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

Status: Unknown status
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Maximum Age: 28 days
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
France
Department of pediatric surgery, Bordeaux hospital
Bordeaux
Time Frame
Start Date: August 2012
Completion Date: August 2019
Participants
Target number of participants: 92
Treatments
Other: Antibiotic prophylaxis alone
Children will be on antibioprophylaxis and will not have a circumcision.
Experimental: Circumcision and antibiotic prophylaxis
Children will have a circumcision at the time of valve resection and will be on antibioprophylaxis
Sponsors
Leads: Centre Hospitalier Universitaire de la Réunion

This content was sourced from clinicaltrials.gov

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