NCT03729336

PEEZY Midstream Urine Device Compared to Catheterized Urine Sample

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Baylor Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 95 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lower Urinary Tract Symptoms
• Lower Urinary Tract Infection

Interventions

Type	Name	Description
DEVICE	Midstream urine collection device	Non-invasive midstream urine collection device
DEVICE	Catheter for urine collection	In-and-out catheter obtains urine through the urethra.

Timeline

• Start date: 2019-02-06
• Primary completion: 2019-04-12
• Completion: 2019-06-01
• First posted: 2018-11-02
• Last updated: 2019-06-05

Locations

1 site across 1 country: United States