Functional Outcomes in Ulcerative Colitis Patients With Ileal Pouch Anal Anastomosis Treated With High Intensity Focused Electromagnetic Stimulation: A Prospective Pilot Study
Phase: NA
Conditions: Fecal Incontinence
Sponsor: Cedars-Sinai Medical Center

Functional Outcomes in Ulcerative Colitis Patients with Ileal Pouch Anal Anastomosis 
Treated with High Intensity Focused Electromagnetic Stimulation 
NCT has not yet been assigned  
6/16/2025 

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CONSENT FORM FOR RESEARCH
For Cedars-Sinai and Participating Affiliates1
Study title: 
Functional Outcomes in Ulcerative Colitis Patients with Ileal Pouch Anal 
Anastomosis Treated with High Intensity Focused Electromagnetic Stimulation: 
A Prospective Pilot Study
Study support provided by: Internal Department Funding
Cedars-Sinai Principal Investigator: Karen Zaghiyan , MD 
Cedars-Sinai study contact phone number: (310) 423-1682
Cedars-Sinai after-hours emergency contact (24 hours): (310) 423-1682
To help guide your review of this form, the main sections include:
1. Key Information
2. Purpose of the Study
3. Main Study Procedures 
4. Possible Benefits from Taking Part in the Study
5. Possible Risks and Discomforts of the Main Research Procedures
6. Common Medical Procedures Performed for Research Purposes and Risks
7. Reasons Participation May Be Stopped by the Researchers or Sponsor
8. Voluntary Participation and Other Options
9. Confidentiality Protections
10. Research-Related Illness or Injury
11. Financial Considerations
12. Contact for Questions or Problems
Experimental Subjects Bill of Rights
Authorization for Use or Disclosure of Identifiable Health Information for Research
Flowchart of Visits, Tests and Procedures
1 The Cedars-Sinai Affiliated Covered Entity (“ACE”) is comprised of covered entities under the common 
ownership or control of Cedars-Sinai Health System, including Cedars-Sinai Medical Center (CSMC); Cedars-
Sinai Medical Care Foundation; Cedars-Sinai Marina Del Rey Hospital (MDRH); Torrance Memorial Medical 
Center (TMMC); Torrance Health Association, Inc., d/b/a Torrance Memorial Physician Network; Huntington 
Hospital (HH), and Huntington Medical Foundation.
CSMC IRB No: STUDY00003888
CSMC Date Effective: 4/8/2025

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Signature Page
1. Key Information
Thank you for considering research participation. Research helps make medical and scientific 
advancements possible.  In this form, we are asking for your consent to take part in this 
research study. Taking part in this research study is voluntary.
This section provides key information about the study. Please take your time to read this entire 
form. Also, please ask questions before deciding whether to take part in this research study. 
You are welcome to talk with family, friends and other healthcare providers before you decide. 

Purpose: The purpose of this research is to see if treatment with the Emsella Chair 
improves fecal incontinence (inability to control bowel movements) and quality of life in 
patients with Ulcerative Colitis and Inflammatory Bowel Disease Unclassified (IBDU) 
who have received an ileal pouch anal anastomosis (IPAA), commonly referred to as a J 
pouch. 

Duration: Taking part in this study will last about 3 months. 

Procedures: The main things that will happen in this study are: Completing surveys 
on fecal incontinence symptoms, quality of life, anxiety, depression and gastrointestinal 
habits. Additionally, participants will receive treatment with Emsella chair twice a week 
for three weeks. Section 3 includes more details.

Benefits: The possible benefits of taking part in this study are improved fecal 
incontinence symptoms and improved quality of life. Additionally, the information from 
this study may help others in the future. Section 4 includes more details.

Risks: All research studies involve some risks. Risks or discomforts from this study 
may be embarrassing or personal questions about sexual and bowel health as well as 
possible gluteal pain, changes in bowel habits or discomfort with urination: Section 5 
includes more details.
o
If you have problems during the study, contact the study team using the contact 
information on the first page of this consent form.

