PEEZY Midstream Urine Device Compared to Catheterized Urine Sample

NCT ID: NCT03729336

Last Updated: 2019-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-06
• Study Completion Date: 2019-06-01

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.

Conditions

Lower Urinary Tract Symptoms; Lower Urinary Tract Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PEEZY specimen

All subjects will use PEEZY to give a urine specimen.

Group Type: EXPERIMENTAL

Midstream urine collection device

Intervention Type: DEVICE

Non-invasive midstream urine collection device

CATHETER specimen

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

Group Type: PLACEBO_COMPARATOR

Catheter for urine collection

Intervention Type: DEVICE

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

Interventions

Midstream urine collection device

Non-invasive midstream urine collection device

Intervention Type: DEVICE

Catheter for urine collection

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

Intervention Type: DEVICE

Other Intervention Names

PEEZY; Straight catheter

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Forte Medical

UNKNOWN

Sponsor Role: collaborator

Baylor Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel High, DO

Role: PRINCIPAL_INVESTIGATOR

Baylor Scott and White Health

Locations

Baylor Scott and White Health

Temple, Texas, United States

Countries

United States

Other Identifiers

018-702

Identifier Type: -

Identifier Source: org_study_id