Implementation of a Text Message and Multimedia-based Program for Women Newly Diagnosed With Interstitial Cystitis/Bladder Pain Syndrome
Phase: NA
Conditions: Cystitis, Interstitial
Sponsor: University of Pennsylvania

Study title: Smartphone-based Self-care Education Program for Women With 
Interstitial Cystitis: Educational Remote IC Aide 
PI: Edward Kim, MD, MPH 
Institution: University of Pennsylvania 
NCT Number: 05260112 
Document date: 02/02/2021 

Page 1 of 12
Protocol Details
Basic Info
Conﬁrmation Number:
didaffdb
Protocol Number:
844895
Created By:
KIM, EDWARD
Principal Investigator:
ARYA, LILY A
Protocol Title:
Smartphone-based self-management program for women newly diagnosed with interstitial cystitis/bladder
syndrome
Short Title:
ERICA
Protocol Description:
American Urological Association's 1st and 2nd line therapies such as patient education, bladder 
retraining, pelvic ﬂoor physical therapy, and mind-body therapies are highly effective 
management strategies for IC/BPS. We developed a smartphone-based program to remotely teach 
patients with IC/BPS how to self-manage their symptoms, and also provide support and guidance 
via clinically-validated messages. We plan to test the clinical efﬁcacy of this program for 50 
patients.
Application Type:
EXEMPT Category 3
Resubmission*
Yes
Hospital Sites
Will any research activities and/or services be conducted at a Penn Medicine afﬁliated hospital site?
No
Study Personnel
Principal Investigator
Name:
ARYA, LILY A
Dept / School / Div:
4333 - OB-Obstetrics and Gynecology
Campus Address
Mail Code
4283
Address:
HUP
3400 SPRUCE ST
City State Zip:
PHILADELPHIA PA 19104-4283
Phone:
215-662-4144
Fax:
-
Pager:
Email:
larya@obgyn.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
Yes
Training Expiration Date:
03/11/2023
Name of course completed :
Good Clinical Practice: An Introduction to ICH (GCP) Guidelines

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Study Contacts
Name:
THOMAS, TRACEY
Dept / School / Div:
4628 - WM-Ctr for Res on Reprod and Women's Health
Campus Address
Mail Code
Address:
City State Zip:
Phone:
Fax:
Pager:
Email:
Tracey.Thomas@Pennmedicine.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
Yes
Training Expiration Date:
01/13/2023
Name of course completed :
Good Clinical Practice: An Introduction to ICH (GCP) Guidelines
Name:
VRESILOVIC, JULIA M
Dept / School / Div:
4628 - WM-Ctr for Res on Reprod and Women's Health
Campus Address
Mail Code
Address:
Suite 810 3701 Market St 
City State Zip:
Philadelphia PA 19104-0000
Phone:
Fax:
Pager:
Email:
Julia.Vresilovic@pennmedicine.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
06/13/2024
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
Yes
Training Expiration Date:
07/22/2025
Name of course completed :
Good Clinical Practice (GCP) Simulation

Page 3 of 12
Name:
KENNEDY, ZANDRA B
Dept / School / Div:
4628 - WM-Ctr for Res on Reprod and Women's Health
Campus Address
Mail Code
Address:
City State Zip:
Phone:
Fax:
Pager:
Email:
Zandra.Kennedy@pennmedicine.upenn.edu
HS Training Completed:
No
Training Expiration Date:
Name of course completed :
GCP Training Completed:
Yes
Training Expiration Date:
03/04/2025
Name of course completed :
Good Clinical Practice: An Introduction to ICH (GCP) Guidelines
Other Investigator
Name:
KIM, EDWARD
Dept / School / Div:
2100 - Health System
Campus Address
Mail Code
Address:
Hospital of the University of Pennsylvania
Ob-Gyn Residents
City State Zip:
Phone:
Fax:
Pager:
Email:
Edward.Kim@Pennmedicine.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
No
Training Expiration Date:
Name of course completed :
Responsible Org (Department/School/Division):
4333 - OB-Obstetrics and Gynecology