New Information: During the study, we may find out new information about this 
study. We will tell you about any important changes or new findings that may impact 
your decision to continue taking part in the study.
2. Purpose of the Study 
We are doing this study to evaluate whether patients with ulcerative colitis or IBD-U who have 
received an ileal pouch anal anastomosis (IPAA), commonly referred to as J pouch, have 
improvement in fecal incontinence and quality of life after 3 weeks of treatment with Emsella 
chair. 
CSMC IRB No: STUDY00003888
CSMC Date Effective: 4/8/2025

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J Pouches are a surgical option for patients with ulcerative colitis whose disease is not well 
managed with medications. They provide disease management while avoiding a permanent 
ostomy. However, a known side effect of a J pouch surgery is fecal incontinence, which can 
occur in up to 5-15% of patients. Fecal incontinence is the inability to control bowel 
movements, which can have a significant impact on quality of life. The Emsella chair uses a 
type of high intensity focused electromagnetic (HIFEM) stimulation to contract and strengthen 
the pelvic floor muscles. Patients sit on the chair and electromagnetic energy is directed at the 
pelvic floor muscles for 28-minute sessions 2 times per week over 3 weeks, to help improve 
muscle tone. It was first developed in the early 2000s as a noninvasive treatment option for 
urinary incontinence. A growing number of studies have shown improvement in urinary 
incontinence in half of the patients one month after treatment. The nerves and pelvic floor 
muscles are the same for urinary and fecal incontinence, so we think that treatment with the 
Emsella chair will improve patient fecal incontinence and quality of life. Treatment of fecal 
incontinence with HIFEM has not yet been studied. If this study can show improvement in 
fecal incontinence, the Emsella chair could provide an accessible, noninvasive, treatment plan 
for patients struggling with fecal incontinence. 
You are being asked to take part in this research study because you are an adult with a history 
of ulcerative colitis treated with a J pouch and have experienced some difficulty with fecal 
incontinence since getting the J pouch. 
The study will include up to 20 people total.
The U.S. Food and Drug Administration (FDA) approved the Emsella chair for urinary 
incontinence. However, in this study, we are using it differently from what was approved by the 
FDA. We will be evaluating the use of the Emsella chair for fecal incontinence, using the same 
protocols used for urinary incontinence. 
3. Main Study Procedures
This section talks about what will happen in this study. When you read this section, also read 
the table of procedures. The table is given with this consent form.   
The table of procedures shows:

When study procedures will occur, 

Whether they will be covered by the study or billed to you and/or your insurance, and 

Which study procedures are research-related and which are standard of care (routine). 
Research-related procedures are procedures done only for the research study. They would 
not be performed for your routine care outside of the study. Standard of care (routine) 
procedures are routine care generally given to people with your condition. They would be 
performed even if you did not take part in this study. The researchers will schedule the visits 
and procedures at the listed timepoints.   
    
CSMC IRB No: STUDY00003888
CSMC Date Effective: 4/8/2025

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Description of main research procedures:
This study has one study group. Every participant will receive treatment with Emsella chair. 
You will be treated 2 times per week for 3 weeks, for a total of 6 treatments.  For each 
treatment, you will sit on the Emsella chair for 28 minutes. You will be fully clothed for the 
treatment, but you cannot wear anything metal. Treatment should not feel painful, but you 
may feel a tingling sensation.
We will administer surveys before your first treatment and at 1 and 3 months after your final 
treatment.
How long will you be in the study?
We think you will be in this study for/until about 3 months. This includes twice weekly 
sessions with the Emsella therapy for three weeks and questionnaire follow up at initial 
appointment, 1 month and 3 months. Each treatment session is 28 minutes long. Your medical 
records will be evaluated from your preoperative screening to the current post operative 
period. 
4. Possible Benefits From Taking Part in the Study
Being in this research study may or may not have direct medical benefit to you. The possible 
benefits of taking part in the research study are improved fecal incontinence and overall quality 
of life. However, no benefit is guaranteed. It is possible that your condition may stay the same 
or even get worse.
We hope the information learned from this research study will allow the use of Emsella as a 
noninvasive treatment option for those struggling with fecal incontinence. 
5. Possible Risks and Discomforts of the Main Research Procedures
This section talks about the possible risks and discomforts of the main study procedures. 
Emsella is not part of the current stand of care for patients with fecal incontinence. Risks of the 
Emsella include possible gluteal discomfort or pain, changes in bowel habits including possible 
worsening of fecal incontinence and discomfort with urination. 
Risks of common medical procedures being done for research purposes are described below in 
Section 6. Side effects and risks of standard of care procedures are not described in this 
consent form. 
Unknown Risks
There may be other risks that we cannot predict. Many complications are minor and do not last 
long.  However, in rare cases, they can be long-lasting. 
CSMC IRB No: STUDY00003888
CSMC Date Effective: 4/8/2025

