Foot/Hand Neuromodulation for Overactive Bladder (OAB)
Phase: NA
Conditions: Overactive Bladder
Sponsor: Christopher J Chermansky, MD

Official Title: Foot/Hand Neuromodulation for Overactive Bladder (OAB) 
Clinical Trials.gov ID: NCT01972061 
Document Date: August 1, 2018 
 

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Section: Triage
     [reviewer notes¬] 
Provide a short title for this study (200 characters or less):
Foot/Hand Neuromodulation for Overactive Bladder (OAB) 
T1.0
Select the type of application:
New Research Study  
 
T2.0
Is the proposed research study limited to the inclusion of deceased individuals? 
* No
T2.1
Are any research activities being conducted at the VA Pittsburgh Healthcare
System or with VA funds? 
* No
 
  
     [reviewer notes¬] 
T3.0
What is the anticipated risk to the research participants?
Greater Than Minimal Risk
 
 
@) University of Pittsbw:gh 
OSIRIS 

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Section: Cover Sheet
     [reviewer notes¬] 
CS1.0
What is the reason for this submission?
New Research Protocol Submission
CS1.1
Has this research study been approved previously by the University of Pittsburgh
IRB?
*  No
CS1.1.1
Has this research study (or a substantially similar research study) been previously
disapproved by the University of Pittsburgh IRB or, to your knowledge, by any other
IRB?
*  No
 
    [reviewer notes¬] 
CS2.0
Title of Research Study:
Foot/Hand Neuromodulation for Overactive Bladder (OAB)
CS2.0.1
   
Requested approval letter wording:
CS2.1
Research Protocol Abstract:
The purpose of this study is to determine the efficacy of foot stimulation for the treatment
of overactive bladder (OAB) symptoms. Electical stimulation will be applied to the foot via
skin surface elecrodes to 20 subjects during CMG testing in the clinical setting to determine
if bladder capacity can be increased by stimulation. 
Electrical stimulation will also be used by another 80 subjects at home for a one week
period and we will collect a voiding diary one week before, one week during, and one week
after the stimulation. 20 subject will use foot stimulation for 3 hours in the evening prior to
sleep; 20 subjects will use foot stimulation for half hour in the evening prior to sleep; 20
subjects will use hand stimulation for three hours in the evening prior to sleep; and 20
subjects will use foot stimulation after stopping use of the OAB drugs. 20 subjects will be
enrolled in a 12-week foot stimulation test. They will be asked to stimulate for the following
duration: Week1:3 hours every evening prior to sleep, Week 2-12: 3 hours of foot
stimulation prior to sleep, every third day. 3-day voiding diaries will be completed: before
foot stimulation, 6 weeks after beginning foot stimulation, the last three days of the 12
week period, the week after completing foot stimulation. The subjects will be adult (>18
year old, male or female) idiopathic OAB patients without known neurological or urinary
tract disease.
 
 
CS2.2
Select the category that best describes your research:
Biomedical research
     [reviewer notes¬] 
CS3.0
Name of the Principal Investigator:

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Section: Cover Sheet
Christopher Chermansky
Note: Adjunct faculty of the University, including lecturers and instructors, are not
permitted to serve as a PI or Faculty Mentor but may serve as co-investigators. Refer to
Chapter 4 on the HRPO website for more information.
CS3.1
Affiliation of Principal Investigator:
UPitt faculty member 
 
If you chose any of the Pitt options, please indicate the specific campus:
Main Campus - Pittsburgh
 If you chose the UPi  faculty member op on, provide the PI’s University Faculty Title:
Assistant Professor  
CS3.2
Address of Principal Investigator:
700 Kaufmann Building 
CS3.3
Recorded Primary Affiliation of the Principal Investigator:
U of Pgh | School of Medicine | Urology 
CS3.4
Identify the School, Department, Division or Center which is responsible for
oversight of this research study:
U of Pgh | School of Medicine | Urology 
 
 
CS3.5
Telephone Number of Principal Investigator:
412-692-4099 
CS3.6
Recorded Current E-mail Address of Principal Investigator to which all
notifications will be sent:
chermanskycj2@upmc.edu
CS3.7
Fax Number:
412-641-1366
CS3.8
Does this study include any personnel from Carnegie Mellon University, and/or
use any CMU resources or facilities (e.g., Scientific Imaging and Brain Research
Center (SIBR)?
*  No
CS3.9
Is this your first submission, as PI, to the Pitt IRB?  
*  No
  
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Section: Cover Sheet
     [reviewer notes¬] 
CS4.0
List of Co-Investigators: 
Last First
Organization
Tai
Changfeng U of Pgh | School of Engineering
 
  
  
    [reviewer notes¬] 
CS5.0
Name of Primary Research Coordinator:
Janet Okonski
 
 
 
CS5.1
Address of Primary Research Coordinator:
700 Kaufmann Building
CS5.2
Telephone Number of Primary Research Coordinator:
412-692-4099
CS6.0
Name of Secondary Research Coordinator:
Anna Wecht
CS6.1
Address of Secondary Research Coordinator: 
 
700 Kaufmann Building
CS6.2
Telephone Number of Secondary Research Coordinator:
 
412-647-5907
CS6.3
Key Personnel/Support Staff (Only list those individuals who require access to
OSIRIS): 
Last
First
Organization
Bansal
Utsav
Other
Chermansky Christopher U of Pgh | School of Medicine | Urology
Karausky
Patricia
U of Pgh | Associate Vice Chancellor of Human Resources | All
Temps
Okonski
Janet
U of Pgh | School of Medicine | Urology
Shen
Bing
U of Pgh | School of Medicine | Pharmacology
Tai
Changfeng U of Pgh | School of Engineering
     [reviewer notes¬] 
CS7.0
Will this research study use any Clinical and Translational Research Center (CTRC)
resources?
No
 

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Section: Cover Sheet
     [reviewer notes¬] 
CS8.0
Select the entity responsible for scientific review.
 
Department Review - (a dean, department chair, division chief, or center head) 
Note: DoD funded studies require departmental review 
 
CS8.1
Select the school, department or division which is responsible for scientific review
of this submission.
U of Pgh | School of Medicine | Urology
 
 
  
     [reviewer notes¬] 
CS9.0
Does this research study involve the administration of an investigational drug or
an FDA-approved drug that will be used for research purposes?
* No  
CS10.0
Is this research study being conducted under a University of Pittsburgh-based,
sponsor-investigator IND or IDE application?
 
*  No 
If YES, you are required to submit the IND or IDE application and all subsequent FDA
correspondence through the Office for Investigator-Sponsored IND and IDE Support
(O3IS).  Refer to applicable University policies posted on the O3IS website
 (www.O3IS.pitt.edu).
  
     [reviewer notes¬] 
CS11.0
Use the 'Add' button to upload one or more of the following:
the sponsor protocol (including investigator initiated studies) and/or
other brochures
the multi-center protocol and consent form template, if applicable
Name Modified Date
Is this research study supported in whole or in part by industry?  This includes the
provision of products (drugs or devices).  
 
*  No
Is this a multi-centered study?
*  No
 
 
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Section: Cover Sheet
     [reviewer notes¬] 
CS12.0
Does your research protocol involve the evaluation or use of procedures that emit
ionizing radiation?
*  No 
CS13.0
Does this research study involve the deliberate transfer of recombinant or
synthetic nucleic acid molecules into human subjects?
 
