About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Adult women with symptoms of overactive bladder persisting longer than three months willing to participate in the study.
Trial design
Case-only
Prospective
Treatments tested in this trial
Urine Microbiological and Metabolomic Analysis
Diagnostic testMicrobiological and metabolomic analysis of a urine sample will be performed in the study subjects, before and after the end of the treatment.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of responders to the OAB treatment
The proportion of study subjects responding to the treatment of OAB symptoms will be observed.
Secondary outcomes
Change in UMM characteristics between both groups
Changes in UMM characteristics based on laboratory examination will be compared between the two study groups (responders vs non-responders)
Sponsors and contacts
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University Hospital Ostrava
Lead sponsor
University Hospital Bulovka
Collaborator
Thomayer University Hospital
Collaborator
Institute of Microbiology of the Czech Academy of Sciences
Collaborator