Actively Recruiting

Age: 18Years +
FEMALE
ID06921746

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

Led by University Hospital Ostrava · Updated on 2025-05-04

80

Participants Needed

4

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

University Hospital Ostrava

Lead Sponsor

U

University Hospital Bulovka

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying women with overactive bladder (OAB) to understand how the urinary microbiome and metabolome (UMM) change during treatment. This observational study focuses on female patients diagnosed with idiopathic OAB who seek or are referred for treatment. The study aims to compare the characteristics of UMM before and after treatment and to assess treatment response based on symptom improvement. Participants will receive standard drug treatment for OAB over five weeks. Before starting treatment, urine samples will be collected during routine clinical care to analyze the urinary microbiome and metabolome. After five weeks of treatment, participants will complete symptom questionnaires, and a second urine sample will be collected for comparison. Patients will then continue their usual care outside the study. During the study, participants will be asked to provide urine samples and complete standard questionnaires about their OAB symptoms. Researchers will measure treatment response by tracking the reduction in episodes of severe urgency and urge incontinence using a voiding diary. The primary outcome is the proportion of patients responding to treatment after six weeks. Safety monitoring is aligned with routine clinical practice, and participation ends after the second urine collection and questionnaire assessment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 65 8
Not Eligible

You will not qualify if you...

  • Known congenital developmental defects of the urinary tract such as congenital hydronephrosis, vesicoureteral reflux, renal agenesis, hypoplasia, multicystic or polycystic kidneys
  • Any previous treatment for overactive bladder
  • Recurrent urinary tract infections with more than 3 episodes in the last 12 months
  • Presence of foreign body in the urinary tract including urolithiasis, urinary catheter, ureteral stent
  • Acute or chronic diseases that may affect lower urinary tract function
  • Rheumatoid arthritis
  • Diabetes mellitus

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) to verify inclusion and exclusion criteria and collect baseline urine samples and questionnaires

Monitoring

Duration - 5 weeks

Participants undergo standard drug treatment for overactive bladder for five weeks while their symptoms and urine characteristics are monitored.

Participants complete symptom questionnaires and standardized urine collection before and after treatment

Follow-up

Duration - 1 day

Participants complete a final evaluation of treatment effect using symptom questionnaires and urine sample collection to assess changes in urinary microbiome and metabolome.

1 final visit (in-person) for post-treatment assessments

Trial Site Locations

Total: 4 locations

1

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, Czechia, 70852

Actively Recruiting

2

Thomayer University Hospital

Prague, Czechia, 14059

Actively Recruiting

3

Institute of Microbiology of the Czech Academy of Sciences

Prague, Czechia, 14200

Actively Recruiting

4

University Hospital Bulovka

Prague, Czechia, 18081

Actively Recruiting

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Research Team

J

Jiří Hynčica

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

European Association of Urology Guidelines on the Diagnosis and Management of Female Non-neurogenic Lower Urinary Tract Symptoms. Part 1: Diagnostics, Overactive Bladder, Stress Urinary Incontinence, and Mixed Urinary Incontinence.

Arjun K Nambiar, Salvador Arlandis, Kari Bø...

https://pubmed.ncbi.nlm.nih.gov/35216856

Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study.

Debra E Irwin, Ian Milsom, Steinar Hunskaar...

https://pubmed.ncbi.nlm.nih.gov/17049716

What is the most bothersome lower urinary tract symptom? Individual- and population-level perspectives for both men and women.

Arnav Agarwal, Leyla N Eryuzlu, Rufus Cartwright...

https://pubmed.ncbi.nlm.nih.gov/24486308

The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society.

Paul Abrams, Linda Cardozo, Magnus Fall...

https://pubmed.ncbi.nlm.nih.gov/11857671

1H-nuclear magnetic resonance spectroscopy for identifying and quantifying common uropathogens: a metabolic approach to the urinary tract infection.

Ashish Gupta, Mayank Dwivedi, Abbas Ali Mahdi...

https://pubmed.ncbi.nlm.nih.gov/19239442

An Overview of the Microbiota of the Human Urinary Tract in Health and Disease: Current Issues and Perspectives.

Marica Colella, Skender Topi, Raffaele Palmirotta...

https://pubmed.ncbi.nlm.nih.gov/37511861