Mindfulness and Yoga for Pain With Interstitial Cystitis Evaluation
Phase: NA
Conditions: Interstitial Cystitis
Sponsor: University of New Mexico

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PROTOCOL TITLE:
MYPAICE- Mindfulness and Yoga for Pain with Interstitial Cystitis Evaluation 
PRINCIPAL INVESTIGATOR:
Kate Meriwether, MD
Department of Obstetrics and Gynecology
ADMINISTRATIVE CONTACT:
Name: Karen Taylor
Department of OB/GYN
VERSION NUMBER:
2
DATE:
01/03/2023
REGULATORY FRAMEWORK:
Please indicate all that apply:
DOD (Department of Defense)
DOE (Department of Energy)
DOJ (Department of Justice)
ED (Department of Education)
EPA (Environmental Protection Agency)
FDA (Food and Drug Administration)
X
HHS (Department of Health and Human Services)
VA
Other:      
FUNDING:
Pelvic Floor Disorders Research Foundation American Urogynecologic Society Grant
UNM Department of OB/GYN Henrietta Lacks Grant
CLINICAL TRIALS
Is this a clinical trial per the NIH definition of a Clinical Trial?   X Yes   
 No

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NIH Definition of a Clinical Trial: 
A research study in which one or more human subjects are prospectively assigned to one 
or more interventions. An "intervention" is defined as a manipulation of the subject or 
subject’s environment for the purpose of modifying one or more health-related 
biomedical or behavioral processes and/or endpoints. Examples include: drugs/small 
molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery 
systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related 
behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment 
strategies; prevention strategies; and, diagnostic strategies (which may include placebo or 
other control) to evaluate the effects of those interventions on  health-related biomedical 
or behavioral outcomes. 
Use the following four questions to determine the difference between a clinical study 
and a clinical trial:       
1)
Does the study involve human participants? X Yes   
 No
2)
Are the participants prospectively assigned to an intervention? X Yes   
 No
3)
Is the study designed to evaluate the effect of the intervention on the participants? 
X Yes   
 No 
4)
 Is the effect being evaluated a health-related biomedical or behavioral outcome? 
X Yes   
 No
Note that if the answers to the 4 questions are yes, your study meets the NIH definition of 
a clinical trial, even if… 

You are studying healthy participants

Your study does not have a comparison group (e.g., placebo or control)

Your study is only designed to assess the pharmacokinetics, safety, and/or 
maximum tolerated dose of an investigational drug

Your study is utilizing a behavioral intervention
If yes to all 4 questions, please confirm that the research team is familiar with and agrees 
to comply with the investigator requirement to register the study on the ClinicalTrials.gov 
database. Additionally, the approved consent document(s) must be uploaded to the 
ClinicalTrials.gov database    X Yes   
 No 
For any assistance with registration of your trial or the requirements, please contact HSC-
CTSCResearchConcierge@salud.unm.edu 

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Table of Contents
1.
Objectives.....................................................................................................................6
2.
Background ..................................................................................................................6
3.
Study Design ................................................................................................................6
4.
Inclusion and Exclusion Criteria ..................................................................................6
5.
Number of Subjects......................................................................................................6
6.
Study Timelines............................................................................................................7
7.
Study Endpoints ...........................................................................................................7
8.
Research Setting...........................................................................................................7
9.
Resources Available.....................................................................................................7
10.
Prior Approvals.........................................................................................................8
11.
Multi-Site Research ..................................................................................................8
12.
Study Procedures ......................................................................................................9
13.
Data Analysis..........................................................................................................10
14.
Provisions to Monitor the Data to Ensure the Safety of Subjects...........................10
15.
Withdrawal of Subjects...........................................................................................10
16.
Data Management/Confidentiality..........................................................................11
17.
Data and Specimen Banking...................................................................................12
18.
Risks to Subjects.....................................................................................................13
19.
Potential Benefits to Subjects .................................................................................13
20.
Recruitment Methods..............................................................................................13
21.
Provisions to Protect the Privacy Interests of Subjects ..........................................14
22.
Economic Burden to Subjects.................................................................................14
23.
Compensation .........................................................................................................15
24.
Compensation for Research-Related Injury............................................................15
25.
Consent Process......................................................................................................15
26.
Documentation of Consent .....................................................................................18
27.
Study Test Results/Incidental Findings ..................................................................19
28.
Sharing Study Progress or Results with Subjects...................................................19
29.
Inclusion of Vulnerable Populations ......................................................................20
30.
Community-Based Participatory Research.............................................................21
31.
Research Involving American Indian/Native Populations .....................................21
32.
Transnational Research...........................................................................................21
33.
Drugs or Devices ....................................................................................................22
34.
Principal Investigator’s Assurance .........................................................................22
35.
CHECKLIST SECTION ........................................................................................24
36.
Partial Waiver of Consent for Screening/Recruitment ...........................................24
37.
Partial Waiver of HIPAA Authorization for Screening/Recruitment.....................25
38.
Waiver of Documentation of Consent ....................................................................25
39.
Alteration of Consent..............................................................................................26
40.
Full Waiver of Consent/Parental Permission..........................................................27
41.
Full Waiver of Consent/Parental Permission (Public Benefit or Service Programs)
28
42.
Full Waiver of HIPAA Authorization (Checklist)..................................................28
43.
Other Waiver Types (Checklist).............................................................................29
44.
Vulnerable Populations (Checklist)........................................................................29

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45.
Medical Devices (Checklist)...................................................................................35
46.
Export Control (Checklist) .....................................................................................36
47.
Data Transfer/Sharing (Checklist)..........................................................................36
48.
Specimen Transfer/Sharing (Checklist)..................................................................37

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1. Objectives
1.1 The objective of this research is to perform a non-masked, randomized clinical 
trial to assess pain levels and function and level of care required by patients with 
interstitial cystitis/painful bladder syndrome (IC/BPS) randomized to treatment   
with mindfulness and yoga + standard of care compared to standard care alone. 
Standard of care for IC/BPS is defined as treatments recommended in the 
American Association of Urology (AUA) guidelines (see Table 1). The target 
population is patients who have IC/BPS and are willing to be randomized to 
mindfulness/yoga therapy or standard of care therapies
Table 1: AUA Treatment Guidelines for IC/PBS 
First Line
General relaxation/ Stress management, pain management, patient 
education, self-care, behavioral modification
Second Line
Appropriate manual physical therapy techniques, oral agents 
including: amitriptiline, cimetidine, hydroxyzine, PPS, intravesical 
instillation of DMSO, heparin, lidocaine.
Third Line
Cystoscopy under anesthesia with hydrodistension, treatment of 
Hunner’s lesions if found.
Fourth Line
Intradetrusor Botulinum Toxin A, Neuromodulation. 
Fifth Line
Cyclosporine A
Sixth Line
Diversion with or without cystectomy, substitution cystoplasty
1.2 Our central hypothesis is that IC/BPS participants treated with yoga and 
mindfulness will have greater improvement in their symptoms than those treated 
with standard of care alone. Specifically:
1.3 Outcomes & Hypotheses:  
i) IC/BPS participants treated with mindfulness and yoga will assess their 
response to treatment based on the Graded Response Assessment (GRA) scale 
(described below) at 3 months compared to standard care participants. 
Hypothesis: IC/BPS participants treated with mindfulness & yoga + Standard of 
care will have superior scores on the GRA scale compared to those treated with 
Standard of Care alone.

