Feasibility Testing of Transpelvic Magnetic Stimulation as a Novel Intervention toImprove Urogenital Function in Prostate Cancer Survivors
Phase: NA
Conditions: Prostate Cancer, Erectile Dysfunction
Sponsor: VA Office of Research and Development

Feasibility Testing of Transpelvic Magnetic 
Stimulation as a Novel Intervention toImprove 
Urogenital Function in Prostate Cancer 
Survivors
NCT04488068
September 14, 2020

Human Protocol (Version 1.2)
General Information
*Please enter the full title of your study::
Feasibility Testing of Transpelvic Magnetic Stimulation as a Novel Intervention to Improve 
Urogenital Function in Prostate Cancer Survivors
 
 
*Please enter the Study Number you would like to use to reference the study:
Magnetic Stimulation - Human
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this 
study.
 
 
Add departments
and Specify Research Location:
Is 
Primary? Department Name
VASDHS - VASDHS
 
Assign key study personnel(KSP) access to the study
*Please add a Principal Investigator for the study:
 
Rajasekaran, Mahadevan, PhD
 
3.1 If applicable, please select the Research Staff personnel
 
A) Additional Investigators
Albo, Michael E., MD 
 Co-Investigator
Bhargava, Valmik, PhD 
 Co-Investigator
Chang, Eric Y., MD 
 Co-Investigator
Sakamoto, Kyoko, MD 
 Co-Investigator
B) Research Support Staff
Cano Sanchez, Christopher 
 Study Coordinator
Sorkhi, Samuel 
 Study Coordinator
G

*Please add a Study Contact
 
Bhargava, Valmik, PhD 
Rajasekaran, Mahadevan, PhD 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal 
Investigator themselves).
 
VASDHS IRB
Human Subjects Protocol
v20190121
Section 1 - Preliminaries
Principal Investigator:
Mahadevan Rajasekaran, PhD
Protocol Title:
Feasibility Testing of Transpelvic Magnetic Stimulation as a Novel Intervention to Improve 
Urogenital Function in Prostate Cancer Survivors
IRB Protocol Number:
H200110
Protocol Nickname:
Magnetic Stimulation - Human
Form Template Version:
v20150115
Date Prepared:
08/03/2020
Please be advised that this protocol application form has changed as a result of the 2018 Common 
Rule.  There are new questions and sections, and you may be required to provide additional information to 
previous sections.
1a) Is this study considered human research?
Yes 
No 
I don't know 
1b) Please select:
This is an application for a NEW human subject research protocol 
This is a revision of an existing protocol 
Was this study initially approved prior to January 21, 2019?
 Yes  
 No
Were you instructed to convert to the 2018 Common Rule Requirements?
 Yes  
 No

 Section 2 - Research Subjects
 
2a) What is the total planned number of VA-consented subjects?
Include the total number of subjects who will prospectively agree to participate in the study (e.g., documented 
consent, oral consent, or other).
20
 
2b) What is the total number of VA subjects who WILL NOT be consented?
Include the total number of subjects that will be included without consent (e.g., chart review).  Note: Data about 
people are still considered “human subjects” by the IRB, so even if you do not intend to contact the patients 
whose charts you will review, you still should enter the number of charts as your “planned subjects."
0
 Section 2.1 Consented Subject Groups
2.1) For each of the subject categories listed below, indicate whether or not these subject groups will 
participate in the study: 
2.1a) Children under the age of 18
Note:   If neonates or children will be involved in this study, certification by the Medical Center Director will be 
required. Only minimal risk research may be performed with children.  Only non-invasive monitoring and/or 
prospective observational and retrospective record review studies that are minimal risk can be conducted in VA 
involving neonates.
  Yes  
  No
2.1b) Pregnant women
  Yes  
  No
2.1c) Individuals with cognitive/decisional impairment
  Yes  
  No
2.1d) Non-English-speaking individuals
  Yes  
  No
2.1e) Prisoners of War (explicitly targeting this group)
  Yes  
  No
2.1f) Non-Veterans (Note: Justification for inclusion of non-Veterans will be required)
  Yes  
  No
2.1g) Incarcerated individuals (Note: VA CRADO approval will be required)
  Yes  
  No
2.1h) VA employees - including VA paid, IPA, or WOC (Note: Union review and authorization may be 
required)
  Yes  
  No
2.1i) Students of the institution (e.g., resident trainees) or of the investigator
  Yes  
  No
2.1j) Patients with cancer (or high cancer risk) [explicitly targeting this group]
 Yes  
 No

 Section 3 - Study Features   (these items default to "No" for convenience)
  
3) This section consists of several Yes/No questions addressing protocol characteristics.     Click on Save and 
.
Continue
 Section 3.1 Protocol Basics
Select all that apply
3.1a) The research 
 the participant.
intends to change
 Yes  
 No
3.1b) 
 with living participants to collect data or specimens with no intent to change them.
Interactions
  Yes  
  No
3.1c) This is a study that 
 has any 
 
never
subject contact and does not collect subject identifiers
  Yes  
  No
3.1d) This is a 
study involving retrospective or prospective medical records.
chart review 
  Yes  
  No
3.1e) This is a 
study occurring in-part or in-full at other locations.
multi-site 
  Yes  
  No
3.1f) There is an 
 component to this research. 
international
International research includes sending or receiving 
human derived data or specimens (identifiable, limited data set, coded, or deidentified) to or from an 
international source.  International research does not include studies in which VA is only one of multiple 
participating sites where the overall study-wide PI is not a VA investigator.
  Yes  
  No
3.1g) This study includes 
 (not including VA-leased space or CBOC clinics) conducted 
off-station activity
under VASDHS IRB approval.  Note: this does not include research conducted by a collaborator at their home 
institution under their institutional approval.
  Yes  
  No
3.1h) VA subjects will 
 in part or in full 
 (not including VA-leased space or 
participate
at other locations
clinics) under VASDHS IRB approval. Note: if this study involves remote participation of subjects, please 
indicate "no" and describe their remote participation in section 9 of the application.  This question is intended 
to understand whether participants must physically go to a non-VA location to participate in this VA research 
study. 
  Yes  
  No
 Section 3.2 Specimen Use and Data Repository
Indicate whether or not each of the following applies to this protocol
3.2a) Involves specimens that are left over from pathological or diagnostic testing (
)
non-research specimens
  Yes  
  No
3.2b) Involves 
 purposes 
specimens collected for research
only
  Yes  
  No
3.2c) This study includes 
 (specimens are retained for use outside of the purposes of this 
specimen banking
protocol)