Page 4 of 12
Key Study Personnel
Name:
HARVIE, CAMRYN E
Department/School/Division:
Research Services
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
No
Training Expiration Date:
Name of course completed:
Name:
HARVIE, HEIDI S
Department/School/Division:
OB-Obstetrics and Gynecology
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed:
CME Credit for POR Expedited Review - SOM
GCP Training Completed:
Yes
Training Expiration Date:
07/10/2023
Name of course completed:
CITI Good Clinical Practice (GCP) - OCR
Disclosure of Signiﬁcant Financial Interests*
Does any person who is responsible for the design, conduct, or reporting of this research protocol have 
a FINANCIAL INTEREST?
No
Penn Intellectual Property*
To the best of the Principal Investigator's knowledge, does this protocol involve the testing, 
development or evaluation of a drug, device, product, or other type of intellectual property (IP) that is 
owned by or assigned to the University of Pennsylvania?
No
Certiﬁcation
I have reviewed the Financial Disclosure and Presumptively Prohibited Conﬂicts for Faculty 
Participating in Clinical Trials and the Financial Disclosure Policy for Research and Sponsored 
Projects  with all persons who are responsible for the design, conduct, or reporting of this research; and 
all required Disclosures have been attached to this application.
Yes
HRPP
Human Source Material*
Does this research include collection or use of human source material (i.e., human blood, blood 
products, tissues or body ﬂuids)? IF YES, consult the EHRS web site: www.ehrs.upenn.edu/programs/
bio/bbpathogens.html for information on OSHA Bloodborne Pathogens requirements (training, 
vaccination, work practices and Exposure Control Plan). If you have questions, call 215-898-4453. 
No
HIPAA / Protected Health Information
Does the research proposal involve accessing (viewing / using), collecting, or disclosing of protected 
health information (PHI) directly from participants or their medical or dental record for research 
purposes?
No

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HIPAA / Protected Health Information
Does the research proposal involve accessing (viewing / using), collecting, or disclosing of protected 
health information (PHI) directly from participants or their medical or dental record for research 
purposes?
No
Remote Study Visits
Does the research proposal involve conducting research visits remotely via any type of video 
conferencing software?
No
Remote Study Visits
Does the research proposal involve conducting research visits remotely via any type of video 
conferencing software?
No
CHPS Resources*
Does the research involve CHPS resources?
No
HUP Inpatient Nursing Resources
Does this research include an inpatient admission at HUP?
No
Pathology and Laboratory Medicine Resources*
Will samples be collected by hospital phlebotomy and/or processed or analyzed by any of the clinical 
laboratories of the University of Pennsylvania Health System?
No
Research Involves Apheresis, Cell Collection, and/or Blood Product Collection*
Does this research involve collection of blood products in the Penn Donor Center and/or the use of 
apheresis for treatment or collection of cells or other blood components?
No
Research involving blood transfusion or drug infusions*
Will your research involve blood transfusion or infusion of study drug in 3 Ravdin Apheresis Unit for 
research purposes?
No
Trial in Radiation Oncology
Is this research a prospective trial being done in Radiation Oncology, and if so, has this protocol been 
approved by the Radiation Oncology Protocol committee?
No
Study in Radiation Oncology
Is this research a retrospective study being done in Radiation Oncology, and if so, has this project been 
reviewed by the Radiation Oncology Clinical Research Group?
No
Use of UPHS services*
Does your study require the use of University of Pennsylvania Health System (UPHS) services, tests or 
procedures , whether considered routine care or strictly for research purposes? (UPHS includes all Penn 
hospitals and clinical practices, including the Clinical Care Associates network of community 
practices). Examples of UPHS services/tests/procedures includes the Clinical Translational Research 
Center (CTRC), laboratory tests, use of the pathology lab, cardiovascular imaging tests or radiology 
imaging tests (whether being billed via the Service Center or through UPHS), other diagnostic tests & 
procedures and associated professional services, etc. 
No

