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

NCT02092558 | Completed DMC

• 2 other identifiers: KB/677/09Bioethics Commitee of Regional
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Symptoms of stratified squamous metaplasia of urinary bladder and treatment's ways

  5 years

Study Arms (2)

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

Interventions

Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solution DRUG

Female 1

cephalosporin with chemotherapeutics DRUG

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

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital, Dziekanów Leśny, Poland: lead

Study Sites (1)

Children's Hospital, Marii Konopnickiej Street 65

Dziekanów Lesny, 05-092, Poland

Location

Related Links

• Bioethics Commitee in Warsaw

MeSH Terms

Conditions

Urolithiasis; Hematuria; Metaplasia

Interventions

Second Generation Cephalosporins; Nitrofurantoin; Cephalosporins

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

beta Lactam Antibiotics; Anti-Bacterial Agents; Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Nitrofurans; Nitro Compounds; Organic Chemicals; Furans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD MD

Study Record Dates

• First Submitted: March 14, 2014
• First Posted: March 20, 2014
• Study Start: January 1, 2005
• Primary Completion: January 1, 2009
• Study Completion: December 1, 2013
• Last Updated: March 20, 2014

Record last verified: 2014-03

Locations

PL (1)