Urinary Tract InfectionNCT00528476
Risk Factors for Recurrent Urinary Tract Infection in Children
An observational study of Urinary Tract Infection and Pyelonephritis, run by Kaunas University of Medicine at 1 site in Lithuania.
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Urinary Tract Infection, Pyelonephritis, Cystitis
- How many people
- 161 participants
- Where
- 1 siteLithuania
- Study dates
- Nov 2004to Jan 2007
- Phase
- Observational
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 5-18 years old children, who were treated because of cystitis and pyelonephritis in Kaunas Medical University Hospital
Who cannot join
- urinary tract malformations
- neurogenic bladder dysfunction
- patients, who received immunosuppressive drugs
- pregnant girls
- children with non bacterial urinary tract infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Clinical and Urodynamic Risk Factors for Recurrent Urinary Tract Infection in 5-18 Years Old Children
The purpose of this study is to determine clinical and urodynamic risk factors for recurrent urinary tract infection in 5-18 years old children.
Read the 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.
- Conditions
- Urinary Tract Infection, Pyelonephritis, Cystitis
- Keywords
- pyelonephritis, cystitis, risk factor, children, urodynamics
- Medical subject headings
- Urinary Tract Infections, Pyelonephritis, Cystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients, who were treated because of recurrent (2 or more urinary tract infections per year) pyelonephritis or cystitis. | |
| 2 | Patients with nonrecurrent urinary tract infections (patients who had no history of more than one urinary tract infections in last year). |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2007 (estimated)
- Study startNov 2004
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaunas University of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Sarunas Rudaitis, MD, Principal investigator, Clinic of Children's Diseases, Kaunas University of MedicineBirute Pundziene, MD, PhD, Study chair, Clinic of Children's Diseases, Kaunas University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528476
- Sponsor's protocol ID
- BE-2-68
- Status last verified
- Sep 2007
- First submitted
- 10 Sep 2007
- Last updated
- 12 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Clinical and Urodynamic Risk Factors for Recurrent Urinary Tract Infection in 5-18 Years Old Children
- ClinicalTrials.gov ID
- NCT00528476
- Acronym / sponsor ID
- BE-2-68
- Conditions
- Urinary Tract Infection, Pyelonephritis, Cystitis
- Keywords
- pyelonephritis, cystitis, risk factor, children, urodynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Kaunas University of MedicineUniversity, hospital or other
- Study start
- Nov 2004
- Study completion
- Jan 2007 (actual)
- First posted
- 12 Sep 2007 (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.
The purpose of this study is to determine clinical and urodynamic risk factors for recurrent urinary tract infection in 5-18 years old children.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients, who were treated because of recurrent (2 or more urinary tract infections per year) pyelonephritis or cystitis. |
| 2 | – | –Patients with nonrecurrent urinary tract infections (patients who had no history of more than one urinary tract infections in last year). |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 5-18 years old children, who were treated because of cystitis and pyelonephritis in Kaunas Medical University Hospital
Key exclusion criteria (5 listed)
- urinary tract malformations
- neurogenic bladder dysfunction
- patients, who received immunosuppressive drugs
- pregnant girls
- children with non bacterial urinary tract infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 12 Sep 2007.
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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.
Sarunas Rudaitis, MD principal investigator
Clinic of Children's Diseases, Kaunas University of Medicine
Birute Pundziene, MD, PhD study chair
Clinic of Children's Diseases, Kaunas University of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Tract Infection and Pyelonephritis, run by Kaunas University of Medicine at 1 site in Lithuania.
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 1 inclusion and 5 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 12 Sep 2007. 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 Lithuania. 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.
Where can I read the original study information?
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 12 Sep 2007; AzTrials last refreshed its copy on 6 Nov 2026.