Medical University of Vienna
Vienna, 1090, Austria
Location status: Recruiting
Location contact
Barbara Bodner-Adler, Prof. MD
CONTACT
Marianne Koch, PD MD PhD
CONTACT
Marianne Koch, PD MD PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06546189
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).
Interested in participating?
Request Info18 year and older
Female
Interventional
Not applicable
Vienna, 1090, Austria
Location status: Recruiting
Barbara Bodner-Adler, Prof. MD
CONTACT
Marianne Koch, PD MD PhD
CONTACT
Marianne Koch, PD MD PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The product "OMNi BiOTiC® 41167" contains lactobacillus strains
Placebo
Time frame: 6 months
yes/no
Time frame: 6 months
Time frame: 3 months and 6 months
between groups and within one participant
Contact information is provided by the study sponsor or research team.
Medical University of Vienna
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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