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Pregnancy and Reproductive Information
Pregnant people are excluded from the study. However, it is possible that someone 
participating could become pregnant during participation in this study. The next sections 
review the potential risks if this were to happen. 
Unknown Risks to the Developing Embryo or Fetus (an unborn baby)
If you are pregnant, or become pregnant during participation in this research, the Emsella 
Chair might involve risks to an embryo or fetus, which are currently unknown. It is important 
that you contact the researcher immediately if you believe you might be pregnant. 
6. Common Medical Procedures Performed for Research Purposes and Risks
The procedures listed below are often part of routine care for a person with your condition. 
They are not experimental procedures. That said, for this study these procedures and their 
risks are research-related. This means they are being repeated or performed more frequently 
for this study. These common procedures and their risks should be the same as when 
performed outside this study.
Study Procedure
Related Risks
Medications: We will ask you about 
your past and current medications. 
Talk with the study team about any non-
study medications. Non-study 
medications include any prescription 
drugs, over-the-counter drugs, 
supplements and vitamins.
This does not have any physical risks.
Demographic Information: We will 
ask you about demographics, which may 
include your age, gender identity, sexual 
orientation, race and ethnicity.
This does not have any physical risks.
Medical History Review: We will ask 
you about your medical and surgical 
history. We will also ask about your 
history with irritable bowel disease, prior 
surgeries, fecal incontinence and prior 
treatments utilized for your fecal 
incontinence. 
This does not have any physical risks.
Questionnaire: You will be asked to 
complete a questionnaire. We will ask you 
questions to find out your quality of life, 
mental health, fecal incontinence and 
sexual health. We think it should take 5-
10 minutes to complete the questionnaire. 
Questionnaires will ask you to respond to 
Some questions may make you feel uncomfortable or 
embarrassed. 
The questionnaire will be labeled with a unique 
study number. This will link your identity so that 
only the research team can recognize you. 
CSMC IRB No: STUDY00003888
CSMC Date Effective: 4/8/2025

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sensitive questions about your sexual 
health.
7. Reasons Participation May Be Stopped by the Researcher or Sponsor
Your participation in this study may be stopped at any time. The researcher or the sponsor can 
stop your participation without your consent for any reason. If your participation is stopped 
early, the study doctor will discuss next steps with you. Some reasons for stopping your 
participation include:
The study is stopped or suspended.
Funding for the study is reduced, stopped or withdrawn.
It is in your best interest.
You do not follow the study procedures.
8. Voluntary Participation and Other Options
Taking part in research is voluntary. You have the right to choose not to take part. You can stop 
taking part in this research study at any time. You can do this without any penalty or loss of 
benefits to which you would be entitled outside of the study. Your choice not to take part or to 
stop taking part will not affect the care you get at Cedars-Sinai. 
If you decide to stop taking part, we will keep any data collected on you up to the time you 
choose to stop. Also, if you stop taking part, the study team may ask you whether you want to 
give further data from your routine medical care.
You can decide not to take part in this study. You have other choices. For example, you may choose: 
To be treated following the usual clinical approach: antidiarrheal medications such as 
loperamide, stool bulking agents (fiber), dietary modification (limiting high lactose or fructose 
containing foods), pelvic floor physical therapy, sphincter repair, sacral nerve stimulation, or an 
injectable bulking agent 
To take part in a different study at Cedars-Sinai 
To not be treated.
The study team will discuss these options and their risks and benefits with you. You may also 
choose to discuss these with your treating physician.
9.
Confidentiality Protections 
General Confidentiality
We will do our best to keep your personal information collected as part of this study private. 
But we cannot guarantee total privacy. We may put a copy of your research consent and 
authorization forms in your electronic medical record at Cedars-Sinai. Your personal 
information may be given out if required by law. Publications or presentations about this study 
at scientific meetings will not use your name and other identifiable personal information. 
CSMC IRB No: STUDY00003888
CSMC Date Effective: 4/8/2025

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Organizations that may look at and/or copy your medical records for research oversight, 
quality assurance and data analysis include:
Accrediting agencies (agencies that grant official certifications to educational institutions)
Government and regulatory groups, such as the Food and Drug Administration (FDA) and 
Office for Human Research Protections (OHRP)
The Institutional Review Board (IRB), which reviews research to protect people taking part 
in studies
Safety monitors, which monitors the safety of individual participants and the overall safety 
of the study
Companies that sponsor the study and authorized representatives of the sponsor 
Attached to this consent form is an Authorization Form. It outlines with whom your 
information may be shared for this research and under what circumstances.  
Sharing Information or Samples
We might share your information and/or research samples collected in this study. The 
information shared may include genomic data and health data or samples that could be used in 
future genomic research. It might be shared with other researchers at Cedars-Sinai, other 
researchers outside of Cedars-Sinai, or third-party commercial entities for future research 
without additional informed consent from you. In some cases, your information and/or 
specimens may be submitted to a database or repository for future research. These databases 
and repositories have safeguards to prevent inappropriate access to and use of the information 
and specimens. Information that identifies you will be removed and will not be shared with 
other researchers or anyone outside of Cedars-Sinai. However, there is a remote possibility that 
someone could identify you.
A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by 
U.S. Law. This website will not include information that can identify you. At most, the website 
will include a summary of the results. You can search this website at any time. 
10.Research-Related Illness or Injury
Contact in Case of Illness or Injury
We do not expect you will have any illness or injury from this research study. If you believe that 
you are ill or have been injured from this study, please contact the study team at the phone 
number listed on page 1 of this consent form.
Who pays for my research-related illness or injury?
Cedars-Sinai has no plans to pay for costs associated with the treatment of research-related 
injury or illness. We will make every effort to seek reimbursement from your health plan. 
However, you will be responsible for any deductibles and copayments required under your 
health plan and for any claims ultimately denied by your health plan. Financial assistance may 
be available under Cedars-Sinai’s Financial Assistance Program. If you feel that you have had a 
research-related injury and need financial assistance, please contact the IRB Office at 310-423-
3783. You do not waive any of your legal rights by signing this form.
CSMC IRB No: STUDY00003888
CSMC Date Effective: 4/8/2025

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11. Financial Considerations
Costs of Participation
You and your insurance company will not be charged for your participation in this research 
study. The Study Sponsor will cover the cost of all items, drugs and services required by this 
study. This includes any procedures required by the study that may be standard of care.
Payment
You will not be paid for taking part in this research study.
Financial Interest in the Research
The principal investigator and institution have no potential financial conflict of interest with 
this study.
12. Contact for Questions or Problems 
Please contact the investigator for questions, problems or concerns about the research. Their 
contact information is on page 1 of this form.  
You might have feedback, questions, problems, concerns or want to obtain more information 
about this study. If so, you can talk with someone who is not part of this study by contacting:
Cedars-Sinai Human Research Protection Program (HRPP) 
Phone: 310-423-3783
Email: ResearchConcerns@cshs.org
Website: cedars-sinai.org/research/administration/office-of-research-compliance/review-
board.html
The Cedars-Sinai HRPP protects the rights and welfare of research participants.  
CSMC IRB No: STUDY00003888
CSMC Date Effective: 4/8/2025

