Overactive Bladder
Conditions
Keywords
Overactive Bladder, Urinary Microbiome, Urinary Metabolome
Brief 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.
Detailed description
Participation in the study will be offered to female patients who seek treatment for OAB symptoms themselves or are referred to centers participating in the project if a clinical diagnosis of idiopathic OAB is established in their case as part of the standard examination process. Patients will be approached by one of the authorized team members with information about the possibility of participating in this study. If the patient is interested in participating in the study, she will give written informed consent to participate in the study. Subsequently, the inclusion and exclusion criteria for participation in the study will be verified and a standardized urine collection will be performed to examine the characteristics of UMM. At the same time, the patient will fill in standard questionnaires used to determine the severity of OAB symptoms. To research changes in UMM during OAB treatment, patients will be divided into a group with a good treatment response (responders) and a group without a good treatment response (non-responders). The primary indicator of a good treatment effect (definition of responder) is a reduction in the number of episodes of severe urgency with or without urge incontinence over 3 days documented by a voiding diary by more than 50% compared to the state before treatment. Based on the available data, treatment success is anticipated in 60% of patients. Subsequently, the study participants will be treated with standard drug treatment for five weeks. They will then be invited to evaluate the effect of treatment using standard symptom questionnaires. At the same time, a control standardized urine collection will be performed to examine the characteristics of UMM. The patients will then end their participation in the study and will continue their treatment according to the valid clinical recommendations for treatment.
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.
Sponsors
University Hospital Bulovka
Thomayer University Hospital
Institute of Microbiology of the Czech Academy of Sciences
University Hospital Ostrava
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of responders to the OAB treatment | 6 weeks | The proportion of study subjects responding to the treatment of OAB symptoms will be observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in UMM characteristics between both groups | 6 weeks | Changes in UMM characteristics based on laboratory examination will be compared between the two study groups (responders vs non-responders) |
Countries
Czechia
Contacts
Primary ContactJiří Hynčica
Outcome results
None listed