PEEZY Midstream Urine Device Compared to Catheterized Urine Sample

NCT03729336 | Completed DMC

• 1 other identifier: 018-702
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lower Urinary Tract Symptoms; Lower Urinary Tract Infection

Keywords

urine specimen; contamination

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual Analog Scale (this is the only title for this scale)

  Performed one time immediately after intervention. This will not be repeated.

Other Outcomes (1)

• Patient Preference

  Performed one time immediately after intervention. This will not be repeated.

Study Arms (2)

PEEZY specimen

EXPERIMENTAL

All subjects will use PEEZY to give a urine specimen.

Device: Midstream urine collection device

CATHETER specimen

PLACEBO COMPARATOR

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

Device: Catheter for urine collection

Interventions

Midstream urine collection device DEVICE

Non-invasive midstream urine collection device

Also known as: PEEZY

PEEZY specimen

Catheter for urine collection DEVICE

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

Also known as: Straight catheter

CATHETER specimen

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females presenting to the Urology or Urogynecology clinic for consultation or evaluation of lower urinary tract complaints.

You may not qualify if:

• Known pregnancy
• Use of antimicrobial oral or vaginal therapy in the past 4 weeks
• Use of Pyridium in the past 4 weeks

Sponsors & Collaborators

• Baylor Research Institute: lead
• Forte Medical: collaborator

Study Sites (1)

Baylor Scott and White Health

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms

Interventions

Catheters; Urine Specimen Collection

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Rachel High, DO

  Baylor Scott and White Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patient spontaneously voids in the bathroom using PEEZY (research sample). Within 10 minutes, patient is catheterized during physical exam (control sample) for post-void residual.

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: November 2, 2018
• Study Start: February 6, 2019
• Primary Completion: April 12, 2019
• Study Completion: June 1, 2019
• Last Updated: June 5, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)