About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
diagnosis of overactive bladder syndrome or mixed urinary incontinence with predominance of overactive bladder symptoms
Disqualifiers
under age 18
neurogenic overactive bladder
Trial design
Parallel
Treatments tested in this trial
OMNi BiOTiC® 41167
Dietary supplementThe product "OMNi BiOTiC® 41167" contains lactobacillus strains
Placebo
Other interventionPlacebo
Treatment groups
Trial outcomes
Primary outcomes
symptom reduction
yes/no
ICIQ-OAB symptom score reduction
Secondary outcomes
change in vaginal/urethral/bladder microbiom
between groups and within one participant
Sponsors and contacts
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