OAB and the Microbiome

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04831801
• Other study ID #: 20201001
• Status: Terminated
• Start date: June 30, 2021
• Est. completion date: November 20, 2023

Study information

• Verified date: May 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: November 20, 2023
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Syndrome
• Urgency-frequency Syndrome
• Urinary Bladder, Overactive

Locations

Country	Name	City	State
United States	Holy Cross Hospital	Fort Lauderdale	Florida
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with Lactobacillus in samples.	Evaluation of urine and perineal samples by PCR.	Day 1
Primary	Proportion of patients negative for repeat sequencing.	Evaluation of urine and perineal samples by PCR.	Day 1
Primary	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