Clinical trial NCT03447639
Conditions: Catheter; Infection (Indwelling Catheter) Catheter Infection Catheter-Related Infections Catheter Bacteraemia Urinary Tract Infections
Keywords: Catheter associated UTI Povidine iodine Bladder Irrigation
Sponsor: William Beaumont Hospitals
Start date: 2018-03-29; Completion date: 2018-10-22
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Over the last decade, there has been great emphasis on reducing the incidence of hospital-acquired infections, including catheter-associated UTI (CAUTI). This study will evaluate the effectiveness of Betadine irrigation solution (2% povidone-iodine) instilled into the bladder immediately prior to indwelling catheter removal to decrease the risk of subsequent bacteriuria, leading to decreased rates of NHSN defined CAUTI.

Detailed description:
Indwelling urinary catheters are routinely used in the care of hospitalized patients for a variety of reasons, including monitoring of urine output in critically ill patients, relief of urinary obstruction, and prevention of contamination of decubitus ulcers. Bacteriuria increases by 3-10% each day a catheter is left in place, meaning that by 30 days, generally 100% of patients with indwelling catheters will have bacteria in their urine. The majority of these people do not have urinary tract infections (UTIs), they are merely colonized and do not require treatment.

To define a standard (and ultimately to compare hospitals against each other), a surveillance definition for CAUTI has been developed by the National Healthcare Safety Network (NHSN). While useful for surveillance, the definition does not correlate with clinical UTIs, leading to over diagnosis and over-reporting of UTIs (in other words, those with merely bladder colonization being diagnosed as having a UTI). Despite continuing progress in standard methods of reducing infection rates (including decreasing the number of catheters inserted, ensuring proper catheter maintenance, and removing catheters when no long necessary) there continue to be unacceptably high rates of CAUTIs.

A single dose of povidone-iodine prior to catheter removal seems a novel and promising practice for several reasons. First, we suspect it will be helpful in reducing rates of NHSN defined CAUTI, as these are still diagnosed for 2 days after the catheter is removed. Second, using multiple doses of povidone-iodine would be inadvisable, since we suspect bacteria over time would become resistant even to this antiseptic. Third, we suspect use of an antiseptic is preferable to an antibacterial for preventing further antimicrobial resistance development. Finally, use of this method, as opposed to the suggested use of systemic antibiotics at time of removal, is potentially preferable from the downstream standpoint of less antimicrobial resistance and reduced risk of Clostridium difficile infection.

Arms: arm 1: Bladder irrigation with 2% povidine-iodine irrigation immediately prior to catheter removal arm 2: Catheter removal with no bladder irrigation
Interventions: intervention 1: Povidone-iodine irrigation
Intervention descriptions: intervention 1: Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique

Protocol documents:
Prot_SAP_000.pdf: 
IRB NUMBER: 2018-001
IRB APPROVAL DATE: 10/25/2018
1
A Randomized Trial of Betadine Bladder Irrigations vs. Standard of Care 
Prior to Indwelling Catheter Removal to Reduce Bacteriuria and Catheter-
Associated Urinary Tract Infections
Principal Investigator 
Jay Hollander MD
Co-Investigators 
Paul Chittick MD
Matthew Sims MD
Bobby Boyanton MD 
Spencer Hiller MD
Deborah Hasenau RN
PROTOCOL DATE: SEPTEMBER 26, 2018
TABLE OF CONTENTS
I.
BACKGROUND AND RATIONALE…………………………………..
2
II.
OBJECTIVES AND ENDPOINT………………………………………
3
III.
METHODOLOGY……………………………………………………
3
IV.
RISKS AND BENEFITS………………………………………………
6
V.
ELIGIBILITY CRITERIA…………………………………………….
7
VI.
DATA ANALYSIS……………………………………………………
8
VII.
DATA SAFETY MONITORING PLAN………………………………..
10
VIII.
REFERENCES……………………………………………………….
11
APPENDIX A: QUESTIONNAIRE…………………………………………
12


IRB NUMBER: 2018-001
IRB APPROVAL DATE: 10/25/2018
2
I.
BACKGROUND AND RATIONALE
Indwelling urinary catheters are routinely used in the care of hospitalized patients for a variety of 
reasons, including monitoring of urine output in critically ill patients, relief of urinary 
obstruction, and prevention of contamination of decubitus ulcers. Bacteriuria increases by 3-10% 
each day a catheter is left in place1, 2 meaning that by 30 days, generally 100% of patients with 
indwelling catheters will have bacteria in their urine. The majority of these people do not have 
urinary tract infections (UTIs), they are merely colonized and do not require treatment.
 
