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

NCT06546189 | Recruiting

• 1 other identifier: 1917/2024
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Overactive Bladder Syndrome

Outcome Measures

Primary Outcomes (2)

• symptom reduction

  yes/no

  6 months

• ICIQ-OAB symptom score reduction

  6 months

Secondary Outcomes (1)

• change in vaginal/urethral/bladder microbiom

  3 months and 6 months

Study Arms (2)

1

ACTIVE COMPARATOR

OMNi BiOTiC® 41167 sachet diluded in a glass of water twice daily oral intake for 6 months

Dietary Supplement: OMNi BiOTiC® 41167

2

PLACEBO COMPARATOR

Placebo sachet diluted in a glass of water twice daily oral intake for 6 months

Other: Placebo

Interventions

OMNi BiOTiC® 41167 DIETARY_SUPPLEMENT

The product "OMNi BiOTiC® 41167" contains lactobacillus strains

1

Placebo OTHER

Placebo

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of overactive bladder syndrome or mixed urinary incontinence with predominance of overactive bladder symptoms

You may not qualify if:

• under age 18
• neurogenic overactive bladder

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Central Study Contacts

Marianne Koch

CONTACT

+4314040029150; marianne.koch@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Priv.-Doz.Dr.med.univ., PhD

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-06

Locations

AU (1)