CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves

NCT01537601 | Completed

• 1 other identifier: 2012/CHR/01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Urethral Valves

Keywords

Posterior urethral valves; Febrile urinary tract infection; Circumcision; Antibioprophylaxis; Impact on family

Outcome Measures

Primary Outcomes (1)

• Relative risk of presenting a febrile UTI

  24 months

Secondary Outcomes (6)

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

  24 months

• Evolution of compliance to antibioprophylaxis.

  24 months

• Evolution of the grade of reflux

  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.

  24 months

• number and type of adverse effects related to circumcision and antibiotic prophylaxis

  24 months

Study Arms (2)

Antibiotic prophylaxis alone

OTHER

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

Other: Antibiotic prophylaxis alone

Circumcision and antibiotic prophylaxis

EXPERIMENTAL

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

Procedure: Circumcision

Interventions

Circumcision PROCEDURE

Circumcision

Circumcision and antibiotic prophylaxis

Antibiotic prophylaxis alone OTHER

Antibiotic prophylaxis alone

Antibiotic prophylaxis alone

Eligibility Criteria

• Age: Up to 28 Days
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• boys with hypospadias or epispadias or any other anomaly rendering circumcision impossible
• concomitant participation to another clinical trial

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

Department of pediatric surgery, Bordeaux hospital

Bordeaux, 33076, France

Location

Related Publications (6)

• 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.

  PMID: 11533916 BACKGROUND

• 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.

  PMID: 3408870 BACKGROUND

• 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.

  PMID: 15890696 BACKGROUND

• 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.

  PMID: 21115400 BACKGROUND

• 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.

  PMID: 19231547 BACKGROUND

• 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.

  PMID: 34563412 RESULT

MeSH Terms

Interventions

Circumcision, Male; Antibiotic Prophylaxis

Intervention Hierarchy (Ancestors)

Body Modification, Non-Therapeutic; Cosmetic Techniques; Therapeutics; Surgical Procedures, Operative; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Chemoprevention; Drug Therapy; Premedication

Study Officials

• Frédérique Sauvat, MD

  Regional Hospital Reunion Island - Felix Guyon Site

  PRINCIPAL INVESTIGATOR

• Eric Dobremez, MD

  CHU Bordeaux, Hôpital Pellegrin Enfants

  PRINCIPAL INVESTIGATOR

• Laurent Fourcade, MD

  CHU Limoges - Hôpital de la mère et de l'enfant

  PRINCIPAL INVESTIGATOR

• Nicolas Kalfa, MD

  CHU Montpellier - Hôpital Lapeyronie

  PRINCIPAL INVESTIGATOR

• Frédéric Auber, MD

  CHU St Jacques - Besançon

  PRINCIPAL INVESTIGATOR

• Benjamin Frémond

  CHU Rennes

  PRINCIPAL INVESTIGATOR

• Alaa El Ghoneimi, MD

  CHU Robert Debré

  PRINCIPAL INVESTIGATOR

• Thomas Blanc, MD

  CHU de Necker Enfants Malades

  PRINCIPAL INVESTIGATOR

• Jean Michel Guys, MD

  Hôpital d'enfants de la Timone, Marseille

  PRINCIPAL INVESTIGATOR

• Thierry Merrot, MD

  CHU Nord, Marseille

  PRINCIPAL INVESTIGATOR

• Marc David Leclair, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

• Georges Audry, MD

  CHU Armand Trousseau, Paris

  PRINCIPAL INVESTIGATOR

• Marie-Laurence Poli-merol, MD

  CHU de Reims

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2012
• First Posted: February 23, 2012
• Study Start: August 1, 2012
• Primary Completion: February 1, 2019
• Study Completion: February 18, 2019
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

FR (1)