Clinical trial NCT03101371
Conditions: Urinary Tract Infections Catheter Infection Catheter-Related Infections
Sponsor: University of Colorado, Denver
Start date: 2017-10-10; Completion date: 2019-02-15
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Urinary Tract Infection (UTI) complications following catheter use in surgical patients remains high. Using an aseptic protocol has been shown to drastically reduce UTI incidence by 50%. Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use associated with this complication and improve cost-effectiveness of care. The investigators hypothesize that they can reduce the incidence of UTIs after catheter placement with the implementation of a Quality Improvement (QI) protocol to prevent excess exposure to the environment exposure of the catheter before, during and after insertion.

Detailed description:

Arms: arm 1: Standard of care catheter insertion in which catheter is inserted right out of package/non-treated catheter. arm 2: Aseptic protocol for catheter insertion using Povidone Iodine treated catheter and maintaining plastic sleeve on catheter
Interventions: intervention 1: Catheter insertion with Povidone Iodine intervention 2: Standard of care catheter insertion
Intervention descriptions: intervention 1: The catheter will be treated with Povidone Iodine prior to insertion. intervention 2: Catheter inserted right out of package.

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
 
Reducing Urinary Tract Infection Rates using a Controlled Aseptic Protocol for Catheter Insertion 
PI: Christopher Breed, MD (Gynecologic Oncology Fellow) 
Faculty Mentor: Saketh R. Guntupalli, MD (Gynecologic Oncology) 
COMIRB #16-1096 
Version  21-Oct-2019 
NCT03101371 
 
 
 


I. Hypotheses and Specific Aims: Urinary Tract Infection (UTI) complications following catheter use in 
surgical patients remains high.  Using an aseptic protocol has been shown to drastically reduce UTI 
incidence by 50%. [2] Reducing UTIs will prevent extended hospital stays, readmission, and antibiotic use 
associated with this complication and improve cost-effectiveness of care. We hypothesize that we can 
reduce the incidence of UTIs after catheter placement with the implementation of a QI protocol to prevent 
excess exposure to the environment exposure of the catheter before, during and after insertion.   
 
II. Background and Significance: 
Infections resulting from health-care complications are the greatest cause of morbidity and mortality in 
hospitalized patients in the US. [1] Urinary tract infection (UTI) is the most common health care 
complication following surgery. [2] Rates are high, causing longer hospital stays, readmissions, and 
antibiotic use.  Rates at UCH are near 40%, high compared to the national standard. About 15% of post-op 
complications result in extended stays or readmissions and costly antibiotic treatments. These infections 
should be preventable with prophylaxis and pre-treatment protocols but there is no standard protocol at 
UCH for minimizing the risk of UTI infection. We propose a catheter management protocol in which the 
catheters are treated with betadine and then inserted while remaining protected within the plastic sleeve, 
reducing airborne/contact exposures to the catheter. Betadine is a topical antiseptic used in the prevention 
of infections.  It is widely available and a cost-effective intervention. Similar aseptic protocols have been 
tested and implemented in other countries however we lag behind in having a systematic protocol for 
reducing the incidence of UTIs complications.[2-4] A study in rural-India found that antiseptic techniques 
were the best preventable measure for device-related infections.[5] Patients currently receive what will be 
considered standard of care intra-operative catheter placement which involves placement of catheter in a 
sterile field, drainage to a closed system and shortest possible duration of catheter placement.  We 
hypothesize that the implementation of a controlled antiseptic protocol to inserting the urinary catheter will 
reduce UTI rates following surgery.  
   
III.  Preliminary Studies/Progress Report: 
The Gynecologic Oncology service performs between 15-20 surgeries per week.  There are 5 providers who 
would require training in the protocol.  The providers all have similar practice patterns as they pertain to 
current standard of care catheter placement. Training would be relatively straight forward and protocol 
adherence is expected to be high.  Adherence can be monitored on the service by the principle investigator.   
Faculty Mentors include Dr. Guntupalli who is an assistant professor in the department of Obstetrics 
and Gynecology at the UCH. He serves as the Principal Investigator for the Gynecologic Oncology 
Group, a national research consortium. His research has focused on all gynecologic cancer sites and 
surgical improvements.  
 