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Experimental Subject’s Bill of Rights
In accordance with California Health and Safety Code 24172, any person who is required to 
consent to participate as a subject in a research study involving a medical experiment or who is 
requested to consent on behalf of another has the right to:
1. Be informed of the nature and purpose of the experiment.
2. Be given an explanation of the procedures to be followed in the medical experiment, and 
any drug or device to be utilized.
3. Be given a description of any attendant discomforts and risks to the subject reasonably to 
be expected from the experiment.
4. Be given an explanation of any benefits to the subject reasonably to be expected from the 
experiment, if applicable.
5. Be given a disclosure of any appropriate alternative procedures, drugs or devices that might 
be advantageous to the subject, and their relative risks and benefits.
6. Be informed of the avenues of medical treatment, if any, available to the subject after the 
experiment if complications should arise.
7. Be given an opportunity to ask any questions concerning the experiment or the procedure 
involved.
8. Be instructed that consent to participate in the medical experiment may be withdrawn at 
any time and the subject may discontinue participation in the medical experiment without 
prejudice.
9. Be given a copy of any signed and dated written consent form used in relation to the 
experiment.
10. Be given the opportunity to decide to consent or not to consent to a medical experiment 
without the intervention of any element of force, fraud, deceit, duress, coercion, or undue 
influence on the subject’s decision.
CSMC IRB No: STUDY00003888
CSMC Date Effective: 4/8/2025

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AUTHORIZATION FOR USE AND DISCLOSURE OF IDENTIFIABLE 
HEALTH INFORMATION FOR RESEARCH
FOR CEDARS-SINAI AFFILIATED COVERED ENTITIES2
1. USE AND DISCLOSURE OF HEALTH INFORMATION
If you agree to this Authorization, you give permission to the Sponsor, Principal 
Investigator, other investigators and their research team described in the Consent Form 
for Research (“Research Team”) to use or disclose your identifiable health information 
(“private information”) for the research study titled “Functional Outcomes in 
Ulcerative Colitis patients with Ileal Pouch Anal Anastomosis Treated with High 
Intensity Focused Electromagnetic Stimulation: A Prospective Pilot Study” which 
is described in the Consent Form for Research (“Consent Form”) to which this 
Authorization is attached. In particular, you authorize the research team acting under the 
direction of the Principal Investigator to review your medical records and collect your 
private information from the following sources: 
☒ Laboratory tests
☒ Pathology reports
☒ Imaging reports (e.g., x-rays or scans)
☐ Photographs or videos of your image
☒ Doctor/clinic records  
☒ Hospital/medical records
☐ Billing records
☒ Demographics, which may include, but is not limited to, age, gender identity, 
race, ethnicity, and/or sexual orientation
☐ Mental health records
☐ Substance abuse records  
☐ HIV test results
☒ Other tests or other types of medical information: Surveys
2 The Cedars-Sinai Affiliated Covered Entity (“ACE”) is comprised of covered entities under the common 
ownership or control of Cedars-Sinai Health System, including Cedars-Sinai Medical Center (CSMC); Cedars-Sinai 
Medical Care Foundation; Cedars-Sinai Marina Del Rey Hospital (MDRH); Torrance Memorial Medical Center 
(TMMC); Torrance Health Association, Inc., d/b/a Torrance Memorial Physician Network; Huntington Hospital (HH), 
and Huntington Medical Foundation.
CSMC IRB No: STUDY00003888
CSMC Date Effective: 4/8/2025

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2. WHO WILL HAVE ACCESS TO YOUR PRIVATE INFORMATION?
Your private information will be used by and/or shared with the Research Team.  
In addition to the research team, if applicable, the following parties may receive your 
private information and inspect your records: 

The reviewing Institutional Review Boards and Cedars-Sinai offices with authority to 
oversee research compliance.

U.S. government agencies, such as the Food and Drug Administration and the 
Department of Health and Human Services. 

Researchers at other organizations who are participating in this research study.

The Study Sponsor, its business partners, and Cedars-Sinai’s business partners for 
matters related to research study oversight, conduct of the research, data analysis, use 
of research results in product development, and payment or reimbursement. 