  Yes  
  No
3.2d) The study involves 
genotyping or other 
DNA 
genetic analysis
  Yes  
  No
3.2e) Biological
will be sent outside of the VA.
 specimens/material 
  Yes  
  No
3.2f) A 
 is maintained (data are retained after completion of the protocol for other uses, 
data repository
 see  before checking "yes")
IMPORTANT:
?
  Yes  
  No
3.2g)  
of the VA (identifiable, coded, limited data set, or deidentified)
Data will be shared outside 
  Yes  
  No
 Section 3.3 Treatment and Clinical Trials
Indicate whether or not each of the following applies to this protocol
3.3a) Includes a 
 component (a research treatment)
treatment
 Yes  
 No
3.3b) Study is a 
  
clinical trial. Note:  A clinical trial is a research study in which one or more human subjects 
are 
 (which may include placebo or other control) to 
prospectively assigned to one or more interventions
evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
 Yes  
 No
3.3c) Has a data safety monitoring board (
or data safety monitoring committee.
DSMB) 
  Yes  
  No
3.3d) Has a 
 (but not a DSMB) (this is not the data security plan, it is a safety plan).
data safety monitoring plan
 Yes  
 No
 Section 3.4 Drugs and Devices
Indicate whether or not each of the following applies to this protocol
3.4a) 
 that require 
 action such as an Investigational New Drug (IND) approval or exemption or 510
Drugs
FDA
(k) approval.
  Yes  
  No
3.4b) Other drugs, supplement, etc. that
action for inclusion in the study.
 do not require FDA 
  Yes  
  No
3.4c) Medical 
 IDE approval or waiver
devices requiring FDA
 Yes  
 No
3.4d)
 medical 
 Other
devices
 Yes  
 No
 Section 3.5 Risk and Hazards

Indicate whether or not each of the following applies to this protocol
3.5a) Study places subjects at 
(do not include risks that are due to standard care)
greater than minimal risk 
  Yes  
  No
3.5b) Human subjects are exposed to 
 (do not include standard care).
radioisotopes
  Yes  
  No
3.5c) Subjects have other 
 (e.g., x-rays) (do not include standard clinical use).
radiation exposure
  Yes  
  No
3.5d) Target population has psychiatric diagnosis, behavioral complaint, or chronic pain.
  Yes  
  No
 Section 3.6 Clinical Facilities and Standard Care
Indicate whether or not each of the following applies to this protocol
3.6a) Study 
 (e.g., adds required tests run in the VA lab for study purposes; research 
uses VA clinical services
procedures concurrent with clinical care)
 Yes  
 No
3.6b) Includes procedures or drugs that will be considered part of standard care.
  Yes  
  No
3.6c) Involves 
purposes.
lab tests done for research 
  Yes  
  No
 Section 3.7 Subject Expenses and Compensation
Indicate whether or not each of the following applies to this protocol
3.7a) There may be expense or added 
or the subject's insurance.
costs to the subject 
  Yes  
  No
3.7b) This is a 
 and subjects may be billed for study drugs or procedures.
qualifying cancer treatment trial
  Yes  
  No
3.7c) This is a cancer treatment trial but 
 for study drugs or procedures.
subjects will not be billed
  Yes  
  No
3.7d) Subjects will be
(either in cash or other means such as a gift certificate).
 compensated 
 Yes  
 No
 Section 3.8 Subject Activities
Indicate whether or not each of the following applies to this protocol
3.8a) Involves 
 completed by subjects
surveys or questionnaires
 Yes  
 No

3.8b) Includes the use of 
 such as flyers, advertisements, or letters
recruitment materials
  Yes  
  No
3.8c) Involves facial 
 or audio or video 
of 
photographs
recordings 
patients
  Yes  
  No
 Section 3.9 Sponsors and Collaboration
Indicate whether or not each of the following applies to this protocol
3.9a) This research is a funded research project (commercial (industry) sponsor, NIH, VA, other).
 Yes  
 No
3.9b) Other 
is provided (e.g., drugs or supplies).
commercial (industry) non-financial support 
  Yes  
  No
3.9d) The protocol has 
 involvement (e.g., subjects or funding).
Department of Defense
  Yes  
  No
3.9c) The PI or other study staff member has a financial interest or other
related to 
 real or potential conflict 
this study.
  Yes  
  No
3.9e) This study involves 
research activities (research conducted at other institutions under the 
c llaborative 
o
authorities or approvals of the other institution/s). Note: this may include other VA and/or non-VA institutions, 
but does not include off-site VA research.
  Yes  
  No
 Section 4 - Estimated Duration
4) What is the estimated duration of the entire study?  (From IRB approval to IRB closure)
3 years
 Section 5 - Lay Language Summary
5) Provide a summary or synopsis of the proposed study using non-technical language (not more than 1 
paragraph)
The overall purpose of this project is to improve the quality of life of prostate cancer survivors. 
Prostate cancer is most common in men over 50 years. With early diagnosis, patients can pursue 
potentially curative interventions that include surgical procedures. These surgical treatments lead 
to sexual dysfunction and leakage of urine. Although it is recognized that bladder control and 
sexual functions are important issues affecting quality of life, there has been only limited 
research into methods to prevent these forms of dysfunctions in cancer survivors. We are 
proposing a new preventive strategy using magnetic stimulation to strengthen the muscles that 
are responsible for maintaining these functions.
 Section 6 - Specific Aims
6) Provide a statement of specific aims and 
 that serve as the basis for this protocol.  Emphasize 
hypotheses
those aspects that justify the use of human subjects.
1) To show feasibility of recruitment of prostate cancer survivors, acceptability of transpelvic 