IV. Project Design and Procedures.  
a. Performance Measurement. The primary outcome is UTI within 14 +/- 2 days post-surgery.  A 
UTI is defined as an infection in any part of your urinary system which may include the kidneys, 
ureters, bladder, and urethra.  Most infections involve the lower urinary tract (bladder and urethra), 
and are treatable with antibiotics.  If a UTI spreads to the kidney, it can become a more serious 
complication. Women are at a greater risk of developing a UTI than men are.  
Pre-operative antibiotics will be collected to determine if this directly affects the outcome of a UTI. 
Visits to the ED for urinary pain, incontinence, or fever will also be followed for determination of 
UTI. Participants will provide a urine sample 0-24 hours before surgery.  The sample will be tested 
with a rapid urine analysis (UA) test.  This measure was chosen so that study UAs results are not to 
be confused with standard UAs conducted with samples collected after catheter placement. 
Participants will be followed up by research staff ~24 hours post-surgery for a second UA test.  A 
third UA will be conducted at the patients’ post-op check.  At follow-up visits, participants will also 


be assessed for symptoms of UTI since surgery by assessment of: urethral discomfort, suprapubic 
tenderness or pelvic pain, sense of urinary urgency, frequency or dysuria, fever, antibiotic use, and 
clinical and laboratory data suggesting infection (UA with +leukocyte esterase +/- nitrates, urine 
culture with >10^5 bacterial colony forming units per mL (CFU)).  Asymptomatic bacteriuria will 
be considered a UTI for this study (defined as >10^5 CFU/mL on urine culture).  Patients who are 
treated with antibiotics for UTI without laboratory data suggesting infection will be included in UTI 
group.  For participants reporting ED visits prior to 14 +/- 2 day visit, ED reports will be obtained 
and an assessment will be made regarding the symptomatic UTI diagnosis.  Those meeting these 
criteria will be followed with symptom and laboratory analysis. All positive UA test will be 
confirmed by laboratory analysis for final diagnosis.  Results of +leukocyte esterase +/‐ nitrites will 
be considered abnormal.  If a diagnosis of UTI does not exist in the patient chart outside of study, 
the patient’s clinical picture will be evaluated independently by 2 separate care providers to 
determine if meeting criteria for UTI (symptomatic bacteriuria as defined above).  If there is 
discrepancy a third provider will be the determining opinion. Participants meeting the primary 
endpoint (UTI) will be discontinued from the study following.   
 
Secondary outcomes include: hospital length of stay, readmissions, antibiotic use at the time of 
surgery and post-surgery.  Measures of UTI, and secondary outcomes will be collected from 
observation during study visits and from the patient medical charts., If closed drainage system was 
disrupted during placement (to back fill bladder intra-operatively), and method of catheter 
discontinuation (“fill and pull” versus “pull and void” methods) will be collected for comparison 
between the groups for analysis as a possible confounding variables.  
 
Additional secondary outcomes to be evaluated will include patient discomfort with catheter, 
tolerability of catheter, length of hospital stay, and number of post-operative evaluations required.  
A cost-analysis will be performed as a secondary endpoint based on this cost factors (length of 
hospital stay, readmission, additional clinic/ED visits, antibiotic costs).  Costs of hospital days, 
clinic visits, other appointments, and antibiotics will be standardized for evaluation based on 
literature for cost analysis in gynecologic oncology literature. 
 
b. Target population. Women undergoing extended surgery lasting >1 hour and requiring urinary 
catheter will be eligible for enrollment.  All patients will have surgery performed by one of the trained 
Gynecologic Oncologists at the University of Colorado Hospital.   
Inclusion criteria will include:  
1)  women 18-89 years of age  
2) admitted for surgery lasting >1 hour and requiring urinary catheter,  
3) have normal urine analysis within 24 hours pre-surgery, and  
4)   able to provide informed consent.   
 
Women with dialysis, chronic urinary infection, and current infection will not be eligible to participate. 
Women who are pregnant or breast feeding will not be included in the study.  Men will not be included 
because of their lower incidence of UTIs compared to our female population.   
 
The null hypothesis is that there will be no difference in UTI rates between the standard of care catheter 
placement and the sterile protocol placement.  If we use the current rates of UTI after catheter placement 
described above at 40%, we would need to enroll 100 patients per arm (total 200) to see a 50% reduction 
in UTI rates in the intervention group with an alpha of 0.05 and a power of 0.84.  The Gynecologic 
Oncology services averages around 5 surgical patients who would be eligible for this study per week.  
We anticipate needing between 10-12 months to complete enrollment. 
 


c. Study Design and Research Method. We will conduct a single-site Randomized Control Trial 
(RCT) in order to examine the use of an aseptic protocol for catheter insertion during gynecologic 
oncology surgeries for quality improvement.  This study will take place at the UCH inpatient surgical 
unit of gynecologic oncology. The catheter protocol for QI will be conducted in the operating room 
prior to surgery and will not increase prep time or operating room time. Follow-up will be conducted 
during standard outpatient care visits and will also not increase clinic use time. 
 
The intervention in this study is a controlled aseptic pre-treatment protocol for catheter use in the 
operating room involving dipping the tip of the catheter into betadine prior to insertion and maintaining 
catheter in the sterile plastic sleeve during preparation, insertion and post-operatively to avoid excess 
exposure to the environment. The Physician performing the operation will be responsible for inserting 
the catheter. Patients with normal UA pre-surgery will be randomized 1:1 to one of two arms prior to 
surgery:  
 
1) Aseptic protocol for catheter insertion using betadine treated catheter and maintaining plastic 
sleeve on catheter or  
2) SOC catheter insertion in which catheter is inserted right out of package/non-treated catheter.  
 
Prior to study initiation, the PI will train providers on the proper use of the protocol. Catheter insertion 
procedures will be documented in the operation note following surgery.  Compliance will be measured 
by adherence to both betadine use and maintenance of plastic sleeve.  Standard of care practices for 
infection control are to be conducted by providers on all participants. This includes: hand hygiene, 
inserting catheters for appropriate indications, remove catheters when no longer needed, maintain a 
close system keeping bag and tubing below the bladder.  
 
We will collect general patient demographics to assure similarities between the randomized groups.  
These will include age, race/ethnicity, BMI, insurance type,  diagnosis (reason for surgery), history of 
diabetes, menopausal status, and smoking status. MRN data will be collected in order to pull data 
directly into the OnCore data management system.  
 
d.  Study Procedures 
Participants will conduct the following study visits over 2 weeks. All costs associated with routine 
standard of care procedures for catheter insertions and diagnosing and treatment of a UTI will be the 
responsibility of the patient and/or their insurance provider.  All costs associated with procedures 
conducted for research only will be paid for by the research study.  
• Visit 1 Screening and Enrollment: Potential participants will be screened and consented for 
study up to 30 days prior to their surgical procedure.  Inclusion/Exclusion criteria will be 
reviewed at the time of consent and baseline data including physical exam, health history, 
clinical diagnosis and concomitant medications will be collected following consent.  A urine 
sample will be collected and analyzed 0-24 hours prior to procedure.  
• Visit 2 Randomization and Catheter Insertion: Participants will be randomized to either the 
SOC catheter protocol or catheter insertion including Betadine on the day of procedure.  
Standard protocol will be followed for catheter preparation and insertion.  Any adverse events 
following insertion will be recorded. Pre-operative antibiotics will also be recorded.   
• Visit 3, 24-hour post-op: Patients will be assessed at 24 hours post-op in-patient.  A urine 
sample will be collected and analyzed.  Any positive urine analysis will be further analyzed and 
confirmed by the UCH laboratory per SOC procedures.  Patients will be assessed for 
symptomatic signs of UTI and review of AEs following procedure.   


• Visit 4; 2-week post op: Patients will be assessed 2-weeks post-op at their SOC post-op clinic 
visit.   A urine sample will be collected and analyzed.  Any positive urine analysis will be further 
analyzed and confirmed by the UCH laboratory per SOC procedures.  A physical exam will also 
be collected.  Patients will be assessed for symptomatic signs of UTI and review of AEs and ED 
visits since the last visit.  Data including hospital stay, readmission, and antibiotic use will be 
collected.  Patient satisfaction with catheter procedure will also be collected. Patient will be 
finished with study following visit 4.  
  
e.  Description, risks, and justification of procedures and data collection tools: 
• 
Consent and randomization: Patients will be randomized to standard of care intraoperative 
catheter placement versus aseptic protocol for catheter insertion upon providing informed 
consent.  Randomization will be performed using the REDCap randomization module and will 
be performed by the study coordinator or research manager. 
• 
Urine analysis with urine dip:  Patients will be asked to provide a clean catch urine sample in 
provided collection cup prior to surgery (done as standard of care), a catheter collected urine 
sample at 24hrs post-operatively (research procedure) and another clean catch specimen at their 
2-week surgical follow-up (research procedure).  This collection and analysis is low risk except 
for the possibility of unnecessary treatment if abnormal sample is obtained.  Abnormal samples 
will be correlated with patient history/complaints and confirmed with formal urine analysis.  
Confirmation of UTI would also utilize urine culture. The urine analysis by dip gives a fast yet 
reliable indicator of urinary tract infections. Pre-operative/pre-randomization allows us to 
exclude patients who may have underlying UTI prior to initiation of the study.  
• 
Catheter placement:  The aseptic protocol involves dipping standard catheter in an aseptic 
betadine solution and leaving a pre-existing plastic cover in place over the catheter during 
insertion and while in place.  We do not anticipate any added risk of the aseptic protocol to the 
patient although patients may experience some increased irritation due to the protective plastic 
cover. 
 
