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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00528476
Other study ID # BE-2-68
Secondary ID
Status Completed
Phase N/A
First received September 10, 2007
Last updated September 11, 2007
Start date November 2004
Est. completion date January 2007

Study information

Verified date September 2007
Source Kaunas University of Medicine
Contact n/a
Is FDA regulated No
Health authority Lithuania: State Medicine Control Agency - Ministry of Health
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 161
Est. completion date January 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 18 Years
Eligibility Inclusion Criteria:

- 5-18 years old children, who were treated because of cystitis and pyelonephritis in Kaunas Medical University Hospital

Exclusion Criteria:

- urinary tract malformations

- neurogenic bladder dysfunction

- patients, who received immunosuppressive drugs

- pregnant girls

- children with non bacterial urinary tract infection

Study Design

Observational Model: Case Control, Time Perspective: Longitudinal


Locations

Country Name City State
Lithuania Kaunas University of Medicine Kaunas

Sponsors (1)

Lead Sponsor Collaborator
Kaunas University of Medicine

Country where clinical trial is conducted

Lithuania, 

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