Over the last decade, there has been great emphasis on reducing the incidence of hospital-
acquired infections, including catheter-associated UTI (CAUTI). Hospitals have had relatively 
good results, though there is certainly still room for improvement. To define a standard (and 
ultimately to compare hospitals against each other), a surveillance definition for CAUTI3 has 
been developed by the National Healthcare Safety Network (NHSN). While useful for 
surveillance, the definition does not correlate with clinical UTIs, leading to over diagnosis and 
over-reporting of UTIs (in other words, those with merely bladder colonization being diagnosed 
as having a UTI). Despite continuing progress in standard methods of reducing infection rates 
(including decreasing the number of catheters inserted, ensuring proper catheter maintenance, 
and removing catheters when no long necessary) we continue to have unacceptably high rates of 
CAUTIs. As hospital-acquired infection rates are increasingly tied to reimbursement from 
governmental agencies, there is a great need to reduce infection, either by meeting surveillance 
criteria or through novel clinical approaches.
 
Studies from the 1980s and 1990s investigated a variety of compounds for local instillations into 
the bladder in attempts to decrease bacteriuria and prevent infections. One of the more promising 
solutions instilled was povidone-iodine.  A single preoperative instillation of 1% povidone-
iodine prior to prostatectomy in patients with indwelling catheters reduced the rate of post-
operative bacteriuria from 100% to 22.5% 4. Similarly, bladder irrigation with 2% povidone-
iodine prior to prostatectomy in patients with indwelling catheters was well tolerated and 
achieved urine sterilization in 75% of patients in another study5. While neither of these studies 
looked at reducing rates of CAUTI, we hypothesize that they could provide a benefit, given their 
effectiveness at decreasing bacteriuria in patients with indwelling catheters.  Both studies 


IRB NUMBER: 2018-001
IRB APPROVAL DATE: 10/25/2018
3
reported that a low concentration of 1 or 2% was well tolerated by patients. A study from the 
Netherlands evaluated use of pre-removal povidone-iodine bladder irrigation6. No reduction in 
bacteriuria was found in cultures at days 4 to 14 after removal, though there was a trend towards 
less bacteriuria in the first 3 days after removal. Additionally, more than half of the patients had 
only had catheters in place for 3 days or less prior to removal, and only 13.6% of patients had 
positive urine cultures prior to removal, which may have minimized the potential differences. 
A single dose of povidone-iodine prior to catheter removal seems a novel and promising practice 
for several reasons. First, we suspect it will be helpful in reducing rates of NHSN defined 
CAUTI, as these are still diagnosed for 2 days after the catheter is removed. Results of a recent 
review revealed that 15-20% of diagnosed CAUTIs at Beaumont occurred during this window. 
Second, using multiple doses of povidone-iodine would be inadvisable, since we suspect bacteria 
over time would become resistant even to this antiseptic. Third, we suspect use of an antiseptic is 
preferable to an antibacterial for preventing further antimicrobial resistance development. 
Finally, use of this method, as opposed to the suggested use of systemic antibiotics at time of 
removal7, is potentially preferable from the downstream standpoint of less antimicrobial 
resistance and reduced risk of Clostridium difficile infection.
II.
OBJECTIVE AND ENDPOINT
Objective:
To evaluate the effectiveness of Betadine irrigation solution (2% povidone-iodine) instilled into 
the bladder immediately prior to indwelling catheter removal to decrease the risk of subsequent 
bacteriuria, leading to decreased rates of NHSN defined CAUTI.
Endpoint:
Presence or absence of NHSN defined CAUTI at 48-72 hours after indwelling urinary catheter 
removal, as assessed by urinalysis (UA), urine culture (UC), and UTI Symptom Assessment 
questionnaire (UTISA)8.
III.
METHODOLOGY
A total of 110 men will be enrolled in this randomized trial, which will be conducted at 
Beaumont Hospital, Royal Oak. Eligible patients will be consented and randomized into 1 of 2 


IRB NUMBER: 2018-001
IRB APPROVAL DATE: 10/25/2018
4
groups. Ideally, fifty-five men will be in each group. 120 men may need to be enrolled to achieve 
the desired number of patients completing the 48-72-hour post-catheter removal visit, which is 
the study endpoint.
Despite optimal “clean catch” collection techniques, it is often difficult to obtain a non-
contaminated urine sample from females without performing sterile catheterization due to the 
chronically colonized vaginal flora. In order to minimize patient risks and difficulty with 
recruitment associated with additional catheterization, we have chosen to exclude females from 
this initial study. The male anatomy allows for adequate sample collection via “clean-catch” 
alone. By enrolling only males we hope to reduce the possibility of contamination in the clean-
catch specimens collected at the 48-72 hour follow up visit9. Future studies would include 
females as well.
Study staff will review patient charts from all Beaumont Hospital, Royal Oak units (including 
rehabilitation units) in order to identify patients who may be eligible to participate.  Appropriate 
patients will be approached, the study will be described to them in detail, and informed consent 
will be obtained. Eligibility criteria will be reviewed, including current antibiotic use, which is 
exclusionary. If the patient meets all of the inclusion criteria and none of the exclusion criteria, a 
urine sample will be obtained for UA and UC. All urine test results will be for research purposes 
only and not part of the patient’s clinical chart/electronic medical record. All UA and UC results, 
collected for research, will be reviewed by one of the study investigators. If a patient develops 
symptoms at any point in the study, a UA and UC could be obtained at the care provider’s 
discretion.
Patients will be randomized 1:1 to receive either standard of care (catheter removal with no 
bladder irrigation) or bladder irrigation with 2% povidone-iodine solution immediately prior to 
catheter removal. Randomization envelopes will be provided by the biostatistician and stored in a 
secure location in Urology Research. At the time research staff contact the pharmacist with the 
Betadine request, group assignment will be verified. 


