The Utility of Urinalysis Prior to In-Office Procedures: A Randomized Clinical Trial
Phase: NA
Conditions: Urinary Tract Infections
Sponsor: University of Wisconsin, Madison

 
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The Utility of Urinalysis Prior to In-office Procedures: A Randomized Clinical Trial 
 
Principal Investigator (PI):  
Kyle A. Richards, MD 
Assistant Professor 
University of Wisconsin School of Medicine and Public Health 
Department of Urology 
William S. Middleton Memorial Veterans Hospital 
Chief of Urology 
Telephone: 608.262.0759 
Fax: 608.262.6453 
E-mail: richardsk@urology.wisc.edu 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Project Summary:  
The current state of practice requires every patient to have a urinalysis (UA) and if positive then a urine 
culture (UC) prior to any in office urology procedure. This practice may cause diagnostic delays, 
unnecessary cancellation of procedures and the over use of antibiotics, promoting antibiotic resistance. 
We predict that there is no difference in the number of cases of urinary tract infections (UTI) in patients 
that undergo in office procedures with or without prior UA. While a few procedure specific studies have 
shown this trend, this will be the first time this hypothesis is tested on a broad spectrum of procedures in 
a randomized clinical trial setting. The trial will consist of two randomized groups of patients. The control 
arm will receive a standard of care urinalysis with a reflex culture if positive that their treating physician 
will be able to view before the procedure and may choose to delay/cancel the procedure if they deem 
necessary. The experimental arm will receive a urinalysis with a reflex culture if positive, but their treating 
physician will not view the urinalysis results before the subject’s procedure. Both groups of patients will 
be followed-up via phone at one week and one month post-procedure to assess the intervention’s impact 
on the number of post-procedure UTI cases. Any patients with positive urine cultures will be alerted and 
treated accordingly.  
Background and Significance:  
Currently all BCG patients undergo UA before their procedures, this practice is upheld at both the UW 
Urology Clinic and the VA. The reasoning behind the current practice is that any sign of a tentative 
infection could be aggravated by the treatment. Retrospective studies have suggested that there is no 
difference in the rates of UTI in people who were administered UA tests before BCG treatments versus 
people who were not administered UA tests before treatment. [1] However, for patients that had a UA, 
BCG instillation was delayed for 2.5% of the cases. [2] Additionally, a study aimed at understanding the role 
of preventative antibiotics prior to in office cystoscopy found that the risk of symptomatic UTI is only 4.5% 
of patients, therefore the vast majority of patients did not benefit from UA or preventative antibiotics. [3] 
These studies suggest that a change in the standard protocol before in-office procedures is in order. 
The current guidelines for urologic in-office procedures might be hindering patient care instead of 
improving it. A recent study by Zhao et al established that the cost of every UA is approximately $4.24, 
which for the course of this proposed study alone (664 patients) could add up to $1,300 approximately 
when accounting for the randomization of the study. [1] The economic aspect shows a drain in resources 
that could be otherwise allocated to improve care. Furthermore, the results of these UA tests will 
occasionally lead to delays in procedures. If the UA was positive, then the procedure would be delayed at 
the physician’s discretion. It is important to note that a previous study conducted at the Madison VA 
urology clinic has shown that >1% of urologic procedures have ever been cancelled due to a positive UA.[4] 
Additionally, a study on the urine cultures of 150 men prior to prostate needle biopsy procedures found 
that fewer than 5% of men undergoing the procedure had a positive urine culture and none of the men 
with positive urine cultures showed evidence of developing an infection the morning following their 
procedures. [5] Delays are cumbersome to the patients, but can also cause delays in more serious 
diagnosis, for potential cancer patients undergoing cystoscopy or prostate biopsies which could alter the 
care options available to the patient. We hypothesize that eliminating UA before in-office procedures 

