Use of Hyoscyamine Versus Tamsulosin for Management of Ureteral Stent Irritation
Phase: PHASE4
Conditions: Lower Urinary Tract Symptoms
Sponsor: University of Kansas Medical Center

ClinicalTrials.gov 
Cover Page – Protocol including Statistical Analysis Plan 
 
 
 
NCT Number NCT03750656 
Study Title 
Use of Hyoscyamine versus Tamsulosin for Management 
of Ureteral Stent Irritation 
Document Description Protocol including Statistical Analysis Plan 
Document Date 2019-08-16 
 

               
THE UNIVERSITY OF KANSAS HEALTH SYSTEM 
                                   Department of Urology 
 
 
Investigator Initiated Trial 
Use of Hyoscyamine versus Tamsulosin for Management of 
Ureteral Stent Irritation 
 
PRINCIAL INVESTIGATOR 
David Duchene, MD FACS 
Associate Professor 
3901 Rainbow Boulevard, Kansas City, KS 66160 
Phone: 913-588-1227 
Fax: 913-588-8697 
Email: dduchene@kumc.edu 
 
Protocol Number:  TBD 
Study Type: Interventional 
Initial Version:  July 23, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
CONFIDENTIAL 
This material is the property of the University of Kansas Health System Department of Urology   Do not 
disclose or use except as authorized in writing by the study sponsor.  
 

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LIST OF KEY PERSONNEL 
 
PRINCIPAL INVESTIGATOR 
David Duchene, MD 
Email: dduchene@kumc.edu 
Phone: 913-588-1227 
Fax: 913-588-8697 
 
SUB-INVESTIGATOR 
Sida Niu, MD 
Email: sniu@kumc.edu 
Phone: 913-908-8108 
Fax: 913-588-8697 
 
Jeff Thompson 
Email: jthompson21@kumc.edu 
Phone: 913-588-8790 
 
Connor Chestnut 
Email: cchestnut2@kumc.edu 
Phone: 785-764-9315 
Fax: 913-588-8697 
 
Wilson Molina 
Email: wmolina@kumc.edu 
Phone: 913-588-7564 
Fax: 913-945-8728 
 
Raphael Vendrame Carrera 
Email: rvendramecarrera@kumc.edu 
 
PROJECT COORDINATORS 
Katie Glavin 
Email: kglavin@kumc.edu 
Phone: 913-588-8721 
Fax: 913-588-8697 
 
Alexandra Dahlgren 
Email: adahlgren@kumc.edu 
Phone: 913-574-0847 

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Fax: 913-588-8697 
 
 
 
 
 

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TABLE OF CONTENTS 
 
LIST OF KEY PERSONNEL .............................................................................................. 2 
LIST OF ABBREVIATIONS .............................................................................................. 4 
1.0 STUDY SUMMARY .................................................................................................. 5 
1.1 AIMS AND HYPOTHESIS............................................................................... 5 
2.0 BACKGROUND AND RATIONALE ............................................................................. 5 
2.1 DIESASE BACKGROUND ............................................................................... 5 
2.2 RATIONALE ................................................................................................. 6 
3.0 STUDY OBJECTIVES ................................................................................................ 6 
3.1 PRIMARY OBJECTIVES ................................................................................. 6 
4.0 PATIENT ELIGIBILITY ............................................................................................... 6 
4.1 INCLUSION CRITERIA ................................................................................... 7 
4.2 EXCLUSION CRITERIA .................................................................................. 7 
4.3 WITHDRAWL/TERMINATION CRITERIA ........................................................ 7 
5.0 STUDY PROCEDURES .............................................................................................. 8 
5.1 SCREENING/BASELINE PROCEDURE ............................................................. 8 
5.2 STUDY PARTICIPANT IDENTIFICATION ID ..................................................... 8 
5.3 STUDY PROCEDURES ................................................................................... 8 
5.4 SCHEDULE OF EVENTS ................................................................................. 10 
6.0 LABORATORY  ........................................................................................................ 8 
6.1 LABORATORY .............................................................................................. 8 
6.2 SERUM COLLECTION ................................................................................... 9 
6.3 URINE COLLECTION ..................................................................................... 9 
6.4 TISSUE COLLECTION .................................................................................... 10 
7.0 REGULATORY PROCEDURES ................................................................................... 10 
7.1 PROTOCOL REVIEW AND AMENDMENTS ..................................................... 10 
7.2 INFORMED CONSENTS ................................................................................ 10 
7.3 ETHICS AND GOOD CLINICAL PRACTICE (GCP)  ............................................. 11 
8.0 REGISTRATION PROCEDURES ................................................................................. 12 
8.1 PATIENT REGSTRATION ............................................................................... 12 
9.0 STUDY MANAGEMENT ........................................................................................... 12 
9.1 INVESTIGATOR FILES AND RETENTION OF DOCUMENTS .............................. 12 
9.2 CASE REPORT FORMS .................................................................................. 12 
9.3 DATA MANAGEMENT AND SECURITY .......................................................... 12 
10.0 REFERENCES ......................................................................................................... 14 
 
