Targeting Microbiota in Female Overactive Bladder Syndrome

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05328011

Enrollment

100

Registered

2022-04-14

Start date

2020-12-01

Completion date

2024-11-30

Last updated

2022-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbiota, Urinary Bladder, Overactive

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame
urinary bacterial and viral microbiome	1 day

Secondary

Measure	Time frame
bacterial and viral microbiome of vagina, urethra, feces and oral cavity	1 day

Countries

Austria

Contacts

Primary ContactMarianne Koch, MD PhD

marianne.koch@meduniwien.ac.at+4314040029150

Outcome results