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ii) Participants will start with 1st  and 2nd Line therapy as recommended by the 
AUA guidelines (AUA guidelines categorize treatments as 1st through 6th Lines of 
care) and we will record the numbers of participants that accelerate to higher lines 
of therapy. Hypothesis: IC/BPS participants treated with mindfulness & yoga + 
Standard of care will have fewer participants who accelerate to higher Lines of 
care compared to those treated with Standard of care alone.  
iii) Participants will record pain, function and other IC/BPS symptoms using 
validated questionnaires at baseline and at follow-up (approximately at 6 and 12 
weeks of treatment). Hypothesis: IC/BPS participants treated with mindfulness & 
yoga + Standard of care will have greater improvement in pain, function and 
other IC/BPS symptoms compared to participants treated with Standard of care 
alone, based on validated questionnaires. 
iv) Cost-analysis will be performed comparing treatment groups. Hypothesis: 
Cost analysis will find that those treated with mindfulness & yoga + Standard of 
care will incur less cost than Standard of care alone.
v) Qualitative outcomes will be obtained  with an optional response during the 
weekly interviews to see how participant’s feel their treatment is going. At a later 
time we may go back and enter quotes into qualitative software for analysis of 
themes. Hypothesis: Patients in the mindfulness& yoga + Standard of care may 
feel more empowered about their health. 
2. Background
IC/PBS is a chronic urologic pain disorder associated with significant 
morbidity. It is defined by the American Urogynecological Association 
(AUA) as “a complex sensation (pain, pressure, or discomfort) perceived to be 
related to the urinary bladder, associated with lower urinary tract symptoms of 
more than 6 weeks duration, in the absence of infection or any other 
identifiable causei.”  A 2015 survey of 1,982 patients with IC/BPS noted that, 
of the 180 treatment modalities, none were truly effective.  In the survey, 
patients were surveyed about their usage of complementary and alternative 
medicine (CAM). Of those who responded, 84.2% had tried CAM and 55% 
had been recommended CAM by their physiciansii.   There are many reasons 
as to why patients turn to CAM, including side effects experienced from 
traditional therapies, lack of efficacy and frustration with providersiii. 
Some of the more widespread CAM modalities recommended in medicine 
include yoga and mindfulness, as these have gained popularity for chronic 
pain disorders. Yoga has been shown to improve outcomes in such pain 
disorders as low back pain, primary dysmenorrhea, endometriosis, and 
fibromyalgiaiv. This is likely secondary to the physical components of holding 
poses and mindfulness of breath.  However, no studies have been performed 
to evaluate the impact of yoga on patient’s perception of pain with IC/BPS.  

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Indeed, there have been few RCTs evaluating its effects, and thus many 
recommendations for yoga come from expert opinion.  
Mindfulness is also gaining popularity for treatment of chronic pain disorders. 
Using the biopsychosocial model it is postulated that there is a central pain 
mechanism that further induces pain. Patients with chronic pain conditions 
also often have musculoskeletal pain. Patients’ overall perception of pain may 
be increased with chronic stress, anxiety and allodyniav.  However newer apps 
such as Headspace and Calm have proven beneficial for improvements in the 
affect, stress and irritability associated with chronic pain in as little as 8 
weeksvi. One systematic review even noted that an 8 week mindfulness course 
induced brain changes similar to traditional long term meditation practice on 
functional MRIvii. 
Mind/body interventions have successfully treated chronic pain conditions 
such as low back painviii, irritable bowel syndromeix and fibromyalgiax. 
Reports regarding treatment response using mind/body therapies for patients 
with IC/BPS are fewer, thus our aim was to assess the impact of yoga and 
mindfulness practice+ Standard of care compared to Standard Care alone. 
Standard of care treatments for IC/BPS have been well defined by American 
Urologic Association Guidelines (see Table 1). Our hypothesis is that patients 
who undergo mindfulness & yoga therapy + Standard of Care compared to 
Standard of care alone, will have improved response to treatment. We also 
hypothesize that they will have greater improvement in their pain, activities 
and require fewer treatment interventions. If funding allows, we will also 
compare cost of treatment between groups. 
3. Study Design
We will perform an unmasked, randomized controlled trial comparing yoga and 
mindfulness impact on 1) treatment response 2) level of treatment required 3) pain, 
activity and quality of life for patients with IC/BPS compared to standard care alone 
as recommended by the AUA (Table 1). The target population will be those patients 
with IC/BPS who are cared for by the urogynecology, gynecology and urology 
specialties. After obtaining informed consent, women will be randomized to either 
yoga & meditation + Standard of care compared to Standard of care alone. Masking is 
not possible with this study design, as participants randomized to the 
yoga/mindfulness versus standard of care will clearly know their treatment arm. 
4. Inclusion and Exclusion Criteria
4.1 We will recruit patients who present with IC/BPS per the AUA definition. To 
confirm the diagnosis of IC/PBS,.We will also administer the O’Leary-Sant 
Interstitial cystitis Symptom Index and Problem Index to determine if patients are 
candidates for the study. We will also require that they have a physical exam 
performed in the past 2 years.  As documented by others, a domain score of >6 will 
indicate applicability for enrollment in either symptom or problem domainxi. 
Additional inclusion criterion include: evidence of an absent UTI (e.g. negative urine 

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dipstick, a negative urinalysis or urine culture) within 2 months of enrollment as well 
as ability to speak and understand English or Spanish. We will recruit only patients 
who will be undergoing first-line and second-line treatment, as defined by AUA and 
who have not made treatment changes to their regimen in the past 4 weeks. 
 Patients will be excluded if they have: 

unevaluated hematuria, 

a history of recurrent urinary tract infection (UTI), as defined by AUA criteria as 
>2 culture-proven UTIs in 6 months or 3 UTIs in one year within the last 5 years,

 urinary retention, defined  as a post-void residual (PVR) of >150 mL confirmed 
by bladder scan or catheterization, 

a history of augmentation cystoplasty or urinary diversion, 

a history of cyclosporine A use

a history of pelvic radiation or chemotherapy in the past 2 years 

history of radiation induced cystitis

if patients are currently pregnant or lactating or planning on becoming pregnant in 
the next 3-4 months

have demonstrated Hunner’s ulcers on cystoscopy, treated or untreated by 
fulguration or steroid injection, within the last 6 months

As our intervention requires Smartphone utilization and video usage, we will be 
excluding patients whose hearing or vision would interfere with ability to use the 
yoga video or meditation app.  

Neurogenic bladder (e.g. secondary to CVA with residual deficits, Multiple 
Sclerosis, Parkinsonism)

Severe mobility impairment or physical conditions that would interfere with their 
ability to perform yoga as they would be unable to perform certain Yoga postures. 

Inability to speak/understand English or Spanish

Inability to perform study follow up
4.2 Main inclusion criteria is as follows: 

Female subjects≥18 years old

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
IC/BPS clinical diagnosis, which requires >6 weeks of symptoms 
consistent with IC/BPS and lack of other bladder pathology (such 
as radiation exposure, active urinary tract infection, pelvic trauma, 
etc.) that would explain symptoms 

English or Spanish reading/writing

Own a Smartphone to be able to watch an online video or use 
Smartphone meditation app. 