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IRB APPROVAL DATE: 10/25/2018
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The first group will receive standard of care (SOC) only (indwelling catheter removal without 
any other interventions). If the patient is randomized to the SOC arm, the research nurse will 
simply remove the indwelling catheter.  The second group will receive a single dose of 
approximately 60 cc of 2% povidone-iodine (Betadine) placed into the bladder. When the patient 
is randomized to the Betadine rinse arm, the research pharmacist will be contacted. The 
pharmacist will prepare and deliver the Betadine filled syringe to the research staff for 
instillation. The Betadine solution will be instilled through the catheter and left to dwell for 10 
minutes, drained, and then the catheter will be removed. Research staff will be trained by a 
physician to remove the catheter using aseptic technique and prevent introduction of bacteria. To 
ensure patients are able to adequately void after catheter removal, designated study personnel 
(Urologists), will manage the study patient’s voiding trial. 
 
48-72 hours after catheter removal a urine sample will be obtained to repeat UA and UC. If 
enrolled patients are still inpatient at this time point, study staff will see the patient in the hospital 
and conduct the Visit 2 activities. If the patient has been discharged from the hospital, this visit 
will occur in the Urology Research office. While not ideal or preferred, if the patient is not 
available for an in-person visit, the questionnaire may be completed over the phone, or sent to 
the patient and returned by mail (returned by USPS, email, or fax).  In addition to the UA and 
UC, the UTISA questionnaire will also be completed. The UTISA questionnaire is a validated 
tool which will be utilized to assess the “severity” and “bothersomeness” of the most frequently 
reported signs and symptoms of uncomplicated UTI8.  The Beaumont laboratory will evaluate all 
collected specimens. If a patient develops symptoms suggestive of a UTI, then further testing 
may be performed at the discretion of their managing physician or one of the study 
investigators. Research staff will also contact patients by phone at 7 and 28 days after catheter 
removal. At that time the UTISA will be administered to assess urinary symptoms, including 
diagnosed UTIs since the time of catheter removal. The UTISA may be completed verbally over 
the phone or by mail (returned by USPS, mail, or fax). If the patient’s responses indicate a 
possible UTI, the patient will be referred to their primary care provider and/or other health care 
provider for evaluation.


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IRB APPROVAL DATE: 10/25/2018
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Patients requiring reinsertion of an indwelling catheter prior to study completion will be 
withdrawn from the study. Patients that do not comply with the study protocol may also be 
withdrawn from the study by the Principal Investigator (PI).
SCHEDULE OF ACTIVITIES
Screening & 
Treatment Visit
Inpatient Visit
Visit 2 
48-72 Hours
Clinic or Inpatient 
Visit
Visit 3 
7 ± 3 days
Phone Call
Visit 4
28 ± 3 days
 Phone Call
Informed Consent
X
Review Inclusion and Exclusion 
Criteria
X
Review of Current Antibiotic 
Medication Use
X
X
X
X
Urine collection: UA & UC
X
X
UTISA Questionnaire
Xa
Xb
Xb
Indwelling Catheter Removal
X
Betadine Bladder Irrigation
Xc
Assess for Adverse Events
X
X
X
X
aAt Visit 2 the UTISA may be completed in person, over the phone, or by mail (returned via USPS, email, or fax).
bAt visits 3 and 4 the UTISA may be completed over the phone or by mail (returned via USPS, email, or fax).
cBetadine Bladder Irrigation will only be completed with those patients who are randomized to the treatment group.
IV.
RISKS AND BENEFITS
Potential Benefits: This intervention may be beneficial for both patients and the hospital. The 
rate of hospital acquired CAUTIs may be reduced without increasing the risk of antimicrobial 
resistance. 
Potential Risks: 
Risks of Urinary Catheterization: 
Less Frequent (occurring from 1% to 10% of the time):

Temporary inability to urinate

Bleeding

Mild cramping

Urinary tract infection


IRB NUMBER: 2018-001
IRB APPROVAL DATE: 10/25/2018
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Risks of Betadine:
Less Frequent (occurring from 1% to 10% of the time):

Local irritation of the bladder
Rare (occurring less than 1% of the time):

Allergic reaction
Unknown Risk:

Brown discoloration of urine
Risks of Bladder Irrigation:
Less Frequent (occurring from 1% to 10% of the time):

