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NCT02092558 Clinical Trial

Evaluation of Immunological Disorders of T Lymphocytes and Endocrinological Disorders as Pathogen Factors in Patients With Metaplasia of Urinary Bladder

Night Wetting and Day Wetting, Menstruation's Disorders, Urolithiasis, Defects of Urinary Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02092558
Other study ID # KB/677/09
Secondary ID Bioethics Commit
Status Completed
Phase N/A
First received March 14, 2014
Last updated March 19, 2014
Start date January 2005
Est. completion date December 2013

Study information
Verified date March 2014
Source Children's Hospital, Dziekanów Lesny, Poland
Contact n/a
Is FDA regulated No
Health authority Poland: Ethics Committee
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 2
Est. completion date December 2013
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 17 Years
Eligibility Inclusion Criteria:

- The follow-up duration was 1-8 years.

- The main reasons behind visiting the hospital were:

1. recurrent urinary tract infection,

2. urinary urgencies,

3. pollakiuria,

4. difficulty in initiating micturition,

5. pain in hypogastrium,

6. night wetting and day wetting,

7. menstruation's disorders,

8. urolithiasis,

9. defects of urinary system and hematuria.

Exclusion Criteria:

- No confirmation of squamous metaplasia of the urinary bladder in diagnostic cystoscopy

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Drug:
• Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solution

• cephalosporin with chemotherapeutics
Second-generation cephalosporin was prescribed for 10 days, and then treatment crossover with chemotherapeutics in therapeutic dose (change in every week) during 3 months

Locations
Country Name City State
Poland Children's Hospital, Marii Konopnickiej Street 65 Dziekanów Lesny

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital, Dziekanów Lesny, Poland

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptoms of stratified squamous metaplasia of urinary bladder and treatment's ways 5 years No

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