Ability/willingness to participate in follow up questionnaires

O’Leary-Sant ICSI/ICPI >6 
4.3   As noted above: Adults unable to consent, pregnant women, and prisoners 
will not be included in this study. 
4.4  As noted above: We will include English and Spanish speaking populations 
only.  We are excluding men as we are a Urogynecology practice and therefore do 
not have access to that population, and the vast majority of sufferers from IC/BPS 
are womenxii.  Unfortunately, we do not have the ability to recruit in other 
languages beyond English and Spanish, as our primary outcome measures have 
not been validated in other languages.
5. Number of Subjects
5.1 This is a single-center study at University of New Mexico, so the total number of 
subjects at the University of New Mexico is the total number of subjects for the study.
5.2 The total number of subjects to be recruited at this site is 60-120 patients.
5.3 Sample size calculation: The primary outcome for this study is a linear mixed 
model of GRA variation over time.  Weekly GRA and O’Leary-Sant values will be 
obtained on all participants. We will then further characterize patients as either 
treatment responder or non-responders, with treatment response defined as “moderate 
(+2)” or The primary outcome for this study is a linear mixed model of GRA 
variation over time.  Weekly GRA and O’Leary-Sant values will be obtained on all 
participants. We will then further characterize patients as either treatment responder 
or non-responders, with treatment response defined as “moderate (+2)” or “marked 
(+3)” improvement on the GRA. We used previously reported outcomes from an 
RCT regarding impact of medication on ICBPS symptoms. 
Given that we will be performing a linear mixed model, we powered our study to 
detect a 30% change in treatment response between groups on the GRA, with baseline 
response rate of 26%.  We require 41 participants/group (total N=82) to obtain 80% 
power (α=0.05), assuming an effect size of 0.85. Allowing for a dropout rate of 15%, 
we aim to randomize 94 women (47/group).  We will be able to recruit the required 
number of participants. We see 12-15 new patients with ICBPS per month and should 

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be able to adequately recruit 6-7 patients/month, allowing us to meet the necessary 
sample of patients within 14 months of study initiation.  Despite COVID-19, we still 
continue to care for this number of patients. The study has maximized digital & 
phone contact and minimized in-person contact. We foresee that we should meet our 
recruitment aims despite the pandemic’s restrictions.
6. Study Timelines
6.1 Based on current clinic volume in the UNM division of the Urogynecology, from 
which we are recruiting, we estimate that recruitment of 60-120 patients will be 
feasible over approximately 2-3 years. Per chart review, the urogynecology division 
sees patients who meet criteria for this study at the rate of 10-20 per month. 
Assuming that approximately 25% of patients will agree to study participation (due to 
issues of time commitment and eligibility criteria), we believe that we will be able to 
recruit an appropriate number of patients in approximately 2-3 years. We believe that 
an additional 3 months will be needed for follow up data. We anticipate that data 
analysis and manuscript writing will take an additional 6-9 months.
7. Study Endpoints
7.1 The primary endpoint of our study is to determine the 3 month Global Response 
Assessment (GRA) in patients who perform yoga & mindfulness + Standard of care 
compared to patients who undergo Standard of Care alone,  as well as a linear mixed 
model analysis of the GRA over time. Our secondary endpoints include: (i) 
proportion of patients in each group using accelerated lines of treatment (2-6) based 
on the AUA guidelines (i) the following validated questionnaires:) ), O’Leary-Sant 
Symptom and Problem Index (OSPI/OSCI), patient self-efficacy questionnaire 
(PSEQ-2), the PROMIS- Pain Interference Short Form 6b (PROMIS-PI and a visual 
analog scale,  and the hospital anxiety and depression scale (HADS-A/D) (iii) Cost 
analysis potentially using, for example, the QALY scale if funds are found to support 
this.
7.2 We will not have any primary or secondary safety endpoints for which the study 
will be powered, as the interventions are extremely low risk (mindfulness and yoga).
7.3 Our exploratory endpoints are to investigate compliance to mindfulness and 
yoga treatment. Due to the extremely low-risk nature of therapeutic interventions, we 
do not have any safety endpoints.
8. Research Setting
8.1 The study will be performed at the University of New Mexico (UNM) 
Eubank Women’s Primary Care Clinic and Sandoval Regional Medical 
Center (SRMC) Urogynecology clinics. These Urogynecology clinics are 
dedicated to care of women with pelvic floor disorders such as interstitial 
cystitis/bladder pain syndrome (IC/BPS), the target population for this 
study.

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8.2 Potential subjects will be recruited in the UNM Eubank and SRMC 
clinics when they present for care for IC/BPS, either in person or virtually 
via telephone or Zoom care visits. All patients will have a history and 
physical taken to determine their study eligibility, as well as a baseline 
BPIC-SS. Recruitment will take place either in private exam rooms at 
these clinics or over HIPAA-compliant telephone or Zoom conversation, 
and informed consent conversations regarding these clinics will take place 
via the same means.
8.3 There are no other laboratory tests in this trial other than would be 
routinely collected in the work up of IC/BPS.
8.4 There will not be involvement of any community advisory board.  
8.5 There will not be any research conducted outside of the UNM HSC 
and its affiliates. 
9. Resources Available
9.1. Qualifications of PI and study staff:  Dr. Kate Meriwether is a board 
certified subspecialist in Urogynecology and will serve as the primary 
investigator (PI) for this study.  She is an experienced researcher at UNM 
and eligible PI at UNM, in addition to serving on an HRRC at the UNM 
HSC Institutional Review Board, which makes her familiar with ethical 
and compliant practices.  She has been the PI on multiple research trials 
and has successfully completed randomized control trials both as a fellow 
and now as faculty at UNM. Dr. Yuko Komesu, a co-investigator on this 
project is an experienced researcher at UNM and has previously 
evaluated mind/body therapies in both IC/BPS and urgency urinary 
incontinence based on RCTs. She is a tenured professor and the vice-
chair of research for the department of OB/GYN, which makes her very 
familiar with ethical and compliance practices. She is also a Howard 
Friedman endowed professor in OB/GYN. Dr. Sierra M. Jansen, a co-
investigator on this project, is the fellow who has a total of 12 months of 
protected research time during her fellowship in order to complete this 
study. 
9.2 This trial does not require any medical decision-making or ordering of 
therapeutics due to research protocols.
9.3 Resources available to conduct the research:  The University of New 
Mexico (UNM) Urogynecology division operates at two main locations. 
UNM Eubank Urogynecology Clinic located in Northeast Albuquerque 
provides a full range of services for women with pelvic floor disorders. 
The Eubank clinic consists of 8 examination rooms, 2 treatment rooms, 
and 2 physical therapy rooms. Our second location is at Sandoval 

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Regional Medical Center (SRMC), a community-based facility located in 
Rio Rancho, New Mexico, a large suburb located outside of Albuquerque.  
Research Staff: The Urogynecology Division employs a clinical research 
specialist as well as research coordinators. Our research staff has 
extensive experience conducting multi-center investigations and 
recruiting patients to clinical studies, with special expertise in 
community-based research and quality of life studies.
Research Experience: The Urogynecology Division at UNM has a 
strong history of conducting high quality research and collaboration with 
other investigators in the US and abroad, and has consistently met or 
exceeded recruitment goals on time. We have been members of the 
NICHD-sponsored Pelvic Floor Disorders Network (PFDN), and have 
met recruitment goals with high rates of follow-up and accurate data 
collection. In addition to PFDN research, Dr. Kate Meriwether has 
mentored and has been the PI on multiple clinical trials and contributes 
multiple publications in peer-reviewed journals. Her Curriculum Vitae is 
attached. 
Our group is well versed in the importance of adherence to protocols, 
timely completion of regulatory requirements, effective recruitment 
strategies, and the importance of the inclusion of minority subjects. 
Research is integral to all aspects of Divisional work; importantly, all 
members of the clinical team participate in research efforts.  There are 
weekly research meetings to discuss the progress of the ongoing studies 
within the department, and it is an excellent forum to ensure that all 
involved are adequately informed of their duties, of the protocol, and of 
the procedures. 
We do not anticipate that emergency care will be needed for this study; the 
urogynecology physicians are available on a 24 hour basis, 7 days per week for 
their patients requiring emergency care.
10.Prior Approvals
The only approval prior to commencing research will be with Dustienne Miller, 
PFPT.  She is a certified yoga teacher and a pelvic floor physical therapist with 
extensive background in making online yoga tutorials. She is designing this yoga 
sequence for our study (see supplemental materials). This study was presented to 
Dr. Eve Espey for approval, and the signed Departmental Review Form can be 
found in the “Supporting Documents” Section.  
This study does not include ionizing radiation, biological specimens, or drugs. 
11.Multi-Site Research
 This is not a multi-site research study. 

