NCT06921746

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: University Hospital Ostrava · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Overactive Bladder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Urine 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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-04-10
• Last updated: 2025-05-04

Locations

4 sites across 1 country: Czechia