OAB and the Microbiome

University of Miami

Status: Terminated

Conditions: Urgency-frequency Syndrome; Overactive Bladder

Study type: Observational

Funder types: Other

Identifiers

NCT04831801

20201001

Details and patient eligibility

About

To determine differences in the urinary microbiomes, identified by polymerase change reaction (PCR) (UTIP™), of female patients with urgency and frequency syndrome with or without pelvic pain (Group A) compared to female controls without symptoms of lower urinary tract symptoms (LUTS) (Group B).

Enrollment: 39 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 y/o-90 y/o
• Able to consent
• Group A only: Urgency and Frequency Syndrome or OAB only. UDI-6 answer of "moderately" to "quite a bit" on questions 1 or 2.
• Group B only: Urinary Distress Inventory 6 (UDI-6) answer "not at all" or "somewhat" for questions 1 or 2.

Exclusion criteria

• Pregnant
• Pelvic radiation
• Urinary retention (>200 ml)
• Renal calculi
• Recurrent urinary tract infection (UTI) (2 in 6 months), or
• Current UTI
• Immunosuppressed or radiation history
• Neurologic disorder

Trial design

39 participants in 2 patient groups

Female patients with overactive bladder (OAB)

Description:

Patients with urgency and frequency syndrome with or without pelvic pain (Group A) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient.

Female control patients without LUTS

Description:

Patients without LUTS (Group B) will provide two urine samples. One urine sample is a clean catch and the other is a catheterized specimen. Both will be sent for analysis. A perineal swab will also be collect and analyzed for each patient.