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

Sponsor

Children's Hospital, Dziekanów Leśny, Poland (Other)

Overall Status

Completed

CT.gov ID

NCT02092558

Collaborator

(none)

Enrollment

Location

107

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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.	Drug: Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solution Drug: cephalosporin with chemotherapeutics

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

Study Type:

Observational

Actual Enrollment :

2 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Study Start Date :

Jan 1, 2005

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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.	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.	Drug: 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

Arm

Intervention/Treatment

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.

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

Male 2

Drug: 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