OAB and the Microbiome

NCT04831801 | Terminated

• 1 other identifier: 20201001
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 2

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).

Conditions

Overactive Bladder; Urgency-frequency Syndrome

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (2)

Holy Cross Hospital

Fort Lauderdale, Florida, 33301, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Laura Martin, DO

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 5, 2021
• Study Start: June 30, 2021
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)