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

Effect of Circumcision on the Risk of Febrile Urinary Tract Infections in Children With Posterior Urethral Valves.

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.

Study Overview

• Status: Completed
• Conditions: Posterior Urethral Valves
• Intervention / Treatment: Other: Antibiotic prophylaxis alone; Procedure: Circumcision

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.

• Study Type: Interventional
• Enrollment (Actual): 92
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • Department of pediatric surgery, Bordeaux hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Antibiotic prophylaxis alone; Children will be on antibioprophylaxis and will not have a circumcision.	Other: Antibiotic prophylaxis alone; Antibiotic prophylaxis alone
Experimental: Circumcision and antibiotic prophylaxis; Children will have a circumcision at the time of valve resection and will be on antibioprophylaxis	Procedure: Circumcision; Circumcision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relative risk of presenting a febrile UTI	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of children with febrile UTIs in each group at two years	24 months
Evolution of compliance to antibioprophylaxis.	24 months
Evolution of the grade of reflux	At diagnosis and at 3 months
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.	24 months
number and type of adverse effects related to circumcision and antibiotic prophylaxis	24 months
Identification of the responsible bacteria	24 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion
• Investigators: Principal Investigator: Frédérique Sauvat, MD, Regional Hospital Reunion Island - Felix Guyon Site; Principal Investigator: Eric Dobremez, MD, CHU Bordeaux, Hôpital Pellegrin Enfants; Principal Investigator: Laurent Fourcade, MD, CHU Limoges - Hôpital de la mère et de l'enfant; Principal Investigator: Nicolas Kalfa, MD, CHU Montpellier - Hôpital Lapeyronie; Principal Investigator: Frédéric Auber, MD, CHU St Jacques - Besançon; Principal Investigator: Benjamin Frémond, CHU Rennes; Principal Investigator: Alaa El Ghoneimi, MD, CHU Robert Debré; Principal Investigator: Thomas Blanc, MD, CHU de Necker Enfants Malades; Principal Investigator: Jean Michel Guys, MD, Hôpital d'enfants de la Timone, Marseille; Principal Investigator: Thierry Merrot, MD, CHU Nord, Marseille; Principal Investigator: Marc David Leclair, MD, CHU Nantes; Principal Investigator: Georges Audry, MD, CHU Armand Trousseau, Paris; Principal Investigator: Marie-Laurence Poli-merol, MD, CHU de Reims

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 18, 2019

Study Registration Dates

• First Submitted: February 17, 2012
• First Submitted That Met QC Criteria: February 22, 2012
• First Posted (Estimated): February 23, 2012

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Circumcision; Posterior urethral valves; Febrile urinary tract infection; Antibioprophylaxis; Impact on family
• Additional Relevant MeSH Terms: Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Urinary Tract Infections; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 2012/CHR/01