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Completed

NCT Number: NCT03729336

PEEZY Midstream Urine Device Compared to Catheterized Urine Sample

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

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Key information

Conditions

Lower Urinary Tract Symptoms Lower Urinary Tract Infection Pathological Conditions, Signs and Symptoms Signs and Symptoms Urological Manifestations

Age range

18 year–95 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Baylor Scott and White Health

Temple, Texas, 76508, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Midstream urine collection device

Device

Non-invasive midstream urine collection device

Other names: PEEZY

Catheter for urine collection

Device

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

Other names: Straight catheter

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Collaborators

  • Forte Medical

Registry information

Official study title

Midstream Urine Collection Device Compared to Catheterized Sample: Contamination and Patient Satisfaction.

Acronym: PEEZY

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 2, 2018
Registry last updated
Jun 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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