13 Apr 2026 (estimated)
- Primary completion
- 13 Apr 2032 (estimated)
- Study completion
- 13 Apr 2032 (estimated)
- First posted
- 14 Apr 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.
Boys with posterior urethral valves (PUV) are at increased risk of developing febrile urinary tract infections (fUTIs). As shown in the CIRCUP trial, circumcision plus antibiotic prophylaxis reduces the risk of FUTIs compared with antibiotic prophylaxis alone. This multicenter randomised controlled trial prospectively compares circumcision alone with circumcision plus antibiotic prophylaxis for the prevention of fUTIs in boys with PUV, enriched with external historical data from the CIRCUP trial)
Detailed description
Posterior urethral valves (PUV) are the most common cause of Lower Urinary Tract Obstruction (LUTO) in boys. They affect around 1:5000 births, causing increased intravesical pressure during fetal kidney development. They are associated with congenital renal dysplasia, abnormal bladder function and represent the most common obstructive cause of End-Stage Renal Failure in childhood. Postnatal primary valve ablation is the treatment of choice.
Despite optimal postnatal management, these patients present an increased risk of febrile urinary tract infection (fUTI). Febrile urinary tract infections in infants cause morbidity, require intravenous treatment and if they recur, can contribute to renal damage. Long-term prophylactic antibiotic treatment was therefore, until recently, the standard of care.
At the same time, circumcision was also supposed to decrease the rate of fUTI. This is why we conducted, between 2012 and 2017, the CIRCUP randomized controlled trial (PHRC-I) to determine whether circumcision in addition to antibiotic prophylaxis further decreased the risk of fUTI in boys with PUV, within the first two years of life.
We chose boys with PUV as they were undergoing surgery for their valve resection in any case, and the circumcision did not require an additional anaesthesia.
The results of the CIRCUP study were clear. The risk of fUTI was 3% in the Circumcision and antibiotic prophylaxis group vs 20% in the antibiotic prophylaxis alone group (RR: 10.3 (95% CI: 1.3 - 82.5)) (Circumcision and risk of febrile urinary tract infection in boys with posterior urethral valves. Harper L et al. 2022. Eur Urol (5), Annex 1).
The results from this study brought us, as well as several other teams (who either contacted us directly or as comments to our published study) to question the utility of antibiotic prophylaxis in circumcised boys with PUV (antibiotic prophylaxis has potential deleterious effects, both individually, and in terms of public health perspective). Circumcision alone could be a legitimate prophylactic strategy, in terms of balance between efficacy and risk of promoting antibiotic resistance.
We therefore aim to conduct a new clinical trial in boys with PUV to assess the effects of circumcision alone (without antibiotic prophylaxis) on the risk of fUTI using an efficient randomized trial design in this pediatric rare disease setting by incorporating data from the previous CIRCUP trial. This would allow us the identify risk of presenting a febrile UTI in circumcised boys with PUV and no antibiotic prophylaxis. This would help us determine the optimal strategy for UTI prevention in this population and discuss options with the parents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Research strategy | Experimental | Procedure: CircumcisionProspective strategy administered to participants of CIRCUP 2: Antibiotics-sparing strategy: Circumcision alone, performed at the time of valve resection |
| Reference strategy 1 | Active comparator | Drug: Antibiotics strategy, Procedure: CircumcisionCircumcision, performed at the time of valve resection, plus daily antibiotic prophylaxis up to two years Prospective strategy administered to participants of CIRCUP 2 + Use of data from historical controls from CIRCUP |
| Reference strategy 2 | Active comparator | Drug: Antibiotics strategyDaily antibiotic prophylaxis up to two years Use of data from historical controls from CIRCUP |
Who may qualify
- Ages
- 1 day to 31 days
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Antibiotics strategydaily antibiotic prophylaxis up to two years | Drug | Reference strategy 1, Reference strategy 2 |
| CircumcisionCircumcision performed at the time of valve resection | Procedure or surgery | Reference strategy 1, Research strategy |
Primary outcome
Time to first febrile urinary tract infections (fUTI) between baseline and 2 years
Time frame: between baseline and 2 years
The diagnosis of fUTI is defined as fever (>38.5° Celsius) with evidence of pyuria and culture-proven infection on urinalysis, obtained by urethral catheterization or suprapubic aspiration, as well as biological signs of inflammation.
5 secondary outcomes
Median number of fUTIs
Time frame: at 2 years
The proportion of children with worsening renal scans (defined as an increase in heterogeneity and number of cortical defects)
Time frame: between baseline and 2-years
Absolute risk difference of first fUTI with circumcision alone versus circumcision and antibiotic prophylaxis
Time frame: at 2 years
Absolute risk difference of first fUTI with circumcision alone versus antibiotic prophylaxis alone
Time frame: at 2 years
Absolute risk difference of first fUTI with circumcision and antibiotic prophylaxis versus antibiotic prophylaxis alone
Time frame: at 2 years
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 14 Apr 2026.
- Background: PubMed 34563412Harper L, Blanc T, Peycelon M, Michel JL, Leclair MD, Garnier S, Flaum V, Arnaud AP, Merrot T, Dobremez E, Faure A, Fourcade L, Poli-Merol ML, Chaussy Y, Dunand O, Collin F, Huiart L, Ferdynus C, Sauvat F. Circumcision and Risk of Febrile Urinary Tract Infection in Boys with Posterior Urethral Valves: Result of the CIRCUP Randomized Trial. Eur Urol. 2022 Jan;81(1):64-72. doi: 10.1016/j.eururo.2021.08.024. Epub 2021 Sep 22.
- 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.
Luke HARPER, MD principal investigator
University Hospital, Bordeaux
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Antibiotics strategy and Circumcision in people with Posterior Urethral Valves, run by University Hospital, Bordeaux at 13 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?
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: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Aurore Capelli, PhD (+33557820877, aurore.capelli@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first febrile urinary tract infections (fUTI) between baseline and 2 years (time frame: between baseline and 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07527442, which also lists 1 linked publication.
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 14 Apr 2026.