Examining changes in the urinary microbiome and metabolome in women with overactive bladder
Official title: Changes in the Urinary Microbiome and Metabolome During Treatment of the Overactive Bladder in Female Patients
Run by University Hospital Ostrava · NCT06921746 · Data updated 2026-11-12
This study looks at how the bacteria and substances in the urine of women with overactive bladder change before and after they receive standard treatment to see if these changes relate to their improvement in symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 80 (estimated) |
| Sponsor | University Hospital Ostrava Academic / other |
| Locations | 4 sites (Ostrava, Moravian-Silesian Region and 3 other locations) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | May 4, 2025 |
| Trial ID | NCT06921746 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult women over 18 years old experiencing OAB symptoms for more than three months.
✕Probably not a fit
Patients with known congenital urinary tract defects or those who have previously received treatment for OAB may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the urinary microbiome and metabolome in female patients diagnosed with overactive bladder (OAB) as they undergo standard treatment. Participants will provide urine samples before and after treatment, which will be analyzed to identify changes in microbial and metabolic profiles. The study aims to categorize patients based on their treatment response, using a defined criterion of symptom improvement. Standard questionnaires will also be utilized to assess the severity of OAB symptoms throughout the study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the urinary microbiome's role in OAB treatment, potentially leading to more personalized and effective therapies.
How similar studies have gone: While the specific approach of examining the urinary microbiome and metabolome in OAB is novel, similar studies in other conditions have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia Recruiting -
Thomayer University Hospital
Prague, Czechia Recruiting -
Institute of Microbiology of the Czech Academy of Sciences
Prague, Czechia Recruiting -
University Hospital Bulovka
Prague, Czechia Recruiting
Study contacts
- Principal investigator: Jan Krhut, prof., MD, PhD — University Hospital Ostrava
- Study coordinator: Jiří Hynčica
- Email: jiri.hyncica@fno.cz
- Phone: 0042059737
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.