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

Sponsors

Lead Sponsor: Children's Hospital, Dziekanów Leśny, Poland

Source Children's Hospital, Dziekanów Leśny, Poland
Brief 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.

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.

Overall Status Completed
Start Date January 2005
Completion Date December 2013
Primary Completion Date January 2009
Study Type Observational
Primary Outcome
Measure Time Frame
Symptoms of stratified squamous metaplasia of urinary bladder and treatment's ways 5 years
Enrollment 2
Condition
Intervention

Intervention Type: Drug

Intervention Name: Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solution

Arm Group Label: Female 1

Intervention Type: Drug

Intervention Name: cephalosporin with chemotherapeutics

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

Arm Group Label: Male 2

Eligibility

Sampling Method: Probability Sample

Criteria:

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

Gender: All

Minimum Age: 5 Years

Maximum Age: 17 Years

Healthy Volunteers: No

Location
Facility: Children's Hospital, Marii Konopnickiej Street 65
Location Countries

Poland

Verification Date

March 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Children's Hospital, Dziekanów Leśny, Poland

Investigator Full Name: Beata Jurkiewicz

Investigator Title: PhD MD

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Female 1

Description: 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.

Label: Male 2

Description: 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.

Study Design Info

Observational Model: Case-Control

Time Perspective: Retrospective

Source: ClinicalTrials.gov