Discomfort while the indwelling urinary catheter is clamped
All patients will be closely monitored by the research staff during the instillation, if applicable, 
and during catheter removal. All unanticipated problems will be reported to Beaumont’s 
Investigational Review Board (IRB) per policy.
V.
COMPENSATION
Patients will be reimbursed for time and travel during the course of the study, as outlined in the 
table below. Stipend checks will be sent, via US mail, in the amount listed below after each 
completed visit which is eligible to receive a stipend. If patients are unable to complete all study 
visits, they will be paid only for the visits they were able to complete. 
Visit
Stipend Per Visit
Screening and Treatment Visit
$25.00
Study Visit 2
$25.00
Study Visit 3
$0.00
Study Visit 4
$0.00 
Maximum Total (if all visits are included)
$50.00 


IRB NUMBER: 2018-001
IRB APPROVAL DATE: 10/25/2018
8
VI.
ELIGIBILITY CRITERIA 
Inclusion:
1) Provide written informed consent and the willingness and ability to comply with all 
aspects of study requirements
2) Male
3) Inpatients ≥ 18 years of age with an indwelling catheter in place for at least 5 days with a 
plan for removal
Exclusion:
1) Patients planned for discharge with an indwelling catheter in place
2) Patients unable to report urinary symptoms accurately
3) Patients with hyper-sensitivity or allergic reaction to Betadine, iodine, shellfish or other 
related compounds 
4) Clinical signs or symptoms of urinary tract infection at the time of consent
5) Patients currently being treated for UTI
6) Patients currently taking any antibiotic medication, other than those listed in Appendix B
7) Patients already taking medications known to potentially irritate the bladder, such as, but 
not limited to, cyclophosphamide, ifosfamide, and other chemotherapeutic agents
8) Patients with history of bladder cancer, pelvic radiation or interstitial cystitis
9) Patients unable to comply with study requirements 
10) Any other condition which, per investigators’ judgment, may increase patient risk and/or 
impede the reliability of study data
VII.
DATA ANALYSIS
An infection rate of 25% is anticipated at day 2 post catheter removal for the SOC group. A 
difference has been shown of a 75% drop in infection rate using povidone-iodine bladder 
irrigation5. A power analysis using these estimates yields 55 patients needed in each arm to have 
80% power at a 0.05 significance level to detect a difference of 25% versus 6.25%. We estimate 
at most a 10% dropout rate and plan to enroll 60 patients per arm to account for this.
Descriptive statistics will be provided for all data collected. Categorical variables will be 
reported as counts and percent frequencies. All continuous variables will be reported as means 


IRB NUMBER: 2018-001
IRB APPROVAL DATE: 10/25/2018
9
+/- the standard deviation followed by the median, minimum to maximum or the median (25th, 
75th percentiles) then minimum to maximum dependent on the normality of the data. 
The endpoint of presence or absence of bacteriuria at 48-72 hours post catheter removal will be 
examined with a Fisher’s exact tests, odds ratio and 95% confidence intervals. If any differences 
are found in what appear to be confounders for UA, a multivariate logistic regression analysis 
may be completed adjusting for these differences.
The categorical variables will be examined using Pearson’s Chi-square tests where appropriate 
(expected frequency >5), otherwise Fisher’s exact tests will be used. Continuous variables will 
be examined for normality. Normally distributed variables will be analyzed using t-tests. Non-
normally distributed variables will be examined using non-parametric Kruskal-Wallis tests.
REDCap (Research Electronic Data Capture) is the web-based software program that will be 
utilized for data collection and management. Urology Research will be responsible for all data 
management responsibilities including, but not limited to, database creation, data entry and query 
resolution. Data analyses will be performed by a Beaumont Biostatistician utilizing statistical 
software.  
 
VIII.
DATA SAFETY MONITORING PLAN
Ongoing safety monitoring will be performed by the study staff, including the PI and co-
investigators. The PI will have ultimate responsibility of assuring patient safety. A Medical 
Safety Monitor (MSM) will be assigned by the PI. The MSM will be a physician who is not 
involved in the study and who has no conflict of interest. The MSM will review Serious Adverse 
Events (SAEs) and will determine expectedness and causality of the event. The MSM may 
suggest protocol modifications to prevent the occurrence of adverse events (e.g., modifying the 
protocol to require frequent measurement of laboratory values predictive of the event or to 
improve expeditious identification of SAEs). If the MSM is unavailable for an extended period 
(i.e. extended vacation, illness, etc.) a back-up MSM will be nominated by the study PI. Safety 
issues will also be addressed in the annual reports to Beaumont’s IRB.


