CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves

NCT ID: NCT01537601

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2019-02-18

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.

Conditions

Posterior Urethral Valves

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Antibiotic prophylaxis alone

Children will be on antibioprophylaxis and will not have a circumcision.

Group Type: OTHER

Antibiotic prophylaxis alone

Intervention Type: OTHER

Antibiotic prophylaxis alone

Circumcision and antibiotic prophylaxis

Children will have a circumcision at the time of valve resection and will be on antibioprophylaxis

Group Type: EXPERIMENTAL

Circumcision

Intervention Type: PROCEDURE

Circumcision

Interventions

Circumcision

Circumcision

Intervention Type: PROCEDURE

Antibiotic prophylaxis alone

Antibiotic prophylaxis alone

Intervention Type: OTHER

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

• Maximum Eligible Age: 28 Days
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frédérique Sauvat, MD

Role: PRINCIPAL_INVESTIGATOR

Regional Hospital Reunion Island - Felix Guyon Site

Eric Dobremez, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Bordeaux, Hôpital Pellegrin Enfants

Laurent Fourcade, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Limoges - Hôpital de la mère et de l'enfant

Nicolas Kalfa, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Montpellier - Hôpital Lapeyronie

Frédéric Auber, MD

Role: PRINCIPAL_INVESTIGATOR

CHU St Jacques - Besançon

Benjamin Frémond

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Alaa El Ghoneimi, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Robert Debré

Thomas Blanc, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Necker Enfants Malades

Jean Michel Guys, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital d'enfants de la Timone, Marseille

Thierry Merrot, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Nord, Marseille

Marc David Leclair, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Georges Audry, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Armand Trousseau, Paris

Marie-Laurence Poli-merol, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Reims

Locations

Department of pediatric surgery, Bordeaux hospital

Bordeaux, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 11533916 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 3408870 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15890696 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21115400 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19231547 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34563412 (View on PubMed)

Other Identifiers

2012/CHR/01

Identifier Type: -

Identifier Source: org_study_id