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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol Version 5/28/2020 | Other Identifier | UW Madison | |
| A539998 | Other Identifier | UW Madison | |
| SMPH\VOLUNTEER STAFF\UROLOGY | Other Identifier | UW Madison |
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The primary focus of this randomized clinical trial is to assess the usefulness of urinalysis prior to in-office urology procedures.
OVERVIEW:
Current urology practice requires every patient to have a urinalysis lab done prior to any in-office procedures. If the patient's 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | The control group will have a urine sample taken for a urinalysis prior to their procedure, which will have a reflex urine culture done if urinalysis results are positive. The results of the urinalysis will be reported to the doctor performing the procedure. The provider may require participants to take antibiotics and/or delay their procedure as a result of the urinalysis. |
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| Experimental | Experimental | The experimental group will have a urine sample taken for a urinalysis prior to their procedure, which will have a reflex urine culture done if urinalysis results are positive. The results of the urinalysis will NOT be reported to the doctor performing the procedure. Instead, the provider will conduct the procedure without looking at or acting upon the results of the urinalysis. The urinalysis and urine culture results will be monitored by the research team, and the participant will be informed if the urine culture results are positive for an infection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Behavioral | The provider will review the urinalysis results prior to conducting the in-office procedure and will make clinical decisions taking into account those results. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients who Developed a Urinary Tract Infection Post Procedure | Will compare difference in overall UTI rate between control and experimental groups.The results of the trial will be analyzed using a T-test for comparison of means, a Mann-Whitney U test for comparison of medians, Fisher's exact and chi-squared tests for comparison of categorical variables, and a logistic regression for predictors of UTI. | 1 year |
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Inclusion Criteria:
• Patients receiving an in office cystoscopy, intravesical BCG treatment, or prostate biopsy
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle A Richards, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William S. Middleton Memorial Veterans Hospital | Madison | Wisconsin | 53705 | United States | ||
| University of Wisconsin Hospital and Clinics |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 24, 2018 | Jan 18, 2019 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 27, 2018 | Jan 18, 2019 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Experimental | Behavioral | The provider will not review the urinalysis results prior to conducting the in-office procedure, and therefore will not make clinical decisions taking those results into account. |
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| Madison |
| Wisconsin |
| 53792 |
| United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |