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OpenTrials
Completed

NCT Number: NCT02092558

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solution

Drug

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

Primary outcomes

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

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Children's Hospital, Dziekanów Leśny, Poland

Other

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2013
First posted
Mar 20, 2014
Registry last updated
Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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