OAB and the Microbiome
Terminated
- Conditions
- Overactive BladderUrgency-frequency Syndrome
- Registration Number
- NCT04831801
- Lead Sponsor
- University of Miami
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 39
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients negative for repeat sequencing. Day 1 Evaluation of urine and perineal samples by PCR.
Proportion of patients with change in UDI-6 score Up to 4 weeks UDI 6 question 1 and 2 has a total score from 0-6 with a high score indicating more distress. Proportion of patients with a decrease in score from baseline will be reported for this outcome.
Proportion of patients with Lactobacillus in samples. Day 1 Evaluation of urine and perineal samples by PCR.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Holy Cross Hospital
🇺🇸Fort Lauderdale, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States