Posterior Urethral Valves
Conditions
Keywords
Posterior urethral valves, Febrile urinary tract infection, Circumcision, Antibioprophylaxis, Impact on family
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.
Interventions
PROCEDURECircumcision
Circumcision
OTHERAntibiotic prophylaxis alone
Antibiotic prophylaxis alone
Sponsors
Centre Hospitalier Universitaire de la Réunion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
No minimum to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative risk of presenting a febrile UTI | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Evolution of compliance to antibioprophylaxis. | 24 months |
| Evolution of the grade of reflux | At diagnosis and at 3 months |
| Number of children with febrile UTIs in each group at two years | 24 months |
| number and type of adverse effects related to circumcision and antibiotic prophylaxis | 24 months |
| Identification of the responsible bacteria | 24 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 |
Countries
France
Outcome results
None listed