*  No
Upload Appendix M of NIH Guidelines:
Name
Modified Date
 
CS14.0
Are you using UPMC facilities and/or UPMC patients during the conduct of your
research study?
 
*  Yes 
If Yes, upload completed Research Fiscal Review Form:
Name
Modified Date
Fiscal Review and Institutional Account Request Form.docx
3/8/2013 3:38 PM
  
     [reviewer notes¬] 
CS15.0
Indicate the sites where research activities will be performed
and/or private information will be obtained.
Choose all sites that apply and/or use Other to include sites not listed:
Sites:
University of Pittsburgh
UPMC
 
University of Pittsburgh
Campus:
Main Campus - Pittsburgh
List university owned off-campus research sites if applicable:
 
UPMC 
Sites:
UPMC Presbyterian
UPMC Magee Women's Hospital
UPMC Mercy
UPMC Shadyside
 
 

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Section: Cover Sheet
 
If you selected School, International or Other, list the sites:
 
*For research being conducted at non Pitt or UPMC sites, upload a
site permission letter granting the researcher permission to
conduct their research at each external site:
Name Modified Date
 
CS15.1
Have you, Christopher Chermansky , verified that all members of
the research team have the appropriate expertise, credentials,
and if applicable, hospital privileges to perform those research
procedures that are their responsibility as outlined in the IRB
protocol?
*  Yes
 
CS15.2
Describe the availability of resources and the adequacy of the
facilities to conduct this study:
*  Dr. Christopher Chermansky is an urologist at the UPMC urology
department. The CMG tests will be performed by Dr. Chermansky at a
UPMC clinic that has adequate resources and equipment for performing
these tests. We have a CMG machine at our Magee Women's Hospital
clinic that is easily accessible. The investigators have access to protected
servers for data security and information protection. 
 
 
    [reviewer notes¬] 
CS16.0
Special Research Subject Populations: 
Categories
None
    [reviewer notes¬] 
CS17.0
Does your research involve the experimental use of any type of human stem cell?
*  No
 

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Section: Cover Sheet
     [reviewer notes¬] 
 
NIH Definition of a Clinical Trial
A research study1 in which one or more human subjects2 are prospectively
assigned3 to one or more interventions4 (which may include placebo or other
control) to evaluate the effects of those interventions on health related biomedical
or behavioral outcomes.5
1 See Common Rule definition of research at 45 CFR 46.102(d) .
2 See Common Rule definition of human subject at 45 CFR 46.102(f) .
3 The term “prospectively assigned” refers to a pre-defined process (e.g.,
randomization) specified in an approved protocol that stipulates the assignment of
research subjects (individually or in clusters) to one or more arms (e.g., intervention,
placebo, or other control) of a clinical trial.
4 An intervention is defined as a manipulation of the subject or subject’s environment
for the purpose of modifying one or more health-related biomedical or behavioral
processes and/or endpoints.  Examples include:  drugs/small molecules/compounds;
biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g.,
telemedicine, face-to-face interviews); strategies to change health-related behavior
(e.g., diet, cognitive therapy, exercise, development of new habits); treatment
strategies; prevention strategies; and, diagnostic strategies.
5 Health-related biomedical or behavioral outcome is defined as the pre-specified
goal(s) or condition(s) that reflect the effect of one or more interventions on human
subjects’ biomedical or behavioral status or quality of life.  Examples include: 
positive or negative changes to physiological or biological parameters (e.g.,
improvement of lung capacity, gene expression); positive or negative changes to
psychological or neurodevelopmental parameters (e.g., mood management
intervention for smokers; reading comprehension and /or information retention);
positive or negative changes to disease processes; positive or negative changes to
health-related behaviors; and, positive or negative changes to quality of life.
CS18.0
* Based on the above information, does this study meet the NIH definition of a
clinical trial?
  
Yes 
No 
 
 
If Yes, click Save and then Click Here For Study Team's CITI Training Records .  Please
ensure all personnel's training is up to date
@ 
0 

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Section: Section 1 - Objective, Aims, Background and Significance
     [reviewer notes¬] 
1.1
Objective: What is the overall purpose of this research study?  (Limit response to 1-
2 sentences.)
To determine the effects of electrical stimulation of the nerves in the foot on overactive
bladder conditions. 
 
 
1.2
Specific Aims: List the goals of the proposed study (e.g., describe the relevant
hypotheses or the specific problems or issues that will be addressed by the
study).
Aim #1: To determine if foot stimulation can increase bladder capacity during CMG test.
Aim #2: To determine if foot stimulation can improve OAB symptoms during a 3-week
period with foot stimulation applied during the second week.
Aim #3: To determine the possible placebo effect of foot stimulation on OAB symptoms
using hand stimulation.
Aim #4 To determine if foot stimulation can improve OAB symptoms during a 12-week foot
stimulation period 
 
1.3
Background: Briefly describe previous findings or observations that provide the
background leading to this proposal. 
Our previous animal studies using cats have shown that electrical stimulation of the foot via
skin surface electrodes inhibits bladder overactivity. Our recent study in healthy human
subjects further showed that bladder capacity can be significantly increased by foot
stimulation. In this study, we aim to determine the effects of electrical stimulation of the
nerves in the foot on patients with medically refractory overactive bladder. 
 
 
1.4
Significance: Why is it important that this research be conducted? What gaps in
existing information or knowledge is this research intended to fill? 
Pharmacotherapy for OAB is not effective and has significant adverse effects, causing more
than 70% OAB patients to stop taking the medication. Alternative therapies include sacral
or tibial neuromodulation, and intravesical botox injections. Sacral neuromodulation is
invasive, requiring surgeries to implant a small electrial stimulator and electrodes to
stimulate nerves near the sacral spinal nerves. Tibial neuromodulation is less invasive but
requires insertion of a needle at the ankle to stimulate the tibial nerve for 30 minutes, once
a week for 12 weeks at the doctors office; thereafter, it's once a month. Botox injection
therapy requires placing a camera into the bladder to inject the medicine into the muscle of
the bladder. This is also invasive and it carries with it a 20% chance of urinary retention. If
our study is sucessful, it will improve OAB conditions by electrically stimulating the nerves
of the foot. This foot stimulation is non-invasive, can be individualized (some patients may
require more frequent stimulation than others), can be performed at home, and has no
adverse effects. Foot stimulation therapy will likely be accepted by more patients and can
make a broader impact on the improvement of OAB conditions.
  

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Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
2.1
Does this research study involve the use or evaluation of a drug, biological, or
nutritional (e.g., herbal or dietary) supplement?
*  No
 
    [reviewer notes¬] 
2.2
Will this research use or evaluate the safety and/or effectiveness of one or
more devices?
 