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Additional data safety monitoring procedures include:

Research Administration’s Clinical Research Quality and Process Improvement Program 
(CRQIP) will perform in-house monitoring of the first patient enrolled after the 
completion of visit 1

Safety data review at study team meetings


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IX.
REFERENCES
1. Warren, J. W., Platt, R.J., Rosner, B., & Kass, E. H. (1978). Antibiotic irrigation and catheter-
associated urinary-tract infections. New England Journal of Medicine, 299, 570-573. 
doi:10.1056/NEJM197809142991103
2. Haley, R.W., Hooton, T.M., Culver, D.H., Stanley, R.C., Emori, T.G., Hardison, C.D., Quade, 
D., Shachtman, R.H., Schaberg, D.R., Shah, B.V., Schatz, G.D. (1981). Nosocomial infections 
in U.S. hospitals, 1975-1976: estimated frequency by selected characteristics of patients. 
American Journal of Medicine, 70(4), 947-959.
3. Urinary Tract Infection (Catheter-Associated Urinary Tract Infection [CAUTI] and Non-
Catheter-Associated Urinary Tract Infection [UTI]) and Other Urinary System Infection 
[USI]) Events. National Healthcare Safety Network (NHSN) Patient Safety Component 
Manual (pp. 7.1-7.19) (2017, January). Retrieved from 
https://www.cdc.gov/nhsn/pdfs/pscmanual/pcsmanual_current.pdf
4. Richter,S., Kotliroff, O., & Nissenkorn, I. (1991). Single preoperative bladder instillation of 
povidone-iodine for the prevention of postprostatectomy bacteriuria and wound infection.  
Infect Control & Hospital Epidemiology, 12(10), 579-582.
5. Merimsky, E., Werbin, N., & Canetti, R. (1981). Pre-operative bladder irrigation with 
povidone-iodine.  British Journal of Urology, 53(4), 330-332.
6. Schneeberger, P.M., Vreede, R.W., Bogdanowicz, J.F., & van Dijk, W.C. (1992).  A 
randomized study of the effect of bladder irrigation with povidone-iodine before removal of an 
indwelling catheter.  Journal of Hospital Infection, 21(3), 223-229.
7. Marschall J., Carpenter, C.R., Fowler, S., & Trautner, B.W. (2013). Antibiotic prophylaxis for 
urinary tract infections after removal of urinary catheter: meta-analysis. BMJ, 346(3147). doi: 
10.1136/bmj.f3147.
8. Clayson, D., Wild, D., Doll, H., Keating, K., & Gondek, K. (2005). Validation of a patient-
administered questionnaire to measure the severity and bothersomeness of lower urinary tract 
symptoms in uncomplicated urinary tract infection (UTI): the UTI Symptom Assessment 
questionnaire. BJU International, 96(3), 350-359. doi: 10.1111/j.1464-410X.2005.05630.x
9. Frazee, B.W., Enriquez, K., Ng, V., & Alter, H. (2015). Abnormal urinalysis results are 
common, regardless of specimen collection technique, in women without urinary tract 
infections. Journal of Emergency Medicine, 48(6). doi: 10.1016/j.jemermed.2015.02.020.


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Appendix A: Urinary Tract Infection Symptom Assessment (UTISA) 
8. Please give an overall rating of the severity of your urinary tract infection symptoms as they are at this 
moment (Please circle the number of your answer)
0   No symptoms                      1   Mild                               2   Moderate                               3 Severe
Additional questions at Visits 3 and 4:
9. Since you last completed this questionnaire, have there been any changes in your urinary tract infection 
symptoms? (Please circle the number of your answer)
0  about the same
1  better (if patient responded 1=better, go to question 10)
2  worse
10. Please indicate how much better (Please circle the number of your answer)
6  a very great deal better
5  a great deal better
4  a good deal better
3  moderately better
2  somewhat better
1  a little better
About Your Symptoms and Their Impact on Your Life 
Please indicate whether you have had 
the following symptoms/problems in the 
past 24 hours and how severe they were: 
(Please circle one number for each 
symptom)
If you have experienced these 
symptoms/problems in the past 24 hours, 
please indicate how bothersome they were? 
(Please circle one number for each 
symptom)
Did not have   Mild     Moderate   Severe
SYMPTOMS
Not at all     A little       Moderately     A lot
        0                 1                 2               3
Frequency of urination (going to 
the toilet very often)
    0                 1                     2                 3
        0                 1                 2               3
Urgency of urination (a strong 
and uncontrollable urge to pass 
urine)
    0                 1                     2                 3
        0                 1                 2               3
Pain or burning when passing 
urine
    0                 1                     2                 3
        0                 1                 2               3
Not being able to empty your 
bladder completely/passing only 
small amounts of urine
 0                 1                     2                 3
        0                 1                 2               3
Pain or uncomfortable pressure 
in the lower abdomen/pelvic 
area caused by your urinary tract 
infection
    0                 1                     2                 3
        0                 1                 2               3
Lower back pain caused by your 
urinary tract infection
    0                 1                     2                 3
        0                 1                 2               3
Blood in your urine
    0                 1                     2                 3


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Appendix B: Antibiotic Medications which are NOT Exclusionary

Vancomycin (Vancocin)