 

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LIST OF ABBREVIATIONS (Examples) 
 
SID           Study Identification 
KUMC     University of Kansas Medical Center 
U              Urine 
S               Serum 
T               Tissue 
M             Month 
HSC#        Human Subjects Committee # 
USSQ       Ureteral Stent Symptom Questionnaire 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0 STUDY SUMMARY 
 
1.1 AIM AND HYPOTHESIS 
The objective of this project is to compare the efficacy of hyoscyamine to tamsulosin 
monotherapy in treating lower urinary tract symptoms in patients with indwelling double-J 
ureteral stents. 
 
Ureteral stents are routinely used in a variety of urologic conditions. Unfortunately, indwelling 
ureteral stents commonly cause significant pain and discomfort due to irritation to the urinary 
system. Many studies have looked at methods to reduce these uncomfortable symptoms ranging 
from altering stent designs to pharmacologic therapies attempting to alleviate stent-discomfort. 
However, stent-related discomfort continues to be an issue and is often the cause of their 
removal earlier than planned. While the efficacy of certain alpha blockers and anticholinergics in 
treating stent-related symptoms have been studied, the data for the use of hyoscyamine in this 
setting is lacking. A literature search yielded no studies evaluating the use of hyoscyamine in this 
setting to date. We hypothesize that hyoscyamine (brand name Levsin) is equivalent to 
tamsulosin in treating lower urinary tract symptoms in patients with indwelling double-J ureteral 
stents due to its anticholinergic properties. Furthermore, we hypothesize that patients in the 
hyoscyamine arm will not require additional pain medications (e.g. Pyridium, narcotics) to help 
control stent-related discomfort compared to the tamsulosin arm. 
 
BACKGROUND AND RATIONALE 
 
2.1 DISEASE BACKGROUND 
Ureteral double-J stent was first described by Finney et al in 1978, and has since become a routine 
and indispensable urological tool used in a variety of conditions including obstructing kidney 
stones, obstructing ureteral or bladder masses, injury or trauma to the ureter or kidney, scarring 
in the ureter, or for masses in the pelvis that extrinsically compress the ureter.1–3 Despite the 
usefulness of ureteral stents, patients experience uncomfortable stent-related symptoms 
including bladder spasms, pain, frequency, urgency, and as a result, an overall decrease in quality 
of life. Studies investigating the etiology of these symptoms found that the important factors 
contributing to stent discomfort include the pressure transmitted to the renal pelvis during 
urination, irritation to the trigone caused by the intravesicular curl of the stent, and spasms of 
ureteral smooth muscle due to the presence of a indwelling foreign object.4 One study showed 
80% of patients had stent related discomfort that interfered with their daily activities, which 
resulted in 32% of patients requesting the stent removed prematurely.5 Many studies have 

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looked at improving these uncomfortable symptoms including using stents with tapering tails at 
the distal end6, various stent coatings including Hydrogel and carbon7,8, and pharmacological 
treatments with alpha blockers, anticholinergics and empirically prescribed analgesics.9    
 
