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

Completed

• 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.
• Interventions: Drug: Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solution; Drug: cephalosporin with chemotherapeutics

• Registration Number: NCT02092558
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2009-01
• Study Completion: 2013-12
• Status Verified: 2014-03
• Study First Submitted: 2014-03-14
• Study First Submitted QC: 2014-03-19
• Last Update Submitted: 2014-03-19
• Study First Posted: 2014-03-20
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Female 1	Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solution	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.
Male 2	cephalosporin with chemotherapeutics	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.

Primary Outcome Measures

Name	Time	Method
Symptoms of stratified squamous metaplasia of urinary bladder and treatment's ways	5 years

Trial Locations

Locations (1)

Children's Hospital, Marii Konopnickiej Street 65; 🇵🇱 Dziekanów Lesny, Poland