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12.Study Procedures 
This non-blinded randomized control trial will be conducted at the UNM Eubank 
clinic and SRMC Urogynecology clinic. We will recruit participants and plan 
to randomize approximately 60-120 participants from these sites. 
Collaborating investigators will be members of the urogynecology division at 
UNM HSC. 
Our primary aim is to determine whether the participants assess themselves as 
improving following the interventions based on the GRA at 3 months. The 
target population will be patients with IC/BPS who are seeking care. The 
current recommendation is to advise patients to undergo conservative 
management with self-care, behavioral modification techniques.  If a patient is 
interested in this and fulfills study inclusion criteria then we will offer her the 
choice of volunteering for the study. All women will give consent prior to 
their enrollment, after they have had time to carefully consider whether they 
want to participate in the study. Research staff and clinicians will obtain 
consent either in clinic or via zoom. After enrollment, participants will fill out 
baseline surveys including: )the O’Leary-Sant Symptom and Problem Index 
(OSPI/OSCI)Patient Self Efficacy Questionnaire-2 (PSEQ-2), Hospital 
Anxiety and Depression Scale (HADS-A/D), PROMIS- Pain Interference 
Short Form 6B ( PROMIS-PI), and a visual analog scale
In addition to the above outcomes, we will collect patient demographics, 
medical/surgical history and information regarding their IC/BPS (e.g. time 
since IC/BPS diagnosis, previous treatments for IC/BPS tried) and patient 
contact information. Once this information is collected, patients will also fill 
out an attestation of use, which they will sign/e-sign in REDCap, an affidavit 
that if they are randomized to mind/body they will use these daily to the best 
of their ability. 
Randomization: Randomization assignment will be generated by computer 
generated randomization scheme used by appropriate personnel such as a 
statistician.  Participants will be randomized in a 1:1 ratio by a computer 
generated sequence at enrollment. Randomization assignments will be 
completed via REDCAP.   Randomization will only occur after consent has 
been obtained and all baseline data has been obtained.
Interventions:
Yoga & mindfulness meditation + Standard of care: Women will be asked to 
perform mindfulness meditation via a commercially available smartphone app 
and yoga through an online video tutorial (designed by a Physical Therapist 
expert in IC/BPS care and designed specifically for IC/BPS patients). Our 
online tutorial is currently in the process of being formatted however see 
supplemental materials for yoga flow.  Patients will be instructed to perform 

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approximately 10 minutes of meditation daily via a commercially available 
app (either Calm App or Headspace App, both of which are commercially 
readily available) and approximately 15 minutes of yoga via the online 
tutorial. Yoga & use of the meditation app is estimated to take approximately 
30 minutes per day. Patients may engage in any other of the 1st Line AUA 
therapies as well taking over the counter medications (Table 1). Patients will 
be called weekly to ascertain treatment compliance and monitor their 
progress. If symptoms are not improving there will be the option to discuss 
other treatment options (e.g. accelerate to higher lines of therapy based on 
AUA guidelines) at 6 weeks. 
Women assigned to the Standard of Care alone group will receive any 1st Line 
and 2nd Line treatments (excluding use of the online yoga and meditation app). 
Patients will also be called weekly to monitor progress and to ensure no 
treatment effect secondary to phone calls. If symptoms are not improving 
there will be the option to discuss other treatment options (e.g. accelerate to 
higher lines of therapy based on AUA guidelines) at 6 weeks. At the 
termination of the study women in the standard of care group will receive 3 
months of Calm App. 
At the 6 week follow-up phone call patients will be given the option for escalation 
of therapy. Patients will be given the opportunity to escalate their treatment 
for IC/PBS to higher lines of treatments: use of intravesical Botox or use of 
sacral neuromodulation. We will record any accelerated therapy used by the 
patient that may be added during study participation. 
For participants who have completed the study but treatment escalation data was 
not properly captured in RedCap surveys, These participants will be notified 
via email through RedCap to complete this additional survey.
Outcome measures: 
GRA: The Global Response Assessment is a validated tool to assess response to 
treatment. It is comprised of a single question and has been utilized widely in 
IC/BPSxiii. This will be collected weekly. However, the primary outcome is 
the 12 week (3 month) result. 
THERAPY ESCALATION:  We will record when and what women use that is 
greater than 1st line and 2nd line therapies during their participation in the 
study. They will discuss escalation of therapy with their provider and study 
personnel will record the additional therapy as an outcome measure. This will 
be utilized to perform cost utility analysis to determine if the intervention is 
cost-effective. 
PSEQ-2:  The Patient Self-Efficacy Questionnaire Short Form is a 2 question 
questionnaire that has been used in multiple chronic pain conditions to 

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document feelings of self-efficacy. The Short form is validated in chronic 
pelvic painxiv.  This will be collected at baseline and at 12 weeks. 
PROMIS-PI:  The PROMIS-Pain interference short form 6B is an NIH PROMIS 
measure that measures the extent that pain interferes with daily activities. It is 
comprised of 6 questionsxv.  This measure will be collected weekly. 
HADS: This is formally called Hospital Anxiety/Depression Scale.  This is a 7 
item inventory that assesses generalized anxiety including: tension, worry, 
fear, difficulty relaxing and restlessnessxvi. This measure will be collected at 
baseline and at 12 weeks. 
Euroqol-5d. (EQ-5d) This is a validated measure utilized to measure health statesxvii. 
O’Leary-Sant Interstitial Cystitis Symptom and Problem Index: 
This validated survey assesses severity of symptoms and bother in IC/BPS 
and is commonly used for IC/BPS trials. Symptom index, which has been 
explicitly analyzed in a prospective trial to detect change, and problem 
index are to be separately analyzedxviii
Data Analysis
Data Analysis: Between and within group differences will be evaluated using 
chi-square analysis as deemed appropriate by the statistician involved in study 
analysis (e.g. Fisher’s Exact test for non-normal distributions of categorical 
variables and T-test for continuous variables). Differences between groups will be 
evaluated using Chi-square analyses for categorical variables as deemed 
appropriate by the statistician involved in study analysis (e.g. Fisher’s Exact test 
for non-normal distributions). T-tests will be utilized for continuous variables, 
with comparison by Mann Whitney U for non-normal distributions. Within-group 
differences over time will be analyzed using the McNemar’s test.  If any baseline 
differences exist between the groups, a regression or multivariable analysis will 
determine the contribution of these differences to observed differences between 
groups. As the GRA and O’Leary-Sant will be collected more frequently, we plan 
to analyze these results with linear mixed models analysis.  
Power Analysis: Power analysis was performed based on previously reported 
means and standard deviation from treatment effect based on GRA  We assumed 
that 41 patients in each arm (total 82) would be required to find a difference of 
30% between group’s pain scores (the primary outcome) with 80% power and 
alpha of 0.05. In order to achieve power we will need a total of 82 patients. 
Assuming an approximate 20-25% dropout or loss to follow-up rate, we will plan 
to randomize approximately 60-120 patients. 