magnetic stimulation (TPMS) intervention and retention of this Veteran population. 
2) To test the feasibility of administering symptom scores in this population to detect severity 
and early recovery of functional impairment. 
3) To test the feasibility of diagnostic imaging to establish: penile/pelvic floor muscle (PFM) blood 
flow, PFM anatomical and morphological changes before surgery, immediately after surgery, and 
after TPMS interventions. 
 Section 7 - Background and Significance
7) Provide a succinct discussion of relevant background information to justify performing the proposed study.
Literature suggests that  prostate cancer is the most common type of cancer in men over 50 
years old, with an estimated 218,000 new cases each year. This cancer’s incidence is especially 
prevalent (29%) among VA patients
. Surgical therapy for prostate cancer is a significant risk 
13
factor for urogenital complications which dramatically affect the quality of life for male Veterans, 
such as erectile dysfunction (ED), or the inability to initiate or maintain adequate erection for 
intercourse, and urinary incontinence 20-80% of these men will never regain normal erectile 
function and 31% will have urinary incontinence. Transpelvic magnetic stimulation (TPMS) for 
Urogenital and Pelvic Floor Disorders: Recently, TPMS therapy has been recognized as beneficial 
in treating nerve and muscle injuries. TPMS acts by strong pulsing magnetic fields that depolarize 
neural elements, resulting in improved muscle contraction. Repetitive contraction and relaxation 
of normal skeletal muscle results in increased muscle strength, endurance, and circulation. 
Previous studies showed beneficial effects of TPMS in UI in females. However, these studies were 
inconclusive. Apparently, these clinical studies attempted to reverse the established neuropathy 
and muscle dysfunction in symptomatic patients. Our proposed studies will evaluate the 
preventive potential of TPMS in acute neuropraxia related penile and sphincter muscle 
dysfunction. Recent reports showing efficacy of TPMS for skeletal muscle regeneration after 
surgical trauma clearly supports our claim. TPMS does not cause adverse effects but improves 
muscle function by minimizing post-injury inflammation, atrophy and scar formation. Based on 
published reports and taking advantage of muscle regeneration potential, we propose TPMS after 
surgery (as acceptable to the urologic surgeon) to enable systematic evaluation of its potential to 
prevent muscle dysfunction, i.e., immediate muscle recovery prior to fibrosis onset (never 
attempted before). Furthermore, TPMS treatment will lead to muscle strengthening. In addition, 
low intensity (5-10% amplitude) TPMS improves blood flow as shown in our laboratory (AUA 2018 
oral presentation by Kim, et al- TRANSPELVIC MAGNETIC STIMULATION (TPMS) AS A 
NOVEL THERAPY TO ENHANCE PENILE MICRO AND MACRO CIRCULATION, J Urology, Vol. 199, 
No. 4S, Supplement, Saturday, May 19, 2018), and higher intensity (30-50% amplitude- based 
on the amplitude that results in patient feeling the muscle activity) helps muscle regeneration and 
function by minimizing post-injury inflammation, atrophy and scar formation. Based on these 
observations, we hypothesize that TPMS: (a) will prevent pelvic floor muscle atrophy and result in 
improved strength and (b) will decrease muscle fibrosis by improving penile and pelvic 
muscles blood flow leading to accelerated recovery after injury. TPMS has been employed as a 
nonsurgical intervention for stress UI in females since 1998. For treatment with TPMS, an 
embedded magnetic coil positioned on the chair generates pulsed electromagnetic fields that can 
penetrate into the pelvic floor muscles, leading to nerve stimulation and muscle contractions. 
Pelvic floor muscle blood flow can be non-invasively measured simultaneously using Doppler 
probe placed on the penile skin as is done routinely for clinical diagnosis. Pelvic floor muscle 
changes can be non-invasively measured by MR imaging. The proposed mechanism is to increase 
pelvic muscle strength and endurance through repetitive contractions. Proposed TPMS may result 
in increased urethral pressure and may strengthen muscles to prevent venous leak. Non-invasive 
TPMS has several advantages and has never been tried in post-prostatectomy patients.
 
Recently, application of neuromodulation using 
 (rMS) has 
repetitive magnetic stimulation
 
shown to be a safe, effective, and preferred approach of treatment for muscular and neurological 
injuries of several conditions, including urinary incontinence
 as it is non-invasive and relatively 
1,2
pain free. In addition, rMS displays potential to improve blood flow , muscle regeneration and 
3
function by minimizing post-injury inflammation, atrophy and scar formation . 
4
 
We plan to use MagVenture R30 device and associated coils/paddles for which we are attaching 
510Ks, users manual and brochures. In addition, please see online link: https://www.magventure.
com/en-gb/Products/MagPro-magnetic-stimulators/MagPro-R30 for more details. 
 
All parameters are within the FDA approved range for pulse frequency, amplitude and duration.
Magnetic stimulation device MagVentrure's R30 (FDA approved for peripheral stimulation) that 
targets pelvic floor muscles will be used. We propose 10 Hz (for blood flow stimulation)  and 30 

Hz (for pelvic muscle strengthening), in an 8 seconds on- 4 seconds off pulsing manner TPMS that 
encompass previously employed range of frequencies in humans for pelvic floor stimulation 
(based on published methodology -Lim et al, J Urol 197:1302, 2017, attached). Number of  trains 
will be about 50. no of pulses in train would be about 240.   Each cycle will be of  total 20 minutes 
duration, followed by 20 min of coil cooling period before the second cycle. Based on our 
preliminary studies in 2 subjects for about 8 weeks, this protocol was well toleated. Both subjects 
felt the sensations at the high frequency 30 Hz.  In these preliminary studies perfomed in two 
cancer surivors using a previously approved protocol, we observed a significant improvement in 
continence function (number of pads used)  after 4 -6 weeks of TPMS.
 
1. Almeida FG, Bruschini H, Srougi M. Urodynamic and clinical evaluation of 91 female patients 
with urinary incontinence treated with perineal magnetic stimulation: 1-year followup. J Urol 
2004;171:1571-4; discussion 4-5.
2. Lim R, Liong ML, Leong WS, et al. Pulsed Magnetic Stimulation for Stress Urinary Incontinence: 
1-Year Followup Results. J Urol 2017;197:1302-8.
3. Liu P, Gao J, Pan S, et al. Effects of High-Frequency Repetitive Transcranial Magnetic 
Stimulation on Cerebral Hemodynamics in Patients with Disorders of Consciousness: A Sham-
Controlled Study. Eur Neurol 2016;76:1-7.
4. Stolting MN, Arnold AS, Haralampieva D, et al. Magnetic stimulation supports muscle and 
nerve regeneration after trauma in mice. Muscle Nerve 2016;53:598-607.
 Section 9 - Design and Methods
9) Describe the research design and the procedures to be used to accomplish the specific aims of the 
project.  Provide a precise description of the planned data collection (include what systems or databases will 
be used/accessed to gather data), analysis and interpretation.  For chart review studies, include the timeframe 
of collection.  Address sample size, inclusion of women and minorities.  Define in clear terms exactly what will 
 
be done to the human subjects.
This is a previously approved protocol-H180085- “Development of a Novel Method to Strengthen 
” with some minor modifications. TPMS will be 
Pelvic Floor Muscles Using Magnetic Stimulation
performed at the Urology Suite, SCI section, I floor of the main hospital. 
Our specific aims are:
1) To show feasibility of recruitment of prostate cancer survivors, acceptability of transpelvic 
magnetic stimulation (TPMS) intervention and retention of this Veteran population.  
2) To test the feasibility of administering symptom scores in this population to detect severity and 
early recovery of functional impairment. 
3) To test the feasibility of diagnostic imaging to establish: penile/pelvic floor muscle (PFM)  blood 
flow, PFM anatomical and morphological changes before surgery, immediately after surgery, and 
after TPMS interventions.
Patient Recruitment: Our co-investigator, Dr Sakamoto will recruit patients from her urology clinic 
men over 50 years old who are enrolled for prostate surgery  (n=20). After recruitment, 20 male 
patients will be assigned 1:1 to either age-matched control (G1; sham TPMS) or age-matched 
intervention (G2; TPMS) groups using computer-generated randomization, and baseline 
parameters (continence, sexual functions-using standadized questionnaires (please see 
attachments for reference) , PRM, ICM and penile morphology- by MRI, blood flow- using laser 
Doppler measurement) will be established. All patients will be instructed (Dr. KS) to perform 
standard of care pelvic floor exercise for the duration of the study. Patients will under go three 
month TPMS treatment every  week (2-visits per week from 0- 12 weeks as shown in Figure) 
starting when she feels the patient is ready for this treatment (after catheter removal). Patients 
will be evaluated (symptom score, MRI and blood flow) at baseline and at the end of the study 
(timeline attached). All enrolled patients will undergo TPMS treatment in addition to standard 
clinical- pelvic floor exercise. The study will be conducted after removal of the in dwelling catheter 
on patients who: had robotic assisted laparoscopic radical prostatectomy and have no evidence of 
metastasis and postoperative PSA < 0.2.  The TPMS operator will not be blided but those 
analyzing the IIEF, IQIC scores, and evaluating Doppler blood flow and MRI findings will be 
blinded to the assignment. 
Impact of COVID-19 Pandemic: Due to on-going COVID-19 pandemic, proposed timeline may be 
impacted due to the restrictions on human research. The scheduling for this research study will 
be based on availability of SCI suite for exclusive research study use when there are no other 
patients at that time. Research study patient will be the only patient in the suite at that time of 
the research study. All  facility mandated santization and social distancing protocols will be strictly 
implemented and followed.
 
