Trials Sponsors Conditions Drugs Pricing

Conditions

Lower Urinary Tract Infection Lower Urinary Tract Symptoms

Keywords

urine specimencontamination

Outcome Measures

Primary Outcomes (1)

Contamination of urine specimen with urethral and vaginal flora
Contamination defined as: presence of urethral or vaginal flora on urine culture OR epithelial cell presence in urinalysis
2 specimens from each subject (1 from each arm) will be taken to the lab for urinalysis and culture immediately after specimens are given. Culture results will be reported in 48 hours. After results are recorded, no further assessment of this outcome.

Secondary Outcomes (1)

Visual Analog Scale (this is the only title for this scale)
Performed one time immediately after intervention. This will not be repeated.

Other Outcomes (1)

Patient Preference
Performed one time immediately after intervention. This will not be repeated.

Study Arms (2)

PEEZY specimen

EXPERIMENTAL

All subjects will use PEEZY to give a urine specimen.

Device: Midstream urine collection device

CATHETER specimen

PLACEBO COMPARATOR

All subjects will use CATHETER (performed by their clinician) to give a urine specimen, following PEEZY use.

Device: Catheter for urine collection

Interventions

Midstream urine collection deviceDevice

Non-invasive midstream urine collection device

Also known as: PEEZY

PEEZY specimen

Catheter for urine collectionDevice

In-and-out catheter obtains urine through the urethra.

Also known as: Straight catheter

Eligibility Criteria

Age18 Years - 95 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Females presenting to the Urology or Urogynecology clinic for consultation or evaluation of lower urinary tract complaints.

You may not qualify if:

Sponsors & Collaborators

Forte Medical
Type not reportedcollaborator
Baylor Research Institute
Otherlead

Study Sites (1)

Baylor Scott and White Health

Temple, Texas, 76508, United States

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

CathetersUrine Specimen Collection

Condition Hierarchy (Ancestors)

Urological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and SuppliesSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

Rachel High, DO
Baylor Scott and White Health
PRINCIPAL INVESTIGATOR

Enrollment

74 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 26, 2018

First Posted

November 2, 2018

Study Start

February 6, 2019

PEEZY Midstream Urine Device Compared to Catheterized Urine Sample

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

PEEZY specimen

CATHETER specimen

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

PEEZY specimen

CATHETER specimen

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations