The Follow-up Duration Was 1-8 Years.NCT02092558
Evaluation of Immunological Disorders of T Lymphocytes and Endocrinological Disorders as Pathogen Factors in Patients With Metaplasia of Urinary Bladder
An observational study of The Follow-up Duration Was 1-8 Years. and The Main Reasons Behind Visiting the Hospital Were Recurrent Urinary Tract Infection,, run by Children's Hospital, Dziekanów Leśny, Poland at 1 site in Poland.
Trial summary
Background: Squamous metaplasia refers to the pathological transformation of the urothelium leading to non-keratinised stratified squamous metaplasia (N-KSM). Objective: To present the investigators experiences in the diagnosis and treatment of N-KSM of the urinary bladder in children. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- The Follow-up Duration Was 1-8 Years., The Main Reasons Behind Visiting the Hospital Were Recurrent Urinary Tract Infection,, Urinary Urgencies, Pollakiuria, Difficulty in Initiating Micturition, Pain in Hypogastrium,
- What is being tested?
- Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solution and cephalosporin with chemotherapeutics
- How many people
- 2 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2005to Dec 2013
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: In all, 119 children (116 girls and 3 boys), aged between 5 and 17 years (mean age, 13.7 years), who were treated in the Pediatric Surgery Department during the period of 2005-2013 were included in this study
Who may be able to join
- The follow-up duration was 1-8 years.
- The main reasons behind visiting the hospital were:
- recurrent urinary tract infection,
- urinary urgencies,
- pollakiuria,
- difficulty in initiating micturition,
Show all 11Show fewer
- pain in hypogastrium,
- night wetting and day wetting,
- menstruation's disorders,
- urolithiasis,
- defects of urinary system and hematuria.
Who cannot join
- No confirmation of squamous metaplasia of the urinary bladder in diagnostic cystoscopy
Trial locations and contacts
1 site in 1 country.
Poland1 site
Children's Hospital, Marii Konopnickiej Street 65
Dziekanów Lesny, 05-092
About this study
Background: Squamous metaplasia refers to the pathological transformation of the urothelium leading to non-keratinised stratified squamous metaplasia (N-KSM).
Objective: To present the investigators experiences in the diagnosis and treatment of N-KSM of the urinary bladder in children.
Read the detailed description
Design, setting, and participants: In this study, the investigators present their experiences in the diagnosis and treatment of N-KSM of the urinary bladder in children aged from 5 to 17 years. From 2005 to 2013, metaplasia was diagnosed in 119 patients - 116 girls and 3 boys. The reasons behind visiting the hospital were non-specific intense pain in the abdomen, recurrent urinary tract infections, and urination disorders. The most common symptoms of urinary bladder dysfunction were pollakiuria and difficulties in initiating micturition and retention of urine (reduced detrusor muscle activity).
Outcome measurements and statistical analysis: In 20 patients (16.8%), metaplasia was incidentally diagnosed during cystoscopy performed for other causes. Only the children whose bladders showed metaplastic changes on cystoscopy were subjected to a bladder biopsy for collecting specimens for further histopathological examination.
- Conditions
- The Follow-up Duration Was 1-8 Years., The Main Reasons Behind Visiting the Hospital Were Recurrent Urinary Tract Infection,, Urinary Urgencies, Pollakiuria, Difficulty in Initiating Micturition, Pain in Hypogastrium,, Night Wetting and Day Wetting, Menstruation's Disorders, Urolithiasis, Defects of Urinary, System and Hematuria.
- Being tested
- Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solution, cephalosporin with chemotherapeutics
- Keywords
- metaplasia, dysfunction, urinary bladder, children
- Medical subject headings
- Urolithiasis, Hematuria, Metaplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solutionDrug
cephalosporin with chemotherapeuticsDrug
Second-generation cephalosporin was prescribed for 10 days, and then treatment crossover with chemotherapeutics in therapeutic dose (change in every week) during 3 months
| Study group | Role | What they receive |
|---|---|---|
| Female 1 | Owing to the absence of an established treatment modality for squamous metaplasia of the urinary bladder in children, we developed our own treatment modalities. Children presenting with recurrent urinary tract infections on medical interview, were subjected to ultrasonography of the urinary system, repeated urinalysis, and urine culture tests. Then, on the basis of antibiogram findings, antibiotic and chemotherapeutic treatment was administered to eliminate the bacteriological factors. Second-generation cephalosporin was prescribed for 10 days, and then treatment crossover with chemotherapeutics in therapeutic dose (change in every week) during 3 months. Receives: Drug: Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solution | |
| Male 2 | Owing to the absence of an established treatment modality for squamous metaplasia of the urinary bladder in children, we developed our own treatment modalities. Children presenting with recurrent urinary tract infections on medical interview, were subjected to ultrasonography of the urinary system, repeated urinalysis, and urine culture tests. Then, on the basis of antibiogram findings, antibiotic and chemotherapeutic treatment was administered to eliminate the bacteriological factors. Second-generation cephalosporin was prescribed for 10 days, and then treatment crossover with chemotherapeutics in therapeutic dose (change in every week) during 3 months. Receives: Drug: cephalosporin with chemotherapeutics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of stratified squamous metaplasia of urinary bladder and treatment's ways
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startJan 2005
- Primary completionJan 2009
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Follow-up Duration Was 1-8 Years.Studies 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
- Retrospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital, Dziekanów Leśny, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beata Jurkiewicz, Children's Hospital, Dziekanów Leśny, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092558
- Sponsor's protocol ID
- KB/677/09
- Other IDs
- Bioethics Commitee of Regional, KB/677/09
- Status last verified
- Mar 2014
- First submitted
- 14 Mar 2014
- Last updated
- 20 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Immunological Disorders of T Lymphocytes and Endocrinological Disorders as Pathogen Factors in Patients With Metaplasia of Urinary Bladder
- ClinicalTrials.gov ID
- NCT02092558
- Acronym / sponsor ID
- KB/677/09
- Conditions
- The Follow-up Duration Was 1-8 Years., The Main Reasons Behind Visiting the Hospital Were Recurrent Urinary Tract Infection,, Urinary Urgencies, Pollakiuria, Difficulty in Initiating Micturition, Pain in Hypogastrium,, Night Wetting and Day Wetting, Menstruation's Disorders, Urolithiasis, Defects of Urinary, System and Hematuria.
