Lower Urinary Tract SymptomsPEEZYNCT03729336
PEEZY Midstream Urine Device Compared to Catheterized Urine Sample
A study testing Midstream urine collection device and Catheter for urine collection in people with Lower Urinary Tract Symptoms and Lower Urinary Tract Infection, run by Baylor Research Institute at 1 site in United States.
Trial summary
Urine culture and microscopic urinalysis will be compared between 2 collection methods: PEEZY midstream urine collection, and urethral catheter collection. Read more about this study
- Who is it for?
- Ages 18 to 95 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lower Urinary Tract Symptoms, Lower Urinary Tract Infection
- What is being tested?
- Midstream urine collection device and Catheter for urine collection
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2019to 1 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females presenting to the Urology or Urogynecology clinic for consultation or evaluation of lower urinary tract complaints.
Who cannot join
- Known pregnancy
- Use of antimicrobial oral or vaginal therapy in the past 4 weeks
- Use of Pyridium in the past 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Midstream Urine Collection Device Compared to Catheterized Sample: Contamination and Patient Satisfaction.
Urine culture and microscopic urinalysis will be compared between 2 collection methods: PEEZY midstream urine collection, and urethral catheter collection.
Read the 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.
- Being tested
- Midstream urine collection device, Catheter for urine collection
- Keywords
- urine specimen, contamination
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midstream urine collection deviceDevice
Also called PEEZY
Non-invasive midstream urine collection device
Catheter for urine collectionDevice
Also called Straight catheter
In-and-out catheter obtains urine through the urethra.
| Study group | Role | What they receive |
|---|---|---|
| PEEZY specimen | Experimental | All subjects will use PEEZY to give a urine specimen. Receives: 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. Receives: Device: Catheter for urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
On a questionnaire: patient rates level of distress experienced during each urine donation method. The scale is from 1 to 10. On this scale 10 is associated with the word "agonizing", 8 is associated with "horrible", 4 is associated with "uncomfortable", 2 is associated with "annoying", and 0 is associated with "None". Unbearable distress is marked near 10. No distress is marked near 0. On this scale responses can only be reported as a number from 0-10, and a lower number indicates a better outcome. There are no subscales.
Measured: Performed one time immediately after intervention. This will not be repeated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2018
- Study start6 Feb 2019
- Primary completion12 Apr 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Urinary Tract SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Forte Medical
- Responsible party
- Sponsor
- Investigators
- Rachel High, DO, Principal investigator, Baylor Scott and White Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03729336
- Sponsor's protocol ID
- 018-702
- Acronym
- PEEZY
- Status last verified
- Feb 2019
- First submitted
- 26 Oct 2018
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midstream Urine Collection Device Compared to Catheterized Sample: Contamination and Patient Satisfaction.
- ClinicalTrials.gov ID
- NCT03729336
- Acronym / sponsor ID
- PEEZY / 018-702
- Keywords
- urine specimen, contamination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- Forte Medical
- Study start
- 6 Feb 2019 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 2 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| PEEZY specimen | Experimental | Device: Midstream urine collection deviceAll subjects will use PEEZY to give a urine specimen. |
| CATHETER specimen | Placebo comparator | Device: Catheter for urine collectionAll subjects will use CATHETER (performed by their clinician) to give a urine specimen, following PEEZY use. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Females presenting to the Urology or Urogynecology clinic for consultation or evaluation of lower urinary tract complaints.
Key exclusion criteria (3 listed)
- Known pregnancy
- Use of antimicrobial oral or vaginal therapy in the past 4 weeks
- Use of Pyridium in the past 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midstream urine collection deviceAlso: PEEZYNon-invasive midstream urine collection device | Device | PEEZY specimen |
| Catheter for urine collectionAlso: Straight catheterIn-and-out catheter obtains urine through the urethra. | Device | CATHETER specimen |
Primary outcome
Contamination of urine specimen with urethral and vaginal flora
Time frame: 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.
Contamination defined as: presence of urethral or vaginal flora on urine culture OR epithelial cell presence in urinalysis
1 secondary outcome
Visual Analog Scale (this is the only title for this scale)
Time frame: Performed one time immediately after intervention. This will not be repeated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel High, DO principal investigator
Baylor Scott and White Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midstream urine collection device and Catheter for urine collection in people with Lower Urinary Tract Symptoms and Lower Urinary Tract Infection, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contamination of urine specimen with urethral and vaginal flora (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2019.