CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves

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.

Conditions

• Posterior Urethral Valves

Interventions

PROCEDURE

Circumcision

Circumcision

OTHER

Antibiotic prophylaxis alone

Antibiotic prophylaxis alone

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion

  lead OTHER

Principal Investigators

• Frédérique Sauvat, MD · Regional Hospital Reunion Island - Felix Guyon Site

• Eric Dobremez, MD · CHU Bordeaux, Hôpital Pellegrin Enfants

• Laurent Fourcade, MD · CHU Limoges - Hôpital de la mère et de l'enfant

• Nicolas Kalfa, MD · CHU Montpellier - Hôpital Lapeyronie

• Frédéric Auber, MD · CHU St Jacques - Besançon

• Benjamin Frémond · CHU Rennes

• Alaa El Ghoneimi, MD · CHU Robert Debré

• Thomas Blanc, MD · CHU de Necker Enfants Malades

• Jean Michel Guys, MD · Hôpital d'enfants de la Timone, Marseille

• Thierry Merrot, MD · CHU Nord, Marseille

• Marc David Leclair, MD · Nantes University Hospital

• Georges Audry, MD · CHU Armand Trousseau, Paris

• Marie-Laurence Poli-merol, MD · CHU de Reims

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Max Age

28 Days

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2019-02-28

Completion

2019-02-18

Countries

• France

Study Locations