- Keywords
- metaplasia, dysfunction, urinary bladder, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Children's Hospital, Dziekanów Leśny, PolandUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2009 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Mar 2014 (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.
Background: Squamous metaplasia refers to the pathological transformation of the urothelium leading to non-keratinised stratified squamous metaplasia (N-KSM).
Objective: To present the investigators experiences in the diagnosis and treatment of N-KSM of the urinary bladder in children.
Detailed description
Design, setting, and participants: In this study, the investigators present their experiences in the diagnosis and treatment of N-KSM of the urinary bladder in children aged from 5 to 17 years. From 2005 to 2013, metaplasia was diagnosed in 119 patients - 116 girls and 3 boys. The reasons behind visiting the hospital were non-specific intense pain in the abdomen, recurrent urinary tract infections, and urination disorders. The most common symptoms of urinary bladder dysfunction were pollakiuria and difficulties in initiating micturition and retention of urine (reduced detrusor muscle activity).
Outcome measurements and statistical analysis: In 20 patients (16.8%), metaplasia was incidentally diagnosed during cystoscopy performed for other causes. Only the children whose bladders showed metaplastic changes on cystoscopy were subjected to a bladder biopsy for collecting specimens for further histopathological examination.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Female 1 | – | Drug: Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solutionOwing to the absence of an established treatment modality for squamous metaplasia of the urinary bladder in children, we developed our own treatment modalities. Children presenting with recurrent urinary tract infections on medical interview, were subjected to ultrasonography of the urinary system, repeated urinalysis, and urine culture tests. Then, on the basis of antibiogram findings, antibiotic and chemotherapeutic treatment was administered to eliminate the bacteriological factors. Second-generation cephalosporin was prescribed for 10 days, and then treatment crossover with chemotherapeutics in therapeutic dose (change in every week) during 3 months. |
| Male 2 | – | Drug: cephalosporin with chemotherapeuticsOwing to the absence of an established treatment modality for squamous metaplasia of the urinary bladder in children, we developed our own treatment modalities. Children presenting with recurrent urinary tract infections on medical interview, were subjected to ultrasonography of the urinary system, repeated urinalysis, and urine culture tests. Then, on the basis of antibiogram findings, antibiotic and chemotherapeutic treatment was administered to eliminate the bacteriological factors. Second-generation cephalosporin was prescribed for 10 days, and then treatment crossover with chemotherapeutics in therapeutic dose (change in every week) during 3 months. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- In all, 119 children (116 girls and 3 boys), aged between 5 and 17 years (mean age, 13.7 years), who were treated in the Pediatric Surgery Department during the period of 2005-2013 were included in this study
Key inclusion criteria (11 listed)
- The follow-up duration was 1-8 years.
- The main reasons behind visiting the hospital were:
Key exclusion criteria (1 listed)
- No confirmation of squamous metaplasia of the urinary bladder in diagnostic cystoscopy
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 |
|---|---|---|
| Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solution | Drug | Female 1 |
| cephalosporin with chemotherapeuticsSecond-generation cephalosporin was prescribed for 10 days, and then treatment crossover with chemotherapeutics in therapeutic dose (change in every week) during 3 months | Drug | Male 2 |
Primary outcome
Symptoms of stratified squamous metaplasia of urinary bladder and treatment's ways
Time frame: 5 years
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 20 Mar 2014.
- Bioethics Commitee in WarsawLink provided by the sponsor.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 The Follow-up Duration Was 1-8 Years. and The Main Reasons Behind Visiting the Hospital Were Recurrent Urinary Tract Infection,, run by Children's Hospital, Dziekanów Leśny, Poland at 1 site in Poland.
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 11 inclusion and 1 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 20 Mar 2014. 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 Poland. 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?
Symptoms of stratified squamous metaplasia of urinary bladder and treatment's ways (time frame: 5 years). It is what the study was designed to measure, not a finding.
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 20 Mar 2014.