Clinical trial NCT01537601: CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves
Official title: Effect of Circumcision on the Risk of Febrile Urinary Tract Infections in Children With Posterior Urethral Valves.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Urethral Valves
Keywords: Posterior urethral valves
Febrile urinary tract infection
Circumcision
Antibioprophylaxis
Impact on family
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2012-02-23
Enrollment: 92
Sex: MALE
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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. At 24 months follow-up, an "impact on family scale" survey (IOFS) will be proposed parents.

Detailed description: 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 between 1 and 4 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.

At 24 months follow-up, "impact on family scale" survey (IOFS) whose main objective is to evaluate the impact of family support for a child with posterior urethral valves will be proposed parents.

Eligibility criteria: 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

Primary outcomes:
measure: Relative risk of presenting a febrile UTI
timeFrame: 24 months
Secondary outcomes:
measure: Number of children with febrile UTIs in each group at two years
timeFrame: 24 months
measure: Evolution of compliance to antibioprophylaxis.
timeFrame: 24 months
measure: Evolution of the grade of reflux
timeFrame: At diagnosis and at 3 months
measure: 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.
timeFrame: 24 months
measure: number and type of adverse effects related to circumcision and antibiotic prophylaxis
timeFrame: 24 months
measure: Identification of the responsible bacteria
timeFrame: 24 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Department of pediatric surgery, Bordeaux hospital
Study officials:
affiliation: Regional Hospital Reunion Island - Felix Guyon Site
name: Frédérique Sauvat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Bordeaux, Hôpital Pellegrin Enfants
name: Eric Dobremez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Limoges - Hôpital de la mère et de l'enfant
name: Laurent Fourcade, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Montpellier - Hôpital Lapeyronie
name: Nicolas Kalfa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU St Jacques - Besançon
name: Frédéric Auber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Rennes
name: Benjamin Frémond
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Robert Debré
name: Alaa El Ghoneimi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Necker Enfants Malades
name: Thomas Blanc, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital d'enfants de la Timone, Marseille
name: Jean Michel Guys, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Nord, Marseille
name: Thierry Merrot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nantes University Hospital
name: Marc David Leclair, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Armand Trousseau, Paris
name: Georges Audry, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Reims
name: Marie-Laurence Poli-merol, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1053/jarr.2001.26348.
citation: 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. doi: 10.1111/j.1464-410x.1988.tb04267.x.
citation: 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. doi: 10.1136/adc.2004.049353. Epub 2005 May 12.
citation: 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. 2012 Jun;8(3):320-3. doi: 10.1016/j.jpurol.2010.10.008. Epub 2010 Nov 5.
citation: 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. doi: 10.1016/j.jpedsurg.2008.10.102.
citation: 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.