RecruitingNCT06921746

Changes in the Urinary Microbiome and Metabolome During Treatment of the Overactive Bladder in Female Patients


Sponsor

University Hospital Ostrava

Enrollment

80 participants

Start Date

May 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This is a non-interventional study that will not pose any burden for the participants. The study subjects will be examined and treated in a standard manner according to current clinical recommendations for the treatment of overactive bladder (OAB). A portion of urine samples, which are routinely collected for biochemical and culture examinations as part of the diagnostic process, will be sent for examination of the characteristics of the urinary microbiome and metabolome (UMM) before and after treatment.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • Adult women over 18 years of age
  • Written consent to participate in the study
  • Willingness to undergo OAB evaluation and treatment according to the protocol
  • OAB symptoms lasting longer than 3 months
  • At least 3 episodes of severe urgency with or without urge incontinence within 3 days documented by voiding diary
  • OAB symptom score V8 questionnaire ≥ 8

Exclusion Criteria7

  • Known congenital developmental defects of the urinary tract (congenital hydronephrosis, vesicoureteral reflux, renal agenesis and hypoplasia, multicystic and polycystic kidneys)
  • Any previous treatment for OAB
  • Recurrent urinary tract infections (more than 3 episodes in the last 12 months)
  • Presence of a foreign body in the urinary tract - urolithiasis, urinary catheter, ureteral stent
  • Acute or chronic diseases with possible influence on the function of the lower urinary tract (LUT)
  • Rheumatoid arthritis
  • Diabetes mellitus

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Interventions

DIAGNOSTIC_TESTUrine Microbiological and Metabolomic Analysis

Microbiological and metabolomic analysis of a urine sample will be performed in the study subjects, before and after the end of the treatment.


Locations(4)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czechia

Thomayer University Hospital

Prague, Czechia

Institute of Microbiology of the Czech Academy of Sciences

Prague, Czechia

University Hospital Bulovka

Prague, Czechia

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NCT06921746


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