CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Posterior Urethral Valves

Intervention / Treatment
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* Procedure: Circumcision
* Other: Antibiotic prophylaxis alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 28 Days

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posterior urethral valves, Febrile urinary tract infection, Circumcision, Antibioprophylaxis, Impact on family