Clinical trial NCT03729336: PEEZY Midstream Urine Device Compared to Catheterized Urine Sample
Official title: Midstream Urine Collection Device Compared to Catheterized Sample: Contamination and Patient Satisfaction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Lower Urinary Tract Infection
Keywords: urine specimen
contamination
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
Collaborators: name: Forte Medical
First posted: 2018-11-02
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Contamination of urine specimen with urethral and vaginal flora
timeFrame: 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:
measure: Visual Analog Scale (this is the only title for this scale)
timeFrame: Performed one time immediately after intervention. This will not be repeated.
Other outcomes:
measure: Patient Preference
timeFrame: Performed one time immediately after intervention. This will not be repeated.
Locations:
city: Temple
country: United States
facility: Baylor Scott and White Health
state: Texas
Study officials:
affiliation: Baylor Scott and White Health
name: Rachel High, DO
role: PRINCIPAL_INVESTIGATOR
References: