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Completed

NCT Number: NCT01537601

CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves

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.

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Key information

Conditions

Posterior Urethral Valves

Age range

Up to 28 day

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of pediatric surgery, Bordeaux hospital

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Circumcision

Procedure

Circumcision

Antibiotic prophylaxis alone

Other

Antibiotic prophylaxis alone

Primary outcomes

  1. Relative risk of presenting a febrile UTI

    Time frame: 24 months

Secondary outcomes

  1. Number of children with febrile UTIs in each group at two years

    Time frame: 24 months

  2. Evolution of compliance to antibioprophylaxis.

    Time frame: 24 months

  3. Evolution of the grade of reflux

    Time frame: At diagnosis and at 3 months

  4. 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.

    Time frame: 24 months

  5. number and type of adverse effects related to circumcision and antibiotic prophylaxis

    Time frame: 24 months

  6. Identification of the responsible bacteria

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Official study title

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

Acronym: CIRCUP

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Feb 23, 2012
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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