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.

NCT07527442 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: CHUBX 2023/522024-519166-48-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 13

Brief 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. 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)

Conditions

Posterior Urethral Valves

Keywords

Posterior urethral valves; Febrile Urinary Infection; Circumcision; Antibiotic prophylaxis

Outcome Measures

Primary Outcomes (1)

• 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.

  between baseline and 2 years

Secondary Outcomes (5)

• Median number of fUTIs

  at 2 years

• The proportion of children with worsening renal scans (defined as an increase in heterogeneity and number of cortical defects)

  between baseline and 2-years

• Absolute risk difference of first fUTI with circumcision alone versus circumcision and antibiotic prophylaxis

  at 2 years

• Absolute risk difference of first fUTI with circumcision alone versus antibiotic prophylaxis alone

  at 2 years

• Absolute risk difference of first fUTI with circumcision and antibiotic prophylaxis versus antibiotic prophylaxis alone

  at 2 years

Study Arms (3)

Research strategy

EXPERIMENTAL

Prospective strategy administered to participants of CIRCUP 2: Antibiotics-sparing strategy: Circumcision alone, performed at the time of valve resection

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

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

Drug: Antibiotics strategy

Interventions

Antibiotics strategy DRUG

daily antibiotic prophylaxis up to two years

Reference strategy 1; Reference strategy 2

Circumcision PROCEDURE

Circumcision performed at the time of valve resection

Reference strategy 1; Research strategy

Eligibility Criteria

• Age: 1 Day - 31 Days
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (13)

CHU de Besançon

Besançon, France

Location

CHU de Bordeaux

Bordeaux, France

Location

CHU de Limoges

Limoges, France

Location

APHM

Marseille, France

Location

CHU de Montpellier

Montpellier, France

Location

CHU de Nantes

Nantes, France

Location

APHP Hôpital Armand Trousseau

Paris, 75012, France

Location

APHP Hôpital Necker

Paris, 75015, France

Location

APHP Hôpital Robert Debré

Paris, 75019, France

Location

CHU de Reims

Reims, France

Location

CHU de Rennes

Rennes, France

Location

CHU de la Réunion

Saint-Denis, 97400, France

Location

CHU de Toulouse

Toulouse, France

Location

Related Publications (1)

• 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.

  PMID: 34563412 BACKGROUND

MeSH Terms

Interventions

Circumcision, Male

Intervention Hierarchy (Ancestors)

Body Modification, Non-Therapeutic; Cosmetic Techniques; Therapeutics; Surgical Procedures, Operative; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Luke HARPER, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurore Capelli, PhD

CONTACT

+33557820877; aurore.capelli@chu-bordeaux.fr

Luke HARPER, MD

CONTACT

05 56 79 56 17; luke.harper@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 14, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): April 13, 2032
• Study Completion (Estimated): April 13, 2032
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (13)