Anticipated Risks 
While the study anticipates minimal risks, the following outlines any potential minimum risk to 
subjects: 
i. Breach of Confidentiality:  Data obtained using information from medical records poses 
minimal risk.  All procedures in which information is being obtained will be conducted per 
standard of care.  There is a risk that a patient’s privacy may not be protected. This risk is 
uncommon.  
 
ii. Discomforts:  Persons receiving catheter insertion can anticipate the following risks: 
primarily ascending infection of the urinary tract.  This usually presents initially with symptoms 
such as pain with urination, urinary urgency, urinary frequency, abdominal pain, chills, and/or 
fever. As discussed above the number of patients with evidence of clinical (symptomatic) and 
subclinical (asymptomatic) UTI has been reported to be as high as 40%.  Other risks of catheter 
placement include urinary leakage around the catheter and bladder spasm/irritation while the 
catheter is in place.  These symptoms usually resolve when the catheter is removed.  Uncommon 
risks include injury to the bladder or urethra, urethral narrowing or urinary stone formation.  
Patients in both arms will be monitored for these risks throughout the study period. The addition 
of Betadine on the catherter prior to insertion is not expected to pose an increase in the described 
risks or discomforts.   
 
Participation in this study will not have any influence on the patient’s current treatment. The study 
may include risks that are unknown at this time. 


 
Event reporting 
Adverse Events 
An Adverse Event [AE] is defined as any unfavorable and unintended sign (including abnormal 
laboratory finding), symptom, or disease temporally associated with the use of a medical treatment 
or procedure, regardless of whether it is considered related to the medical treatment or procedure 
(attribution of unrelated, unlikely, possible, probable or definite).  An unanticipated event is defined 
as any adverse experience where the nature, severity or frequency is not identified in the 
investigational brochure described in the application form or detailed in the consent form. This can 
also include non-compliance issues such as over enrollment of subjects without prior COMIRB 
approval. 
 
Investigators will report the following to COMIRB within 5 days: 
• Adverse events which in the opinion of the principal investigator are both unexpected and 
probably or definitely related to the intervention/ drug or device. 
• Probably related: In the opinion of the PI, it is more likely than not that the adverse event is 
related to the study intervention. 
• Definitely related: In the opinion of the PI, it is very likely that the adverse event is related to 
the study intervention 
• An unforeseen development that potentially increases the likelihood of harm to participants or 
others in the future. 
• Information that indicates a change to the risks or potential benefits of the research 
 
Adverse events that are deemed not related will be documented in the study AE log, subject study 
charts, and reported to COMIRB at the time of annual review, per their policy. The PI will review 
AEs on an ongoing basis.  
 
Anticipated clinical adverse events associated with urine catheter is: urethral/bladder irritation 
requiring removal of catheter prematurely, bladder or urethral injuries related to catheter placement, 
folliculitis of the genital area, change in urine color and UTI infection.  Symptoms of a UTI are 
anticipated and include:  fever, chills, urethral discomfort, incontinence, dark urine, urinary pain, 
suprapubic tenderness or pelvic pain, urinary urgency, frequency or dysuria, antibiotic use, 
prolonged hospital stay or readmission following symptoms. Severe UTIs may result in spread to 
the kidneys and present with abnormal kidney function assessment.  
 
Anticipated clinical adverse events associated with the use of Betadine are as follows: 
• Common: skin irritation (burning, redness, or general irritation) 
• Rare but Severe: severe allergic reaction including rash, gives, itching, difficult breathing, 
tightness of the chest, swelling of the face, lips or tongue.   
• Unlikely: balance/hearing problems, hair bumps (folliculitis), change in the amount of urine 
 
There are no known contraindicated medications associated with the use of Betadine.   
 
Serious Adverse Event  
A Serious Adverse Event (SAE) is any untoward medical occurrence at any dose that:  
• Results in death 
• Is life-threatening (defined as an event in which the subject was at risk of death at the time of 
the event; it does not refer to an event which hypothetically might have caused death if it were 
more severe) 


• Requires inpatient hospitalization or causes prolongation of existing hospitalization (see 
NOTE*: below for exceptions) 
• Results in persistent or significant disability/incapacity 
• Is a congenital anomaly/birth defect 
Is an important medical event, defined as a medical event that may not be immediately life-
threatening or result in death or hospitalization but, based on appropriate medical and scientific 
judgment, may jeopardize the subject or may require intervention (e.g., medical, surgical) to 
prevent one of the other serious outcomes listed above.  
Suspected transmission of an infectious agent (e.g., pathogenic or non-pathogenic) via the study 
treatment is an SAE.  
 