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Veteran's Affairs (VA) Patients or Subjects
Does your study involve data from Veteran's Affairs (VA) patients or subjects?
No
If yes, was this approved by the Philadelphia VA?
No
Out of State Research
Will any Penn personnel conduct any research activities outside of the State of Pennsylvania?
Yes
Please identify the location of research activities:
New Jersey
Research involving Virtua Health
Will any Penn personnel conduct any research activities at a Virtua Health site location, OR in 
collaboration with Virtua Health System personnel, OR using any Virtua Health System resources (e.g., 
medical records)?
No
Primary Focus*
Sociobehavioral (i.e. observational or interventional)
Protocol Interventions
x Sociobehavioral (i.e. cognitive or behavioral therapy)
Drug
Device - therapeutic
Device - diagnostic (assessing a device for sensitivity or speciﬁcity in disease diagnosis)
Surgical
Diagnostic test/procedure (research-related diagnostic test or procedure)
Obtaining human tissue for basic research or biospecimen bank
Survey instrument
None of the above
The following documents are currently attached to this item:
There are no documents attached for this item.
Sponsors
Business Administrator
Name:
IMBALZANO, MICHAEL
Dept / School / Div:
4322 - NE-Neurology
Phone:
215-573-4784
Fax:
-
Pager:
Email:
imbalzan@upenn.edu

Page 7 of 12
Department budget code
000 - 000 - 0 - 000000 - 0000 - 0000 - 0000
Funding Sponsors
Funding sponsors billing address
If you have selected a commercial or industry sponsor, please provide the appropriate address and 
contact information for the Sponsor for the purposes of billing for IRB review fees (initial review, 
continuing review and convened modiﬁcation fees apply here). If the Sponsor is not industry/
commercial, this information is not necessary to provide with your application.
Funding sponsors gift
Is this research being funded by a philanthropic gift?
Project Funding*
Is this project funded by or associated with a grant or contract?
No
Sponsor Funding
Is this study funded by an industry sponsor?
Status of contract
The following documents are currently attached to this item:
There are no documents attached for this item.
Protocol
Objectives
Overall objectives
Our objective is to test the clinical efﬁcacy of our smartphone-based self-management education 
program for IC/BPS (ERICA) on 50 patients with IC/BPS.
Background
Interstitial cystitis/bladder pain syndrome (IC/BPS), a condition of co-existing chronic pelvic pain and 
urinary symptoms, affects more than 6 million women in the U.S. Though IC/BPS has an immense 
impact on quality of life, effective treatment options are lacking. In a survey of 1628 females with BPS/
IC, Lusty et al reported that female patients with BPS/IC reported that the most effective treatments 
were opioid analgesics, phenazopyridine, and alkalinizing agents, however, they perceived evidence-
based treatments such as amitriptyline and anti-histaminics as only moderately effective. These ﬁndings 
suggest that that there is a disconnect between patient perceived real-world effectiveness of IC/BPS 
treatments and efﬁcacy reported from clinical trial data and subsequent guidelines developed from this 
efﬁcacy data. In focus group studies, women with IC/BPS report frustration with the lack of effective 
treatment options, a sense of isolation, and lack of support from medical care providers as critical 
elements that worsen their urinary and pain symptoms. Several prior studies have established that 
patients are willing to communicate with their providers using texting technology. The goal of this 
proposal is to develop and test a digital platform that would allow women to self-manage their IC/BPS 
symptoms using evidence-based behavioral treatments.
Study Design
Design
Prospective cohort study