*  Yes 
 
2.2.1
Does this research study involve an evaluation of the safety and/or effectiveness
of one or more devices not currently approved by the FDA for general marketing?
* No
 
  

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Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
2.2.2
Does this research study involve the use or evaluation of the safety and/or
effectiveness of one or more devices approved by the FDA for general marketing?
*  Yes
 
2.2.2.1
Does this research study involve an evaluation of one or more FDA-approved
devices for a clinical indication, subject population, and/or operational parameter
that is not specified in the current FDA-approved product labeling for that device
(i.e., for an “off-label” indication)?  
* Yes
2.2.2.1.1
List each of the devices being evaluated for an “off-label” indication. Specify for
each listed device the corresponding Investigational Device Exemption (IDE)
number for this device/research study; or provide a justification for why you feel
that this device and its “off-label” use, as proposed in this research study (i.e., to
include potential failure of the device) constitute a non-significant risk to the
involved research subjects.
*
 
Device
IDE
#
Non-significant risk justification
View
Transcutaneous
Electrical Nerve
Stimulator
(TENS)
 
The transcutaneous electrical nerve stimulator (TENS) is a battery
powered stimulator that is commercially available and FDA-
approved for individual use at home to stimulate muscles/nerves.
1. It is not an implant. 2. It is not used in supporting or sustaining
human life. 3. It does not aid in diagnosing, curing, mitigating, or
treating disease. 4. It does not present a potential for serious risk
to the health, safety, or welfare of a subject. TENS will be used in
this study to deliver electrical stimulation via adhesive pad
electrodes attached to the skin surface of the foot. The proposed
use parallels the safety parameters of TENS already approved by
the FDA. The investigators, Drs. Tai, Chen, and Shen, have many
years of experience with electrical stimulation and
neurophysiology. They are qualified in using the TENS stimulator
correctly. Furthermore, the FDA approves of TENS use at home for
muscle/back pain and neuropathy. Therefore, we believe this is a
non-significant risk device.
 
  

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Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
2.3
Summarize the general classification (e.g., descriptive, experimental) and
methodological design (e.g., observational, cross-sectional, longitudinal,
randomized, open-label single-blind, double-blind, placebo-controlled, active
treatment controlled, parallel arm, cross-over arm) of the proposed research
study, as applicable.
This is an experimental, single-blind, placebo controlled study. Only the study team know
that the hand stimulation is a placebo, but the subjects do not know. The results obtained
before and after the treatment (foot stimulation or hand stimulation) will be compared in the
same subject.
2.3.1
Does this research study involve a placebo-controlled arm?
*  Yes
    [reviewer notes¬] 
2.3.1.1
Is there a commonly used diagnostic/treatment approach that is currently
recognized as being effective for the proposed subjects' disease or condition, and
that will be withheld from subjects assigned to the placebo arm of this research
study?
No; subjects assigned to the placebo and experimental arms of the research study will
continue to undergo a commonly used diagnostic/treatment approach
    [reviewer notes¬] 
2.4
Will any research subjects be withdrawn from known effective therapy for the
purpose of participating in this research study?
*  Yes 
 
2.4.1
Provide a justification for discontinuing subjects from known effective therapy for
the purpose of study participation.
One group of subjects will be asked to stop the OAB drugs, so that the effects of foot
neuromodulation on OAB conditions can be determined without any effects of OAB drugs.
The drugs can potentially interact with foot neuromodulation.
2.4.2
Describe the risks to subjects associated with discontinuing them from known
effective therapy for the purpose of study participation.
Currently available OAB drugs can only improve the OAB conditions by reducing an average
of 1-2 voids/day, which are not very effective therapies and most often associated with
many adverse effects. Therefore, the only risks for stopping these OAB drugs will be losing
the benefits of reducing 1-2 voids/day. Most OAB patients have a frequency of voiding about
10-15 times/day. Those patients are taking the drug because currently there is no other
better drug.
 

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Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
2.5
Will screening procedures (i.e., procedures to determine research subject
eligibility) be performed specifically for the purpose of this research study?
*  Yes
2.5.1
List the screening procedures that will be performed for the purpose of this
research study.  Do NOT include the inclusion/exclusion criteria in this section as
they will be addressed in section 3; questions 3.13 and 3.14.
The screening procedure only includes a review of patient's medical records. No other
precedures will be performed. Patient's medical record has all the information we need to
determine the idiopathic OAB condition.
An urinalysis is normally done as part of standard of care and will be checked in the medical
record for evidence of UTI. The standard office visit questions, which is also available in the
medical record and includes questions about prior strokes, spinal cord injuries, and so forth,
will be used to rule out those who may have a neurologic reason for bladder overactivity.
Dr. Chermansky who has clinical responsibilities to the patient will review the medical
records for eligibility. We also request a waive of consent for this review on section 4.7.
  
     [reviewer notes¬] 
 
2.6
Provide a detailed description of all research activities (e.g., all drugs or devices;
psychosocial interventions or measures) that will be performed for the purpose of
this research study. 
This description of activities should be complete and of sufficient detail to permit
an assessment of associated risks.  
At a minimum the description should include:
all research activities
personnel (by role) performing the procedures
location of procedures
duration of procedures
timeline of study procedures
The CMG test (1 hour duration) will be performed on 20 subjects by Dr. Chen and Dr.
Chermansky at UPMC urology clinics as follows (this group is numbered as group 5):
1. A sterile urethral catheter will be inserted by a physician, physician assistant, or nurse
into the bladder for cystometrogram (CMG), i.e. measuring bladder pressure while infusing
the bladder with sterile saline. Prophylactic dose of antibiotic (typically cipro 500mg or
bactrim DS) is provided before placing the catheter.
2. Skin surface electrodes will be attached to the bottom of one foot for electrical
stimulation. The stimulator and electrodes are FDA-approved devices for transcutaneous
electrical nerve stimulation (TENS) and are commercially available. The stimulation
characteristics include a continuous frequency of 5 Hz, pulsewidth 0.2 ms, and intensity 2-4
times the threshold voltage required for inducing toe twitching - or the intensity that the
subject feels comfortable with. 
3. Total of 2 CMGs will be performed on each subject. In the first group (10 subjects), the
 
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Section: Section 2 - Research Design and Methods
foot stimulation will not be applied during the first CMG but will be applied during the
second CMG. In the second group (10 subjects), the foot stimulation will be applied during
the first CMG but not during the second CMG. The repeated CMG effect (if any) can be
detected by comparing the results from the 2 subject groups.
------------------------------------------------------------------------------------------------------
--------------------------
The 3-week voiding diary test will be performed by 80 subjects at home as follows:
1. The subject will be instructed to record a voiding diary that includes the time and urine
volumes per void, the number of incontinence and nocturia episodes, and an urinary
urgency score every day during the 3-week period. The voiding diary form is included in the
IRB application. The subjects will also be instructed how to use the stimulator and where to
attach the electrodes on the foot at the beginning of the study. The investigator will provide
the stimulator and electrodes. The subjects will be asked to wear socks to prevent the
electrodes from detachment and to stop the stimulation during walking or in any non-
resting situation. The subjects will be asked to complete two brief questionnaires (UDI-6
and IIQ-7) about their bladder symptoms. 
2. During the second week, skin surface electrodes will be attached to the bottom of one
foot or the palm of the hand for electrical stimulation. The stimulator and electrodes are
FDA-approved devices for transcutaneous electrical nerve stimulation (TENS) that are
commercially available. The stimulation parameters include a continuous frequency of 5 Hz,
pulsewidth 0.2 ms, and intensity 2-4 times the threshold voltage for inducing toe twitching
or the intensity that the subject feels comfortable with. At the end of the second week,
subjects will complete the two brief bladder questionnaires (UDI-6 and IIQ-7) at home. 
3. STUDY GROUPS:
Group 1: (20 subjects) foot stimulation will only be applied for 3 hours in the evening prior
to sleep.
Group 2: (20 subjects) foot stimulation will be applied for one half hour in the evening prior
to sleep 
Group 3: (20 subjects) hand stimulation will be applied for 3 hours in the evening prior to
sleep. 
Group 4: (20 subjects) Patients will be specifically asked to stop their OAB drug 2 weeks
prior to starting the study. Once the OAB specific drug has been "washed out", the subject
will begin the 3 week trial (week 1 voiding diary without foot stimulation; week 2 voiding
diary with foot stimulation, and week 3 voiding diary without foot stimulation). This group
will not be done until group 1 and 2 are completed and an interim analysis is done to
determine which is more effective. The subjects will use either 3 hours or half hour
stimulation in the evening depending on which is more effective, or use the half hour
stimulation if both stimulation durations are equally effective.
4. The subjects can call or email the investigators anytime during the 3-week at-home test
for questions or any problems encountered. At the end of the 3-week test, the subjects are
asked to return the stimulator and voiding diary to the investigator's office. At the end of
the 3 week diary, subjects will complete the two brief bladder questionnaires (UDI-6 and
IIQ-7) at home.
------------------------------------------------------------------------------------------------------
--
The 12-week Foot Stimulation Test will be performed by 20 subjects as follows:
Subjects will be asked to record in a three day voiding diary four times over a 14 week
period. A urine collection hat with measurement scale will be provided to subjects to collect
and measure the voided urine volume.
The three day voiding diary will be completed at the following timepoints: Before foot
stimulation, 6 weeks after beginning foot stimulation, the last three days of the 12 week
foot stimulation period., the week after completing foot stimulation.
Electrical stimulation of the foot via skin surface electrodes will be self-applied at home. We
will meet subjects prior to the home test to teach how to use the transcutaneous electrical
nerve stimulator (TENS) and where to attach the skin surface electrodes.

