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

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ClinicalTrials.gov Identifier: NCT03729336
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : June 5, 2019
Sponsor:
Collaborator:
Forte Medical
Information provided by (Responsible Party):
Baylor Research Institute

Brief Summary:
Urine culture and microscopic urinalysis will be compared between 2 collection methods: PEEZY midstream urine collection, and urethral catheter collection.

Condition or disease Intervention/treatment Phase
Lower Urinary Tract Symptoms Lower Urinary Tract Infection Device: Midstream urine collection device Device: Catheter for urine collection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Midstream Urine Collection Device Compared to Catheterized Sample: Contamination and Patient Satisfaction.
Actual Study Start Date : February 6, 2019
Actual Primary Completion Date : April 12, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PEEZY specimen
All subjects will use PEEZY to give a urine specimen.
Device: Midstream urine collection device
Non-invasive midstream urine collection device
Other Name: PEEZY

Placebo Comparator: CATHETER specimen
All subjects will use CATHETER (performed by their clinician) to give a urine specimen, following PEEZY use.
Device: Catheter for urine collection
In-and-out catheter obtains urine through the urethra.
Other Name: Straight catheter




Primary Outcome Measures :
  1. Contamination of urine specimen with urethral and vaginal flora [ 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. ]
    Contamination defined as: presence of urethral or vaginal flora on urine culture OR epithelial cell presence in urinalysis


Secondary Outcome Measures :
  1. Visual Analog Scale (this is the only title for this scale) [ Time Frame: Performed one time immediately after intervention. This will not be repeated. ]
    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.


Other Outcome Measures:
  1. Patient Preference [ Time Frame: Performed one time immediately after intervention. This will not be repeated. ]
    Questionnaire created by investigator asks: Which way would you prefer to give a urine sample, if needed in the future? PEEZY or catheter.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729336


Locations
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United States, Texas
Baylor Scott and White Health
Temple, Texas, United States, 76508
Sponsors and Collaborators
Baylor Research Institute
Forte Medical
Investigators
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Principal Investigator: Rachel High, DO Baylor Scott and White Health
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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT03729336    
Other Study ID Numbers: 018-702
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Baylor Research Institute:
urine specimen
contamination
Additional relevant MeSH terms:
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Urinary Tract Infections
Lower Urinary Tract Symptoms
Infections
Urologic Diseases
Urological Manifestations