CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves

Posterior Urethral Valves Clinical Trial

— CIRCUP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01537601
• Other study ID #: 2012/CHR/01
• Status: Completed
• Phase: N/A
• Start date: August 2012
• Est. completion date: February 18, 2019

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: February 18, 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Posterior Urethral Valves
• Urinary Tract Infections

Intervention

Procedure:
• Circumcision
Circumcision

Other:
• Antibiotic prophylaxis alone
Antibiotic prophylaxis alone

Locations

Country	Name	City	State
France	Department of pediatric surgery, Bordeaux hospital	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

References & Publications (6)

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 In — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative risk of presenting a febrile UTI		24 months
Secondary	Number of children with febrile UTIs in each group at two years		24 months
Secondary	Evolution of compliance to antibioprophylaxis.		24 months
Secondary	Evolution of the grade of reflux		At diagnosis and at 3 months
Secondary	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.		24 months
Secondary	number and type of adverse effects related to circumcision and antibiotic prophylaxis		24 months
Secondary	Identification of the responsible bacteria		24 months