2.2 RATIONALE 
Providers routinely prescribe alpha antagonists and/or anticholinergics to patients in order to 
relax the bladder and minimize the discomfort. Numerous studies have investigated the 
beneficial effect of alpha antagonists for ureteral stent-related discomfort. Tamsulosin is a 
selective α1a-blocker that antagonizes α1 mediated contraction of prostate, bladder and proximal 
urethral smooth muscle. Owing to this mechanism, it reduces urethral and bladder outlet 
resistance and decreases urinary reflux, ureteric motility and bladder hyperactivity, all of which 
work to alleviate stent-related discomfort.10,11 Similarly, many studies have evaluated the utility 
of anticholinergics in treating stent discomfort since many of the stent-related symptoms are 
similar to overactive bladder symptoms caused by muscarinic receptor mediated involuntary 
bladder contractions.12–15 Hyoscyamine is a prescription drug that became available before 1938 
and is considered a ‘Grandfather Drug.’ Hyoscyamine is one of the least expensive 
anticholinergics on the market, and furthermore, it has more favorable pharmacokinetics 
compared to other anticholinergics that are typically prescribed for stent-related discomfort. 
Oxybutynin, for example, has an onset of action of 30 minutes to 1 hour with time to peak effect 
of 3 to 6 hours,16 compared to Hyoscyamine which has an onset of action of 2-3 minutes with 
time to peak effect of 30 minutes to 1 hour.17,18 Since stent-related discomfort can be aggravated 
with activity and typically presents in a waxing and waning fashion, the rapid acting therapeutic 
effects of hyoscyamine may provide tremendous relief for patients with indwelling stents. A 
review of literature in PubMed did not yield any studies evaluating the efficacy of hyoscyamine 
in the treatment of stent-related discomfort. Since we routinely use hyoscyamine to treat 
patients with ureteral stent discomfort, it would be interesting to know how effective 
hyoscyamine is when used in this setting. Given the well-published data on tamsulosin, we would 
like to conduct a formal study comparing the efficacy of hyoscyamine to tamsulosin for treating 
symptoms associated with ureteral stents as assessed by a validated questionnaire, the Ureteral 
Stent Symptom Questionnaire, and provide the first research-based evidence regarding the 
efficacy of hyoscyamine for the treatment of stent-related discomfort. 
 
3.0 STUDY OBJECTIVES 
 
3.1 PRIMARY OBJECTIVE 

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To evaluate the efficacy of hyoscyamine compared to tamsulosin in improving the lower urinary 
tract symptoms of patients with indwelling double-J ureteral stents as assessed by the validated 
Ureteral Stent Symptom Questionnaire (USSQ). 
 
3.2 SECONDARY OBJECTIVE 
To determine if there is a difference between the amount of additional medications needed to 
treat stent related discomfort between patients receiving hyoscyamine versus those that receive 
tamsulosin.  
 
To determine factors contributing to patients needing additional medication for treatment of 
stent-related discomfort.   
 
4.0 PATIENT ELIGIBILITY 
 
4.1    INCLUSION CRITERIA 
1. Patients must be 18 years of age or older 
2. Patient must require placement of a ureteral stent(s), per standard of care, following 
routine urological procedures including, but not limited to, ureteroscopy, stone 
extraction, or management of upper tract transitional cell carcinoma 
3. Patient must agree to abstain from other clinical studies during the study period  
 
4.2 
EXCLUSION CRITERIA 
1. Patients younger than 18 years of age 
2. Patients with chronic or pre-existing indwelling stents 
3. Patients currently receiving anticholinergic or alpha blocker therapy 
4. Patients with chronic opioid or analgesic usage 
5. Patients with chronic pain syndrome or symptomatic benign prostatic hyperplasia 
6. Patients with an active untreated urinary tract infection 
7. Patients who are currently pregnant or nursing  
8. Patients with allergies or contraindication to either tamsulosin or hyoscyamine  
9. Patients on active chemotherapy 
10. Patients currently receiving other investigational therapy 
11. Patients who are unable to sign consent/answer questionnaire due to compromised 
mental capacity or language barrier (the questionnaire is not validated in other languages) 
12. Patients who have a stent placed emergently for an obstructing stone or septic stone 
without immediate stone removal,  

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13. Any stents placed that will stay in for longer than 2 weeks, including patients who suffered 
a ureteral injury (Grade 2 or above) during the procedure that will be classified as a screen 
fail 
 
4.3 
WITHDRAWL/TERMINATION CRITERIA 
Patients who do not undergo the placement of a ureteral stent following a routine urological 
procedure will be withdrawn from the study. If the patient was scheduled to undergo the stent 
placement and for any reason the plan changed or was cancelled that patient will be taken off 
the protocol and considered discontinued. The patient spot will be replaced and the study ID 
number will not be reused. This will allow the protocol to be completed once 94 patients have 
completed treatment based on statistical calculations from the Biostatistics department (below).  
 
