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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antibiotic prophylaxis alone | Other | Children will be on antibioprophylaxis and will not have a circumcision. |
|
| Circumcision and antibiotic prophylaxis | Experimental | Children will have a circumcision at the time of valve resection and will be on antibioprophylaxis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Circumcision | Procedure | Circumcision |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relative risk of presenting a febrile UTI | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Rennes University Hospital | 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of pediatric surgery, Bordeaux hospital | Bordeaux | 33076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11533916 | Background | 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. | |
| 3408870 | 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. |
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| ID | Term |
|---|---|
| D002944 | Circumcision, Male |
| D019072 | Antibiotic Prophylaxis |
| ID | Term |
|---|---|
| D046289 | Body Modification, Non-Therapeutic |
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Antibiotic prophylaxis alone |
| Other |
Antibiotic prophylaxis alone |
|
| 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 |
| Identification of the responsible bacteria | 24 months |
| 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 |
| 15890696 | 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. |
| 21115400 | 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. |
| 19231547 | 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. |
| 34563412 | Result | 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. |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D018890 | Chemoprevention |
| D004358 | Drug Therapy |
| D011292 | Premedication |