CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves (CIRCUP)

• Number of children with febrile UTIs in each group at two years [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• Evolution of compliance to antibioprophylaxis. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• Evolution of the grade of reflux [ Time Frame: At diagnosis and at 3 months ] [ Designated as safety issue: No ]
• Comparison of the number of children who will show deterioration of their DMSA scan between children who have had UTIs and those who have not. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• number and type of adverse effects related to circumcision and antibiotic prophylaxis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
• Identification of the responsible bacteria [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Children with posterior urethral valves (PUV) are at risk of presenting febrile urinary tract infections (UTI). Circumcision has been shown to decrease the number of febrile UTIs in healthy children. The effect of circumcision on the number of UTIs in boys with PUV has not yet been studied. Through a prospective randomised trial of children with posterior urethral valves the investigators wish to determine the effect of circumcision on the risk of presenting febrile UTIs. One group will be on antibiotic prophylaxis alone and the other will be on antibiotic prophylaxis plus circumcision performed at the time of valve resection. Both groups will be followed for two years, with clinical examination at 1, 3, 6, 12, 18 and 24 months. A DMSA scan will be performed at 1-2 and 24 months and biological renal function will also be monitored. The relative risk of presenting a febrile UTI in each group will be determined. Clinical, radiological and antenatal data concerning each child will be analysed.

After diagnosis of posterior urethral valves, children will be randomised either to antibioprophylaxis alone or antibioprophylaxis plus circumcision. Circumcision will be performed at the time of valve resection. Children will undergo a cystogram at three months to control valve resection. They will be followed for two years and the number of febrile UTIs in each group will be compared. The diagnosis of febrile UTI will be confirmed by urethral catheterisation or suprapubic aspiration. A DMSA scan will be performed at the beginning and end of the study to determine whether children who have presented febrile UTIs show deterioration of their DMSA as compared to those who did not present febrile UTIs.

• Procedure: Circumcision
  Circumcision
• Other: Antibiotic prophylaxis alone
  Antibiotic prophylaxis alone

• Antibiotic prophylaxis alone
  Children will be on antibioprophylaxis and will not have a circumcision.
  Intervention: Other: Antibiotic prophylaxis alone
• Experimental: Circumcision and antibiotic prophylaxis
  Children will have a circumcision at the time of valve resection and will be on antibioprophylaxis
  Intervention: Procedure: Circumcision

• Woolf AS, Thiruchelvam N. Congenital obstructive uropathy: its origin and contribution to end-stage renal disease in children. Adv Ren Replace Ther. 2001 Jul;8(3):157-63. Review.
• Parkhouse HF, Barratt TM, Dillon MJ, Duffy PG, Fay J, Ransley PG, Woodhouse CR, Williams DI. Long-term outcome of boys with posterior urethral valves. Br J Urol. 1988 Jul;62(1):59-62.
• Singh-Grewal D, Macdessi J, Craig J. Circumcision for the prevention of urinary tract infection in boys: a systematic review of randomised trials and observational studies. Arch Dis Child. 2005 Aug;90(8):853-8. Epub 2005 May 12. Review.
• Simforoosh N, Tabibi A, Khalili SA, Soltani MH, Afjehi A, Aalami F, Bodoohi H. Neonatal circumcision reduces the incidence of asymptomatic urinary tract infection: A large prospective study with long-term follow up using Plastibell. J Pediatr Urol. 2010 Nov 4. [Epub ahead of print]
• Mukherjee S, Joshi A, Carroll D, Chandran H, Parashar K, McCarthy L. What is the effect of circumcision on risk of urinary tract infection in boys with posterior urethral valves? J Pediatr Surg. 2009 Feb;44(2):417-21.

Inclusion Criteria:

• male
• aged 0 to 28 days
• diagnosed with posterior urethral valves within the 28 first day of life
• holders of parental authority affiliated to French national health insurance
• informed consent signed by holders of parental authority

Exclusion Criteria:

• boys with hypospadias or epispadias or any other anomaly rendering circumcision impossible
• concomitant participation to another clinical trial