 
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will not significantly affect the number of UTI cases reported post-procedure, but it will increase the 
efficiency of care provided.  
 An additional aspect of this study seeks to support antibiotic stewardship across patient care. 
Preventative antibiotics are potentially contributing to a worldwide rise in multidrug resistance. [3] By 
eliminating UA prior to in-office procedures and thus the need to use antibiotics as a preventative 
measure, we will be making responsible use of antibiotics in the care provided. Antibiotic stewardship 
could be especially prudent in patients undergoing BCG treatments. One mechanism suggests that BCG 
treatments could be therapeutic by triggering cellular responses that lead to rapid epithelial cell shedding, 
reducing the case for infections. [2] We hypothesize that in the case of BCG treatment an 
immunomodulatory effect will reduce the bacterial load and potentially reduce the risk for UTI by 
comparing the outcomes between delayed and non-delayed procedures.  
Specific Aims/Study Objectives:  
The aim of this study is to assess the usefulness of UA and urine cultures in patients prior to in-office 
urology procedures. Specifically, we want to challenge the current protocol of administering UA prior to 
in office cystoscopy, BCG treatments, and prostate biopsy procedures. A change in protocol could allow 
for improved clinical efficiency, antibiotic stewardship, and be economically advantageous. 
Research Design and Methods:  
1. Study design: Prospective cohort, 664 patients, randomized trial 
2. Data Source: Urology Patients at the University of Wisconsin Hospital and the William S. 
Middleton Memorial Veterans Hospital 
3. Study Population 
a. Inclusion criteria:  
i. Patients receiving an in-office cystoscopy, intravesical BCG treatment prior to 
first instillation, or prostate biopsy 
b. Exclusion criteria:  
i. Patients under 18  
ii. Patients with symptomatic UTI infections at the time of recruitment 
iii. Patients on antibiotics at the time of recruitment, not including prophylaxis 
iv. Patients with a history of UTI within 1 year 
v. Patients with indwelling catheters  
vi. Patients with clean intermittent catheterization 
vii. Patients undergoing stent removals or with ureteral stents  
viii. Patients with history of asymptomatic bacteriuria  
ix. Patients with high risk of infection 
c. Subject Identification: 
i. Subjects will be identified based on daily clinic schedules and screening will 
happen at the time of consent 

 
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ii. Subjects will be given as much time as needed to decide if they would like to 
participate in the study or not 
iii. Patient medical history and current medication list will be confirmed at the time 
of consent    
iv. Patients will be randomized by sealed envelope using a random number 
generator populated with study identification numbers. 
1. Randomization specifications: Patients on this study receive a study 
identification number (Study ID), which corresponds to what number 
patient they are on the study. For example, Study ID 0049 is the 49th 
patient to sign a consent form. A random number generator was 
populated with the 664 study identification numbers used in this study. 
The generator divides the numbers into two equally sized groups, with 
one group being the “control arm” group and the other the 
“experimental arm” group. Sealed envelopes were created from that list 
with the study identification number on the front on the envelope and 
the group sealed inside. That way, when patients are consented into the 
study, their study identification number determines what study 
treatment they will receive, and the consenting/randomizing staff will 
have no way of guessing which arm the patient will get until they open 
the envelope.  
v. Patients will not know to which group they’re assigned  
d. Estimated number of patients to be included:  
i. 664 patients recruited over approximately a year as estimated for an 
equivalence study 
e. Primary Cohorts:  
i. Control: Patients who will receive UA prior to treatment and will be evaluated by 
the physician according to the test results as current standard of care dictates. A 
UC, which will be administered according to the results of the UA. 
ii. Experimental: Patients will receive a UA prior to their procedure, but their 
physician will not evaluate the results of the UA and will instead proceed directly 
to conducting the procedure. The patient’s UA and reflex urine culture (if 
applicable) will be monitored by research staff and Dr. Richards will be alerted of 
any possible infections as soon as results are available. In this manner, we will 
know the necessary course of antibiotics for treatment ahead of time. 
f. Subset Cohort Analysis: 
i. None  
g. Primary Outcome Measured: Number of UTI occurrences within study period. The 
definition of UTI for the study will be inclusive, consisting of a suspicious urinalysis with 
white blood cells, bacteria, or nitrites present and a positive culture >10,000 cfu/mL 
(excluding diptheroids) accompanied by symptoms.   
h. Secondary Outcome Measures:  
i. Streamlining of patient care  