Linezolid (Zyvox)

Daptomycin (Cubicin)

Clindamycin (Cleocin, Evoclin)

Metronidazole (Flagyl)

ICF_001.pdf: 
IRB NUMBER: 2018-001
IRB APPROVAL DATE: 08/02/2018
IRB EXPIRATION DATE: 01/18/2019
IRB #       2018-001                                                                                                                                      Page 1 of 7 
Version       06/19/2018
                                                                 
CONSENT FORM AND AUTHORIZATION FOR DISCLOSURE OF
PROTECTED HEALTH INFORMATION
 
STUDY TITLE: A RANDOMIZED TRIAL OF BETADINE BLADDER IRRIGATIONS VS. 
STANDARD OF CARE PRIOR TO INDWELLING CATHETER REMOVAL TO REDUCE 
BACTERIURIA AND CATHETER-ASSOCIATED URINARY TRACT INFECTIONS
Principal Investigator: Jay Hollander, MD
Hospital: Beaumont Hospital, Royal Oak
Address: 3535 West 13 Mile Road, Suite 438, Royal Oak, MI 48073
INTRODUCTION 
Why is this study being done?
You are being asked to participate in a research study.  The purpose of research is to look at 
the nature of disease and try to develop improved methods to diagnose and treat disease. The 
doctor or clinician in charge of the study believes you meet the initial requirements to take 
part in the study.  Before agreeing to participate, it is important for you to read and 
understand the following explanation of the research procedures.  This Consent and 
Authorization form describes the purpose, procedures, benefits, risks and discomforts of the 
study.  It also describes the alternatives available to you, and your right to withdraw (quit) 
from the study at any time.  
Please read this information carefully and ask as many questions as you like before deciding 
whether or not you would like to take part in this research study.
The goal of this study is to evaluate whether instilling (filling with a liquid) 2% povidone-iodine 
(Betadine) into the bladder before removing an indwelling catheter (one that remains in place 
for a period of time) reduces the rate of urinary tract infections. Povidone-iodine is a 
commonly used solution that reduces the risk of infection on the surface of the skin or in the 
eye. Povidone-iodine is an FDA approved antiseptic, but its use in the bladder is not approved.
Up to 120 patients will be enrolled in the study at Beaumont Hospital, Royal Oak.
How long will I be in the study?
If you decide to take part in this study, your participation is expected to last approximately 1 
month.  You may not take part in this study if you are currently enrolled in another related 
research study which could alter or influence the study results.


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DESCRIPTION OF THE STUDY
What will happen if I take part in the research study?
You are being asked to take part in this research study because you have had an indwelling 
catheter in your bladder for at least five days.  Indwelling bladder catheters increase the 
likelihood of developing bacteriuria (bacteria in the urine) by about 5% each day, as well as 
the risk of actual urinary tract infection.  
If you agree to take part in this study you will be randomly assigned to one of two treatment 
groups. Randomization is like “the flip of a coin”. 
The treatment groups are:  
A. Study drug: approximately 60 mL of 2% povidone-iodine solution will be instilled into 
the bladder through the indwelling catheter and allowed to remain for 10 minutes, at 
which point the bladder will be drained and the catheter will be removed
B.  Standard of care for your condition: immediate removal of the indwelling catheter 
without povidone-iodine instillation. 
Below is a table describing what will occur at each study visit:  
Screening/Treatment
Visit 2 
In Hospital or 
Clinic 
Visit 3 
Phone Call
Visit 4
 Phone Call
Visit Window
48-72 hours
7 ± 3 days 
28 ± 3 days
Informed 
consent
X
Review inclusion 
and exclusion 
criteria 
X
Review 
medications
X
X
X
X
Urine collectiona
X
X
Urinary symptom 
questionnaire
Xb
Xb
Xb
Indwelling 
catheter removal
X
2% Povidone-
Iodine Bladder 
Instillation
Xc
Assess for side 
effects
X
X
X
X
aAll urine test results will be for research purposes only and not part of your clinical chart/electronic medical 
record
bThe Urinary symptom questionnaire may be completed in person, over the phone, or at home and returned by 
US mail, fax, or emailc2% Povidone-Iodine bladder instillation will only be performed if you are randomized to 
receive it


IRB NUMBER: 2018-001
IRB APPROVAL DATE: 08/02/2018
IRB EXPIRATION DATE: 01/18/2019
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FDA Clinical Trial Information 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this website at any time. 
RISKS, SIDE EFFECTS AND DISCOMFORTS
Ask your doctor what the standard of care risks are as well as the study risks.
What side effects or risks can I expect from being in the study?
Risks, side effects, and/or discomforts from the study medication and procedures are 
described below:
Risks of Urinary Catheterization: 
Less Frequent (occurring from 1% to 10% of the time):

Temporary inability to urinate

Bleeding

Mild cramping

Urinary tract infection
Risks of 2% Povidone Iodine:
Less Frequent (occurring from 1% to 10% of the time):

