Targeting Microbiota in Female Overactive Bladder Syndrome

Microbiota Clinical Trial

Official title:

Targeting Microbiota in Female Overactive Bladder Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05328011
• Other study ID #: 2160/2019
• Status: Recruiting
• Start date: December 1, 2020
• Est. completion date: November 30, 2024

Study information

• Verified date: March 2022
• Source: Medical University of Vienna
• Contact: Marianne Koch, MD PhD
• Phone: +4314040029150
• Email: marianne.koch[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to compare the urinary viral microbiome and bacterial microbiome between overactive bladder syndrome (OAB) patients and healthy controls in order to determine a possible alteration in the urinary microbiome which may predispose women for OAB, and also in order to determine a possible influence of the urinary viral microbiome on the urinary bacterial microbiome which may predispose the individual to OAB. Furthermore, we aim to compare the urinary bacterial microbiome to the vaginal, rectal, urethral and salivary bacterial microbiome within the same individual and between the two groups in order to determine a possible route of colonization of the urinary bladder.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (case group):

• symptoms of overactive bladder (urgency with or without urinary leakage, usually with frequency and nocturia)

Exclusion Criteria (case group):

• Pregnant or lactating females

• Neurological conditions (such as MS, Parkinson, spinal cord injury, stroke..)

• Pelvic Organ Prolapse (stage = 3)

• Lower Urinary Tract surgery within past 6 months

• Known history of interstitial cystitis or pain associated with OAB

• Recurrent urinary tract infections > 3/year

• Acute urinary tract infection

• Urinary retention (with or without required self- catheterization)

• Stress urinary incontinence or mixed urinary incontinence

• Bladder cancer

• Renal insufficiency

• Urinary tract stones

Inclusion Criteria (control group):

without symptoms of overactive bladder or any other form of lower urinary tract symptoms

• Age-matched to case group (+/- 5 years)

• BMI-matched to case group (18,5- 24,9 kg/m2 normal weight; 25- 29,9 kg/m2 overweight; 30- 34,9 kg/m2 obesity grade I)

Exclusion criteria (control group):

As case group plus any form of lower urinary tract symptoms including OAB

Related Conditions & MeSH terms

• Microbiota
• Urinary Bladder, Overactive

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary bacterial and viral microbiome		1 day
Secondary	bacterial and viral microbiome of vagina, urethra, feces and oral cavity		1 day