Representatives from regulatory agencies in other countries may join in the review of 
your research records, including research-related medical reports and information, 
with the Sponsor and/or the FDA.
Cedars-Sinai takes steps to protect your private information when sharing it with the 
recipients described above.  Though these steps and applicable law are meant to protect 
your private information, there is a risk that a recipient could share your private 
information without your permission.
3. WHEN WILL MY AUTHORIZATION EXPIRE? 
By signing this document, you authorize the use and sharing of your private information 
until the end of the research study and any related optional sub-study you choose to 
participate in. 
4. REVOKING AUTHORIZATION 
You may change your mind and revoke (take back) this Authorization at any time.  Even 
if you revoke this Authorization, the research team may still use or disclose private 
information they already have obtained about you as necessary to maintain the integrity 
or reliability of the current research. To revoke this Authorization, you must write to the 
Principal Investigator of the research study by writing to the Office of Research 
Compliance and Quality Improvement, 6500 Wilshire Blvd, Suite 1800, Los Angeles, 
Calif. 90048 and/or emailing to ResearchConcerns@cshs.org.  
5. NOTICE OF RIGHTS AND OTHER INFORMATION
CSMC IRB No: STUDY00003888
CSMC Date Effective: 4/8/2025

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You do not have to agree to this Authorization, but if you do not agree, you may not 
participate in the research study. Cedars-Sinai may not condition (withhold or refuse) the 
provision of standard of care treatment for you on whether you agree to this 
Authorization.
If you agree to this Authorization, please sign on the appropriate signature line on the 
Signature Page. You will receive a copy of this Authorization. 
CSMC IRB No: STUDY00003888
CSMC Date Effective: 4/8/2025

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Table of Visits, Tests and Procedures 
Legend
R = Research item/procedure done only for research purposes and their costs are covered by the study. You are not responsible 
for the costs of these procedures.
Procedures 
Screening  
Visit
Visit #1
Week 1
Visit #2
Week1
Visit #3
Week2
Visit #4
Week2
Visit #5
Week 3 
Visit #6
Week 3
1 month
3 months
Informed 
Consent
R
Medical 
History
R
Emsella 
Treatment
R
R
R
R
R
R
Surveys
R
R
R

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Signature Page
Consent Form for Research and Authorization
for Use and Disclosure of Identifiable Health Information (Research)
If you agree to take part in this study, you should sign and date on the signature lines 
below. You will be given a signed and dated copy of this form. This includes the 
“Experimental Subject’s Bill of Rights,” “Authorization for Use and Disclosure of 
Identifiable Health Information (Research)” and any optional sub-study descriptions, when 
applicable.  
Signature by the Participant 
Main Research Study: I agree to take part in the research study described to me 
during the informed consent process and described in this informed consent form. My 
questions have been answered to my satisfaction. 
You will be given a signed and dated copy of this form. 
Participant name (please print)
Signature
Date 
Authorization for Use and Disclosure of Identifiable Health 
Information (Research): I hereby agree that my identifiable health 
information may be used and/or disclosed in accordance with the 
“Authorization for Use and Disclosure of Identifiable Health Information 
(Research).”
Participant name (please print)
Signature
Date
Signature by the Investigator
I attest that all the elements of informed consent described in this form have been 
discussed fully in non-technical terms with the participant. I further attest that all 
questions asked by the participant were answered to the best of my knowledge.
Investigator name (please print)
Signature
Date
CSMC IRB No: STUDY00003888
CSMC Date Effective: 4/8/2025

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Signature by the Interpreter/Witness
(Signature of an interpreter is only required when enrolling a non-English-speaking 
subject with the assistance of an interpreter and IRB-approved “short form” consent 
processes. The witness may be any person who is conversant in both English and the 
language of the non-English-speaking subject, such as a certified hospital interpreter, 
study staff, a family member or other person. The witness signs the consent forms to 
confirm that the oral interpretation occurred.
Signature of a witness is required when an English-speaking subjects who has been 
determined to have capacity to consent is unable to read or physically sign the consent 
form, but choses to indicate via a “mark” or verbally that he/she agrees to 
participate.  The witness signs the consent form to confirm that an oral consent process 
occurred and that the individual verbally consented to participate in the research.)
Interpreter/Witness name (please print)
Signature
Date 
CSMC IRB No: STUDY00003888
CSMC Date Effective: 4/8/2025