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13.Provisions to Monitor the Data to Ensure the Safety of Subjects
A DSMB will not be monitoring safety of these procedures as the study 
risks are low.  The intervention arm includes mindfulness and yoga, both 
of which have been shown to be low-risk interventions with minimal 
adverse eventsxix. The control group will undergo standard of care 
treatments. Theoretically, there could be increased muscle soreness noted 
in patients in yoga treatment arm. There are no documented adverse events 
with mindfulness practice.
We will track adverse events when patients bring up these events during 
the course of the study with their providers or study coordinators. Because 
neither of the studied treatments are experimental or associated with above 
average risk, we do not anticipate any serious adverse events; nonetheless, 
these will be tracked. Participants will have access to a 24/7 phone number 
to reach research or clinical staff with concerns. All adverse events will be 
recorded and reported to the study PI. 
We do not anticipate any conditions that would trigger a suspension or 
termination of the research.
14.Withdrawal of Subjects
Participants may withdraw from the study at any time without penalty and will 
continue to receive the clinical standard of care. A subject may be withdrawn 
from the study without her consent at the discretion of the physician and study 
staff if they believe she no longer meets study inclusion criteria or if she meets 
exclusion criteria, or if they believe that it is not in her best interest to continue 
study participation i.e., desire to undergo surgical treatment. Investigators may 
withdraw a subject if the subject is not following the study protocol. If a woman is 
withdrawn from the study either at her own discretion or that of the research staff, 
she may continue with conservative or surgical management of her IC/BPS in the 
usual fashion. We will collect a withdrawal Global Response Assessment to use 
for her progress and will utilize her data up until the time point that she is 
withdrawn from the study. 
To minimize withdrawal from the study, patients will be randomized after they 
have had what they feel to have been adequate time to consider whether or not 
they would like to participate in the study and they provide consent. We will 
document reasons for withdrawal from the study if the participant willingly 
provides this information. We will report eligibility criteria not met or reasons for 
declining participation in the study if the participant willingly provides this 
information. The withdrawal procedure is clearly documented in the study 
consent.
15.Data Management/Confidentiality

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Participants will be given a de-identified study subject number. Data collection 
sheets and questionnaires will contain the subject number. No other patient 
identifiers will be collected on study forms.  PHI including patient name, date of 
birth, phone number, and medical record number will be collected to track 
appointments and ensure patient follow-up. The data collection, HIPAA and 
consent forms will be maintained in a locked file cabinet in the locked Eubank 
research office. A separate folder will be designated for each participant. PHI will 
not be entered into the study database. The link between PHI and study IDs will 
be kept on a password protected computer on a secure UNM OBGYN department 
server. 
The study database does not include sensitive information or information 
requiring additional protection.
Study binders will be kept in a locked cabinet in the research administrative area. 
In order to further ensure patient confidentiality, the identifying information will 
be kept separately from the numbered study files in a locked cabinet.
Electronic data entry will be performed on REDCAP, using the de-identified 
subject study number.  The electronic data and subject link will be encrypted, 
password protected, and stored on the secure UNM OBGYN department server. 
This server’s electronic security is monitored / maintained by the Health Sciences 
Library and Informatics Center (HSLIC). A REDCAP database will be created to 
collect, store and manage the data. REDCAP databases are reposed securely and 
all data entered is de-identified. The REDCAP database is only accessible using 
an individual unique login and password and access is only provided to co-
investigators.  Access is restricted to co-investigators and research staff and will 
be protected using the unique REDCAP login and password provided to each co-
investigator.
Access to the files and REDCAP will be restricted to research personnel and 
Investigators and will be locked or protected using the unique REDCAP login and 
password provided to each co-investigator. The data will be stored for 5 years 
after completion of analysis and then will be destroyed.
A Certificate of Confidentiality will not be used to protect data from forced release. No 
identifying or study related data will be transported to outside locations. There will be no 
audio or video recordings or photographs taken.
16.Data and Specimen Banking
As stated above, the data collection, HIPAA and consent forms will be maintained 
in a locked file cabinet in the Eubank research area. A separate file will be 
designated for each participant. A key matching study number to subject’s name 
will be stored on a password protected computer on a secure UNM OBGYN 
department server. In order to further ensure patient confidentiality, the 
identifying information will be kept separately from the numbered study files in a 
locked cabinet. The data will be maintained for 5 years after completion of the 
study and then destroyed.

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No specimens will be archived for future use.
17.Risks to Subjects
Risks of enrollment in the study include loss of confidentiality. We will take 
every measure to try to ensure the security and confidentiality of participants. 
Participants will be recruited in a private room or in a private location via phone 
or HIPAA compliant ZOOM and will have ample time to consider whether they 
want to participate in the study. Also, locked cabinets will be used to protect 
patient consent information and collected data. The link identifying patients and 
their study numbers will be also stored on a password protected computer on a 
secure UNM OBGYN department server.
There are minimal risks with the intervention arm of this RCT (yoga and 
mindfulness).  Yoga therapy is associated with low risks, such as muscle 
discomfort or strain though this is rare.  Emotional discomfort due to the 
reflective nature of this therapy is also possible. Both treatment randomizations in 
this study are well established as options for IC/BPS with an excellent safety 
profile.
Pregnant women will not be included in the study, so there is no risk to 
embryos/fetuses. Participants will need to have a negative urine pregnancy test in 
the last 3 months prior to enrollment or have documentation of a hysterectomy or 
tubal ligation. If they are pregnant, the patient meets exclusion criteria and will be 
ineligible to participate. 
There are no risks to those who are not subjects.
18.Potential Benefits to Subjects
The patients enrolled are already opting for first line treatment of their IC/PBS and 
potential use of over the counter medications. Participation in this study may help to 
improve an individual participant’s condition, but it is also possible that the condition 
may not improve. There is no guarantee that any individual will personally benefit by 
participating in this research study. Women assigned to the yoga and meditation group 
will also receive 1) a video that will instruct them on use of yoga that may help with 
IC/BPS symptoms (designed by a physical therapist who specializes in caring for IC/BPS 
patients) and 2) a meditation app. that will be provided to the patient for approximately 3 
months (the study will pay for it for that length of time). Participation in this study may 
provide information that may help other people who have a similar medical problem in 
the future. The literature supports improvement of QOL in similar conditions such as 
endometriosis or primary dysmenorrhea. 
19.Recruitment Methods
The Urogynecology clinics at UNM Eubank, and SRMC have a large referral 
population of patients with pelvic floor conditions such as IC/BPS. Subjects will 
be identified in the clinics at UNM Eubank clinic and SRMC by investigators 

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when thy present either in person or virtually (telephone or Zoom visits) for visits 
for IC/BPS care. The patients will be counseled about possible treatment options 
for IC/BPS and they will be introduced to the study and provided with written 
information that may help them decide if participation in the study is right for 
them. Subjects are encouraged to consult with family, friends, and primary health 
care providers, as well as communicate any questions they may have before 
beginning the written consent process. We will request a waiver of HIPAA 
authorization for recruitment purposes.  
If a woman declines to participate or is withdrawn from the study either by her 
desire or that of the research staff, she will be offered the same treatment options. 
Her follow up appointments will be the same regardless of participation in the 
study.
Potential participants may also self-identify through a recruitment material flyer that will 
be placed in Eubank clinic restrooms, waiting area and in the OB/GYN department at 
UNM. The proposed recruitment flyer is uploaded in the supplemental materials section. 
We will also plan to recruit using social media and at IC/BPS support groups, and over 
the radio. The proposed wording is included in the website advertisement in the 
supplemental materials section. 
20.Provisions to Protect the Privacy Interests of Subjects
Privacy concerns are taken into account with every patient seen at the UNM and 
SRMC clinics. Participants approached and/or interviewed in the clinic setting 
will be in either private offices or examination rooms in the clinics, personal 
Zoom or on telephone calls that are HIPAA compliant. All staff, including 
research staff, are well-versed in sensitive health care discussions and procedures. 
Telephone interviews for recruitment and study data gathering are conducted in 
the research staff area or private physician offices, where all staff have received 
CITI Training.  The office area designated for the entire Urogynecology research 
staff is isolated from the clinical administrative staff area, providing protection for 
participants and potential participants during screening, recruitment, study-
designated calls, and data entry. All study sheets used to collect patient 
information will be de-identified. 
At all times throughout the clinical investigation, confidentiality will be observed by all 
parties involved. All data will be secured against unauthorized access. Privacy and 
confidentiality of information about each subject will be preserved in study reports and in 
any publication. Each subject participating in this study will be assigned a unique 
identifier. An IRB-approved HIPAA authorization within the consent is required to be 
given to the patient. All documents containing personal health information (screening 
logs, consent documents, data forms) are maintained in locked cabinets with access 
available only to research staff and investigators. Data is entered into a password 
protected system. No individual identifiers are entered into the system. The sole link with 
personal information is maintained by the research team on a password protected 
computer on a secure UNM OBGYN department server with access limited to authorized 
research staff and investigators. This information is only to be used at the study center.

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21.Economic Burden to Subjects
There are no study costs to the participant outside of what would be recommended for 
standard care. The meditation app will be provided in kind from UNM if funds are 
available. There is the need for a small amount of data for Calm App, however as part of 
the study we will not be offering to compensate for this. 
Due to COVID-19 our initial visits are remote, as will be our follow up visits thus no 
transportation costs will be incurred. We will plan on using a prior physical exam 
performed by a trained gynecologist or urogynecologist in the last 2 years as a baseline 
exam. 
Responsible Party
Research Procedures
Number of 
Samples/Procedures
Study
3rd Party Payer 
or Participant
Online Yoga
1
X
Calm App
3 month subscription
X
           
 
Responsible Party
Standard of Care Procedures
Number of 
Samples/Procedures
Study
3rd Party Payer 
or Participant
Clinic Visit- remote
1
X
Weekly phone visit- remote
11
X
3 month follow up- remote
1
X
22.Compensation
The patient will receive the following compensation: For completion of the study, each 
patient will be compensated with a merchant card worth $60 total. They will receive a 
$10 merchandise card at their initial study visit (enrollment) and $50 merchandise card at 
their 3-month follow-up visit. This payment is reasonable compensation for the 
inconvenience of participating in a research study due to the additional time the study 
questionnaires will require from the participant. Participants will receive access to the 
meditation app and yoga video (if in the mindfulness/intervention arm) and both groups 
will receive close follow-up and attention from the research staff.  At the end of the study 
women in the standard care group will receive a 3 month subscription to the Calm App. 
23.Compensation for Research-Related Injury
If participants are injured or become sick as a result of this study, which is extremely 
unlikely given the nature of the interventions, UNMHSC will provide emergency 
treatment at the study participant’s cost. No commitment is made by the University of 
New Mexico Health Sciences Center to provide free medical care or money for injuries to 
participants of the study. Reimbursement for treatment for all related costs of care will be 
sought from the participant insurer, managed care plan, or other benefits program. The 
participant will be responsible for any associated co-payments or deductibles required by 
the insurance. Participants will be encouraged to report any illness or injury they believe 
to be related to the study to the investigator or research staff. Participants will be given 
telephone contact information for the Urogynecology office for the purpose of asking any 
questions or stating any concerns about the study or treatment as a research subject. They 

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may also be directed toward the HRPO. This language will be stated in the consent 
document, and reviewed during the informed consent process.
24.
Consent Process
Patients will be approached about the research study at the Urogynecology clinic or 
via virtual consultation at UNM Eubank or SRMC during a discussion for the 
management of IC/PBS. Each patient undergoes counseling in a private room with a 
closed door to ensure privacy. The physicians in the Urogynecology division and 
research staff will be able to given consent letter to patients to allow for inclusion. 
Our division routinely treats this condition and are highly qualified to counsel 
patients regarding the risks, benefits, alternatives for the treatment. Care will not be 
withheld if they decide not to participate. If the patient prefers, she may also be 
counseled about study participation via ZOOM or phone following her clinic 
appointment by providers or study personnel. 
The patients who would like to participate in the study will be given the consent 
letter. Given low risk intervention nature of this trial and the often virtual nature due 
to the pandemic a consent letter will be utilized instead of a consent form requiring 
participant’s signature. By enrolling in the study they will be by proxy giving their 
consent. 
Participants will have these multiple opportunities to ask any questions and they 
will also be provided with the clinic’s contact information to get in touch with 
research investigators to address any additional questions or concerns. 
Subjects will be reassured that participation is completely voluntary and does not 
affect their treatment, their relationship with their providers, or the university to 
minimize the possibility of coercion or undue influence.  The patients will be asked 
that they understand the opportunity to participate and their complete freedom to 
decline.  This will also be asked if they understand and if they have any questions.  
There is no minimum time period needed between informing the patient of the 
study and time of consent.  Subjects will be encouraged to take as much time as 
they need. 
This study will obtain HIPAA authorization prior to enrollment. HIPAA 
authorization will be reviewed with all participants by the physician or research 
staff obtaining consent. Specific information that will be obtained includes prior 
medical history, surgical history, reproductive health history including child 
bearing, drug allergies, age, and ethnicity. This information will obtained by health 
care providers, not research coordinators, as deemed necessary for a more complete 
and accurate medical history of the patient.
Subjects not fluent in English:

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Patients will be consented with a certified translator if Spanish speaking. Spanish-
speaking patients will be offered information about risks, benefits, and 
alternatives to study participation in a private setting and given adequate time to 
consider the risks and benefits of the study prior to offering consent or declining 
to participate.  Yoga tutorial and Calm App is available in Spanish for patients.  
The Spanish consent will be translated from the English consent once the English 
consent is approved, and we will submit a modification in Huron IRB to update 
the study with Spanish materials in the future.
Cognitively Impaired Adults/Adults Unable to Consent/Use of a Legally 
Authorized Representative:
NA. Cognitively impaired subjects will not be included in this study.
Subjects who are not yet adults (infants, children, teenagers):
NA. Only subjects ≥ 18 years of age will be included in this study. 
Waiver or Alteration of Consent Process (consent will not be obtained, required 
element of consent will not be included, or one or more required elements of 
consent will be altered) 
NA. There will be no waiver or alteration of the consent process.
25.Documentation of Consent
a.
Describe if you plan to use a consent form to document consent.  N/A we will 
be using a consent letter. 
b.
If the study is collecting and/or storing tissue samples, include a Tissue Banking 
Consent Form (and Authorization if the specimens will be accompanied by 
PHI).
i. N/A we will not be collecting tissue samples. 
c.
Describe if you plan to obtain consent but will be using a script, information 
sheet, or other mechanism.  If you will obtain consent verbally, attach a consent 
script and information sheet, if you will be providing one.  If you will be 
obtaining consent via an on-line survey, please use the survey cover letter 
consent template on the HRPO website and include your email script with your 
submission. 
Complete the checklist for “Waiver of Documentation of Consent” in the 
Checklists section of this Protocol Template.  If you will be excluding or 
modifying one or more of the required elements of consent you will also need to 
request an Alteration of Consent.
We will be using a Consent letter for documentation of consent given low risk 
nature of study, see attached in supplemental forms. 

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26.Study Test Results/Incidental Findings
We do not intend to share study test or procedure results with study participants, but as 
all of their data collected is subjective and directly from them, they will be aware of all 
the data/information in the study regarding them. Additionally, we do not anticipate that 
the research being conducted will result in incidental findings. Every patient will receive 
the practice’s standard of care regarding workup of IC/PBS, which may include different 
laboratory tests, urine culture, cystoscopy or urodynamic testing if unclear cause of pain, 
or imaging studies, as determined by their other active medical issues. These results are 
not directly a part of the research being conducted and will hence be disclosed to the 
patient. They will not, however, affect randomization. 
27.Sharing Study Progress or Results with Subjects
We do not intend to share study progress with participants while the study is underway as 
not to introduce bias. We do not intend to seek out study participants to disseminate 
information once the study is complete. Women who are interested in the results will be 
provided the information where to read the manuscript once it is published. Study results 
for individual participants will not be shared.  
28.Inclusion of Vulnerable Populations
N/A. There will not be any vulnerable populations included in this study.
29.Community-Based Participatory Research
N/A. There will be no involvement of the community in this research. 
30.Research Involving American Indian/Native Populations
N/A. This research does not specifically target this population. If an American 
Indian woman is a candidate for the study, she will be offered participation if she 
is able to speak/read/write in English or Spanish.
31.
Transnational Research
N/A. This study is domestic. 
32.
Drugs or Devices
N/A.  There is no drug or device utilized in this study. 
33.
Principal Investigator’s Assurance
By submitting this study in the Click IRB system, the principal investigator of this study 
confirms that:
☒ The information supplied in this form and attachments are complete and correct.  
☒ The PI has read the Investigator’s Manual and will conduct this research in accordance 
with these requirements. 
 ☒ Data will be collected, maintained and archived or destroyed per HSC Data Security 
Best Practices, including:

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1. Best Practice for data collection is for it to be directly entered onto a data 
collection form that is in a secured access folder on an HS drive behind a firewall, 
or in a secure UNM Data Security approved system such as REDCAP.
2. Data collection of de-identified data, if done in a clinical setting or other setting 
that does not allow direct entry into a secured system, may be done temporarily 
using a personal or university owned electronic storage device or hard copy 
document. The important security safeguard is that no identifiers be include 
if the data is entered or stored using an untrusted device or storage.
3. Permanent (during data analysis, after study closure) storage must reside on 
HSC central IT managed storage. Processing of data (aggregation, etc.) are to be 
carried out in such a way as to avoid creating/retaining files on untrusted storage 
devices/computers. Trusted devices are HSC managed and provide one or more of 
following safeguards: access logs, encryption keys, backups, business continuity 
and disaster recovery capabilities.
4. Alternate storage media must be approve by HSC IT Security as meeting or 
exceeding HSC central IT provided security safeguards.

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34.CHECKLIST SECTION
This section contains checklists to provide information on a variety of topics that require special 
determinations by the IRB.  Please complete all checklists relevant to your research.
35.Partial Waiver of Consent for Screening/Recruitment
Complete this checklist if you are requesting a partial waiver of consent so that you can review 
private information to identify potential subjects and/or determine eligibility prior to 
approaching potential subjects for consent or parental permission.
We are requesting a partial waiver of consent for screening and recruitment purposes.
A. Describe the data source that you need to review (e.g., medical records):
We would review medical records to ensure that patients have a diagnosis of 
IC/BPS and not an alternative diagnosis (such as recurrent UTI) that would 
make them ineligible for the study.
B. Describe the purpose for the review (e.g., screening):
We would need to review records for screening purposes to ensure that the 
patients meet eligibility criteria.
C. Describe who will conducting the reviews (e.g., investigators, research staff):
The reviews of the medical records will be by research staff and investigators 
in advance of patients’ clinical visits, so that recruitment can be optimized.
D. Do all persons who will be conducting the reviews already have permitted access to the 
data source?
      
 Yes
            
 No. Explain:      
i. Verify that each of the following are true or provide an alternate 
justification for the underlined regulatory criteria:
1. The activity involves no more than minimal risk to the subjects 
because the records review itself is non-invasive and the results of the 
records review will not be used for any purposes other than those 
described above.
 True
 Other justification:      
2. The waiver or alteration will not adversely affect the rights and 
welfare of the subjects because eligible subjects will be approached for 
consent to participate in the research and are free to decline.  Further, 
the information accessed during the records review will not be 

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disclosed to anyone without a legitimate purpose (e.g., verification of 
eligibility).
 True
 Other justification:      
3. The research could not practicably be carried out without the waiver or 
alteration because there is no other reasonably efficient and effective 
way to identify who to approach for possible participation in the 
research.  
 True
 Other justification:      
4. Whenever appropriate, potentially eligible subjects will be presented 
with information about the research and asked to consider 
participation.  (Regulatory criteria: Whenever appropriate, the 
subjects will be provided with additional pertinent information after 
participation.)
 True
 Other justification:      
36.Partial Waiver of HIPAA Authorization for Screening/Recruitment
Complete the following additional questions/attestations if the records you will review to identify 
potential subjects and/or determine eligibility include Protected Health Information (PHI).
We are requesting a partial waiver of HIPAA authorization for screening/recruitment. We will 
review medical records of participants to ensure that they are eligible for the study, in particular 
to review if they have a clinical diagnosis of IC/BPS, and to ensure they don’t have an alternative 
diagnosis that would make them ineligible.
37.Waiver of Documentation of Consent
Complete this checklist if you intend to obtain consent verbally but will not be obtaining 
signatures from subjects on a consent form to document consent.  Waivers of documentation of 
consent are commonly requested when using scripts, information sheets, or email or survey 
introductions to present the elements of consent instead of using a traditional consent form.
A. Are you requesting a waiver of documentation of consent for some or all 
subjects?
X All. Explain: When patients are unable to present in person to the clinic due 
to COVID restrictions, and are having all virtual visits such as HIPAA-
compliant Zoom visits or telephone visits, they will be unable to provide 
written, documented consent.  Therefore, we request the ability to email or 
mail them a consent letter to all patients with virtual visits or hand out a 
consent letter to those in person that allows us to explain the risks and benefits 

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of the study to them after the verbal conversation of consent, and explain to 
them that participation in surveys or the interventions from then forward 
would constitute consent.
B. Provide justification for one of the following:
i.
That the only record linking the subject and the research would be the 
consent document and the principal risk would be potential harm 
resulting from a breach of confidentiality. Each subject will be asked 
whether the subject wants documentation linking the subject with the 
research, and the subject's wishes will govern.
     
ii.
That the research presents no more than minimal risk of harm to 
subjects and involves no procedures for which written consent is 
normally required outside of the research context.
The minimal risk of mindfulness practice and yoga or usual care is 
such that normally, if performing these practices in everyday life, no 
informed consent would be required for these procedures.
C. Do you intend to provide subjects with a written statement regarding the 
research in lieu of a traditional consent form?
 Yes. Please attach a copy to your submission in Click.
 No
38.Alteration of Consent
Complete this checklist if you intend to obtain consent but will be eliminating or altering one or 
more of the required elements of consent. Alterations of consent are commonly requested for 
research involving deception or for minimal risk research when an abbreviated consent is 
desired and one or more of the required element are not relevant to the research.
Note: FDA-regulated research is not eligible for an alteration of consent.
A. Which element(s) of consent do you wish to eliminate and why?
     
