search
Back to results

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

Primary Purpose

Posterior Urethral Valves

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Circumcision
Antibiotic prophylaxis alone
Sponsored by
Centre Hospitalier Universitaire de la Réunion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Urethral Valves focused on measuring Posterior urethral valves, Febrile urinary tract infection, Circumcision, Antibioprophylaxis, Impact on family

Eligibility Criteria

undefined - 28 Days (Child)MaleDoes not accept 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

Sites / Locations

  • Department of pediatric surgery, Bordeaux hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Antibiotic prophylaxis alone

Circumcision and antibiotic prophylaxis

Arm Description

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

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

Outcomes

Primary Outcome Measures

Relative risk of presenting a febrile UTI

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2012
Last Updated
June 19, 2023
Sponsor
Centre Hospitalier Universitaire de la Réunion
search

1. Study Identification

Unique Protocol Identification Number
NCT01537601
Brief Title
CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves
Acronym
CIRCUP
Official Title
Effect of Circumcision on the Risk of Febrile Urinary Tract Infections in Children With Posterior Urethral Valves.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posterior Urethral Valves
Keywords
Posterior urethral valves, Febrile urinary tract infection, Circumcision, Antibioprophylaxis, Impact on family

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antibiotic prophylaxis alone
Arm Type
Other
Arm Description
Children will be on antibioprophylaxis and will not have a circumcision.
Arm Title
Circumcision and antibiotic prophylaxis
Arm Type
Experimental
Arm Description
Children will have a circumcision at the time of valve resection and will be on antibioprophylaxis
Intervention Type
Procedure
Intervention Name(s)
Circumcision
Intervention Description
Circumcision
Intervention Type
Other
Intervention Name(s)
Antibiotic prophylaxis alone
Intervention Description
Antibiotic prophylaxis alone
Primary Outcome Measure Information:
Title
Relative risk of presenting a febrile UTI
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Number of children with febrile UTIs in each group at two years
Time Frame
24 months
Title
Evolution of compliance to antibioprophylaxis.
Time Frame
24 months
Title
Evolution of the grade of reflux
Time Frame
At diagnosis and at 3 months
Title
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
Title
number and type of adverse effects related to circumcision and antibiotic prophylaxis
Time Frame
24 months
Title
Identification of the responsible bacteria
Time Frame
24 months

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédérique Sauvat, MD
Organizational Affiliation
Regional Hospital Reunion Island - Felix Guyon Site
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Dobremez, MD
Organizational Affiliation
CHU Bordeaux, Hôpital Pellegrin Enfants
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laurent Fourcade, MD
Organizational Affiliation
CHU Limoges - Hôpital de la mère et de l'enfant
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nicolas Kalfa, MD
Organizational Affiliation
CHU Montpellier - Hôpital Lapeyronie
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frédéric Auber, MD
Organizational Affiliation
CHU St Jacques - Besançon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Benjamin Frémond
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alaa El Ghoneimi, MD
Organizational Affiliation
CHU Robert Debré
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Blanc, MD
Organizational Affiliation
CHU de Necker Enfants Malades
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean Michel Guys, MD
Organizational Affiliation
Hôpital d'enfants de la Timone, Marseille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thierry Merrot, MD
Organizational Affiliation
CHU Nord, Marseille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc David Leclair, MD
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Georges Audry, MD
Organizational Affiliation
CHU Armand Trousseau, Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marie-Laurence Poli-merol, MD
Organizational Affiliation
CHU de Reims
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of pediatric surgery, Bordeaux hospital
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
11533916
Citation
Woolf AS, Thiruchelvam N. Congenital obstructive uropathy: its origin and contribution to end-stage renal disease in children. Adv Ren Replace Ther. 2001 Jul;8(3):157-63. doi: 10.1053/jarr.2001.26348.
Results Reference
background
PubMed Identifier
3408870
Citation
Parkhouse HF, Barratt TM, Dillon MJ, Duffy PG, Fay J, Ransley PG, Woodhouse CR, Williams DI. Long-term outcome of boys with posterior urethral valves. Br J Urol. 1988 Jul;62(1):59-62. doi: 10.1111/j.1464-410x.1988.tb04267.x.
Results Reference
background
PubMed Identifier
15890696
Citation
Singh-Grewal D, Macdessi J, Craig J. Circumcision for the prevention of urinary tract infection in boys: a systematic review of randomised trials and observational studies. Arch Dis Child. 2005 Aug;90(8):853-8. doi: 10.1136/adc.2004.049353. Epub 2005 May 12.
Results Reference
background
PubMed Identifier
21115400
Citation
Simforoosh N, Tabibi A, Khalili SA, Soltani MH, Afjehi A, Aalami F, Bodoohi H. Neonatal circumcision reduces the incidence of asymptomatic urinary tract infection: a large prospective study with long-term follow up using Plastibell. J Pediatr Urol. 2012 Jun;8(3):320-3. doi: 10.1016/j.jpurol.2010.10.008. Epub 2010 Nov 5.
Results Reference
background
PubMed Identifier
19231547
Citation
Mukherjee S, Joshi A, Carroll D, Chandran H, Parashar K, McCarthy L. What is the effect of circumcision on risk of urinary tract infection in boys with posterior urethral valves? J Pediatr Surg. 2009 Feb;44(2):417-21. doi: 10.1016/j.jpedsurg.2008.10.102.
Results Reference
background
PubMed Identifier
34563412
Citation
Harper L, Blanc T, Peycelon M, Michel JL, Leclair MD, Garnier S, Flaum V, Arnaud AP, Merrot T, Dobremez E, Faure A, Fourcade L, Poli-Merol ML, Chaussy Y, Dunand O, Collin F, Huiart L, Ferdynus C, Sauvat F. Circumcision and Risk of Febrile Urinary Tract Infection in Boys with Posterior Urethral Valves: Result of the CIRCUP Randomized Trial. Eur Urol. 2022 Jan;81(1):64-72. doi: 10.1016/j.eururo.2021.08.024. Epub 2021 Sep 22.
Results Reference
result

Learn more about this trial

CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves

We'll reach out to this number within 24 hrs