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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

Tracking Information
First Submitted Date  ICMJE October 26, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date June 5, 2019
Actual Study Start Date  ICMJE February 6, 2019
Actual Primary Completion Date April 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 1, 2018)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE PEEZY Midstream Urine Device Compared to Catheterized Urine Sample
Official Title  ICMJE Midstream Urine Collection Device Compared to Catheterized Sample: Contamination and Patient Satisfaction.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Lower Urinary Tract Symptoms
  • Lower Urinary Tract Infection
Intervention  ICMJE
  • Device: Midstream urine collection device
    Non-invasive midstream urine collection device
    Other Name: PEEZY
  • Device: Catheter for urine collection
    In-and-out catheter obtains urine through the urethra.
    Other Name: Straight catheter
Study Arms  ICMJE
  • Experimental: PEEZY specimen
    All subjects will use PEEZY to give a urine specimen.
    Intervention: Device: Midstream urine collection device
  • Placebo Comparator: CATHETER specimen
    All subjects will use CATHETER (performed by their clinician) to give a urine specimen, following PEEZY use.
    Intervention: Device: Catheter for urine collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2019)
74
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2018)
80
Actual Study Completion Date  ICMJE June 1, 2019
Actual Primary Completion Date April 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729336
Other Study ID Numbers  ICMJE 018-702
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Baylor Research Institute
Study Sponsor  ICMJE Baylor Research Institute
Collaborators  ICMJE Forte Medical
Investigators  ICMJE
Principal Investigator: Rachel High, DO Baylor Scott and White Health
PRS Account Baylor Research Institute
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP