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Oral Lactobacillus Supplementation as Treatment for Overactive Bladder Syndrome: A Randomised Controlled Trial

Oral Lactobacillus Supplementation as Treatment for Overactive Bladder Syndrome: A Randomised Controlled Trial

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06546189
Enrollment
100
Registered
2024-08-09
Start date
2025-04-01
Completion date
2027-10-01
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder Syndrome

Brief summary

Background: Overactive bladder describes a syndrome characterized by frequent urges to urinate and increased urination with or without nocturia and with or without urinary incontinence. Overactive bladder affects approximately 13% of older women and thus represents a condition with high prevalence. Affected women report significant limitations in daily life, as well as social isolation. Despite the high occurrence of this condition, therapeutic options are limited, partly because the etiology of this condition is not fully understood. Increasingly, studies suggest an imbalance in the urogenital microbiome as a possible cause of the development of the condition. Therefore, the aim of this study is to test, whether the oral administration of a lactobacillus preparation can lead to a reduction in symptoms. Design: Randomized controlled study Methods: Intake of OMNi BiOTiC® 41167 or placebo twice daily for 6 months; swabs (vaginal and urethral) and urine samples from a single-use catheter for microbiome determination at 0, 3, and 7 months. Outcome: Reduction of subjective symptoms (yes/no) after 3 and 7 months; reduction of Overactive Bladder Symptom Score after 3 and 7 months; change in the urogenital microbiome after 3 and 7 months (comparison of intervention vs. placebo).

Interventions

DIETARY_SUPPLEMENTOMNi BiOTiC® 41167

The product OMNi BiOTiC® 41167 contains lactobacillus strains

OTHERPlacebo

Placebo

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
symptom reduction6 monthsyes/no
ICIQ-OAB symptom score reduction6 months

Secondary

MeasureTime frameDescription
change in vaginal/urethral/bladder microbiom3 months and 6 monthsbetween groups and within one participant

Countries

Austria

Contacts

Primary ContactMarianne Koch
marianne.koch@meduniwien.ac.at+4314040029150

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026