 
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1. Delayed procedures and reasoning behind delays will be recorded 
ii. Improved usage of antibiotics 
1. Information on antibiotic use and type of antibiotics used will be 
recorded 
4. Collaborating Sites 
a. None 
5. Information Collected from Patients:  
a. Demographics 
b. Prior history of UTIs 
c. Prior history of urological procedures 
d. Charlson Comorbidity Index 
e. Lower Urinary Track Symptoms (LUTS) Questions: to be collected prior to procedure and 
at all follow ups.  
i. Number of times voided the day before 
ii. Number of times voided throughout the night before  
iii. Current state of urine stream 
iv. Perceived ability to completely empty the bladder 
v. Number of times urgency for the bathroom occurred the day before 
vi. Number of times urine leakage was experienced and was it related to urgency 
or routine (cough/strain/laughing) 
vii. Dysuria, flank pain, or suprapubic pain 
viii. Presence of hematuria  
ix. Experiencing fever or chills  
f. Procedure notes 
g. If procedures are delayed, explanation of surgeons reasoning will also be recorded 
h. UA results  
i. 
Adverse events 
6. Specimen/data collection/storage: 
a. The data will be obtained from surveying urology patients at the VA and the UW urology 
clinics. Only the necessary data for the study will be obtained to answer the research 
question from patient charts. The data might include urologic history and general patient 
information including co-morbidities. Only the PI and authorized research assistants will 
have access to the data.  
b. Study data will be kept in accordance with the Department of Veteran Affairs record 
control.  
Risk-Benefit Analysis: 
This trial poses minimal risk to the patient in the physical, psychological, social and legal aspects. While 
the physician will not have access to the experimental group’s UA results at the time of the procedure, 
the results will be monitored so that patients can be alerted of any medical care needed in case of a UTI. 

 
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To reduce the risk further, every medication and medical history will be confirmed with the subject before 
consenting them into the study. 
 As previously stated, the definition of UTI for the study will be inclusive, consisting of a positive culture 
>10,000 cfu/mL, excluding diptheroids accompanied by symptoms. Any patients that develop 
symptomatic UTIs during the study will be treated with culture specific antibiotics per standard of care. If 
there is an infection detected for a patient in the experimental group Dr. Richards will notify the patients 
and arrange treatment 24 hours a day, 7 days a week. In the rare circumstance that Dr. Richards is not 
reachable, Dr. Sara Best will provide back up to ensure appropriate treatment and follow-up is in place.  
It is recommended that treatment for any infections that require urgent care after hours is administered 
at any ER if warranted at the convenience of the patient. The care provided from the point of admission 
will follow the standard of care protocol at the particular ER. Additionally, an example of standard practice 
for care of a UTI can be seen in the cited document from the UW Health ER SOP for sepsis treatment. [6]  
For patients presenting to the emergency room or any other medical provider for the duration of the 
study, the study team wants to ensure effective communication in regards to any urine culture results or 
other important information related to participation in this study.  Therefore, each participant will be 
provided an information sheet with basic details about the study, the contact information for the PI (and 
back-up), and a place to write down details about the findings when informed about the results by the PI.  
This would be provided to the patient when they enroll and could be provided to the physician in the ER. 
Only the researchers approved by the IRB will have access to any information about the patients, 
protecting privacy. While any study poses a risk for breach of confidentiality, we plan on taking pre-
emptive action to prevent this from happening and in the case of a breach; a report would be made to 
the IRB immediately and resolved with IRB guidance. Considering the benefits of the study, all assessed 
risks are minimal to the patient, and all possible preventative measures will be taken to avoid significant 
risks or harms. All study test results will be monitored as they become available by Dr. Richards’ research 
assistant.  
Data and Safety Monitoring Plan:  
 
The PI and all study team members will be alerted to any unanticipated problems or complications that 
arise. They will be proactive, as described above, to avoid any unanticipated problems or complications. 
If an unanticipated problem or complication does arise, the IRB will be notified. Data analysis will also be 
performed every 100 patients and the experiment will be stopped if there is a statistically significant 
increase in the number of UTI incidences between the control and the variable groups.  We will also plan 
to perform separate analysis for both safety and efficacy between the different treatment groups (i.e. 
BCG controls vs. BCG variable group; prostate biopsy controls vs. prostate biopsy variable group; 
cystoscopy controls vs. cystoscopy variable group). 
Specific provisions are in place to address unanticipated problems or complications BEFORE THEY OCCUR, 
as described above and again herein: All risks of the study will be minimized by monitoring the patients 
test results prior to the study and taking immediate action, within 3 days of the urinalysis test, to prevent 
any UTI from affecting the patient. All standard privacy protective procedures will also be followed.  