*NOTE: The following hospitalizations are not considered SAEs:  
• A visit to the emergency room or other hospital department lasting less than 24 hours that does 
not result in admission (unless considered an “important medical event” or a life-threatening 
event) 
• Elective surgery planned before signing consent 
• Admissions as per protocol for a planned medical/surgical procedure 
• Routine health assessment requiring admission for baseline/trending of health status (e.g., 
routine colonoscopy) 
• Medical/surgical admission other than remedying ill health state that was planned before study 
entry. Appropriate documentation is required in these cases 
• Admission encountered for another life circumstance that carries no bearing on health status and 
requires no medical/surgical intervention (eg, lack of housing, economic inadequacy, caregiver 
respite, family circumstances, administrative reason) 
• Admission for treatment of suspected/confirmed UTI as this is an anticipated risk and the 
primary outcome 
 
Participants experiencing a SAE should be discontinued from the study and followed per clinical 
standard of care.  SAEs should be documented on the AE CRF and reported to the IRB within 48 
hours of notification of event.   
 
There are no known reports of serious adverse events following standard practice of urine catheter 
insertion or associated with the use of Betadine.  
 
 
 
 
 
Data Collection and Confidentiality 
This study will obtain approval for conduct through the Colorado Multiple Institutional Review 
Board (COMIRB) for research involving human subjects.  All patients within the Gynecologic 
Oncology clinic at the University of Colorado Cancer Center who meet the study criteria will be 
considered eligible for the study.  We will not include any vulnerable populations as defined by 
ethical guidelines. Potential participants will be screened by the PI/Co-I and the research team and 
approached for consent.  Consent will occur prior to the initiation of any study procedures at a 
scheduled clinic visit in the Gynecologic Oncology clinics of participating sites. Potential 
participants will be provided a private setting for in-person consent and will be adequately informed 
of the study intent, requirements, and potential risks and benefits.  Patients will also be informed 
that any participation is voluntary and will not affect any clinical care they are to receive. Research 


staff providing consent will be certified in Collaborative Institutional Training Initiative (CITI) and 
Human Insurance Portability and Accountability Act (HIPAA) trainings for ethics and human 
protection.  Patients will have time to review the consent and ask any questions prior to signing 
consent.  
 
Data Collection Tools 
Data will be collected using clinical research forms (CRFs) followed by entry into the OnCore 
clinical trials management system. Research coordinators should verify all demographic and health 
history to the participant’s medical records prior to entry into OnCore. OnCore is a secure, HIOAA 
compliant management system available to trained investigators on the UCD network server. 
OnCore provides: 1) secured interface for validated data entry, 2) audit trails for tracking data 
manipulations and data storage and export procedures, 3) automated export procedures for seamless 
data downloads to common statistical packages, and 4) a library of all approved regulatory 
documents including amendments and consents. The University of Colorado Denver Informational 
Technology (IT) department will provide the host services for OnCore. Data extracted from the 
database for analysis will de-identified and linked to the original source using only a coded study 
number.  All analysis will be conducted using SPSS statistical software program.  
 
Study documents include study consent, CRFs, and a study survey. A study file should be 
constructed for each participant for maintaining these documents.  All paper records will be securely 
stored in the locked research offices with limited access. Study databases will be stored on secure 
computers of the research team and backed by the secured server of the University of Colorado 
Denver.   
 
Data sources will not be shared with outside institutions. Data shared among the researchers will be 
sent in encrypted email messages.  All data will be maintained until completion of study and 
properly stored per federal regulations after completion of study analysis.  Any data remaining on 
research electronic devices (recording devices, computers hard drives) will be properly destroyed 
with the assistance of the University IT department.  
 
 
V. Trial Oversight 
The Principal Investigator will be responsible for the conduct of this study, overseeing participant 
safety, executing the data and safety monitoring (DSM) plan, and complying with all reporting 
requirements to local and federal authorities. This oversight will be accomplished through 
additional oversight from the Data and Safety Monitoring Committee (DSMC) at the University of 
Colorado Cancer Center (CU Cancer Center).  The DSMC is responsible for ensuring data quality 
and study participant safety for all trials at the CU Cancer Center.   A summary of the DSMC’s 
activities is as follows: 
• 
Conduct of internal audits 
• 
Ongoing review of all serious adverse events (SAEs), unanticipated problems (UAPs) and 
reportable adverse events (AEs) 
• 
Has the authority to close and/or suspend studies for safety or conduct issues 
• 
May submit recommendations for corrective actions to the CU Cancer Center’s Executive 
Committee 
 
Per the CU Cancer Center Institutional DSM Plan, SAEs, UAPs and reportable AEs are reported 
to the DSMC, IRB and the sponsor (if applicable) per study protocol.  All SAEs, UAPs and 


reportable AEs are to be reported to the DSMC within 5 business days of the Principal 
Investigator receiving notification of the occurrence. 
 
