Posterior Urethral ValvesCIRCUPNCT01537601
CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves
A study testing Circumcision and Antibiotic prophylaxis alone in people with Posterior Urethral Valves, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 28 days, men only
- Conditions the study is for
- Posterior Urethral Valves
- What is being tested?
- Circumcision and Antibiotic prophylaxis alone
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2012to 18 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- Men only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- boys with hypospadias or epispadias or any other anomaly rendering circumcision impossible
- concomitant participation to another clinical trial
Trial locations and contacts
1 site in 1 country.
France1 site
Department of pediatric surgery, Bordeaux hospital
Bordeaux, 33076
About this study
Official title: Effect of Circumcision on the Risk of Febrile Urinary Tract Infections in Children With Posterior Urethral Valves.
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.
Read the 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.
- Conditions
- Posterior Urethral Valves
- Being tested
- Circumcision, Antibiotic prophylaxis alone
- Keywords
- Posterior urethral valves, Febrile urinary tract infection, Circumcision, Antibioprophylaxis, Impact on family
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CircumcisionProcedure or surgery
Circumcision
Antibiotic prophylaxis aloneOther
Antibiotic prophylaxis alone
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic prophylaxis alone | Other | Children will be on antibioprophylaxis and will not have a circumcision. Receives: 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 Receives: Procedure: Circumcision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative risk of presenting a febrile UTI
Measured: 24 months
Secondary outcomes (6)
Number of children with febrile UTIs in each group at two years
Measured: 24 months
Evolution of compliance to antibioprophylaxis.
Measured: 24 months
Evolution of the grade of reflux
Measured: 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.
Measured: 24 months
number and type of adverse effects related to circumcision and antibiotic prophylaxis
Measured: 24 months
Identification of the responsible bacteria
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2012 (estimated)
- Study startAug 2012
- Primary completionFeb 2019
- Study completion18 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Posterior Urethral ValvesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédérique Sauvat, MD, Principal investigator, Regional Hospital Reunion Island - Felix Guyon SiteEric Dobremez, MD, Principal investigator, CHU Bordeaux, Hôpital Pellegrin EnfantsLaurent Fourcade, MD, Principal investigator, CHU Limoges - Hôpital de la mère et de l'enfantNicolas Kalfa, MD, Principal investigator, CHU Montpellier - Hôpital LapeyronieFrédéric Auber, MD, Principal investigator, CHU St Jacques - BesançonBenjamin Frémond, Principal investigator, Rennes University HospitalAlaa El Ghoneimi, MD, Principal investigator, CHU Robert DebréThomas Blanc, MD, Principal investigator, CHU de Necker Enfants Malades
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01537601
- Sponsor's protocol ID
- 2012/CHR/01
- Acronym
- CIRCUP
- Status last verified
- Jun 2023
- First submitted
- 17 Feb 2012
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11533916Parkhouse 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.
PubMed 3408870Singh-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.
PubMed 15890696Simforoosh 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.
PubMed 21115400Mukherjee 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.
PubMed 19231547Harper 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.
PubMed 34563412
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Circumcision on the Risk of Febrile Urinary Tract Infections in Children With Posterior Urethral Valves.
- ClinicalTrials.gov ID
- NCT01537601
- Acronym / sponsor ID
- CIRCUP / 2012/CHR/01
- Conditions
- Posterior Urethral Valves
- Keywords
- Posterior urethral valves, Febrile urinary tract infection, Circumcision, Antibioprophylaxis, Impact on family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Feb 2019 (actual)
- Study completion
- 18 Feb 2019 (actual)
- First posted
- 23 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic prophylaxis alone | Other | Other: Antibiotic prophylaxis aloneChildren will be on antibioprophylaxis and will not have a circumcision. |
| Circumcision and antibiotic prophylaxis | Experimental | Procedure: CircumcisionChildren will have a circumcision at the time of valve resection and will be on antibioprophylaxis |
Who may qualify
- Ages
- Up to 28 days
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- boys with hypospadias or epispadias or any other anomaly rendering circumcision impossible
- concomitant participation to another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CircumcisionCircumcision | Procedure or surgery | Circumcision and antibiotic prophylaxis |
| Antibiotic prophylaxis aloneAntibiotic prophylaxis alone | Other | Antibiotic prophylaxis alone |
Primary outcome
Relative risk of presenting a febrile UTI
Time frame: 24 months
6 secondary outcomes
Number of children with febrile UTIs in each group at two years
Time frame: 24 months
Evolution of compliance to antibioprophylaxis.
Time frame: 24 months
Evolution of the grade of reflux
Time frame: 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.
Time frame: 24 months
number and type of adverse effects related to circumcision and antibiotic prophylaxis
Time frame: 24 months
Identification of the responsible bacteria
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Background: PubMed 11533916Woolf 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.
- Background: PubMed 3408870Parkhouse 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.
- Background: PubMed 15890696Singh-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.
- Background: PubMed 21115400Simforoosh 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.
- Background: PubMed 19231547Mukherjee 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 publication: PubMed 34563412Harper 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.
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Posterior Urethral Valves
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédérique Sauvat, MD principal investigator
Regional Hospital Reunion Island - Felix Guyon Site
Eric Dobremez, MD principal investigator
CHU Bordeaux, Hôpital Pellegrin Enfants
Laurent Fourcade, MD principal investigator
CHU Limoges - Hôpital de la mère et de l'enfant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circumcision and Antibiotic prophylaxis alone in people with Posterior Urethral Valves, run by Centre Hospitalier Universitaire de la Réunion at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative risk of presenting a febrile UTI (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01537601, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.