Clinical trial NCT02092558: Evaluation of Immunological Disorders of T Lymphocytes and Endocrinological Disorders as Pathogen Factors in Patients With Metaplasia of Urinary Bladder
Study type: OBSERVATIONAL
Overall status: 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.
Keywords: metaplasia, dysfunction, urinary bladder, children
Lead sponsor: Children's Hospital, Dziekanów Leśny, Poland
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 2
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: Symptoms of stratified squamous metaplasia of urinary bladder and treatment's ways
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dziekanów Lesny
country: Poland
facility: Children's Hospital, Marii Konopnickiej Street 65
Study officials:
References: