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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 10, 2007 | ||||||||
| Last Updated Date | September 11, 2007 | ||||||||
| Start Date ICMJE | November 2004 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00528476 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Risk Factors for Recurrent Urinary Tract Infection in Children | ||||||||
| Official Title ICMJE | Role of Clinical and Urodynamic Risk Factors for Recurrent Urinary Tract Infection in 5-18 Years Old Children | ||||||||
| Brief Summary | The purpose of this study is to determine clinical and urodynamic risk factors for recurrent urinary tract infection in 5-18 years old children. |
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| Detailed Description | It is known, that in the group of young children the most common reason of recurrent UTI is anatomic abnormalities, such as vesicoureteral reflux, hydronephrosis. However, not all recurrent UTI can be explained by anatomic abnormalities. The vast majority of school age children with recurrent UTI have anatomically normal urinary tract. Recent studies discuss about the role of behavioral and functional abnormalities (inadequate fluid intake, stool retention, infrequent voiding, etc.) that can predispose recurrent urinary tract infections. Influence of some these abnormalities for recurrent UTI is controversial. Family history, behavioral and functional abnormalities which predispose to urinary tract infections in children with normal urinary tract are neglected in most protocols of urinary tract infection. Children in this study receive a careful evaluation including complete history, voiding-drinking diary, bowel questionnaire, physical investigation, sonography, voiding cystourethrogram. Follow up time - 1 year. Urinalysis once a month and during each episode of fever. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Natural History, Longitudinal, Case Control, Prospective Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 161 | ||||||||
| Completion Date | January 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 5 Years to 18 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Lithuania | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00528476 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | BE-2-68 | ||||||||
| Study Sponsor ICMJE | Kaunas University of Medicine | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Kaunas University of Medicine | ||||||||
| Verification Date | September 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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