Daily oral Lactobacillus to reduce overactive bladder symptoms
Oral Lactobacillus Supplementation as Treatment for Overactive Bladder Syndrome: A Randomised Controlled Trial
This trial will see if taking an oral Lactobacillus supplement twice daily for six months reduces urgency, frequency, or leakage in adult women with overactive bladder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Medical University of Vienna Academic / other |
| Locations | 1 site (Vienna) |
| Trial ID | NCT06546189 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled study randomizing participants to receive OMNi BiOTiC® 41167 or matched placebo twice daily for six months. Investigators will collect vaginal and urethral swabs and urine via a single-use catheter at baseline and follow-up visits to monitor changes in the urogenital microbiome. Symptom changes will be tracked with validated overactive bladder questionnaires and voiding diaries. The protocol seeks to link any symptom improvement to shifts in microbial communities associated with Lactobacillus supplementation.
Who should consider this trial
Good fit: Adult women diagnosed with overactive bladder syndrome or mixed urinary incontinence dominated by overactive bladder symptoms are the intended participants.
Not a fit: People under 18 and those with neurogenic overactive bladder are excluded and are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this could provide a low-risk, non-antibiotic option to reduce urgency, frequency, and incontinence for women with overactive bladder.
How similar studies have performed: Previous small studies of vaginal or oral Lactobacillus for urinary or urogenital symptoms have shown mixed but sometimes promising results, so this approach is not entirely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosis of overactive bladder syndrome or mixed urinary incontinence with predominance of overactive bladder symptoms Exclusion Criteria: * under age 18 * neurogenic overactive bladder
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (Recruiting)
Study contacts
- Study coordinator: Marianne Koch
- Email: marianne.koch@meduniwien.ac.at
- Phone: +4314040029150
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.