Local irritation of the bladder
Rare (occurring less than 1% of the time):

Allergic reaction
Unknown Risk:

Brown discoloration of urine
Risks of Bladder Instillation Procedure:
Less Frequent (occurring from 1% to 10% of the time):

Discomfort while the indwelling urinary catheter is clamped
There is a rare risk of breach of confidentiality (release of information which personally 
identifies you).  
Not all possible effects are known. With any drug, unusual, unexpected or previously 
unreported side effects may occur. You will be informed of any significant new findings, which 
develop during the course of this research study which may change your decision to continue 
participating in this study.
BENEFITS
What are the benefits of taking part in this study?
Receiving Povidone-iodine bladder instillation may reduce the chances of getting a urinary 
tract infection, improve quality of life, and delay or eliminate the need for additional treatment. 
However, there may be no direct benefit to you from taking part in this study. Information 
gained from the results of this study may be of benefit to others in the future, with a similar 
medical condition.  Your condition may improve, but this cannot be guaranteed. 


IRB NUMBER: 2018-001
IRB APPROVAL DATE: 08/02/2018
IRB EXPIRATION DATE: 01/18/2019
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ALTERNATIVE OPTIONS
What are my choices other than taking part in this study?  
You do not have to take part in this study to receive treatment for your condition. The current 
standard of care is to remove the indwelling catheter without any additional treatment.  
ECONOMIC CONSIDERATIONS
What are the costs of taking part in this study?
The study medication will be provided to you at no cost. There will be no cost to you for the 
study procedures described in this consent (e.g. 2 urine sample collections, 3 questionnaires, 
and 1 possible bladder instillation treatment).  Routine procedures you would have had done 
even if you were not taking part in this study will be billed to your health insurance company 
and/or group health plans as usual. If these routine care costs are not covered by your health 
insurance/group health plan, the cost will be your responsibility. 
You will be reimbursed for your time and travel during the course of the study, as outlined in 
the table below. You will receive a stipend check (sent via US mail) in the amount listed below 
after each completed visit which is eligible to receive a stipend. If you are unable to complete 
all study visits, you will be paid only for the visits you were able to complete.
Visit
Stipend Per Visit
Screening and Treatment Visit
$25.00
Study Visit 2
$25.00
Study Visit 3
$0.00
Study Visit 4
$0.00 
Maximum Total (if all visits are included)
$50.00 
COMPENSATION
What happens if I am injured because I took part in this study?
Your involvement in this study is voluntary. The possible risks and side effects which might 
occur during the course of the research study have been described in this Consent and 
Authorization form.
A research injury is any physical injury or illness caused by the medications, devices, or 
procedures required by the study which are administered, used, or performed appropriately.  
These medications, devices, or procedures are different from the medical treatment you would 
have received if you had not taken part in the study.
Should you experience a research injury, there are no designated funds provided for 
subsequent medical care or compensation by either the study doctor/clinician or Beaumont 
Health. 


IRB NUMBER: 2018-001
IRB APPROVAL DATE: 08/02/2018
IRB EXPIRATION DATE: 01/18/2019
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What are my rights if I take part in this study?
You are not giving up any of your legal rights by signing this form.
CONFIDENTIALITY, DISCLOSURE AND USE OF YOUR INFORMATION
Will my medical information be kept private?
We will keep your personal health information as confidential as possible.  It is not likely your 
information will be given to others without your permission.  In order for this research study to 
take place, you must also authorize the researchers to access and use some of your protected 
health information (PHI). PHI is information which could identify you as an individual such as 
name, address, date of birth, etc. By signing this Consent and Authorization Form, you give 
Beaumont permission to use and/or disclose (release) your health information related to this 
research. Your medical and billing records collected for the purpose of the study will remain 
confidential, but may be disclosed (released) or used by the following and/or their 
representatives: 

The investigators (study doctor/clinician, research staff)

Beaumont and its’ parent, Beaumont Health and affiliated hospitals

The Food and Drug Administration

Other governmental regulatory agencies (domestic and/or foreign) 

Your health insurance company and/or group health plans and their intermediaries 
(companies contracted to process claims) may also have access to your medical and billing 
records of the study.

Primary Care Physician
The purpose for this disclosure (release) or use is, for example, to assure compliance with the 
study protocol, to evaluate the effectiveness of the study, and/or to provide protection to you 
as a research study participant. The disclosure and use of your information will continue after 
your involvement in the study has ended. There is no expiration date for the use of your 
medical and billing records from the study. Any information about you disclosed to the parties 
identified above may be re-disclosed by them; however, such re-disclosure is not under the 
protections of this Consent and Authorization. 
You will not be identified in any publication or other release of study results, data, and other 
information (such as in professional writings, at professional meetings, and/or in advertising or 
other promotional materials). 
If you decide to withdraw your authorization for the researchers to access and use your 
protected health information before the end of the study, you will be withdrawn from the 
research study. However, where the study relied on your Consent and Authorization for the 
time you participated in the study, your Consent and Authorization cannot be withdrawn and 
the information already collected may still be used and disclosed as you previously authorized. 


