OAB and the Microbiome

Trends in the Microbiome Profiles of Women With Urgency and Frequency Syndrome, With or Without Pelvic Pain?

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).

Study Overview

• Status: Recruiting
• Conditions: Overactive Bladder; Urgency-frequency Syndrome

• Study Type: Observational
• Enrollment (Anticipated): 210

Contacts and Locations

• Study Contact: Name: Laura Martin, DO; Phone Number: 3052436590; Email: lem114@med.miami.edu

Study Locations

• United States
  • Florida
    • Fort Lauderdale, Florida, United States, 33301
      • Not yet recruiting
      • Holy Cross Hospital
      • Contact: GW Davila, MD; Phone Number: 954-229-8660; Email: gwilly.davila@holy-cross.com
      • Principal Investigator: GW Davila, MD
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Laura Martin, DO; Phone Number: 305-243-6590; Email: lem114@med.miami.edu
      • Principal Investigator: Laura Martin, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Female patients with OAB and controls will be enrolled from University of Miami's or Holy Cross Hospital's female pelvic medicine and reconstructive surgery clinics.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Female patients with overactive bladder (OAB); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with Lactobacillus in samples.	Evaluation of urine and perineal samples by PCR.	Day 1
Proportion of patients negative for repeat sequencing.	Evaluation of urine and perineal samples by PCR.	Day 1
Proportion of patients with change in UDI-6 score	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.	Up to 4 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Laura Martin, DO, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: April 2, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 10, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Disease; Urinary Bladder, Overactive; Syndrome
• Other Study ID Numbers: 20201001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No