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NCT Number: NCT06546189

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OMNi BiOTiC® 41167

Dietary Supplement

The product "OMNi BiOTiC® 41167" contains lactobacillus strains

Placebo

Other

Placebo

Primary outcomes

  1. symptom reduction

    Time frame: 6 months

    yes/no

  2. ICIQ-OAB symptom score reduction

    Time frame: 6 months

Secondary outcomes

  1. change in vaginal/urethral/bladder microbiom

    Time frame: 3 months and 6 months

    between groups and within one participant

Study contacts

Contact information is provided by the study sponsor or research team.

Marianne Koch

CONTACT

[email protected]

+4314040029150

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 9, 2024
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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