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NCT Number: NCT06921746

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Ostrava, Ostrava, Moravian-Silesian Region, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Urine Microbiological and Metabolomic Analysis

Diagnostic Test

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

Primary outcomes

  1. Proportion of responders to the OAB treatment

    Time frame: 6 weeks

    The proportion of study subjects responding to the treatment of OAB symptoms will be observed.

Secondary outcomes

  1. Change in UMM characteristics between both groups

    Time frame: 6 weeks

    Changes in UMM characteristics based on laboratory examination will be compared between the two study groups (responders vs non-responders)

Study contacts

Contact information is provided by the study sponsor or research team.

Jiří Hynčica

CONTACT

[email protected]

0042059737 ext. 2587

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • Institute of Microbiology of the Czech Academy of Sciences
  • Thomayer University Hospital
  • University Hospital Bulovka

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 10, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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