Patients will be allowed to withdraw from the study at any time.  If a patient cancels permission 
to use their health information the research team will stop collecting any additional information 
about them moving forward. The research team may use and share information that was 
gathered before they received the patient’s withdrawal. The entire study may be discontinued 
for any reasons without the patients consent by the investigator conducting the study.   
 
5.0 STUDY PROCEDURES 
 
5.1 SCREENING/BASELINE PROCEDURES 
All patients who present to the University of Kansas Health System Urology clinic will be screened 
for participation in this study. Patients who present to the Kansas Health System Emergency 
Department needing urological consultation will also be screened for participation.  
This an open-label, randomized, prospective study investigating the efficacy of hyoscyamine 
compared to tamsulosin for symptoms of stent irritation in patients undergoing routine 
urological procedures and requiring ureteral stent placement post-procedure. The patient would 
be assured that neither acceptance nor refusal would change their standard of care. The study 
medications are used routinely in our daily practice, and the patient would still be prescribed 
these medications if indicated regardless of participation in the study. Since prescribing these 
medicines is in our current standard of care, patients will not be withdrawn from standard of care 
by either participating or not participating in this study. Patients will be identified through 
standard of care procedures in the evaluation for the need for a ureteral stent. Routine labs (e.g. 
complete blood count, basic or complete metabolic panel, b-hCG, urinalysis and urine culture) 
and imaging will be obtained as per standard care at the provider’s discretion based on the 
patient’s history and physical exam. If a patient meets the study criteria, an informed consent 
will be obtained and the first Ureteric Stent Symptoms Questionnaire will be administered to 
establish baseline symptoms prior to the insertion of a ureteral stent.  
 

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5.2 STUDY IDENTIFICATION 
Patient study identification (SID) will be created by the study team at the time the patient is 
consented and is enrolled in the study. SID will be the HSC# follow by number in chronological 
order. For example: HSC#-XXX.  
 
5.3 STUDY PROCEDURES 
To assess ureteral stent symptoms, we will be conducting the Ureteric Stent Symptoms 
Questionnaire (USSQ). The USSQ was created by Joshi et al as an instrument to measure stent-
related morbidity. The USSQ has been validated as a reliable instrument to measure the impact 
of ureteral stents.19 This validated questionnaire has been used in many previous studies 
regarding stent pain. In our study, the USSQ will be conducted prior to stent placement, on POD1, 
POD7 (or just prior to the time of stent removal if the removal occurs prior to day 7), and POD30. 
Basic demographic information, stent duration, stent size, stone location/size and obstructing vs. 
non-obstructing (if applicable), post stent insertion complications, drug diary information and 
questionnaire responses will be entered into a REDCap database for storage and analysis. The 
stent diameter will be 6Fr for all patients in the study. The appropriate stent length will be 
assigned to the patient based on cross sectional imaging. If cross sectional imaging is not available 
then stent length with be measured using a open-ended catheter to measure ureteral length.  A 
small portion of these patients will be seen in the emergency department or while they are having 
an acute pain episode, so we expect that some of the pre-stenting questionnaires may not 
provide an accurate baseline for symptoms in these patients, hence the POD30 questionnaire 
will be obtained. 
 
After informed consent is obtained, the patient will be prospectively randomized to either 
treatment arm in an open-label fashion using REDCap’s randomization function to determine 
which therapy they will receive after stent placement. In the event that a patient does not find 
relief with their particular treatment arm, they will be permitted to receive additional narcotics 
or Pyridium. Should the patient continue to have unrelieved symptoms, treatment crossover is 
allowed since the study is designed in an intent-to-treat fashion.  
 