Study audits conducted by the DSMC will consist of a review of the regulatory documents, 
consent forms, and source data verification.   
 
Documentation of the audit conducted by the DSMC will then need to be submitted to the IRB of 
record at the time of the IRB’s continuing review of this trial. 
 
 
Potential scientific problems: 
This study proposes the use of a simplified peri-operative catheter insertion protocol aimed at 
reducing the rates of urinary tract infections after catheter placement.  If effective this could be 
represent a low-cost, low-effort intervention however obtaining a clinically meaningful response 
may be the biggest limitation of this study.  Although UTI rates are relatively high after post-surgical 
catheter placement and there have been several studies showing some reductions, there are 
numerous additional studies which have failed to show a difference.  Our goal here is not to merely 
achieve a statistically significant but rather a clinically meaningful response.  We therefore powered 
our study to look for at least a 50% reduction in the rate of UTI’s.   
 
Additionally, there is and will remain practice variations in catheter placement.  While we hope to find 
a difference despite these differences, it is possible that the intervention may give a false impression of 
improvement simply by focusing attention on a protocol. While it is difficult to remove confounding 
from any study, randomization and analysis adjustments will be used to reduce as much as possible. 
 
VI. Data Analysis Plan:  
This study will assess a population of patients undergoing extended surgery requiring catheter 
placement to be performed by the Gynecologic Oncology service.  De-identified patient data will be 
collected into OnCore and exported to SPSS for data analysis.  Initial summary statistics will be 
performed to report the distribution of the data, including variable means, medians, proportions and 
missing data.   
 
An intent-to-treat analysis will be conducted.  All participants receiving treatment per protocol will be 
included in the final analysis.  If there are any participants who are randomized but do not receive the 
intended treatment, we will document the reasons for their being withheld treatment.    
 
For the primary outcome measure of UTI rate at each of the time points (24 hours and 14 +/- 2 days), 
we will perform a test of binomial proportions for testing the null hypothesis of no difference between 
the treatment arms.  Because we are performing tests at two time points, we will adjust for the multiple 
comparisons using Bonferroni’s method.   
 
We will also explore the association between treatment arms and other covariates (symptomatic and 
demographics factors) using bivariate methods. The particular analysis method for testing the 
association between them will depend on the distribution of the covariates. For example, symptomatic 
presentation variables (fever, pelvic pain, sense of urgency or dysuria, and antibiotic use) are 
categorical, and their association with treatment arm will be evaluated with a chi-square statistic. 
 
For demographic variables, Student’s t-test (for continuous variables) and chi-square tests (for 
categorical variables) will be used to compare the two treatment arms. Variables found to be significant 
in these bivariate analyses will be included in multivariable analysis using logistic regression. Logistic 
regression models will be used to identify significant independent predictors associated with UTI 


occurrence for each treatment arm. We will fit separate logistic regression models for UTI occurrence 
at the two time points. The logistic model will allow for control of study covariates simultaneously. A 
p-value of <0.005 will be used to demonstrate statistical significance.  IBM SPSS version 23 will be 
used for all statistical analyses. 
 
Secondary outcomes will include a cost-analysis of the two treatment protocols and a patient satisfaction 
query in regards to the catheter procedure.  
• Cost-analysis: The cost-effectiveness of the interventions will be assessed using hospital stay, 
readmissions, clinic/ED visits, and antibiotic costs per patient during the study period.  An 
estimate of patient care costs will be derived using standard cost data described in the literature.  
The two groups will be compared in terms of average cost of treatment with a 95% confidence 
interval using a Bayesian statistic.  
• Satisfaction: Patient satisfaction with the catheter protocol will be measured using a Likert-like 
scale questionnaire.  Responses between the two groups will be compared using a Mann-
Whitney-Wilcoxon statistic. 
 
VII. Summarized Knowledge to be gained: 
This study aims to reduce the incidence of urinary tract infections in patients undergoing surgery on the 
Gynecologic Oncology service through an aseptic protocol for placement.  Such quality improvement 
studies are needed to help reduce complication rates and health-care costs. 
 
VIII. References: 
 
 
1. Septimus, E.J. and J. Moody, Prevention of Device-Related Healthcare-Associated Infections. 
F1000Res, 2016. 5. 
2. Stephan, F., et al., Reduction of urinary tract infection and antibiotic use after surgery: a 
controlled, prospective, before-after intervention study. Clin Infect Dis, 2006. 42(11): p. 1544-51. 
3. Barbadoro, P., et al., Catheter-associated urinary tract infection: Role of the setting of catheter 
insertion. Am J Infect Control, 2015. 43(7): p. 707-10. 
4. Amine, A.E., M.O. Helal, and W.M. Bakr, Evaluation of an intervention program to prevent 
hospital-acquired catheter-associated urinary tract infections in an ICU in a rural Egypt hospital. 
GMS Hyg Infect Control, 2014. 9(2): p. Doc15. 
5. Singh, S., et al., Surveillance of device-associated infections at a teaching hospital in rural 
Gujarat--India. Indian J Med Microbiol, 2010. 28(4): p. 342-7. 

