What is this study trying to find out about overactive bladder?

This study is observing changes in the urinary microbiome and metabolome during treatment of overactive bladder in women. Researchers want to understand how these urinary characteristics relate to symptom improvement. It is sponsored by the University Hospital Ostrava and helps improve knowledge of OAB treatment effects.

Who may be eligible for this overactive bladder clinical trial?

Women aged 18 years or older with overactive bladder symptoms lasting more than 3 months may be eligible. Participants must not have had previous OAB treatment and should not have recurrent urinary tract infections or certain urinary tract conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this overactive bladder clinical trial?

Study-related care, including standard treatment and all study visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan for any travel costs themselves.

Actively Recruiting

Age: 18Years +

FEMALE

ID06921746

Study of Changes in Urinary Microbiome and Metabolome During Treatment of Overactive Bladder in Adult Women

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

Participants Needed

Research Sites

52 weeks

Total Duration

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

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

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

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