PEEZY Midstream Urine Device Compared to Catheterized Urine Sample

Lower Urinary Tract Symptoms Clinical Trial

— PEEZY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03729336
• Other study ID #: 018-702
• Status: Completed
• Phase: N/A
• Start date: February 6, 2019
• Est. completion date: June 1, 2019

Study information

• Verified date: February 2019
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 1, 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Urinary Tract Infection
• Lower Urinary Tract Symptoms
• Urinary Tract Infections

Intervention

Device:
• Midstream urine collection device
Non-invasive midstream urine collection device
• Catheter for urine collection
In-and-out catheter obtains urine through the urethra.

Locations

Country	Name	City	State
United States	Baylor Scott and White Health	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor Research Institute	Forte Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Preference	Questionnaire created by investigator asks: Which way would you prefer to give a urine sample, if needed in the future? PEEZY or catheter.	Performed one time immediately after intervention. This will not be repeated.
Primary	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	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.	Performed one time immediately after intervention. This will not be repeated.