ICF_001.pdf: 
Consent and Authorization Form
Combined Biomedical Consent and Separate Main and Optional HIPAA authorizations
CF-151.S, Effective 7-19-13
Page 1 of 5
Initials______
Principal Investigator:  
COMIRB No:  
Version Date:  
Study Title:  
Saketh Guntupalli, MD
16-1096
26-Mar-2017
Reducing Urinary Tract Infection Rates using a Controlled Aseptic Protocol for
Catheter Insertion
NCT03101371
You are being asked to be in a research study.  This form provides you with information about the study. A 
member of the research team will describe this study to you and answer all of your questions. Please read the 
information below and ask questions about anything you don’t understand before deciding whether or not to 
take part. 
Why is this study being done?
This study plans to learn more about urinary tract infections (UTI) after surgery and how we can prevent them. 
You are being asked to be in this research study because you are undergoing surgery at the University of 
Colorado Hospital that requires a urinary catheter, and is expected to last more than 1 hour.
Other people in this study
Up to 250 people from your area will participate in the study. 
What happens if I join this study?
If you join the study, you will participate in the following study visits over 2 weeks. 

Visit 1: You will have a physical exam completed and we will ask you questions about your health
history, clinical diagnosis, and current medications. A urine sample will be collected.

Visit 2: You will be randomized (like flipping a coin) to either receive the standard catheter insertion
protocol or your catheter will be dipped in Povidone Iodine prior to insertion and a plastic cover will
be used.

Visit 3: You will be assessed at 24 hours after your operation for signs of a UTI and will be asked to
complete a survey about your satisfaction with the procedure.  A urine sample will be collected.

Visit 4: At your routine care visit 2 weeks after your operation, you will be assessed for signs of a UTI
and will be asked to complete a survey about your satisfaction with the procedure. A urine sample
will be collected.  You will also have a physical exam and we will collect information from your
medical record about your hospital stay.
'If you develop a UTI or abnormal urinalysis results during the study, you will be treated with the current 
standard of care treatment options. Upon completion of Visit 4, your participation in the study will end.
What are the possible discomforts or risks?
Risks or Discomforts which you may experience while in this study include the following:

Breach of Confidentiality: There is a risk that your privacy may not be protected.  We will do all that we can
to keep your information secure.

The placement of catheter: There may be risks associated with this procedure, however, these are risks
that you would encounter even if you were not in this study.  You will be told of these risks as part of your
routine pre-operation care.

Use of Povidone Iodine: You may experience skin irritation (burning, redness, or general irritation).  It is
COMIRB
APPROVED
For Use
01-Mar-2018
28-Feb-2019


Consent and Authorization Form
Combined Biomedical Consent and Separate Main and Optional HIPAA authorizations
CF-151.S, Effective 7-19-13
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possible you could have an allergic reaction to the iodine which could result in a rash, hives, itching, 
difficulty breathing, tightness of your chest, swelling of your face, lips, or tongue.  This is unlikely and rare.  

Use of Plastic Sleeve:  You may experience increased irritation due to the protective plastic cover.
There is a risk that people outside of the research team will see your research information.  We will do all that 
we can to protect your information, but it can not be guaranteed.
The study may include risks that are unknown at this time. 
What are the possible benefits of the study?
This study is designed for the researcher to learn more about urinary tract infections (UTI) after surgery and how 
we can prevent them.
There is no guarantee that you will not develop a UTI if you join this study.  Also, there could be risks to being in 
this study.  These are described in the section above.
Will I be paid for being in the study?  
You will not be paid for participation in this study.
Will I have to pay for anything?
It will not cost you anything to be in the study. However, all costs associated with routine standard of care 
procedures for catheter insertions and diagnosing and treatment of a UTI will be the responsibility of you or 
your insurance provider.
Is my participation voluntary?
Taking part in this study is voluntary.  You have the right to choose not to take part in this study.  If you choose 
to take part, you have the right to stop at any time.  If you refuse or decide to withdraw later, you will not lose 
any benefits or rights to which you are entitled. 
If you leave this study, you will still receive your normal medical care.  The only medical care that you will lose is 
the medical care you are getting as part of this study.  You might be able to get that same kind of medical care 
outside of the study.  Ask your study doctor. 
If there are any new findings during the study that may affect whether you want to continue to take part, you 
will be told about them.
Can I be removed from this study? 
The study doctor may decide to stop your participation without your permission if the study doctor thinks that 
being in the study may cause you harm, or for any other reason. 
What happens if I am injured or hurt during the study? 
If you have an injury while you are in this study, you should call Dr. Guntupalli immediately. His phone number is 
303-266-4172. 
We will arrange to get you medical care if you have an injury that is caused by this research.  However, you or 
your insurance company will have to pay for that care. 