TPMS Treatment: Magnetic stimulation device MagVentrure's R30 (FDA approved for peripheral 
stimulation) that targets pelvic floor muscles will be used. We propose 10 Hz (for blood flow 
stimulation)  and 30 Hz (for pelvic muscle strengthening), in an 8 seconds on- 4 seconds off 

pulsing manner TPMS that encompass previously employed range of frequencies in humans for 
pelvic floor stimulation (based on published methodology -Lim et al, J Urol 197:1302, 2017, 
attached). Number of  trains will be about 50. no of pulses in train would be about 240.   Each 
cycle will be of  total 20 minutes duration, followed by 20 min of coil cooling period before the 
second cycle. Based on our preliminary studies in 2 subjects for about 8 weeks, this protocol was 
well toleated. Both subjects felt the sensations at the high frequency 30 Hz.  Same TPMS device 
will be used for the control (G1: sham) group, but with a sham magnetic coil. Sham coil is 
designed to provide <5% energy during sham TPMS. The treatment regimen will involve two 20-
minute sessions/visit and 2 -visits per week as follows: Weeks: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 
12  (final monitoring at 24 weeks). TPMS will be administered by a trained clinical coordinator 
under the supervision of an urologist. The coordinator will not be involved in subject’s 
assessment. We will apply first low amplitude (5%) to improve blood flow followed by high 
amplitude (30-50 %) TPMS, to strengthen muscles.   Symptom scoring using questionarries and 
blood flow (Doppler) will be  perfomed at:  baseline (before starting TPMS),  and at weeks 4,8, 
13, 24 after starting TPMS as shown in the atatched figure: IRB Methods: Timeline. At the initial 
visit, subjects will receive education about TPMS and anatomy and the role of TPMS in increasing 
pelvic blood flow and muscle strength. This protocol will allow us to quantify the direct beneficial 
effect of TPMS on muscle strengthening. Patients will also get standard clinical care and training 
for pelvic floor exercise.
Chair & Parameters Used: The coil will be placed on a chair manufactured by MagVenture with 
additional sponge to make the coil comfortable to sit on. This coil will be energized to provide 
magnetic stimulation at the identified amplitude, frequency and duration. The magnetic field 
generated during stimulation will subsquently stimulate the tissue in its field. 
Data Analysis & Interpretation: 
Feasibility Outcomes: We will estimate: 1) Numbers of potentially eligible patients, number 
invited, number attending a pre-operative assessment clinic and consent rates (target 
recruitment is 24 or 3 participants per month over an initial 8-month recruitment period). 2) 
Patient concerns about the proposed therapy sessions/week and study duration. 3) Feasibility of 
recruiting in other clinics in which staff are interested in participating in a future main trial. 4) 
Retention, acceptability rates including response to treatment, questionnaires and imaging. 5) 
Intervention fidelity and adherence using study coordinator-completed case responses. 6) 
Determining the sexual function and continence improvement by assessing and comparing 
sensitivity to change. 7) Participant satisfaction with the interventions on a rating (Likert) scale. 
8) Participant confidence to undergo a longer duration TPMS study. 9) Identification of barriers 
and enablers to adherence. 10) Establishment of outcome measures that best reflects the 
participants’ rehabilitation goals.
Data Analysis & Interpretation: We will analyze qualitative interview data using atlas.ti, 
qualitative data analysis software, and the quantitative data using the SPSS version 24. We will 
start by coding, a process in which quotes are marked and labeled. The labeled quotes are then 
sorted and grouped, so that categories, then concepts, then themes can be developed. As is often 
standard practice for qualitative data analysis, analysis will be concurrent with data acquisition. 
Quantitative data will be examined initially for missing values. The primary aims of our data 
analytic strategy will be directed toward the adherence, retention and any guidance to inform 
modification of our method. We will focus our analyses on a feasibility of conducting a larger 
study and report our findings with this limitation in mind. Our goal is to collect important data 
regarding our method, our ability to implement recruitment strategies, and the feasibility of the 
treatment and measurements. Information derived from our research will lead to better-designed 
full-scale studies and informed decisions regarding whether it is worthwhile to commit additional 
resources to future treatment development. For quantitative data, descriptive statistics will be 
used to summarize the variables as well as detect outliers and data entry errors. When 
applicable, normality of the distribution will be examined for outcome variables. Chi-squared and 
Analysis of Variance will be used to assess the effectiveness of the randomization procedures by 
comparing participants in each treatment condition on baseline variables. Due to our small 
sample size our statistical analytical finding will be interpreted with caution. Other preliminary 
analyses will include evaluation of patterns of missing data, dropout rates, distributional 
properties of variables, and correlations among measures. Although there are important 
limitations associated with the analysis of our data, we do propose to conduct limited statistical 
analyses. First, keeping in mind the theoretical and practical issues reviewed above, all analyses 
will be considered preliminary. We will calculate an estimated effect size for our primary outcome, 
though it will be interpreted with caution, and in the context of the 95% confidence interval that 
surrounds it. It will also be interpreted within the context of other important information such as 
the clinical significance of study findings, and existing data from prior relevant research studies.
For aims 2-3, All potential covariates (e.g., age, duration of cancer) will be summarized with 
descriptive statistics and graphs to determine whether a continuous, categorical, or interval 
representation is most appropriate. Second, effect of any systematic differences between 
dropouts and completers will be explored by including the variable of concern to the model as a 
covariate. Third, any comparison can be adjusted for subject-specific characteristics (e.g., 
covariates found in initial analyses). Furthermore, group by time interaction will be included in all 
models. For Aim 2-3, descriptive statistics and exploratory graphing such as frequencies, means, 
standard deviations, box and whisker plots, stem and leaf diagrams, and scatter plots will be used 

to assess normality of the data. If necessary, the continuous outcome data will be transformed 
appropriately. Prior experience leads us to expect that for all variables, the distributions will be 
skewed and the variances will not be homogeneous. Similarly, potential covariates will be 
summarized with descriptive statistics and graphs to determine whether a continuous, categorical 
or an interval representation is the most appropriate approach. Missing data will be examined to 
assess randomness. Analysis of variance will be used to test our hypothesis. We will adjust p-
values for multiple testing using a Bonferroni correction. Data will be analyzed using a Mixed 
Effect Model. This method allows the inclusion of subjects with missing data or those who 
terminated early without relying on data imputation procedures. Denominator degrees of freedom 
will be calculated using the Kenward-Roger small sample correction. Data will be analyzed from 
all randomized subjects for whom we have a baseline assessment and at least one post-baseline 
evaluation. Effect of these mediator variables will be tested using the same mixed model. To test 
for mediation effect, we will utilize the analytic strategy. The multiple-mediation model includes a 
multiple-path mediating effect through both mediators which allows one mediator to causally 
affect the other. We will conduct a Sobel testnto check for significant mediation. Next, we will use 
the formula provided by MacKinnon to determine the percentage of the intervention condition to 
primary outcome path that was accounted for by change in our mediator. Based on our ongoing 
studies, we expect a dropout rate of <10% after baseline assessment. Primary outcomes will be 
tested using an intent-to-treat framework. The data will be analyzed by a “Mixed Effect Model.” 
As we mentioned above, due to our small sample size our statistical analytical finding will be 
interpreted with caution.
Possible Risks: Based on available literature (see references in section 7) it is unlikely that TPMS 
will result in any other complications suggested by the reviewer. 
Abbreviations used in the figure/text: LSCI-    Laser speckle contrast imaging; PW -  Pad 
weight, rMS- Repetitive magnetic stimulation, TPMS- Transpelvic pelvic magnetic stimulation, UI 
-  Urinary incontinence, UTE-     Ultrashort echo time, UPP- Urethral pressure  profile, LPP- Leak 
point pressure , HDM- High definition manometery, DTI- Diffusion tensor imaging and UTI-Urinary 
tract infections.
 Section 9.4 Devices
9.4) For each research device, state the status of the device, the PI’s determination as to whether the device is 
a significant or non-significant risk device, and provide justification for this determination. A copy of 
  
determinations from the FDA should be attached. - Also, for investigational devices describe how and by 
whom the device will be received, stored, secured and dispensed.
Magnetic Stimulation device is a device that is FDA approved for both peripheral and CNS 
stimulation. The FDA approved applications for this specific model Magpro R30 model is to treat 
depression. The proposed application i.e. improving blood flow and strengthening pelvic muscles 
in post-prostatectomy men is an off-label use. This device generates magnetic pulses whose 
amplitude and frequency can be controlled. The device is non-invasive and has been shown to be 
safe with no side effects. When a muscle is stimulated it can cause slight tingling. It is 
commercially available for clinical use and is being used in Anesthesiology and Psychiatry at the 
San Diego VA Hospital for pain management and depression therapy. Doppler device is also 
standard non-invasive FDA approved device used for imaging in cardiology and radiology to 
measure blood flow in blood vessels/tissue.We determined that the magnetic stimulation device 
is a non-significant risk device based on FDA guidance provided in the link:  https://www.fda.gov
/media/75459/download
 Section 9.8 Questionnaires & Surveys
9.8) Provide the name and a reference for questionnaires/surveys that are standard or identify them here and 
attach a copy of the questionnaire/survey.  Questionnaires or surveys that are not clinical standard references 
must be uploaded.  Reference the help link for additional information related to surveys administered to VA 
 
personnel and approved platforms for web-based surveys.
Primary symptom scores will be assessed using International Index of Erectile Function (IIEF-5) 
and International Consultation of Incontinence Questionnaire (ICIQ) symptom scores. Both of 
these questionnaires will take about 15-20 minutes to answer. Both questionnaires will be given 
in hard copy only. Electronic copies of these questionnaire have been attached to the application.
 Section 9.9 Data Safety Monitoring Board or Plan

9.9) Provide a Data Safety Monitoring Plan (DSMP) or the details of a Data Safety Monitoring Board; if a 
written plan is available, attach a copy of the plan to the submission form.
This is a feasibility study using an non-invasive, previously FDA approved device. We will monitor 
for any adverse effects and report these to the IRB within 5 days following the guidelines 
provided in our internal policy (SOP Document 67) -Adverse event /unanticipated outcome. Local 
Research Deaths. We ensure oral notification of the Institutional Review Board (IRB) immediately 
upon becoming aware of any local research death that is both unanticipated and related to the 
research.
Local Serious Adverse Event (SAEs). We will ensure written notification of the IRB within 5 
business days after becoming aware of any local SAE that is both unanticipated and related to 
the research.
Serious Problems. We will ensure written notification of the IRB within 5 business days after 
becoming aware of any serious problem that is both unanticipated and related to the research.
 Section 10 - Human Subjects
10) Describe the characteristics of the proposed subject population. Include age, gender, ethnicity, and health 
status as appropriate.  Note: Data about people are still considered “human subjects” by the IRB, so even if you 
do not intend to contact the patients whose charts you will review, you still describe the characteristics related to 
   
the subjects whose charts you will review.
Provide inclusion and exclusion criteria as appropriate.  Provide a statement how non pregnancy is 
confirmed if pregnancy is an exclusion criteria.
For multisite studies, provide the total number of subjects from all sites and include description of the 
local site's role as a coordinating center if applicable.
Indicate the number of VA participants to be studied.
Indicate the estimated number of 
 subjects that will fail the screening process, if any.
consented
20 male patients who are enrolled for prostate cancer surgery (age 50-80 years). All ethnicity 
will be included. Patients who have pacemakers and any other implants in the pelvic region will 
be excluded from the study.
 Section 11 - Recruitment
11) Describe, step-by-step, the plans for recruitment of subjects (or selection of subjects as in record review). 
This description must include how, when, and where potential subjects are approached as well as procedures 
for identifying potential participants (through medical records, physician referral, third-party 
sources, etc.).  Include how selection is equitable.  Indicate if vulnerability to coercion may be present and if so 
plans to ensure voluntary participation.
Dr. Sakamoto sees and treats this group of patients in her clinic. She will identify potential 
patients from her clinic who meet the inclusion criteria. The recruitment plan is summarized 
below. Potential participants listed for radical nerve sparing prostatectomy & suitability confirmed 
by the surgeon (KS) are identified from the VASDHS urology surgical (waiting) list by PI (MR). 
Patients will be approached by the PI or one of the study coordinators for recruitment. 
Dr. Sakamoto will not be involved in consenting process to avoid any coercion.
 Section 12 - Informed Consent
12) Indicate whether or not each category of consent is involved in this study:
12a) Will the study team obtain information or biospecimens for the purpose of screening, recruiting, or 
determining the eligibility of prospective subjects without (or prior to) obtaining informed consent of the 
prospective subject or the prospective subject’s LAR?
 Yes  
 No
Check one or both of the below boxes if they apply to this study:

Information will be obtained through oral or written communication with the prospective subject or the subject’s 
Legally Authorized Representative (LAR) and this is not a FDA regulated study.
  Yes  
  No
Identifiable information or biospecimens will be obtained by accessing records or stored identifiable 
biospecimens and this is not an FDA regulated study.
  Yes  
  No
Since both boxes were checked "no", a request for an informed consent waiver is needed.
12b) 
 informed consent
Signed
 Yes  
 No
12c) Waiver of documented consent (e.g., 
consent) for all or part of the study.
oral 
  Yes  
  No
12d) Request for a 
 of consent for all or some study activities.
waiver
 Yes  
 No
12e) Alteration of 
 of consent.
other required elements
  Yes  
  No
12f) 
assent to participate (Director approval will be required)
Child 
  Yes  
  No
12g) Will any language 
 be used by those obtaining consent and understood by the 
other than English
prospective participant or the legally authorized representative?
  Yes  
  No
12h) 
 to determine if participants have the capacity to consent for themselves.
Decisional Capacity Assessment
  Yes  
  No
12i) 
 consent (legally authorized representative)
Surrogate
  Yes  
  No
 Section 12.1 Informed Consent Process
12.1a) Will consent be obtained before any study procedures are performed (including screening procedures 
 
except screening procedures with Consent and/or HIPAA waiver when required)?
 Yes  
 No
12.1b) Will the information being communicated to the participant or legally authorized representative 
during the consent process include exculpatory language through which the participant or legally authorized 
representative is made to waive or appear to waive any of the participant’s legal rights or release or appear to 
release the Researcher, Sponsor, the VA or its agents from liability for negligence.
  Yes  
  No
12.1c) A master list of all VA subjects consented (written or not) under this protocol will be maintained.
 Agree
 Disagree

12.1d) Identify the circumstances under which consent will be obtained including where the process will take 
place; any waiting period between describing the research and obtaining consent including sufficient time for 
the prospective participant to consider participation, and any steps taken to minimize the possibility of 
coercion or undue influence.
The patients will be recruited in Dr Sakamoto's clinic and the consent form will be provided and 
patient consent obtained prior to surgery (during pre-op visit) by a staff member. No attempt to 
coerce the patient will be made, the patient will be consented by a staff member other than the 
treating physician.
 Section 12.4 Waiver of Informed Consent
12.4a) Is it practicable to conduct the research without the waiver or alteration of consent?
  Yes  
  No
12.4b) Does the research examine public benefit or service programs and is subject to state or local 
government approval?
  Yes  
  No
12.4c) Will the research involve greater than minimal risk?
  Yes  
  No
12.4d) Will waiving or altering informed consent adversely affect the subjects’ rights and welfare?
  Yes  
  No
12.4e) Is it appropriate to provide pertinent information to subjects later BUT this information will NOT be 
provided?
  Yes  
  No
12.4f) Identify to what aspects of the study you are requesting a waiver of consent (i.e., full study or specific 
aspects). Describe the waiver or alteration needed and why it can be granted (include why the research is not 
practical without the waiver or alteration and how the waiver enables conducting the study).
Waiver of informed consent or alteration of consent elements may be allowed if the IRB documents these 
findings and approves waiver or alteration.
Waiver of consent to review medical records for inclusion/exclusion criteria that will help identify 
potential candidates for study recruitment.
12.4g) Explain why the research could not practicably conducted without using identifiable information.
Without review medical records for inclusion/exclusion criteria it is not possible to identify 
potential candidates for study recruitment.
 Section 12.9 HIPAA Authorization

For each category below, indicate whether or not this study involves the indicated process:
12.9a) 
 HIPAA Authorization.  
Signed
**New Template is available in the ?  Help section**
 Yes  
 No
12.9b) HIPAA waiver to cover the entire study
  Yes  
  No
12.9c) HIPAA waiver for recruitment, screening, and/or for a portion of the study.
 Yes  
 No
12.9d) HIPAA Authorization or waiver is 
 for some or all of the study subjects (e.g. no health data).
not required
  Yes  
  No
 Section 12.10 HIPAA Waivers and Alterations
12.10a) Describe the purpose/nature of the HIPAA waiver or alteration and list specifically, what identifiers 
and health information are being requested under the waiver/alteration and identify whether the waiver is 
for access, use, and/or collection of this information.
Dr. Sakamoto will be reviewing medical records for inclusion/exclusion criteria for this study prior 
to seeking HIPAA authorization. We are requesting a waiver of HIPAA for this screening 
procedure. Name, SSN, clinical appointments and inclusion/exclusion criteria will be reviewed.
12.10b) The proposed access, use, and/or disclosure of PHI involves no more than a minimal risk to the 
privacy of individuals.
 Agree
 Disagree
12.10c) The plan to protect the identifiers from improper use and disclosure is adequate.
 Agree
 Disagree
Describe the plan
Dr. Sakamoto will be reviewing medical records only for inclusion/exclusion criteria for this 
study. Patient identifiers will be coded to protect improper use.
12.10d) An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the 
research, unless there is a health or research justification for retaining the identifiers or such retention is 
otherwise required by law.
 Agree
 Disagree
12.10d2) Describe the plan:
All records will be handled record control schedule #10.
12.10e) By signing this protocol for submission, the PI is providing written assurance that the PHI will not be 
reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the 
research project, or for other research for which the use or disclosure of protected health information would 
 
be permitted by the Privacy Rule.
:  If the waiver of HIPAA authorization is for 
38 U.S.C. 7332 Information
the use of 38 USC 7332 information (applicable to drug abuse, alcohol abuse, HIV infection, and sickle cell 
anemia records), by signing this protocol for submission the PI is providing written assurance that the 
purpose of the data is to conduct scientific research and that no personnel involved may identify, directly or 
indirectly, any individual patient or subject in any report of such research or otherwise disclose patient or 
subject identities in any manner. (Ref:  38 U.S.C. 7332(b)(2)(B))