 
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Specific provisions are in place to address unanticipated problems or complications AFTER THEY OCCUR. 
Namely, the PI and all study team members will document and report them to the IRB. Solutions to 
address any unanticipated problems or complications will be applied, based on advice from the IRB. 
 
Statistical Considerations:  
The study will enroll 664 patients as determined by the standards of an equivalence test with a proportion 
difference of 0.01 between the proportion of UTI for the group with urinalysis and reflexive culture visible 
to physicians (0.03) and the proportion of UTI for the urinalysis not ready for the physician to view prior 
to the in-office procedures. The null proportion difference is set at 0.05 and the alpha and power constants 
are set at 0.05 and 0.8 respectively as is common for studies of this type.  
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. All statistical tests will be two sided with p-values <0.05 
considered significant. 
Data and Record Keeping: 
Measures that will be implemented by our research team to safeguard the identifiable subject information 
from unauthorized use or disclosure for both paper and electronic forms of information, including how 
and where data will be stored, include: 
1.) Any data or information collected will only be available to IRB-approved study team members. 
2.) Collection of sensitive information about subjects is limited to the amount necessary to achieve the 
aims of the research. 
3.) All data or information collected will be stored only on VA servers or hard drive of VA-approved and 
serviced computers with appropriate security (i.e., firewall and password) protections.  
4.) All paper files that store any data or information associated with this study will be housed inside locked 
offices in the security-protected VA office (B7112G). 
5.) Any data or information stored in the excel database will be coded by using a unique study code to 
which only the PI and approved study team members have access.  
6.) Study data and the corresponding master list of identifiers will be stored on a VA departmental server. 
7.) VA research data and information will be retained in accordance with the applicable VA Records 
Control Schedule (NARA RCS 10-1). 
8.) Per VA policy, a copy of all study data will reside within the VA protected environment (B7112G), 
including all codes used to re-identify subjects' PHI. 

 
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9.) VA sensitive data or information will only be transmitted using VA-approved solutions such as FIPS 
140-2 validated encryption or PKI encryption for secure e-mail messages. 
10.) Access to research study data will be removed for study personnel when they are no longer part of 
the research team. 
11.) In accordance with VA policy, the ISO and PO and ACOS for Research will be notified within one hour 
of any actual or suspected data breach (i.e. unauthorized use, disclosure, transmission, removal, theft, 
loss, or destruction of VA research-related PHI, individually identifiable private information, or 
confidential information). 
12.) VA information will be securely returned to the VA.  
References:  
1. Zhao LC, et al. Screening urine analysis before Bacille Calmette-Guerin instillation does not 
reduce the rate of infectious complications. BJU International. 2011. 109, 1819-1821 
2. Herr, HW. Intravesical Bacille Calmette-Guerin Eradicates Bacteriuria in Antibiotic-naïve Bladder 
Cancer Patients. European Association of Urology. August 20, 2012 
3. Herr, HW. Should Antibiotics be given prior to Outpatient Cystoscopy? A plea to Urologists to 
Practice Antibiotic Stewardship. European Association of Urology. August 30, 2013.  
4. Richards KA, Cesario S, Lim, AH, et al. Utility of routine urinalysis and urine culture testing in an 
ambulatory urology clinic: a quality improvement initiative in a Veterans healthcare facility. The 
Canadian Journal of Urology. February 24, 2017. (1):8627-8633.  
5. Qi DZ, et al. Pre-operative urine culture is unnecessary in asymptomatic men prior to prostate 
needle biopsy. International Urology and Nephrology. November 23, 2017.