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Section: Section 2 - Research Design and Methods
Subjects will be asked to stimulate the foot for 12 weeks for the following duration: 
Week1: 3 hours of foot stimulation in the evening prior to sleep
Week 2-12: 3 hours of foot stimulation in the evening prior to sleep, every third day. (A
calendar will be provided to help keep track of the stimulation days)
Two brief questionnaires about bladder symptoms will be completed at four different time
points throughout the study: before the stimulation begins, at the end of the 6th week of
foot stimulation, at the end of the 12th week of foot stimulation and the week after the foot
stimulation is complete
Subject assignment:
The subjects will be assigned by the investigator to either the CMG test, 3-week at-home
test or the 12-week at home test. If the subject would like to participate in both the CMG
test and the 3-week at-home test or 12-week test, they will be allowed to do so. However,
the subjects can only participate in one of the 3-week at-home test groups or 12-week test
group. The subjects will be assigned sequentially to groups 1-4 in the 3-week at-home test
groups. Once the number of subjects in one group is reached, no subject will be further
assigned to that group. 
2.6.1
Will blood samples be obtained as part of this research study?
*  No 
*If submitting a protocol for expedited review, it should be clear that the planned blood
draws are within the parameters described here:
http://www.hhs.gov/ohrp/policy/expedited98.html  (see Expedited Research Category #2)
If Yes, address the frequency, volume per withdrawal, the total volume per visit, and the
qualifications of the individual performing the procedure:
 
 
Study Flow Chart:
Name
Modified Date
     [reviewer notes¬] 
2.7
Will follow-up procedures be performed specifically for research purposes? 
Follow-up procedures may include phone calls, interviews, biomedical tests or
other monitoring procedures.
*  No
 
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Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
2.8
Does this research study involve the use of any questionnaires, interview or
survey instruments?
*  Yes
 
 
Upload a copy of all materials except for the SCID or KSADS which are on file at
the IRB.  The use of all instruments must be addressed in question 2.6 and/or
question 2.7 (except for an exempt submission where they should be addressed
on the appropriate uploaded exempt form).
Name
Modified Date
VoidingDiary-revised.docx
10/23/2013 11:05 AM
Questionnaires (UDI-6 and IIQ-7)
11/24/2014 12:14 PM
Previously the name and publisher for commercially available materials
were listed in the textbox below but effective 9/1/2015, all materials (except for
the SCID and KSADS) must be uploaded using the Add button above.
     [reviewer notes¬] 
2.9
If subjects are also patients, will any clinical procedures that are being used for
their conventional medical care also be used for research purposes?
*  yes
 
If Yes, describe the clinical procedures (and, if applicable, their frequency) that will be
used for research purposes: 
We will not perform a urinalysis specifically for this reseach project. However, the result of
urinalysis as part of standard clinical care will be reviewed in the medical record and used
to screen the patients for eligibility. 
2.10
The blood sample question was moved to 2.6.1.
     [reviewer notes¬] 
2.11
What is the total duration of the subject's participation in this research study
across all visits, including follow-up surveillance?
*  Total 1 hour for CMG test subjects, 3 weeks for voiding diary test subjects. This does not
include a 2 week pre-study drug "wash out" period. 14 weeks for the 12-week study group
    [reviewer notes¬] 
 
2.12
Does this research study involve any type of planned deception? 
If Yes, you are required to request an alteration of the informed consent process (question
4.7)
*  No
 

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Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
 
2.13
Does this research study involve the use of UPMC/Pitt protected health
information that will be de-identified by an IRB approved "honest broker"
system?
 
*  No
 

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Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
 
2.14
Will protected health information from a UPMC/Pitt HIPAA covered entity be
accessed for research purposes or will research data be placed in the UPMC/Pitt
medical record?
*  Yes
 
If you answer Yes, you are required to submit this study to the Research Informatics
Office, Health Record Research Request (R3). Per UPMC Policy HS-RS0005, all research
projects that access or involve UPMC electronic protected health information (e-PHI) must
be submitted to R3, with the exception of clinical trials that are contracted through the
UPMC Office of Sponsored Programs and Research Support (OSPARS).  
Complete the R3 intake form available at http://rio.pitt.edu/services. An R3 representative
will conduct a review. You will be notified once your R3 review is complete or if anything
further is needed. 
Describe the medical record information that will be collected from the UPMC/Pitt
HIPAA covered entity and/or the research-derived information that will be placed
in the medical records.
Medical record will only be accessed for screening the patients for eligilibity. An urinalysis is
normally done as part of standard of care and will be checked in the medical record for
evidence of UTI. The standard office visit questions, which is also available in the medical
record and includes questions about prior strokes, spinal cord injuries, and so forth, will be
reviewed to rule out those who may have a neurologic reason for bladder overactivity.
No research data wil be placed in the medical record.
2.14.1
Will protected health information from a non-UPMC/Pitt HIPAA covered entity be
obtained for research purposes or will research data be placed in the non-
UPMC/Pitt medical record?  
*  No
I, Christopher   Chermansky , certify that any member of my research team
accessing, reviewing and/or recording information from medical records have
completed the CITI Privacy & Information Security course or, if completed within
the past year, the Internet-Based Studies in Education and Research (ISER)
HIPAA for Researchers (Formerly RPF Module 6). The HIPAA certificates must be
available for review if audited but do not need to be uploaded into this OSIRIS
application.
* Yes
2.14.2
Are you requesting a waiver of the requirement to obtain written HIPAA
authorization for the collection of the PHI?
* No
 
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Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
2.15
Does this research study involve the long-term storage (banking) of biological
specimens? 
 