 Agree
 Disagree
12.10f) The research could not practicably be conducted without the waiver or alteration.
 Agree
 Disagree
12.10f2) Describe how the waiver/alteration enables the research to be conducted
This waiver is required for reviewing medical records only for inclusion/exclusion criteria for 
recruitment purpose.
12.10g) The research could not practicably be conducted without access to and use of the PHI.
 Agree
 Disagree
12.10g2) Describe why it would be impracticable to conduct this research without the PHI described 12.10a. (v3
/8/18)
Without this waiver, review of medical records can not be accomplished for recruitment 
purposes.
 Section 13 - Alternatives to Participation
13) Describe the alternatives to participation in this research study (see  for guidance)
?
Alternative to this study is to follow the clinicians instruction for pelvic floor exercise, as usually 
done for prostate surgery patients.
 Section 14 - Potential Risks
14) Describe any potential or known risks or discomforts and assess their likelihood and seriousness (see  for 
?
guidance)
Magnetic stimulation, MRI and Doppler blood flow are non-invasive and non-risk devices. With 
the use of magnetic stimulation there may be slight tingling when the muscles are stimulated.
 Section 15 - Risk Management
15) Describe the procedures for protecting against or minimizing any potential risks/discomforts, and the 
adequacy of resources for conducting the study and resources participants may need as a consequence of the 
research.  When applicable, include detail of the following safety measures:   
(a) The type of safety 
information to be collected, including AEs; 
(b) Frequency of safety data collection; 
(c) 
Frequency or periodicity of review of cumulative safety data; 
(d) Statistical tests for analyzing the 
safety data to determine if harm is occurring; and 
(e) Conditions that trigger an immediate suspension 
of the research.  See  for further requirements.
?
There are no additional risks associated with these devices. There is a limited risk of maintaining 
confidentiality. This will be minimized by de-identifying the patients by providing a code for each 
subject and the identification code linking the subject to their medical record will be maintained 
in a separate file kept in PI's office in room 6058 under lock and key.
 Section 17 - Potential Benefits
17) Discuss benefits that may be gained by the subject as well as potential benefits to society in general  (see  ?
for guidance)

The subject may have reduction in their incontinence and improvement in sexual function, 
leading to improved quality of life.
 Section 18 - Risk/Benefit Analysis
18) Discuss why the risks to subjects are reasonable in relation to the anticipated benefits to subjects and in 
relation to the importance of the knowledge that may reasonably be expected to result.
Risk to benefit ratio is low as there are no known risks and may have significant improvement in 
quality of life and may result in lowering the clinical costs associated, if the subject remained 
untreated.
 Section 20 - Compensation for Participation
20) Provide all details and justifications of the compensation plan.  See  for detailed requirements.
?
We will reimburse transportation expenses (to a maximum of $10/visit) incurred by the subject 
that would not be incurred in the normal course of receiving treatment and which are not 
reimbursed by any other mechanism. This will be provided as vouchers.
 Section 21 - Responsibilities and Qualifications
Here are the identified study staff members
Mahadevan Rajasekaran, PhD
Eric Y. Chang, MD, Kyoko Sakamoto, MD, Michael E. Albo, MD, Valmik Bhargava, PhD, Christopher 
Cano Sanchez, Samuel Sorkhi
21) For each staff member listed above, describe their role and qualifications.  Also indicate which of the 
study staff are authorized to obtain consent, when applicable to the study. 
Drs Raj Rajasekaran and Bhargava are responsible for protocol design and data analysis, Drs. 
Kyoko Sakamoto, & Michael Albo (certified urologists at the VA) will help with patient recruitment 
and follow-up.
For TPMS, Dr. Bhargava (is an electrical engineer) is trained and will train other staff members 
before the start of study. Dr. Bhargava will also be performing data analysis. 
Dr. Eric Chang (radiologist) will support Doppler and MRI studies. 
Study coordinators (Chris Cano-Sanchez, BS and Sam Sorkhi, BS) will help with the informed 
consent process. They will be trained by Dr. Rajasekaran to obtain informed consent.
 Section 22 - Bibliography
22) List relevant articles that the IRB can use to provide necessary background for the protocol. Do not 
include an extensive NIH-grant-style bibliography.  (Up to 5 recommended, but use more if needed to support 
the protocol or citations above.)
1. Lim R, Liong ML, Leong WS, et al. Pulsed Magnetic Stimulation for Stress Urinary 
Incontinence: 1-Year Followup Results. J Urol 2017;197:1302-8.
2. Liu P, Gao J, Pan S, et al. Effects of High-Frequency Repetitive Transcranial Magnetic 
Stimulation on Cerebral Hemodynamics in Patients with Disorders of Consciousness: A Sham-
Controlled Study. Eur Neurol 2016;76:1-7.
3. Stolting MN, Arnold AS, Haralampieva D, et al. Magnetic stimulation supports muscle and 
nerve regeneration after trauma in mice. Muscle Nerve 2016;53:598-607.
4. Almeida FG, Bruschini H, Srougi M. Urodynamic and clinical evaluation of 91 female patients 
with urinary incontinence treated with perineal magnetic stimulation: 1-year followup. J Urol 
2004;171:1571-4; discussion 4-5.
5. Penson DF, McLerran D, Feng Z, et al. 5-year urinary and sexual outcomes after radical 
prostatectomy: results from the Prostate Cancer Outcomes Study. J Urol 2008;179:S40-4.

 Section 23 - Sponsors and Collaborators
23) Clarify any industry financial or other support (e.g., NIH funds the study or Company X provides the 
    
assay kits).
Identify non-VA Research collaborators and their role in this protocol, including whether or not 
 
they have access to subjects or identified data.
Funded by VA Rehab R&D SPiRE award (F3455-P) to Dr. Rajasekaran.
In the submission form, upload a copy of the grant, subaward, CRADA, etc. as appliable to the study.
 Section 25 - Impact on Clinical Services
25a) Which VA Clinical Services participate in the performance of the project? (NOTE: All clinical trials and 
any use of clinical services will require project review and approval by the Office of Research Agreements 
Management (ORAM) to assure availability of those clinical resources. Prior discussion with the appropriate 
clinical service chief is strongly encouraged)
Check all that apply
Pharmacy
Laboratory
Cardiology
Radiology
Nursing
Pathology
Nuclear Medicine
MAS (Charts)
Other (list below)
List others here
Urology
25b)  Describe the specific impact or service that will be provided for this protocol.
We will perform the proposed pelvic magnetic stimulation and the ultrasound imaging (for blood 
flow) in the Spinal Cord Injury clinic space assigned to Urology service in the first floor of 
VASDHS. We will work with clinic manager/ service chief (Dr. Sakamoto) before we plan for the 
proposed studies to ensure that our proposed research will not impact the routine clinical 
services performed in that area. Dr. Chang (Radiology) will support the proposed MRI and 
Doppler studies. We do not anticipate any other impact to other clinical services.
 Section 27 - Privacy, Confidentiality, and Information Security
27a) Provide a brief description of how participant privacy and confidentiality will be protected in this study. 
Describe the circumstance under which it may be possible for a research team member to identify subjects 
and any related protections or assurances to prohibit or avoid identification. Describe how the number of 
people with access to identifiers for research purposes is limited in order to protect a participant’s privacy.
All the research records will be labeled with a code number. The list that matches your name with
the code number will be saved as a file
behind the secure VASDHS computer firewall. All patient information will be coded and saved in 
the R-drive. Only Dr. Rajasekaran, Dr. Bhargava and Chris Cano Sanchez will have access to R-
drive. Only coded information will be provided to the research staff. Code key will be kept under 
a locked cabinet. We will only need SSN for processing payment for transport reimbursement.

