Ignite Creation Date:
2024-05-06 @ 12:16 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01537601
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2012-02-17
Brief Title:
CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves
Sponsor:
Centre Hospitalier Universitaire de la Réunion
Organization:
Centre Hospitalier Universitaire de la Réunion
Study Overview
Official Title:
Effect of Circumcision on the Risk of Febrile Urinary Tract Infections in Children With Posterior Urethral Valves
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CIRCUP
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None