Page 8 of 12
Study duration
To recruit 50 patients, we anticipate 4-6 weeks to recruit and enroll patients on a rolling basis until we 
have all 50. Each subject will participate in the study for 6 weeks. We will begin recruiting as soon as 
we have IRB approval for this modiﬁcation. For 50 patients to complete the program, we anticipate 
approximately 3-4 months. We plan to allot 1-2 months afterwards for data analysis and manuscript 
preparation.
Characteristics of the Study Population
Target population
Women newly diagnosed with interstitial cystitis/bladder pain syndrome. Inclusion criteria: women who 
have access to a smart phone with text messaging capability and are able to read and write English.  
Exclusion criteria: women with recurrent urinary tract infections, neurological conditions such as 
multiple sclerosis, recent (within 6 months) of surgery or pregnancy, prior radiation to pelvic area.
Subjects enrolled by Penn Researchers
50
Subjects enrolled by Collaborating Researchers
0
Vulnerable Populations
Children Form
Pregnant women (if the study procedures may affect the condition of the pregnant woman or 
fetus) Form
Fetuses and/or Neonates Form
Prisoners Form
Other
x None of the above populations are included in the research study
The following documents are currently attached to this item:
There are no documents attached for this item.
Participant recruitment
Please describe the plan to equitably identify and recruit a diverse group of participants that is reﬂective 
of the population under study. If this is a multicenter protocol, the recruitment plan should describe the 
local (Penn) site's plan. Describe:how potential participants may be identiﬁed (review of medical 
records, Slicer Dicer, DAC reports including referrals from physician ofﬁces and clinics);who may 
approach potential participants;methods to achieve sample diversity and inclusiveness;what information 
may be presented to or discussed with them; andthe context and setting in which recruitment will 
happen.
Modiﬁcation: Dr. Kristene Whitmore, a urologist who specializes in IC/BPS and practices at Virtua 
Health, will disseminate information about the study to her patients who may be eligible. She will only 
inform them that there is a remotely-delivered self management education study conducted via Penn 
that they may be interested in and our study coordinator's contact information. She will not be 
responsible for recruitment, consent, or enrollment. Please note that no Virtua Health resources, 
including their electronic medical records, will be used. Prospective recruitment: Female patients with 
interstitial cystitis/bladder pain syndrome (IC/BPS) will be recruited from the clinical practices of Penn 
Urogynecology and Penn Urology. Urogynecology and urology providers outside of Penn can direct 
interested and eligible patients to the study. The study team will reach out to these patients to overview 
the program. Patients who are interested in participating will follow the same consent and enrollment 
process. We will also have a visual ad and accompanying text to be posted on social media accounts 
(Facebook, Instagram, Twitter) of IC Association (non-proﬁt organization supporting patients with IC/
BPS) [IRB and Penn social media committee APPROVED previously]., and via video presentation 