IRB NUMBER: 2018-001
IRB APPROVAL DATE: 08/02/2018
IRB EXPIRATION DATE: 01/18/2019
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STOPPING STUDY PARTICIPATION
What if I decide to stop taking part in the study?
Taking part in this research study is completely voluntary. You may choose not to take part or 
to stop being in the study (withdraw) at any time without penalty or loss of benefits to which 
you are otherwise entitled, or without jeopardizing your medical care by your doctor at 
Beaumont. However, if you do not agree to sign this Consent and Authorization form, you will 
not be able to take part in this study. 
If you decide to withdraw from the study you will need to notify the study doctor/clinician of 
your decision to stop taking part in the study. Written notification is preferred. This notice may 
be sent to Jay Hollander, MD at William Beaumont Hospital, 3535 W. 13 Mile Road, Suite 438, 
Royal Oak, MI 48073. 
Your participation in this study may be stopped by the study doctor/clinician, without your 
consent, for any reason, which will be explained to you. Examples include:

The study medication or procedures appear to be medically harmful to you. 

You fail to follow directions for participating in the study. 

It is discovered you do not meet the study requirements. 

The study is canceled. 

It is determined to be in your best interest (for example, your disease has progressed 
despite treatment).
CONTACTS
Who can answer my questions about the study?
You may talk to the study doctor/clinicians about any questions or concerns regarding your 
study participation, or you think you may have suffered a research-related injury. The 
doctor/clinician in charge of the study, Jay Hollander, MD, may be reached at: (248) 551-9238 
to answer your questions.
Your study contact is Danielle Tenney, MA. You may contact her at (248) 551-3565.
If you have questions regarding your rights as a research participant, or have problems, 
concerns, complaints, want information or would like to offer input, you may contact the 
Institutional Review Board Chairperson at (248) 551-0662.  The Institutional Review Board is 
charged with the oversight of all human participant research conducted at Beaumont facilities.


IRB NUMBER: 2018-001
IRB APPROVAL DATE: 08/02/2018
IRB EXPIRATION DATE: 01/18/2019
IRB #       2018-001                                                                                                                                      Page 7 of 7 
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STATEMENT OF VOLUNTARY PARTICIPATION
I have read the above, have asked questions and have received answers about this study to 
my satisfaction. I understand what I have read and willingly give my consent to participate in 
A RANDOMIZED TRIAL OF BETADINE BLADDER IRRIGATIONS VS. STANDARD OF 
CARE PRIOR TO INDEWELLING CATHETER REMOVAL TO REDUCE BACTERIURIA 
AND CATHETER-ASSOCIATED URINARY TRACT INFECTIONS. I understand I will 
receive a signed copy of this document and will be promptly informed of any new findings 
regarding this study.  I further authorize the use or disclosure of my health and personal 
information contained in records as described above. 
______________________________________
RESEARCH PARTICIPANT NAME (PLEASE PRINT)
      
______________________________________             _______________     ___________________
 RESEARCH PARTICIPANT SIGNATURE
DATE
TIME
ALTERNATIVE SIGNATURE (for use only when participant is a minor, cognitively impaired or critically ill)
AS THE PERSONAL/LEGAL REPRESENTATIVE OF THE STUDY PARTICIPANT, PLEASE PRINT PARTICIPANTS NAME ON THIS 
LINE_____________________________________, AND CHECK ONE OF THE BOXES BELOW AS THE BASIS FOR YOUR 
AUTHORITY TO SIGN THIS CONSENT AND AUTHORIZATION:
 COURT-APPOINTED GUARDIAN
          
 DURABLE POWER OF ATTORNEY                
 NEXT OF KIN
                       
*COURT LETTER IS REQUIRED
         *ATTORNEY LETTER MUST BE PRESENT & VERIFIED BY 2 PHYSICIANS
__________________________________                       ________________________________
NAME (PLEASE PRINT)
                                            RELATIONSHIP TO PARTICIPANT   
_____________________________________                     _____________           ____________
SIGNATURE        
      DATE                          TIME
                   
 WITNESS TO SIGNATURE ON CONSENT       
  WITNESS TO CONSENT PROCESS AND SIGNATURE 
_______________________________________
WITNESS NAME (PLEASE PRINT)
_______________________
     ________________
       ____________
WITNESS SIGNATURE              
  DATE
TIME
AUTHORIZED CONSENT PROVIDER STATEMENT:
I have explained this study and have offered the study participant an opportunity for any further 
discussion or clarification.
_________________________________               ____________                 ___________________
NAME (PLEASE PRINT)
                     CREDENTIALS
          
PHONE NUMBER
_________________________________                __________________          ____________
SIGNATURE
                                                     DATE 
             TIME