Clinical Trial: CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Centre Hospitalier Universitaire de la Réunion

Current Primary Outcome: Relative risk of presenting a febrile UTI [ Time Frame: 24 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of children with febrile UTIs in each group at two years [ Time Frame: 24 months ]
  • Evolution of compliance to antibioprophylaxis. [ Time Frame: 24 months ]
  • Evolution of the grade of reflux [ Time Frame: 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. [ Time Frame: 24 months ]
  • number and type of adverse effects related to circumcision and antibiotic prophylaxis [ Time Frame: 24 months ]
  • Identification of the responsible bacteria [ Time Frame: 24 months ]


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de la Réunion

Dates:
Date Received: February 17, 2012
Date Started: August 2012
Date Completion: August 2018
Last Updated: July 28, 2015
Last Verified: July 2015