Targeting Microbiota in Female Overactive Bladder Syndrome

Medical University of Vienna

Status: Enrolling

Conditions: Urinary Bladder, Overactive; Microbiota

Study type: Observational

Funder types: Other

Identifiers

NCT05328011

2160/2019

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

100 participants in 2 patient groups

overactive bladder syndrome

Description:

female patients with overactive bladder syndrome

controls

Description:

women without overactive bladder syndrome