The first arm is hyoscyamine 0.125 mg tab sublingual every 4 hours as needed for discomfort, 
and the second arm is tamsulosin 0.4mg tab orally daily. Both dosing regimens are standard 
prescription orders. Both medications are routinely used in our practice, so patients are not being 
exposed to new safety risks compared to non-study patients. Risks are reasonable, as the 
medications used in this study are already commonly used in our daily practice. Patients will be 
given contact numbers for the Urology Department should they have any adverse side effects or 
concerns. Hyoscyamine is an anticholinergic and can cause side effects including constipation, 
dry mouth, drowsiness, headache, or lightheadedness. Tamsulosin is an alpha blocker and can 

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cause side effects including dizziness, fatigue, nasal congestion, syncope and retrograde 
ejaculation. Patients who have taken alpha blockers are at risk for intraoperative floppy iris 
syndrome if they are going a cataracts surgery in the near future. Patients will be advised to 
immediately stop the medicine and seek medical care if they develop the rare but severe 
reactions of skin rash, swelling, confusion, irregular or fast heartbeat, eye pain, or hallucinations. 
As part of the standard treatment pathway for post-stent insertion, patients are also sent home 
with a narcotic pain medication to help with pain and discomfort. Our pathway is to prescribe all 
patients with 10 tabs of Norco 5/325 1-2 tabs po q6H PRN unless there are contraindications or 
allergies to this specific narcotic, in which case they are prescribed an alternative narcotic with 
Percocet 5/325 1-2 tabs po q6H PRN. Patients will be given a drug diary to document their usage 
of the study medications to ensure compliance. Patients will also document usage of additional 
prescription medications for stent discomfort, including their narcotic usage, so that this 
information can be tracked as well. Patients will stop drug diary at time of stent removal.  
 
Questionnaires will be completed either in person if patient is in clinic or inpatient, or via a 
REDCap survey prior to stent placement, POD1, POD7 or at the time of stent removal if the 
removal occurs prior to day 7, and POD30. Patients with strings attach to stents will be included 
as there is no literature to suggest that strings cause additional stent irritation. Both medications 
will be stopped once the ureteral stent is removed as part of routine urological follow-up care 
for the primary etiology. Once the number of study participants reaches the pre-determined goal 
as calculated by our biostatistician, study enrollment will conclude and we will begin analyzing 
the data. 
 
5.4 STUDY DESIGN AND SAMPLE SIZE 
Total sample size: 100 
The study will be conducted as a randomized comparative effectiveness trial with two arms. 
Subjects will be randomized to one of two treatments WITH either hyoscyamine or tamsulosin. 
Our hypothesis is that the hyoscyamine is at least as effective as tamsulosin in treating lower 
urinary tract symptoms. Symptoms will be quantified using the Urinary Symptom Index (USI) of 
the validated Ureteral Stent Symptom Questionnaire (USSQ). To address the hypothesis, the 
study will be conducted as a non-inferiority trial, following the hypothesis that hyoscyamine is 
not inferior to tamsulosin by more than a 15% margin in terms of the USI. The sample size was 
estimated using the PowerTOST package for the R statistical environment, based on a nominal 
power of 80% and an alpha-level of .025 for the one-sided t-test. Our null hypothesis is therefore 
that the mean USI for those treated with tamsulosin is more than 15% greater than those treated 
with hyoscyamine, so that by rejecting it, we may conclude hyoscyamine is not-inferior to 
tamsulosin by more than a 15% margin of USI for treating lower urinary tract symptoms. 
Furthermore, we assume that the coefficient of variation (CV) for the mean Urinary Index Score 

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will be similar to that in Park, et al.20 The CV in that study for the Urinary Symptom Index at week 
2 after stent placement for the tamsulosin group was approximately .25. This is slightly higher, 
but similar to the CV of .22 for the USI in Maldonado-Avila, et al. which collected data at week 1, 
and therefore should be slightly conservative.21 Using these assumptions, we estimated that the 
sample size for each arm would need to be approximately 47, in order to have the desired power.  
 
