CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves (CIRCUP)

Centre Hospitalier Universitaire de la Réunion

Status: Completed

Conditions: Posterior Urethral Valves

Treatments: Other: Antibiotic prophylaxis alone; Procedure: Circumcision

Study type: Interventional

Funder types: Other

Identifiers

NCT01537601

2012/CHR/01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: Male

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Antibiotic prophylaxis alone

Other group

Description:

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

Treatment:

Other: Antibiotic prophylaxis alone

Circumcision and antibiotic prophylaxis

Experimental group

Description:

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

Treatment:

Procedure: Circumcision