PEEZY Midstream Urine Device Compared to Catheterized Urine Sample

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: Lower Urinary Tract Symptoms; Lower Urinary Tract Infection

Treatments: Device: Catheter for urine collection; Device: Midstream urine collection device

Study type: Interventional

Funder types: Other

Identifiers

NCT03729336

018-702

Details and patient eligibility

About

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

Full 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.

Enrollment: 74 patients

Sex: Female

Ages: 18 to 95 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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74 participants in 2 patient groups, including a placebo group

PEEZY specimen

Experimental group

Description:

All subjects will use PEEZY to give a urine specimen.

Treatment:

Device: Midstream urine collection device

CATHETER specimen

Placebo Comparator group

Description:

All subjects will use CATHETER (performed by their clinician) to give a urine specimen, following PEEZY use.

Treatment:

Device: Catheter for urine collection