5.5 DATA ANALYSIS 
The main hypothesis of the non-inferiority of hyoscyamine to tamsulosin for treating lower 
urinary tract symptoms will be tested using a t-test for non-inferiority of the change in USI 
between POD1 and POD7 (or day of stent removal if removed before day 7) in each treatment 
arm. This should be slightly more powerful than the t-test at POD7 alone that we used to estimate 
the sample size, but there are not enough data available for the distribution at POD1 in order to 
make a good estimate of the change. The non-inferiority margin will be 15% of the change in USI. 
The primary analysis will be conducted as intention-to-treat (ITT). That is, subjects will be 
analyzed as belonging to the arm they were randomized to, irrespective of later crossover or 
other modifications. This approach is in line with the current statement on Consolidated 
Standards of Reporting Trials (CONSORT).22 Descriptive statistics will be used to describe the 
results from all USSQ domains at each timepoint (i.e. mean and standard deviation, along with 
confidence intervals for urinary symptom index, pain symptom index, etc.). We will also conduct 
non-inferiority tests of change in score for ITT with hyoscyamine versus tamsulosin for the other 
domains spanned by the USSQ, including pain symptom index, general health index, work 
performance index, and sexual matters between POD1 and POD7, although we may not be well-
powered to detect non-inferiority for these additional domains. 
The secondary goal of determining if there are differences in the amount of additional 
medications need to treat stent-related discomfort between treatment arms will be examined 
primarily through descriptive statistics. The drug diaries of all subjects will be used to tabulate 
the kinds and amounts of additional medications used. For each subject, the number of days that 
additional medications were used will be counted. The proportion of days that additional 
medications were used will be calculated for each group and 95% confidence intervals will be 
calculated. 
Finally, we will also calculate the informed consent rate, and the discontinuation rate for those 
patients needing to be removed from the study in each arm. 
In all cases, a p-value ≤ .05 will be taken as a statistically significant result. 
 
5.6 SCHEDULE OF EVENTS 

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Visits 
Enrollment 
Stent 
Placement 
POD1 
POD2 
POD3 
POD4 
POD5 
POD6 
POD7A 
POD30  
USSQ 
X 
 
X 
 
 
 
 
 
X 
X 
Randomization 
X 
 
 
 
 
 
 
 
 
 
Complete Medication Diary 
 
X 
X 
X 
X 
X 
X 
X 
X 
 
REDCap Survey 
 
 
X 
 
 
 
 
 
X 
X 
Stop Medication 
 
 
 
 
 
 
 
 
X 
 
 
Footnotes: A = If stent is removed prior to day seven then USSQ will occur on day of stent removal and diary will be 
stopped. If stent is removed after day seven then USSQ will occur on day seven but the diary will be stopped on day 
of stent removal.  
 
 
6.0 REGULATORY REQUIREMENTS 
 
6.1 PROTOCOL REVIEW AND AMENDMENTS 
The protocol, the proposed informed consent and all forms of participant information related to 
the study and any other necessary documents must be submitted, reviewed and approved by the 
University of Kansas Medical Center (KUMC) properly constituted IRB governing each study 
location. 
Any changes made to the protocol must be submitted as amendments and must be approved by 
the IRB prior to implementation. Any changes in study conduct must be reported to the IRB. The 
Principal Investigator will disseminate protocol amendment information to all participating 
investigators. All decisions of the IRB concerning the conduct of the study must be made in 
writing.  A yearly continuing review will also be submitted to the IRB.  
 
6.2 Informed Consent 
Any patient who is present a consent form that describes this study will be provided the most up 
to date consent form.  The purpose of the consent form is provide sufficient information to the 
study participant in order to make an informed decision about their participation in the study. 
The formal consent of a participant, using the IRB approved consent form, must be obtained 
before the participant is involved in any study-related procedure. The consent form must be 
signed and dated by the participant or the participant’s legally authorized representative, and by 
the person obtaining the consent. The participant must be given a copy of the signed and dated 
consent document. The original signed copy of the consent document must be retained in the 
medical record or research file. 