Consent and Authorization Form
Combined Biomedical Consent and Separate Main and Optional HIPAA authorizations
CF-151.S, Effective 7-19-13
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Who do I call if I have questions?
The researcher carrying out this study is Dr. Saketh Guntupalli.  You may ask any questions you have now. If you 
have questions, concerns, or complaints later, you may call Dr. Guntupalli at (303)266-4172. You will be given a 
copy of this form to keep.  
You may have questions about your rights as someone in this study. You can call Dr. Guntupalli with questions.  
You can also call the responsible Institutional Review Board (COMIRB).  You can call them at 303-724-1055. 
Who will see my research information?
The University of Colorado Denver (UCD) and its affiliated hospital(s) have rules to protect information about 
you.  Federal and state laws including the Health Insurance Portability and Accountability Act (HIPAA) also 
protect your privacy.   This part of the consent form tells you what information about you may be collected in 
this study and who might see or use it.  
The institutions involved in this study include the University of Colorado Denver and the University of Colorado 
Hospital.
We cannot do this study without your permission to see, use and give out your information.  You do not have to 
give us this permission.  If you do not, then you may not join this study.  
We will see, use and disclose your information only as described in this form and in our Notice of Privacy 
Practices; however, people outside the UCD and its affiliate hospitals may not be covered by this obligation.
We will do everything we can to maintain the confidentiality of your personal information but confidentiality 
cannot be guaranteed. 
The use and disclosure of your information has no time limit.  You can cancel your permission to use and 
disclose your information at any time by writing to the study’s Principal Investigator (PI), at the name and 
address listed below.  If you do cancel your permission to use and disclose your information, your part in this 
study will end and no further information about you will be collected.  Your cancellation would not affect 
information already collected in this study.  
Dr. Saketh Guntupalli
12631 E. 17th Street, MS B198-4
Aurora, CO 80045
Both the research records that identify you and the consent form signed by you may be looked at by others who 
have a legal right to see that information, such as: 

Federal offices such as the Food and Drug Administration (FDA) and the Office of Human Research 
Protections (OHRP) that protect research subjects like you.

People at the Colorado Multiple Institutional Review Board (COMIRB)

The study doctor and the rest of the study team.

Officials at the institution where the research is conducted and officials at other institutions involved in 
this study who are in charge of making sure that we follow all of the rules for research
We might talk about this research study at meetings.  We might also print the results of this research study in 
relevant journals.  But we will always keep the names of the research subjects, like you, private. 


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Combined Biomedical Consent and Separate Main and Optional HIPAA authorizations
CF-151.S, Effective 7-19-13
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You have the right to request access to your personal health information from the Investigator. 
Information about you that will be seen, collected, used and disclosed in this study:

Name and Demographic Information (age, sex, ethnicity, address, phone number, etc.)

Portions of your previous and current Medical Records that are relevant to this study, including but not 
limited to Diagnosis(es), History and Physical, laboratory or tissue studies, radiology studies, procedure 
results

Research Visit and Research Test records
What happens to Data and Specimens that are collected in this study? 
Scientists at the University of Colorado Denver and the hospitals involved in this study work to find the causes 
and cures of disease.  The data and specimens collected from you during this study are important to this study 
and to future research.  If you join this study:

The data and specimens given by you to the investigators for this research no longer belong to you.  

Both the investigators and any sponsor of this research may study the data and specimens collected 
from you.

If data and specimens are in a form that identifies you, UCD or the hospitals involved in this study may 
use them for future research only with your consent or Institutional Review Board (IRB) approval.

Any product or idea created by the researchers working on this study will not belong to you.

There is no plan for you to receive any financial benefit from the creation, use or sale of such a product 
or idea. 
Agreement to be in this study and use my data
I have read this paper about the study or it was read to me.  I understand the possible risks and benefits of this 
study.  I understand and authorize the access, use and disclosure of my information as stated in this form.  I 
know that being in this study is voluntary.  I choose to be in this study: I will get a signed and dated copy of this 
consent form.
Signature:
Date:
Print Name:
______
Consent form explained by:
_____________Date:
Print Name:
_______
For subjects unable to read:
Witness Signature: _______________________________________
 Date: ____________
Witness Print Name:
__


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