Page 9 of 12
during ICA's self-care-oriented online event [Script APPROVED by the IRB]. Interested patients will 
have a phone call with one of the clinicians on the study team to conﬁrm eligibility and undergo the 
same consent and enrollment process as those recruited from our clinical practices. Retrospective 
recruitment: Female patients with IC/BPS who were seen by a faculty practices of Urogynecology and 
Urology will be identiﬁed by retrospective chart review. These patients will be messaged using my 
PennMedicine patient portal to reply to the message if they are interested a potential research study 
(recruitment script attached). Overall, recruitment will end when 50 subjects have been recruited.  At a 
time mutually agreed upon by the interested patient and a research team member, study information will 
be presented to them over the phone. Risks and beneﬁts of participation in the study will be discussed. 
Consent form will be signed via Penn's RedCAP platform. https://redcap.med.upenn.edu/surveys/?
s=DE4R83PAJ3 Conﬁdentiality will be maintained throughout the recruitment process as well as 
during study participation.
Recruitment Materials
Is the research team using any recruitment materials? These may include but are not limited to: phone 
call scripts, radio/video scripts, ﬂyers/brochures, internet postings, email, letters to potential 
participants, letters to patient physicians, My Penn Medicine (MPM), other direct messaging, etc. For 
guidance regarding recruitment materials, please review the IRB's guidance on Participant Recruitment 
Materials online:https://irb.upenn.edu/mission-institutional-review-board-irb/guidance
No
Use of Penn Media & Social Media Services
Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for 
outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does 
the study team plan to directly use social media to recruit for the research?
Yes
Please identify which method(s) of social media you will utilize, the content of the text to be used, and 
the method(s) for posting this information (i.e., using Penn supported communication services). When 
proposing the text to utilize, please be aware of any social media limitations (i.e., number of characters 
allowed in a tweet) and any appropriate conﬁdentiality practices necessary to be compliant with posting 
research recruitment text.NOTE: Penn Medicine must utilize one of the centralized PM Facebook 
Pages:ClinicalResearch@Penn Facebook pagePenn Medicine Facebook page@PennCancer Facebook 
pageAll clinical research paid Facebook ads must be listed on Clinical Research @ Penn Facebook 
page,www.facebook.com/ClinicalTrialsAtPenn. Exceptions to the above must get approval from the 
Penn Medicine Social Media Committee: pennmedicinesocialmediacommittee@uphs.upenn.edu. 
[Previously IRB and Penn social media committee APPROVED]. We plan to have IC Association (non-
proﬁt organization supporting patients with IC) post the information about our study on their social 
media accounts (Facebook, Instagram, Twitter). The visual ad is attached (please note that Facebook 
and Instagram ads should contain less than 20% texts thus, we will relay the information required by 
the IRB and OCR in the text accompanying the visual ad. "If you have interstitial cystitis, Drs. Lily 
Arya and Edward Kim at the University of Pennsylvania's Division of Urogynecology are conducting a 
research study to teach patients how to self-manage their symptoms. In this completely remote, 
smartphone-based study, you will receive video treatment modules and check-in messages via a secure 
texting platform over 6 weeks (max 3 texts per week). If you are women over 18, recently diagnosed 
with IC, have a smartphone and interested in evidence-based, holistic ways to manage your symptoms, 
please call our study coordinator Lisa at 267-600-2484." Once they contact us through our study 
coordinator, we will set them up for a phone call with one of the clinicians on our team to conﬁrm 
eligibility. They will then undergo remote consent and enrollment process with our study coordinator.
The following documents are currently attached to this item:
There are no documents attached for this item.
Subject compensation*
Will subjects be ﬁnancially compensated for their participation?
No
The following documents are currently attached to this item:

Page 10 of 12
There are no documents attached for this item.
If there is subject compensation, provide the schedule for compensation per study visit or session 
and total amount for entire participation, either as text or separate document
Study Procedures
Suicidal Ideation and Behavior
Does this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) 
which may carry a potential for central nervous system (CNS) effect(s)? Centeral nervous system(CNS) 
effect: the ability of a test article to enter into and potentially interact with the central nervoous system 
(brain and spinal cord). Clinical Investigation: Any experiment that involves a test article and one or 
more human subjects that either is subject to requirements for prior submission to the Food and Drug 
Adminstration (FDA) under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or is 
not subject to the requirements for prior submission to the FDA under these sections of the act, but, the 
results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an 
application for a research or marketing permit. 
No
Procedures
Eligible participants will be consented via phone or video conferencing (patient choice) with our study 
coordinator.  Then they will be asked to choose a treatment pathway that they are interested in (pelvic 
ﬂoor physical therapy, regulating brain-bladder connection, mindfulness practice). Then they will 
complete the following validated, published questionnaires: - Interstitial cystitis problem index - 
Interstitial cystitis symptom index - Pain self efﬁcacy score - Hospital anxiety and depression score - 
Patient physician communication satisfaction Then the patient will participate in a 6-week texting 
program. They will receive the following evidence-based, standard-of-care treatments for IC/BPS 
delivered via text messages: patient education about IC/BPS, urinary urge suppression exercise 
instructions, pelvic ﬂoor physical therapy instructions, mindfulness practices, cognitive behavioral 
therapy focusing on regulation the brain-bladder. connection, and instruction on how to avoid common 
dietary triggers. Video modules will be texted out twice a week (Monday and Wednesday). Every 
Friday, they will receive a check-in message. If they report severe symptoms, they will be asked if they 
would like to be contacted via phone by a clinician to triage symptoms. After the completion of the 
program, the participants will complete the same set of questionnaires that they did at baseline. In 
addition, they will complete the Net Promoter Score and Systems Usablility Scale, which are validated 
questionnaires to evaluate the quality of a technological program. Conﬁdentiality will be maintained 
throughout the recruitment process as well as during study participation.
The following documents are currently attached to this item:
There are no documents attached for this item.
Deception
Does your project use deception? Deception could be considered any direct misinformation presented to 
the subject or omission of key information pertaining to the design or nature of the project. 
No
International Research
Are you conducting research outside of the United States? 
No
Analysis Plan
Response rate to text messages will be determined. We will also compare score of the validated 
questionnaires before and after participation in the texting project using paired t-test. P values 0.05 will 
be considered signiﬁcant.
The following documents are currently attached to this item:

Page 11 of 12
There are no documents attached for this item.
Subject Conﬁdentiality
Each person will be assigned a study ID number. The ﬁle linking study participants to study ID will be 
stored in a password protected ﬁle to which only study personnel will have access.  For text messages, 
We will utilize Way to Health platform which assures data security and privacy (https://
www.waytohealth.org/ﬁles/W2H.Summary.of.Data.Protections_2020-06-03.docx). Text messages will 
be stored in a secure inbox of the Penn Center for Health Care Innovation. As with any Way to Health 
text messages, Texts will not contain any identifying information other than the participants' names to 
personalize each message (e.g. "Good morning, X!"). Participants will also be instructed to not text 
personal information per Way to Health standard procedures. All patients will be provided a telephone 
number they can call to talk with study clinician about questions. All demographic and questionnaire 
data will stored in secure ﬁles using patient ID and to which only study personnel have access.
Sensitive Research Information*
Does this research involve collection of sensitive information about the subjects that should be excluded 
from the electronic medical record? [NOTE: This does not apply to: 1) research information that would 
not normally be included in the electronic medical record or 2) information that is in the electronic 
medical record as part of clinical care.]
No
Disclosures
Will any data or specimens from Penn participants OR other research generated work product (e.g., 
intellectual property) be disclosed to any individuals, entities, or vendors, etc. outside of Penn?
No
Data Protection*
x Name
x Street address, city, county, precinct, zip code, and equivalent geocodes
x All elements of dates (except year) for dates directly related to an individual and all ages over 89
x Telephone and fax number
x Electronic mail addresses
x Social security numbers
x Medical record numbers
Health plan ID numbers
Account numbers
Certiﬁcate/license numbers
Vehicle identiﬁers and serial numbers, including license plate numbers
Device identiﬁers/serial numbers
Web addresses (URLs)
Internet IP addresses
Biometric identiﬁers, incl. ﬁnger and voice prints
Full face photographic images and any comparable images
Any other unique identifying number, characteristic, or code
None
Does your research request both a waiver of HIPAA authorization for collection of patient information 
and involve providing Protected Health Information ("PHI") that is classiﬁed as a "limited data set" 
(city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a 
recipient outside of the University of Pennsylvania covered entity?
No

Page 12 of 12
Consent
1. Consent Process
Overview
At a mutually agreed upon time, over the phone or video conferencing (patient choice), an interested 
patient and a study team member will review the texting program, the consent form, risks, beneﬁts, and 
alternatives. It will be emphasized that this program is an adjunct to the treatment plan and stress that 
their participation will have no bearing on their existing treatment plan. Patients may opt out at any time 
during the study period if they ﬁnd it to be too burdensome. All questions will be addressed. The patient 
will then be directed to the consent form that they can sign via RedCAP.
Risk / Beneﬁt
Potential Study Risks
Risk of participation is minimal. This study is testing a smartphone-based program to remotely deliver 
evidence-based information on IC/BPS self-management. No new treatments are being tested. All 
treatments delivered through this platform are within standard of care. There is a potential risk of loss of 
conﬁdentiality if subjects share their personal information (via free-texting) other than what is asked by 
the study team.
Potential Study Beneﬁts
Patients may derive some beneﬁt from being reminded of their prescribed treatment strategies.
Risk / Beneﬁt Assessment
Minimal risk
General Attachments
The following documents are currently attached to this item:
Cover Letter (2023.03.17_irbmod_addpersonel_coverletter.docx)