*  No
 
    [reviewer notes¬] 
2.16
Will research participants be asked to provide information about their family
members or acquaintances?
*  No
 
    [reviewer notes¬] 
2.17
What are the main outcome variables that will be evaluated in this study?
1. CMG measurements including the bladder volumes for first sensation, first desire to void,
and strong desire to void.
2. 3 week voiding diary data include voiding frequency, voided volume, number of
incontinence episodes, nocturia, and urgency episodes per day. 
3. 12 week voiding diary data including voiding frequency, voided volume, number of
incontinence episodes, nocturia and urgency episodes per day 
 
2.18
Describe the statistical approaches that will be used to analyze the study data.
*  Addressed below:
The data will be statistically analyzed using student t-test and ANOVA.
     [reviewer notes¬] 
2.19
Will this research be conducted in (a) a foreign country and/or (b) at a site (e.g.,
Navajo Nation) where the cultural background of the subject population differs
substantially from that of Pittsburgh and its surrounding communities?
*  No
Note that copies of training records, licenses, certificates should be maintained in the
study regulatory binder and are subject to audit by the Research Conduct and Compliance
Office (RCCO).
In addition, individuals planning to conduct human subject research outside the United
States must complete an optional module on the CITI training website: International
Studies.  Click here to access the instruction sheet for accessing optional CITI modules.
 
 
  

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Section: Section 2 - Research Design and Methods
     [reviewer notes¬] 
2.21
Will this research study be conducted within a nursing home located in
Pennsylvania?
*  No 
 
 

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Section: Section 3 - Human Subjects
     [reviewer notes¬] 
Section 3 - Human Subjects
3.1
What is the age range of the subject population?
>18 years old 
 
3.2
What is their gender?
*  Both males and females 
 Provide a justification if single gender selected:
3.3
Will any racial or ethnic subgroups be explicitly excluded from participation?
*  No  
If Yes, identify subgroups and provide a justification: 
 
3.4
For studies conducted in the U.S., do you expect that all subjects will be able to
comprehend English?
*  Yes 
 
    [reviewer notes¬] 
3.5
Participation of Children: Will children less than 18 years of age be studied?
*  No
 
If No, provide a justification for excluding children: 
The concern is that children under 18 years old might not follow the procedures as
designed. Also, this is a pilot study aimed at foot neuromodulation of OAB in adult human
subjects.
 
    [reviewer notes¬] 
3.6
Does this research study involve prisoners, or is it anticipated that the research
study may involve prisoners?
*  No
 
 
    [reviewer notes¬] 
3.7
Will pregnant women be knowingly and purposely included in this research study?
*  No
 

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Section: Section 3 - Human Subjects
     [reviewer notes¬] 
3.8
Does this research study involve neonates of uncertain viability or nonviable
neonates?
*  No
 
 
    [reviewer notes¬] 
3.9
Fetal Tissues: Does this research involve the use of fetal tissues or organs?
*  No
 

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Section: Section 3 - Human Subjects
     [reviewer notes¬] 
--->
3.10
What is the total number of subjects to be studied at this site, including subjects
to be screened for eligibility?
Note: The number below is calculated by summing the data entered in question 3.11. Any
additions or changes to the values entered in 3.11 will be reflected in 3.10.
*  120
 
3.11
Identify each of the disease or condition specific subgroups (include healthy
volunteers, if applicable) that will be studied.  
Click on the "Add" button and specify for each subgroup:
1) how many subjects will undergo research related procedures at this site; and
2) if applicable, how many subjects will be required to undergo screening
procedures (e.g., blood work, EKG, x-rays, etc.) to establish eligibility.  Do Not
include subjects who will undergo preliminary telephone screening.
* 
 
Subgroup
Number to undergo
research procedures
Number to undergo
screening procedures
View Group#6: 12-week foot stimulation
test
20
0
View Group #4: drug washout group with
foot stimulation of 3 or 0.5 hrs
20
0
View Group #2: half hour foot stimulation
before sleep
20
0
View Group #3: placebo/hand simulation
group
20
0
View Group #5: CMG group
20
0
View Group #1: 3 hour foot stimulation
before sleep
20
0
 
 
 
3.12
Provide a statistical justification for the total number of subjects to be enrolled
into this research study at the multicenter sites or this site.
*  Described below: 
 
This is a pilot study to determine if foot stimulation has any beneficial effect on OAB. The 6
subgroups as listed above are designed to answer the following questions: 1. Is there any
effect of foot stimulation on bladder activity detectable during CMG (group #5)? 2. What
stimulation duration (3 or 0.5 hours) is required in order to have the optimal effect as
determined on voiding diary (groups #1-#2)? Are the effects of foot stimulation caused by
placebo effect (group #3)? Does a drug washout period affect foot stimulation on OAB
symptoms (group #4)? Does 12 weeks of foot stimulation every third day for 3 hours
improve OAB symptoms? Since the variations of human CMG and voiding diary are
unknown, it is difficult to determine the total number of subjects based on stastistical
analysis. Therefore, we decided to use 20 subjects per group in this pilot study. However,
once statistical significance is reached, we will stop recruiting additional subjects in order to
maintain the subject number at a minimum.
 

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Section: Section 3 - Human Subjects
     [reviewer notes¬] 
3.13
Inclusion Criteria: List the specific criteria for inclusion of potential subjects.
1. 18 year old men and women and older
2. Currently having overactive bladder (OAB) symptoms, i.e. urgency, frequency, or
incontinence
3. No evidence of neurological disorder or urinary tract infection, i.e. clinically diagnosed as
idiopathic OAB 
 
3.14
Exclusion Criteria: List the specific criteria for exclusion of potential subjects from
participation.
1. Pregnant women in their late pregnancy phase will be excluded because the increasing
size of the baby/uterus may cause overactive bladder.
2. Patients with implanted electrical stimulators such as pacemaker will be excluded for
potential interference with the TENS stimulator.
3. Patients who are allergic to Cipro and Bactrim will be excluded from the CMG study. 
3.15
Will HIV serostatus be evaluated specifically for the purpose of participation in
this research study?
*  No 
If Yes, provide a justification:
 

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Section: Section 4 - Recruitment and Informed Consent Procedures
     [reviewer notes¬] 
4.1
Select all recruitment methods to be used to identify potential subjects:
Advertisements
Recruitment Letters and/or Scripts
Pitt + Me
 
Advertisements  
Upload the advertisements for review:
Name
Modified Date
PRO13020474 Tai Chermansky.docx 7/6/2016 4:37 PM
OAB FS flyer4.pdf
2/17/2017 11:04 AM
 
 
 
Recruitment Letters and Scripts
Upload recruitment letters/scripts/text:
Name
Modified Date
RecuitmentLetter-drug.doc
6/3/2015 5:21 PM
RecuitmentLetter-normal.doc 6/3/2015 5:21 PM
 
 
4.2
Provide a detailed description of your recruitment methods, including identifying
and initiating contact with participants:  
The subjects will be initially identified by Dr. Chermansky based on their medical history,
and then be contacted by mail or email using the recruitment letter. The review of patient
medical records is under the Waiver of Consent as described in section 4.7. The flyer will be
given to potential subjects identified in the physicians office. We will also be using Pitt+Me
(formerly called the CTSI Research Participant Registry) to advertise this study including
social media (e.g., Facebook, Twitter)
  
Note: Questions jump from 4.2 to 4.6 as questions 4.3-4.5 have been removed and the information is now
captured in 4.1
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Section: Section 4 - Recruitment and Informed Consent Procedures
     [reviewer notes¬] 
4.6
Are you requesting a waiver to document informed consent for any or all
participants, for any or all procedures? (e.g., a verbal or computerized consent
script will be used, but the subjects will not be required to sign a written informed
consent document.  This is not a waiver to obtain consent.
*  No
 
    [reviewer notes¬] 
4.7
Are you requesting a waiver to obtain informed consent or an alteration of the
informed consent process for any of the following? 
 
* Yes
 
4.7.1
If Yes, select the reason(s) for your request:
Medical record review for ONLY the identification of potential subjects
General Requirements: The Federal Policy [45 CFR 46.116 (d)] specifies in order for a
waiver of consent to be approved, the request must meet four criteria. For each request,
you will be asked to provide a justification addressing how each of these criterion is met.
 
Medical record review for the identification of potential subjects:
The research involves
no more than
minimal risk to the
subjects; 
[45 CFR 46.116 (d)
(1)]
We will only review medical records to identify potential subjects.
We will not extract or record any information from the medical
record. This review procedure imposes no physical or psychological
risks to the patients. Therefore, we believe it has no more than
minimal risk.
The waiver or
alteration will not
adversely affect the
rights and welfare of
the subjects;
[45 CFR 46.116 (d)
(2)]
The rights and welfare of these patients will not be negatively
affected because this research team is lead by a UPMC urologist who
already has legitimate access to the medical records by virtue of his
clinical responsibilities.
The research could
not practicably be
carried out without
the waiver or
alteration;
[45 CFR 46.116 (d)
(3)]
It would not be practicable to obtain the full consent of the urology
patient without first reviewing the medical record. Medical record
review is intented to determine whether or not the patient meets
the eligibility criteria, which can not be used to replace the patient
consent. A full consent will be conducted as described in this
application.
It would not be practicable to obtain the consent of the urology
patient simply to examine his or her PHI only to determine whether
or not s/he meets the eligibility criteria.
Whenever
We will not obtain any pertinent information from the medical record

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Section: Section 4 - Recruitment and Informed Consent Procedures
appropriate, the
subjects will be
provided with
additional pertinent
information after
participation; 
[45 CFR 46.116 (d)
(4)]
review.
 
 
 
 
 
4.7.2
Under what circumstances (if any) will you obtain consent from some of these
subjects?
Under no circumstance, we will obtain consent for medical record review. However, we will
obtain a full consent from the patient for the studies to be performed.
  
     [reviewer notes¬] 
4.8
Are you requesting an exception to the requirement to obtain informed consent
for research involving the evaluation of an 'emergency' procedure?
Note: This exception allows research on life-threatening conditions for which available
treatments are unproven or unsatisfactory and where it is not possible to obtain informed
consent.
*  No
 
--

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Section: Section 4 - Recruitment and Informed Consent Procedures
     [reviewer notes¬] 
4.9
Upload all consent documents for watermarking:
Draft Consent Forms for editing:
Name
Modified Date
draft consent tai normal 2.15.17.doc
2/23/2017 12:40 PM
draft consent form Tai no drug 2.15.17.doc 2/23/2017 12:40 PM
Approved Consent Form(s):
Name
Modified Date
draft consent tai normal 2.15.17.doc
8/1/2018 2:29 PM
draft consent form Tai no drug 2.15.17.doc 8/1/2018 2:29 PM
 
     
     [reviewer notes¬] 
4.10
Will all potential adult subjects be capable of providing direct consent for study
participation? 
* 
Yes 
 
  

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Section: Section 4 - Recruitment and Informed Consent Procedures
     [reviewer notes¬] 
4.11
At what point will you obtain the informed consent of potential research subjects
or their authorized representative?
After performing certain of the screening procedures, but prior to performing any of the
research interventions/interactions 
 
4.11.1
Address why you feel that it is acceptable to defer obtaining written informed
consent until after the screening procedures have been performed.
Our screening procedure only includes a review of patient medical record. We have request a
waiver of consent for accessing medical record and provided the reasons for the waiver on
section 4.7.
4.11.2
Taking into account the nature of the study and subject population, indicate how
the research team will ensure that subjects have sufficient time to decide whether
to participate in this study.  In addition, describe the steps that will be taken to
minimize the possibility of coercion or undue influence.
After sending out the recuitment letter, we will wait for the subject to make a decision to
contact us. If there is no response from the potential subject in 2 weeks, we will send
another recruitment letter. We will also try to contact the subject by phone or email if still no
response in 2 weeks after the second letter to make sure the letter is received. We will not
ask the patients if they want to participate on the phone or email. The intention to
participate will always be initiated by the subject by contacting us.
  

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Section: Section 4 - Recruitment and Informed Consent Procedures
     [reviewer notes¬] 
4.12
Describe the process that you will employ to ensure the subjects are fully
informed about this research study. 
*  Addressed below: 
This description must include the following elements:
who from the research team will be involved in the consent process (both
the discussion and documentation);
person who will provide consent or permission; 
information communicated; and
any waiting period between informing the prospective participant about the study
and obtaining consent
In addition, address the following if applicable based on your subject population:
process for child assent and parental permission
continued participation if a child subject turns 18 during participation
process for obtaining proxy consent and assent for decisionally impaired subjects
continued participation if subject regains capacity to consent
Dr. Chermansky will be involved in the consent process to discuss the study with the
subject, provide the consent form, and ask/answer questions. After informing the subjects
about the study, we will provide them the option to sign the consent forms in a later day if
they prefer to do so.
 
4.13
Are you requesting an exception to either IRB policy related to the informed
consent process?
For studies involving a drug, device or surgical procedures, a licensed physician who
is a listed investigator is required to obtain the written informed consent unless an
exception to this policy has been approved by the IRB 
For all other studies, a listed investigator is required to obtain consent (Note: In
order to request an exception to this policy, the study must be minimal risk)
*  No
If Yes, provide a justification and describe the qualifications of the individual who will
obtain consent:
 
 
4.14
Will you inform research subjects about the outcome of this research study
following its completion?
*  No 
 
If Yes, describe the process to inform subjects of the results:
• 
• 
• 
• 
• 
• 
• 
• 
0 
0 

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Section: Section 5 - Potential Risks and Benefits
     [reviewer notes¬] 
5.1
Describe potential risks (physical, psychological, social, legal, economic or
other) associated with screening procedures, research interventions/interactions,
and follow-up/monitoring procedures performed specifically for this study: 
* 
View
Research Activity:
Cystometrogram (CMG) 
Common Risks:
The feeling of a “full” bladder Discomfort Urgent need to urinate  
Infrequent Risks:
Flushing Nausea Pain Sweating Infection from the urethral catheter
being inserted into the bladder Antibiotics given before CMG may
cause nausea, diarrhea, rash, loss of appetite, or headache 
Other Risks:
Rare Risks: Blood in the urine Bladder perforation (a small hole in
the bladder). Urethral injury or stricture requiring further
interventions such as a chronic catheter and need for further
procedures  
View
Research Activity:
Electrical stimulation of the foot 
Common Risks:
There is a potential risk for foot stimulation to interfere with
implanted electrical stimulators such as pacemaker. Other risks may
include potential foot cramp, skin irritation, redness, or rash. 
Infrequent Risks:
n/a 
Other Risks:
n/a 
View
Research Activity:
OAB drug cessation 
Common Risks:
n/a 
Infrequent Risks:
temporary increase in OAB symptoms 
Other Risks:
n/a 
 
 
5.1.1
Describe the steps that will be taken to prevent or to minimize the severity of the
potential risks:
 
Before CMG, antibiotic will be given to minimize risk of infection. The urethra will also be
generous lubricated to minimize urethral trauma during catheter insertion.
To prevent interference between foot stimulation and implanted electrical stimulator,
subjects with an implanted stimulator will be excluded from this study. To minimize foot
cramping, the lower threshold voltage required will be used for actual stimulation.
To minimize the risks, the research procedures will be conducted by experienced personnel.
The subjects will be appropriately trained on how to use the TENS stimulator and attach the
electrodes. The subjects will also be told that they can call the investigators anytime with
any questions or problems.
OAB drug cessation will not likely worsen the patients' symptoms since only subjects who
are having insufficient relief from their medications are being asked to participate. 
 
5.2
What steps will be taken in the event that a clinically significant, unexpected
disease or condition is identified during the conduct of the study?
*  Addressed below:

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Section: Section 5 - Potential Risks and Benefits
The study will be stopped in the event that a clinically significant, unexpected condition is
identified. The subject will also be referred to appropriate care for the unexpected
condition.
5.3
All the risk questions (screening, intervention/interaction, follow-up) have been merged into
one question (5.1).
     [reviewer notes¬] 
5.4
Do any of the research procedures pose a physical or clinically significant
psychological risk to women who are or may be pregnant or to a fetus?
* No
 
    [reviewer notes¬] 
5.5
Do any of the research procedures pose a potential risk of causing genetic
mutations that could lead to birth defects?
*  No
 
    [reviewer notes¬] 
5.6
Are there any alternative procedures or courses of treatment which may be of
benefit to the subject if they choose not to participate in this study?
*  Not applicable
If Yes, describe in detail:
 
 

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Section: Section 5 - Potential Risks and Benefits
     [reviewer notes¬] 
5.7
Describe the specific endpoints (e.g., adverse reactions/events, failure to
demonstrate effectiveness, disease progression) or other circumstances
(e.g., subject's failure to follow study procedures) that will result in discontinuing
a subject’s participation?
*  Describe below:
The study is expected to end when all the procedures are completed. However, if the subject
can not follow the study procedures, the subject's participation will be discontinued and the
study will be ended.
CMG is a one-time procedure. We won't know if the patient developed an infection until at
least hours or days after the procedure. If infection occurs, it will be treated by additional
antibiotics.
We expect some electrodes to detach from the foot or hand. However, occasional unattached
electrodes will not end the study, since the data will be collected in a week period and a few
occurrences of detachment should not change the results. Also, if skin irritation is caused by
the electrodes, the study will continue by using another foot or hand and giving the irritated
area a day or two to recover. However, if unexpected serious irritation occurs that cannot be
avoided by switching to the other foot or hand, the study will be terminated for that subject.
 
     [reviewer notes¬] 
5.8
Will any individuals other than the investigators/research staff involved in the
conduct of this research study and authorized representatives of the University
Research Conduct and Compliance Office (RCCO) be permitted access to research
data/documents (including medical record information) associated with the
conduct of this research study?
*  No
  
5.9
Has or will a Federal Certificate of Confidentiality be obtained for this research
study?
*  No
 
5.10
Question has been moved to 5.17
5.11
Question has been moved to 5.16
 

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Section: Section 5 - Potential Risks and Benefits
     [reviewer notes¬] 
5.12
Does participation in this research study offer the potential for direct benefit to
the research subjects?
No - Describe the general benefits to society (e.g., increased knowledge; improved safety;
better health; technological advancement) that may result from the conduct of this
research study. 
 
Describe the benefit:
The subject may not receive direct benefit from participation in this research study.
Although the electrical stimulation may help with symptoms of overactive bladder, this
benefit is not known or guaranteed. However, information learned from this study will help
investigators learn how to better manage the conditions of overactive bladder. 
 
5.13
Describe the data and safety monitoring plan associated with this study. If the
research study involves multiple sites, the plan must address both a local and
central review process.
1. Dr. Tai and Dr. Chermansky will be responsible for the data and safety monitoring.
2. Since this is a pilot study only including 20 subjects per group, the investigators will
monitor the progress of the study and the efficacy of the treatment after collecting data
from the first 10 subjects in each group. Any unexpected adverse effect will be addressed
immediately and reported to the IRB committee. In addition to the monitoring of every 10
subjects, an annual review of the study will also be conducted to assure the experimental
design, identify any unexpected adverse effects for reporting, and review the progress of
subject recruitment.
3. The data will be locked in the lab by the investigators for safety and privacy. An annual
review of the safety and privacy of the data will be performed. If any problem occurs, it will
also be addressed immediately during any time of the year.
4. The following will be reported to IRB annually: a list of persons who monitored the data
and safety; the date when the monitoring/review occurs; a summary of any problems
detected; final decisions about changes of the study based on the annual review.
5. The potential adverse events may be reported to IRB including:
Use of TENS stimulator: 
Foot skin irritation, redness, or rash, or foot cramp. 
Cystometrogram (CMG) test:
Flushing
Nausea
Pain
Sweating
Infection 
Blood in the urine
Bladder perforation (a small hole in the bladder). 
Urethral injury or stricture
 
 

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Section: Section 5 - Potential Risks and Benefits
     [reviewer notes¬] 
Section 5 - Potential Risks and Benefits of Study Participation
5.14
What precautions will be used to ensure subject privacy is respected? (e.g. the
research intervention will be conducted in a private room; the collection of sensitive
information about subjects is limited to the amount necessary to achieve the aims of the
research, so that no unneeded sensitive information is being collected, drapes or other
barriers will be used for subjects who are required to disrobe)
 
The CMG test will be conducted in a private office and only the investigators have access.
The 3-week and 12-week voiding diary test will be conducted by the subject at home
without privacy concerns.
 
5.15
What precautions will be used to maintain the confidentiality of identifiable
information? (e.g., paper-based records will be kept in a secure location and only be
accessible to personnel involved in the study, computer-based files will only be made
available to personnel involved in the study through the use of access privileges and
passwords, prior to access to any study-related information, personnel will be required to
sign statements agreeing to protect the security and confidentiality of identifiable
information, whenever feasible, identifiers will be removed from study-related information,
precautions are in place to ensure the data is secure by using passwords and encryption,
because the research involves web-based surveys, audio and/or video recordings of
subjects will be transcribed and then destroyed to eliminate audible identification of
subjects)
 
The subject name will only be used for screening and scheduling purposes. Once the
subject enters the experiment, an ID number (1-120) will be assigned to each subject in
place of his/her name and only the subject's age and gender will be recorded for privacy
reasons. Subject name will not appear on data collection forms. 
The information linking the ID number with the subject's name will be stored in a separate
secure location during the study, and will be destroyed at the end of the study. We will not
keep any document to link the subject's name to the ID number. After the study is finished,
we will have consent forms with subjects names and data forms with ID numbers. Since the
link between names and ID numbers are not kept, there will be no identifiable information
that could be released. However, the data on papers will still be locked for safety reasons
and the electronic data will be stored in password-pretected, firewalled computers.
 
 
 
 
 
5.16
If the subject withdraws from the study, describe what, if anything, will happen to
the subject’s research data or biological specimens.
If the subject withdraws from the study, the subject's data will be deleted immediately. No
further use of the data will be possible. 
 
5.17
Following the required data retention period, describe the procedures utilized to
protect subject confidentiality. (e.g., destruction of research records; removal of
identifiers; destruction of linkage code information; secured long-term retention)
After the required data retention period, all data and subject information will be destroyed.
  

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Section: Section 6 - Costs and Payments
     [reviewer notes¬] 
 
6.1
Will research subjects or their insurance providers be charged for any of the
procedures (e.g., screening procedures, research procedures, follow-up
procedures) performed for the purpose of this research study?
*  
No 
 
    [reviewer notes¬] 
6.2
Will subjects be compensated in any way for their participation in this research
study?
*  Yes
6.2.1
Describe the amount of payment or other remuneration offered for
complete participation in this research study.
$300 for complete participation of one test. $600 for complete participation of both CMG
test and 3-week diary test or 12-week foot stimulation test.
6.2.2
Describe the amount and term of payment or other remuneration that will be
provided for partial completion of this research study.
$50 for partial completion. Partial completion is defined as that the subject has signed the
consent form and the study has begun, but the data collection is not finished.
 
  

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Section: Section 7 - Qualifications and Source(s) of Support
     [reviewer notes¬] 
7.1
Summarize the qualifications and expertise of the principal investigator and listed
co-investigators to perform the procedures outlined in this research
study.               
Christopher Chermansky, MD, Assistant Professor
Dr. Chermansky is a urologist who is qualified for and will be responsible for performing the
CMG test. He will also help identify the idiopathic OAB patients.
Changfeng Tai, PhD, Associate Professor
Dr. Tai has many years of experience in electrical stimulation, neurophysiology, and urologic
studies. The TENS stimulator is a FDA-approved device for rountine use by individuals at
home for muscle and back pain. Therefore, he is qualified for performing the non-invasive
electrical stimulation of the foot using skin surface electrodes and the TENS stimulator
during the initial instruction period for the subjects.
 
     [reviewer notes¬] 
7.2
Indicate all sources of support for this research study.
* 
Selections
Foundation: Upload a copy of the research plan that was submitted to the agency
Other: Upload a copy of the research plan that was submitted for funding (if applicable)
 
If Federal support, provide the sponsor information:
 Federal sponsor Grant Title Grant number Awardee institution Federal grant application
 
For projects not supported by a federal grant, upload the research plan that was submitted
for funding:
Name
Modified Date
Product-Development-Plan v3.docx 9/21/2013 6:17 PM
If Industry support, provide the sponsor information and level of support:
If Foundation support, provide the sponsor information:
Coulter Foundation will provide $100K in support of this study.
If Other support, provide the support information and level of support:
The Department of Urology at the University of Pittsburgh will also provide support in
addition to Coulter Foundation funding.

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Section: Section 7 - Qualifications and Source(s) of Support
     [reviewer notes¬] 
 
7.3
Is this study funded in part or whole by a PHS Agency?
 *  No 
 
Does any investigator* involved in this study (select all that apply):
 
Name
A. Have equity in a publicly-traded entity that either sponsors** this research or
owns the technology being evaluated or developed that exceeds a 5% ownership
interest or a current value of $10,000?
B. Have equity in a non-publicly-traded entity that either sponsors this
research or owns the technology being evaluated or developed?
C. Receive salary, consulting fees, honoraria, royalties or other remuneration from an
entity that either sponsors this research or owns the technology being evaluated or
developed that is expected to exceed $10,000 during the past or next 12 months?
D. Have rights as either the author or inventor of intellectual property being
evaluated or developed in this research that is the subject of an issued patent
or has been optioned or licensed to an entity?
E. Have an officer or management position**** with a Licensed Start-up Company
overseen by the COI Committee that either sponsors this research or owns the
technology being evaluated or developed?
F. Receive compensation of any amount when the value of the compensation would be
affected by the outcome of this research, such as compensation that is explicitly
greater for a favorable outcome than for an unfavorable outcome or compensation in
the form of an equity interest in the entity that either sponsors this research or owns
the technology being evaluated or developed?
None of the above options apply and there are no other financial conflicts of interest
in the conduct of this research.
*Investigator means the PI, co-investigators, and any other member of the study team,
regardless of title, who participates in the design, conduct, or reporting of this research, as
well as his/her spouse, registered domestic partner, dependents, or other members of
his/her household. The PI is responsible for ensuring that s/he and all other
relevant members of the study team review the above questions describing
Significant Financial Interests. 
**through the provision of funds, drugs, devices, or other support for this research
****Such as serving on the Board of Directors or Board of Managers or a position that
carries a fiduciary responsibility to the company (e.g., CEO, CFO, CTO, or CMO).
7.3.1
Provide the name of the investigator(s) and describe the nature of the Significant
Financial Interest(s):
Changfeng Tai, PhD now has significant financial interest in NeuroSpur, which has licensed
the FootStim technology he developed from the University of Pittsburgh
*
Name
Modified Date
COI Management Plan
2/15/2017 2:23 PM
  
D 
(j) 
D 
D 
D 
D 

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Section: Supporting Documentation
     [reviewer notes¬] 
 
Supporting Documentation Section
References and Other Attachments
 
Additional documents:
Name
Modified
Date
Version
References.doc 6/5/2013
3:55 PM
0.01
 
Please use the Add button to the left to upload additional
documents if needed.
    [reviewer notes¬] 
ClinicalTrials.gov is a registry and results database of publicly and privately supported
clinical studies of human participants conducted around the world.
"Applicable clinical trials" are required by federal law to be registered in ClinicalTrials.gov.
Applicable Clinical Trials (ACTs) are studies that meet the following criteria:
The study is an interventional study AND 
The study intervention is a drug, biologic, medical device, radiation or genetic AND
The Study is not Phase 0 or 1 AND
The study has at least one site in the United States or is conducted under an investigational
new drug application or investigational device exemption
NIH Policy
Effective January 18, 2017, revised NIH Policy requires that all clinical trials funded in whole or in
part by the NIH be registered and results information posted on ClinicalTrials.gov. 
As defined by the NIH, a clinical trial is:
A research study in which one or more human subjects are prospectively assigned to one or
more interventions (which may include placebo or other control) to evaluate the effects of
those interventions on health related biomedical or behavioral outcomes.
The NIH Policy extends beyond the Food and Drug Administration Amendment Act (FDAAA 801)
requirements in that it requires registration and results reporting of:
clinical trials of behavioral, surgical and other types of health and medical interventions
phase 1 studies of drugs and biological products
small feasibility studies of device products 
Failure to submit all required registration and results information requested on ClinicalTrials.gov can
jeopardize University grant funding, the future funding of the grantee and subject the University of
Pittsburgh to future monetary penalties.
In addition, to promote transparency of the clinical trials process, the International Committee of
Medical Journal Editors (ICMJE) has established a policy requiring the entry of clinical trials in a
public registry, such as ClinicalTrials.gov, prior to subject enrollment as a condition of consideration
for publication of the trial results.
* Based on the above information, will this study be registered in ClinicalTrials.gov?
Yes 
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Section: Supporting Documentation
 
Who will serve as the Responsible Party? UPMC/Pitt Investigator or IND/IDE Pitt Sponsor 
Why are you registering your study? (Check all that apply)
It is strongly encouraged by the NIH
If you are not yet registered and need to establish an account for the PI or other research staff that
may need to access the record, please send an email to the  University of Pittsburgh PRS
administrator at ctgov@pitt.edu with the following information for each individual:
Full name
Telephone number
Pitt or UPMC email address
If you have any questions or concerns, please email us at ctgov@pitt.edu. 
To find out additional information about how to register your study go to:
https://www.clinicaltrials.gov/ct2/manage-recs/how-register  
 
  
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