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PEEZY Midstream Urine Device Compared to Catheterized Urine Sample (PEEZY)

Primary Purpose

Lower Urinary Tract Symptoms, Lower Urinary Tract Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Midstream urine collection device
Catheter for urine collection
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lower Urinary Tract Symptoms focused on measuring urine specimen, contamination

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Known pregnancy
  • Use of antimicrobial oral or vaginal therapy in the past 4 weeks
  • Use of Pyridium in the past 4 weeks

Sites / Locations

  • Baylor Scott and White Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PEEZY specimen

CATHETER specimen

Arm Description

All subjects will use PEEZY to give a urine specimen.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual Analog Scale (this is the only title for this scale)
On a questionnaire: patient rates level of distress experienced during each urine donation method. The scale is from 1 to 10. On this scale 10 is associated with the word "agonizing", 8 is associated with "horrible", 4 is associated with "uncomfortable", 2 is associated with "annoying", and 0 is associated with "None". Unbearable distress is marked near 10. No distress is marked near 0. On this scale responses can only be reported as a number from 0-10, and a lower number indicates a better outcome. There are no subscales.

Full Information

First Posted
October 26, 2018
Last Updated
June 4, 2019
Sponsor
Baylor Research Institute
Collaborators
Forte Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03729336
Brief Title
PEEZY Midstream Urine Device Compared to Catheterized Urine Sample
Acronym
PEEZY
Official Title
Midstream Urine Collection Device Compared to Catheterized Sample: Contamination and Patient Satisfaction.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
April 12, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
Collaborators
Forte Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Urine culture and microscopic urinalysis will be compared between 2 collection methods: PEEZY midstream urine collection, and urethral catheter collection.
Detailed Description
Female patients presenting to the Baylor Scott & White Health (Temple, TX) Urology clinic for complaints of lower urinary tract symptoms will be included. They will be approached by a clinical research coordinator and given more information. If they meet eligibility by screening, consents will be completed. Patients will proceed with their regular clinic visit with their clinician. Just prior to the physical exam, patients will use the PEEZY device to give a urine specimen in the privacy of the bathroom. The package with PEEZY includes the simple instructions for use. Patients return to the clinic room and the physical exam proceeds. An in-and-out catheter is used to obtain a post-void residual as well as a control urine specimen. After the remainder of the patient routine exam is complete, they will fill out a brief questionnaire. The 2 specimens will then be delivered to the lab. The clinical research coordinator will store consents and questionnaires that include the subjects study identification number in individual opaque envelopes that will be kept in a locked drawer accessible to only the investigators.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Urinary Tract Symptoms, Lower Urinary Tract Infection
Keywords
urine specimen, contamination

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Patient spontaneously voids in the bathroom using PEEZY (research sample). Within 10 minutes, patient is catheterized during physical exam (control sample) for post-void residual.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEEZY specimen
Arm Type
Experimental
Arm Description
All subjects will use PEEZY to give a urine specimen.
Arm Title
CATHETER specimen
Arm Type
Placebo Comparator
Arm Description
All subjects will use CATHETER (performed by their clinician) to give a urine specimen, following PEEZY use.
Intervention Type
Device
Intervention Name(s)
Midstream urine collection device
Other Intervention Name(s)
PEEZY
Intervention Description
Non-invasive midstream urine collection device
Intervention Type
Device
Intervention Name(s)
Catheter for urine collection
Other Intervention Name(s)
Straight catheter
Intervention Description
In-and-out catheter obtains urine through the urethra.
Primary Outcome Measure Information:
Title
Contamination of urine specimen with urethral and vaginal flora
Description
Contamination defined as: presence of urethral or vaginal flora on urine culture OR epithelial cell presence in urinalysis
Time Frame
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 Outcome Measure Information:
Title
Visual Analog Scale (this is the only title for this scale)
Description
On a questionnaire: patient rates level of distress experienced during each urine donation method. The scale is from 1 to 10. On this scale 10 is associated with the word "agonizing", 8 is associated with "horrible", 4 is associated with "uncomfortable", 2 is associated with "annoying", and 0 is associated with "None". Unbearable distress is marked near 10. No distress is marked near 0. On this scale responses can only be reported as a number from 0-10, and a lower number indicates a better outcome. There are no subscales.
Time Frame
Performed one time immediately after intervention. This will not be repeated.
Other Pre-specified Outcome Measures:
Title
Patient Preference
Description
Questionnaire created by investigator asks: Which way would you prefer to give a urine sample, if needed in the future? PEEZY or catheter.
Time Frame
Performed one time immediately after intervention. This will not be repeated.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Females presenting to the Urology or Urogynecology clinic for consultation or evaluation of lower urinary tract complaints. Exclusion Criteria: Known pregnancy Use of antimicrobial oral or vaginal therapy in the past 4 weeks Use of Pyridium in the past 4 weeks
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel High, DO
Organizational Affiliation
Baylor Scott and White Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor Scott and White Health
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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PEEZY Midstream Urine Device Compared to Catheterized Urine Sample

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