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Subjects will have time to ask any questions and will be given the opportunity to review the 
consent form in the absence of members of the study team prior to signing.  Our team assures 
the informed consent process is an ongoing exchange of information between our research team 
and the study participants throughout the course of the research study.  Patients who are 
interested in learning about participation in our trial will be introduced to a member of the study 
team who will then verbally explain the study in detail. Our process ensures respect for persons 
through provision of thoughtful consent for voluntary participation. Information will be 
presented in a manner that will enable the participant to voluntarily decide whether or not to 
participate as a research subject. Our procedures used in obtaining informed consent will 
educate the subject population in terms that they can understand. Therefore, our informed 
consent language and its documentation are written in "lay language" and presented in a way 
that facilitates understanding. It will be explained to the subjects that the study is voluntary and 
that they may discontinue at any time without prejudice. Subjects will have the opportunity to 
ask questions before signing the consent form. Subjects who agree to participate will be 
consented according to our institution’s guidelines and in a private, closed-door setting. The 
consent document will be revised when deficiencies are noted or when additional information 
will improve the consent process. Informed consent will be documented by the use of a written, 
HSC-approved consent form and signed and dated by the subject or the subject's legally 
authorized representative.  A signed copy will be given to the person signing the form. Consent 
forms, and all other study documentation, will be retained in accordance with the KUMC 
Research Records Retention Policy. This policy states, in part, that research records are to be 
retained by the investigator for a minimum of fifteen years. 
 
Participation in the study is entirely voluntary.  Subjects will have time to ask any questions and 
will be given the opportunity to review the consent form in the absence of members of the study 
team prior to signing (further details above). 
 
Since potential subjects will be identified by their clinical care team during the course of routine 
care, the treating provider and care team will already have determined whether the subject is 
able to give informed consent prior to screening for participation.   
 
6.3 ETHICS AND GOOD CLINICAL PRACTIVE (GCP)  
This study is to be conducted according to the following considerations, which represent good 
and sound research practice.  All personnel will have completed all required GCP training.  The 
study conduct will follow the ICH E6 Good Clinical Practice Guidelines.  Along with the US Code 
of Federal Regulations (CFR).  The conduct will follow all state, federal, local, and institutional 
laws, regulations, and policies.   

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It is understood that deviations from the protocol should be avoided, except with necessary to 
eliminate an immediate hazard to the research participant.  In the instance of a deviation, it must 
be reported to the IRB according to the local reporting policy.   
Out of window deviations will not be report to the IRB as they are not considered a risk/hazard 
to the patient.  
 
7.0 PATIENT PROCEDURES         
 
7.1 PATIENT REGISTRATION 
Patient registration will occur at the time of consenting.  Patients will be assigned a SID at time 
for consenting.  Patient SID will be added to Velos(CRIS). 
 
Patient demographics will be added to the redcap.  All completed source documents for patient 
eligibility verification and registration will be kept in a study binder for monitoring and 
documentation purposes.  Consenting process will also be documented.  
 
8.0 STUDY MANAGEMENT 
 
8.1 INVESTIGATOR FILESAND RETENTION OF DOCUMENTS 
The investigator must prepare and maintain adequate and accurate case histories designed to 
record all observations and other data pertinent to the study for each research participant. This 
information enables the study to be fully documented and the study data to be subsequently 
verified. Original source documents supporting entries in the case report forms include but are 
not limited to hospital records, clinic charts, laboratory, ECG, signed ICFs, participant diaries, 
pathology reports and any other related documents. All study-related documents must be 
retained for the maximum period required by applicable federal regulations and guidelines or 
institutional policies. 
 
8.2 CASE REPORT FORMS 
Case report forms will be completed for each subject enrolled.  All data will be entered and stored 
in a KUMC RedCap database.  Only trained and approved personnel will have access to this 
database. Any source documents or additional research related items will be stored behind 
locked doors or on the R Drive within the study folder.  
 
 
8.3 DATA MANAGEMENT AND SECURITY 
The PI and research team will be responsible for handling the data and will allow study personnel to have 
access to study data within the KUMC REDCap database as necessary. Study data will be stored in a secure 
KUMC REDCap database. Permission will only be granted to trained and qualified study team members. 
Human subjects will be identifiable directly within the secure Velos(CRIS) system and information will be 

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kept in REDCap database (excluding MRN# and Names). Study team will be utilizing velos to link the 
patient with the study ID.  This is a locked and secure database and only persons granted 
permission/access will be able to view this system. Data will be stored in Velos, RedCap, R Drive 
and within the Research Urology Offices.   
 
Patient information from the medical record will be stored in a REDCap database outside of the 
medical record.  Study team will abide by all HIPAA privacy laws and will do everything they can 
to ensure confidentiality of patients participation and information about sample collection, 
processing, storage, data, etc. 
9.0 REFERENCES 
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