27.b) Entry of a CPRS 
is required when subjects will be 
 
Research Informed Consent Note
admitted as 
for research 
the study 
inpatients or treated as an outpatients 
 
and
involves research medical care or may affect 
medical care.
If a Research consent Note is required, then a 
 should also be entered for each 
Research Progress Note
procedure or intervention.
Scanning the Consent and HIPAA Authorization into CPRS is 
.  Linking the Consent to the 
not required
Research Informed Consent Note may be permitted and can be useful for trials involving the Research 
Pharmacy or when research will be performed in conjunction with clinical procedures.
For Non-Veterans, if Research Informed Consent Notes are entered, then the 
 
NOPP Acknowledgment
must be scanned into the record.  Otherwise a copy of the signed NOPP must be retained with the 
Investigator's research records and a copy sent to the Privacy Officer; see the   Help for more information.
 ?
27.b1) Is entry of CPRS notes required based on the above criteria?
CPRS notes are needed for ALL subjects 
CPRS notes are needed for SOME subjects 
CPRS notes are NOT needed for any subjects 
27c) Select the VA Sensitive Information (VASI) use category
This study does not collect or use any VASI 
This study uses but does not save, collect, copy, or record VASI 
This study does collect or record VASI 
 Section 27.1  VA Sensitive Information (VASI)
27.1a) For each type of VASI, indicate all that apply:
Indicate which of the following will be collected/recorded:
Protected Health Information (PHI)
Names
Device identifiers and serial numbers
E-mail addresses
Medical record numbers
URLs (Universal Resource Locator)
All elements of dates (except year) or any age over 89
Health plan beneficiary numbers
IP Addresses (Internet Protocol)
Telephone numbers
Account numbers
Biometric Identifiers including finger and voice print
Fax numbers
Certificate or license numbers
Full face photographic images and comparable images
All geographic subdivisions smaller than a state
Vehicle ID and serial numbers including license plate numbers
Social security numbers or scrambled SSNs (describe below)
Other unique identifying number, characteristic, or code (describe below)
27.1a1)  Describe why SSN are needed for this study
Access to the clinical record for a note etc.

27.1b) Consent Forms and/or HIPAA Authorization
 Yes  
 No
27.1c) Images with personal identifiers are used for this study (x-rays, MRI images with patient names, record 
numbers, dates, etc.)?
  Yes  
  No
27.1d) Photos with faces or audio video recordings are used for this study.
  Yes  
  No
27.1e) Biological specimens with identifiers are used for this study.
  Yes  
  No
 Section 27.2  Data Collection, Tools, and Resources
27.2a)  Will any specially obtained software be used?
  Yes  
  No
27.2b) Will any mobile devices (laptop, tablet, portable hard-drive, etc.) be used in support of this study?
  Yes  
  No
27.2c) Does the study require use of an electronic data capture system? 
  Yes  
  No
27.2d) Will any other web-based applications be used (e.g., for recruitment, completing online questionnaires, 
or processing data)?
  Yes  
  No
27.2e)  Will coded data that excludes personal identifiers be used?   Coded data excludes 
HIPAA identifiers 
all 
(per VHA Handbook 1605.1 Appendix B), including dates

 Yes  
 No
27.2e1) Identify where the code key is stored and in what format (electronic, paper).
R:\Rajasekaran\Magnetic Stimulation
 Section 27.3  Data Sharing and Transportation
27.3a) Does this study involve collecting, sharing or transporting any type of data outside of the local VA?
  Yes  
  No
 
Section 27.4  Research Record Storage and Retention
For each type of record, indicate whether it is collected for this study
27.4a) Hardcopy records/data (includes paper, pictures, film, etc.)
 Yes  
 No
27.4a1) Identify precisely where hardcopy data will be stored to include physical site, building, and room 
number, etc.  For each location identify whether VASI or non-sensitive information is stored at that 
location.  For VASI, identify how the data is secured. 
Hardcopies will be stored in PI's office (Building I, room 6058, VASI in a locked cabinet). 
27.4a2) Are all of the above locations at VA?
 Yes  
 No
27.4b) Electronic study records (includes computer files, removable disk files, digital files, etc.).
 Yes  
 No
27.4b1) Identify precisely where 
electronic records/data will be stored to include the full map 
 
non-sensitive
drive, network location/server name, etc., and a brief description of what data/information is stored at each 
location.
R:\Rajasekaran\Magnetic Stimulation
27.4b2) Identify precisely where 
electronic records/data will be stored to include the full map drive, 
 
VASI
network location/server name, etc., and a brief description of what data/information is stored at each location.

If no VASI is collected or recorded for this study, simply indicate that the “Study does not collect or record 
VASI”.
R:\Rajasekaran\Magnetic Stimulation
27.4b3) Are any of the locations described in 27.4b outside of the VA Secure Network? Note: this includes 
storage on a computer local hard drive.
  Yes  
  No
27.4c)  Record Retention - VHA requires compliance with Records Control Schedule (RCS-10) for retention 
of electronic and hard copy records.  Following study closure, these temporary records must be retained 
for six years and then destroyed.  Longer retention may be permitted if requred by other Federal regulations 
or requirements.  Will RCS-10 requirements be followed (i.e., 6-year retention)?
I will adhere to VHA Records Control Schedule-10 requirements 
I request an exception to RCS-10 requirements 
 Section 27.5  Additional Privacy or Information Security Details
Provide any other privacy or information security details here.
none
 Section 27.6  Attestations
In the event of real or suspected breach of security, the Information Security Officer, Privacy Officer, VA 
Police (if appropriate), and the individual’s supervisor will be notified within one hour of learning of the event.
 Agree
 Disagree
Study staff will be up to date on any required VHA Privacy Policy and Information Security training or they 
will not be allowed access to VA Sensitive Information.
 Agree
 Disagree
Access to research sensitive information, if any, will be removed when study personnel are no longer part of 
the research team.
 Agree
 Disagree
At least one copy of all study records (whether sensitive or non-sensitive) will be retained under VA control 
and only destroyed in compliance with the approved Records Control Schedule
 Agree
 Disagree
The VA retains ownership of the research data.  Should the investigator leave the VA, custody of the research 
records will be assigned to another investigator and the Research Service notified in writing, or custody of the 
research records will be transferred to the Research Service.
 Agree
 Disagree

 Section 28 - Protocol Association to New or Existing Project
  
28) Is this a new R&D Project?  Before you go on to complete the 
 (which is 
Initial Review Submission Form
used for attachments), please address the association of this Protocol to an R&D Committee Project.  This 
Protocol may represent a new R&D Project, or it may be an additional Protocol under an existing R&D 
  
Project (such as when a single grant supports multiple Protocols).  Will this Protocol be submitted to the 
R&D Committee as a new Project?
 Yes  
 No
 The Protocol Application is now complete for a Protocol that will also be a new R&D Committee 
Project.
 
Next you will go on to the Initial Review Submission Form which is used to package up the Protocol 
Application and any needed attachments and submit them to the IRB.
Click on Save and Continue