Clinical trial NCT06921746: Changes in the Urinary Microbiome and Metabolome During Treatment of the Overactive Bladder in Female Patients
Official title: Changes in the Urinary Microbiome and Metabolome During Treatment of the Overactive Bladder in Female Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Urinary Microbiome
Urinary Metabolome
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: University Hospital Bulovka
name: Thomayer University Hospital
name: Institute of Microbiology of the Czech Academy of Sciences
First posted: 2025-04-10
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult women with symptoms of overactive bladder persisting longer than three months willing to participate in the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of responders to the OAB treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in UMM characteristics between both groups
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
city: Praha
country: Czechia
facility: Thomayer University Hospital
city: Praha
country: Czechia
facility: Institute of Microbiology of the Czech Academy of Sciences
city: Praha
country: Czechia
facility: University Hospital Bulovka
Study officials:
affiliation: University Hospital Ostrava
name: Jan Krhut, prof., MD, PhD
role: PRINCIPAL_INVESTIGATOR
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