Ignite Creation Date:
2024-05-06 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03526484
Status:
COMPLETED
Last Update Posted:
2021-12-02
First Post:
2018-05-03
Brief Title:
The Utility of Urinalysis Prior to In-Office Procedures
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
The Utility of Urinalysis Prior to In-Office Procedures A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary focus of this randomized clinical trial is to assess the usefulness of urinalysis prior to in-office urology procedures
Detailed Description:
OVERVIEW
Current urology practice requires every patient to have a urinalysis lab done prior to any in-office procedures If the patients urinalysis is positive they are then required to have a urine culture done which takes 1-3 days to show results and they may also be prescribed antibiotics This practice may cause diagnostic delays unnecessary cancellations of procedures and the overuse of antibiotics
The aim of this study is to assess the usefulness of urinalysis labs and urine cultures in patients prior to in-office cystoscopies intravesical BCG treatments and prostate biopsies The investigators predict there is no difference in the number of cases of urinary tract infections in patients that undergo in-office procedures with or without a prior urinalysis The investigators propose a change in protocol could allow for improved clinical efficiency antibiotic stewardship and be economically advantageous
OUTLINE
Participants will be randomly assigned to either receive standard of care before their procedure or have their procedure conducted by their provider without consulting the urinalysis results beforehand Participants will have follow up questionnaires seven days and thirty days after their procedure A total of 664 participants will be enrolled between the two study sites
Current urology practice requires every patient to have a urinalysis lab done prior to any in-office procedures If the patients urinalysis is positive they are then required to have a urine culture done which takes 1-3 days to show results and they may also be prescribed antibiotics This practice may cause diagnostic delays unnecessary cancellations of procedures and the overuse of antibiotics
The aim of this study is to assess the usefulness of urinalysis labs and urine cultures in patients prior to in-office cystoscopies intravesical BCG treatments and prostate biopsies The investigators predict there is no difference in the number of cases of urinary tract infections in patients that undergo in-office procedures with or without a prior urinalysis The investigators propose a change in protocol could allow for improved clinical efficiency antibiotic stewardship and be economically advantageous
OUTLINE
Participants will be randomly assigned to either receive standard of care before their procedure or have their procedure conducted by their provider without consulting the urinalysis results beforehand Participants will have follow up questionnaires seven days and thirty days after their procedure A total of 664 participants will be enrolled between the two study sites
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Protocol Version 5282020 | OTHER | None | None |
| A539998 | OTHER | None | None |
| SMPHVOLUNTEER STAFFUROLOGY | OTHER | UW Madison | None |