Targeting Microbiota in Female Overactive Bladder Syndrome

NCT ID: NCT05328011

Last Updated: 2022-04-14

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2024-11-30

Brief 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.

Conditions

Microbiota; Urinary Bladder, Overactive

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

overactive bladder syndrome

female patients with overactive bladder syndrome

No interventions assigned to this group

controls

women without overactive bladder syndrome

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

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

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Wolfgang Umek, MD

Ao.Univ.-Prof. Dr.med.univ.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Marianne Koch, MD PhD

Role: CONTACT

marianne.koch@meduniwien.ac.at

+4314040029150

Facility Contacts

Marianne Koch, MD PhD

Role: primary

marianne.koch@meduniwien.ac.at

+4314040029150

Other Identifiers

2160/2019

Identifier Type: -

Identifier Source: org_study_id