Oral Lactobacillus Supplementation as Treatment for Overactive Bladder Syndrome: A Randomised Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OMNi BiOTiC® 41167, Placebo.
- Who it may be relevant to
- Registry conditions: Overactive Bladder Syndrome. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 supplement OMNi BiOTiC® 41167
The product "OMNi BiOTiC® 41167" contains lactobacillus strains - Other Placebo
Placebo
Primary outcome measures
- symptom reduction [Time frame: 6 months]
- ICIQ-OAB symptom score reduction [Time frame: 6 months]
Secondary outcome measures (1)
- change in vaginal/urethral/bladder microbiom [Time frame: 3 months and 6 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Austria · 1 center
- Medical University of Vienna — Vienna
Identifiers
NCT: NCT06546189 · 1917/2024