NCT07527442

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.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: Male
• Age: 1 Day – 31 Days
• Healthy volunteers: Not accepted

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)

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

Interventions

Type	Name	Description
DRUG	Antibiotics strategy	daily antibiotic prophylaxis up to two years
PROCEDURE	Circumcision	Circumcision performed at the time of valve resection

Timeline

• Start date: 2026-04-13
• Primary completion: 2032-04-13
• Completion: 2032-04-13
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

13 sites across 1 country: France