CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves (CIRCUP)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Posterior Urethral Valves |
Procedure: Circumcision Other: Antibiotic prophylaxis alone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Circumcision on the Risk of Febrile Urinary Tract Infections in Children With Posterior Urethral Valves. |
- Relative risk of presenting a febrile UTI [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Number of children with febrile UTIs in each group at two years [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Evolution of compliance to antibioprophylaxis. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Evolution of the grade of reflux [ Time Frame: At diagnosis and at 3 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- number and type of adverse effects related to circumcision and antibiotic prophylaxis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Identification of the responsible bacteria [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 90 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Antibiotic prophylaxis alone
Children will be on antibioprophylaxis and will not have a circumcision.
|
Other: Antibiotic prophylaxis alone
Antibiotic prophylaxis alone
|
|
Experimental: Circumcision and antibiotic prophylaxis
Children will have a circumcision at the time of valve resection and will be on antibioprophylaxis
|
Procedure: Circumcision
Circumcision
|
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 at three 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.
Eligibility| Ages Eligible for Study: | up to 28 Days |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Luke harper, MD | +262 (0) 262 90 64 94 | luke.harper@chu-reunion.fr |
| Contact: Vanessa Basque | +262 (0) 262 35 95 25 | vanessa.basque@chu-reunion.fr |
| France | |
| Department of pediatric surgery, Regional Hospital Reunion Island - Felix Guyon Site | Recruiting |
| Saint Denis de La Réunion, France, 97405 | |
| Contact: Luke Harper, MD +262 (0) 262 90 64 94 luke.harper@chu-reunion.fr | |
| Principal Investigator: | Luke Harper, MD | Regional Hospital Reunion Island - Felix Guyon Site |
More Information
Publications:
| Responsible Party: | Centre Hospitalier Universitaire de la Réunion ( Centre Hospitalier Felix Guyon ) |
| ClinicalTrials.gov Identifier: | NCT01537601 History of Changes |
| Other Study ID Numbers: | 2012/CHR/01 |
| Study First Received: | February 17, 2012 |
| Last Updated: | October 23, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Centre Hospitalier Universitaire de la Réunion:
|
Posterior urethral valves Febrile urinary tract infection Circumcision Antibioprophylaxis |
Additional relevant MeSH terms:
|
Urinary Tract Infections Infection Urologic Diseases Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013