OAB and the Microbiome

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04831801

Enrollment

Registered

2021-04-05

Start date

2021-06-30

Completion date

2023-11-20

Last updated

2024-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder, Urgency-frequency Syndrome

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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of patients with Lactobacillus in samples.	Day 1	Evaluation of urine and perineal samples by PCR.
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.

Countries

United States

Outcome results