B. Which element(s) of consent do you wish to alter and why?
     
C. Provide justification for each of the following regulatory criteria:
i.
The research involves no more than minimal risk to the subjects:
     

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ii.
The waiver or alteration will not adversely affect the rights and 
welfare of the subjects:
     
iii.
The research could not practicably be carried out without the waiver or 
alteration:
     
iv.
Whenever appropriate, the subjects will be provided with additional 
pertinent information after participation:
     
N/A we are not requesting an alteration of consent. 
39.Full Waiver of Consent/Parental Permission
Complete this checklist if you are requesting a full waiver of consent for all subjects or 
certain subject groups (e.g., retrospective cohort).  Full waivers of consent are commonly 
requested when the research does not include any opportunity for interaction with subjects 
(e.g., chart review).
Note: FDA-regulated research is not eligible for a full waiver of consent using these criteria.  If 
you believe that your FDA-regulated research may be eligible for a waiver under another 
mechanism, such as planned emergency research, contact the HRPO for assistance in 
determining what information to provide to the HRRC.
A. Are you requesting a waiver for some or all subjects?
 All
 Some. Explain:      
B. Provide justification for each of the following regulatory criteria:
i.
The research involves no more than minimal risk to the subjects:
     
ii.
The waiver or alteration will not adversely affect the rights and 
welfare of the subjects:
     
iii.
The research could not practicably be carried out without the waiver or 
alteration:
     

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iv.
Whenever appropriate, the subjects will be provided with additional 
pertinent information after participation:
     
N/A. We are not requesting a full waiver of consent/parental 
permission.
40.Full Waiver of Consent/Parental Permission (Public Benefit or Service 
Programs)
Complete this checklist if you are requesting a full waiver of consent for all subjects or 
certain subject groups (e.g., retrospective cohort) and the research involves the evaluation of 
a public benefit or service program.  
A. Are you requesting a waiver for some or all subjects?
 All
 Some. Explain:      
B. Provide justification for each of the following regulatory criteria:
i.
The research or demonstration project is to be conducted by or subject 
to the approval of state or local government officials and is designed to 
study, evaluate, or otherwise examine: (i) public benefit or service 
programs; (ii) procedures for obtaining benefits or services under those 
programs; (iii) possible changes in or alternatives to those programs or 
procedures; or (iv) possible changes in methods or levels of payment 
for benefits or services under those programs:
     
ii.
The research could not practicably be carried out without the waiver or 
alteration.
     
N/A. We are not requesting a full waiver of consent/parental 
permission.
41.Full Waiver of HIPAA Authorization (Checklist)
Complete this checklist if you are requesting a full waiver of the requirement to obtain 
HIPAA authorization for all subjects or certain subject groups (e.g., retrospective cohort).  
Full waivers of HIPAA authorization are commonly requested when the research does not 
include any opportunity for interaction with subjects (e.g., chart review).
A. Are you requesting a waiver of authorization for some or all subjects?
 All

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 Some. Explain:      
B. Describe your plan to protect health information identifiers from improper use 
and disclosure:
     
C. Describe your plan to destroy identifiers at the earliest opportunity consistent 
with conduct of the research (absent a health or research justification for 
retaining them or a legal requirement to do so):
     
D. Describe why the research could not practicably be conducted without the 
waiver or alteration:
     
E. The PHI accessed or recorded for identification/screening purposes will not be 
reused or disclosed to (shared with) any other person or entity, except as 
required by law, for authorized oversight of the research study, or for other 
research for which the use or disclosure of the PHI would be permitted under 
the Privacy Rule.
 True
 False
N/A. We are not requesting a full waiver of HIPAA. 
42.Other Waiver Types (Checklist)
If you are seeking another waiver type (e.g., Planned Emergency Research, Waiver of 
Parental Permission to Protect Child Participants, Enforcement Discretion for In Vitro 
Diagnostics, etc. contact the HRPO office for assistance in determining what information to 
submit for the HRRC’s consideration.
N/A. We are not requesting other waiver types. 
43.Vulnerable Populations (Checklist)
A. Adults with Cognitive Impairments
N/A. Adults with cognitive impairments will not be included in this study. 
B. Children
N/A. Children will not be included in this study. 

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C. Pregnant Women and Fetuses
N/A. Pregnant women and fetuses not be included in this study.
D. Neonates of Uncertain Viability or Nonviable Neonates
N/A. Neonates of uncertain viability or nonviable neonates not be included in this study.
E. Nonviable Neonates
N/A Nonviable neonates will not be included in this study. 
F. Biomedical and Behavioral Research Involving Prisoners
N/A. Prisoners will not be included in this study. 
44.Medical Devices (Checklist) 
N/A. No medical devices will be utilized.  
45.Export Control (Checklist)
N/A. There will not be any export control concerns. 
46.Data Transfer/Sharing (Checklist)- 
Complete this checklist if the research involves transferring/sharing of data with an external 
entity (institution, company, etc.). 
A. Will data be transferred/shared with an external entity (institution, company, etc.)?  
 Yes
X No. The remainder of this section does not apply.  
47.Specimen Transfer/Sharing (Checklist)
Complete this checklist if the research involves transferring/sharing of specimens with an 
external entity (institution, company, etc.). 
A. Will specimens be transferred/shared with an external entity (institution, company, etc.)? 
      
 Yes
X No. The remainder of this section does not apply. 
ii American Urological Association. Diagnosis and Treatment of Interstitial Cystitis/ Bladder Pain Syndrome. 2014. 
ii Pang R, Ali A. The Chinese approach to complementary and alternative medicine treatment for interstitial 
cystitis/bladder pain syndrome. Transl Androl Urol. 2015;4(6):653-661. doi:10.3978/j.issn.2223-4683.2015.08.10
iii Atchley MD, Shah NM, Whitmore KE. Complementary and alternative medical therapies for interstitial cystitis: an 
update from the United States. Transl Androl Urol. 2015;4(6):662-667. doi:10.3978/j.issn.2223-4683.2015.08.08
iv Mira TAA, Buen MM, Borges MG, Yela DA, Benetti-Pinto CL. Systematic review and meta-analysis of 
complementary treatments for women with symptomatic endometriosis. Int J Gynaecol Obstet. 2018;143(1):2-9. 
doi:10.1002/ijgo.12576
v Vandyken C, Hilton S. Physical Therapy in the Treatment of Central Pain Mechanisms for Female Sexual Pain. Sex 
Med Rev. 2017;5(1):20-30. doi:10.1016/j.sxmr.2016.06.004

PROTOCOL TITLE: MYPAICE: Mindfulness and Yoga for Pain with Interstitial Cystitis 
Evaluation
Page 32 of 32
vi Economides M, Martman J, Bell MJ, Sanderson B. Improvements in Stress, Affect, and Irritability Following Brief 
Use of a Mindfulness-based Smartphone App: A Randomized Controlled Trial. Mindfulness (N Y). 2018;9(5):1584-
1593. doi:10.1007/s12671-018-0905-4
vii Gotink RA, Meijboom R, Vernooij MW, Smits M, Hunink MG. 8-week Mindfulness Based Stress Reduction induces 
brain changes similar to traditional long-term meditation practice - A systematic review. Brain Cogn. 2016;108:32-
41. doi:10.1016/j.bandc.2016.07.001
viii Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ et al. Cognitive Behavioral Therapy or 
Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain A Randomized Clinical 
Trial. JAMA 2016;315(12):1240-1249.
ix Gaylord SA, Palsson OS, Garland EL, Faurot KR. Coble RS, Mann JD et al. Mindfulness Training Reduces the 
Severity of Irritable Bowel Syndrome in Women: Results of a Randomized Controlled Trial. Am J Gastroenterol 
2011;106:1678-1688
x Cash E et al. Mindfulness meditation alleviates fibromyalgia symptoms in women: results of a randomized clinical 
trial. Ann Behav Med 2015;49(3):319-30.
xi Landis, J.R., Williams, D.A., Lucia, M.S. et al. The MAPP research network: design, patient characterization and 
operations. BMC Urol 14, 58 (2014). https://doi.org/10.1186/1471-2490-14-58
xii Clemens JQ, Clauw DJ, Kreder K, et al. Comparison of baseline urological symptoms in men and women in the 
MAPP research cohort. J Urol. 2015;193(5):1554-1558. doi:10.1016/j.juro.2014.11.016
xiii Propert KJ, Mayer RD, Sant GR, Hanno KM, Peters KM, Kusek JW et al. Responsiveness of Symptom Scales for 
Interstitial Cystitis. J Urol. 2005  (67-1) 55-59. doi:10.1016/j.urology.2005.07.014
xiv Nicholas MK, McGuire BE, Asghari A. A 2-item short form of the Pain Self-efficacy Questionnaire: development 
and psychometric evaluation of PSEQ-2. J Pain. 2015;16(2):153-163. doi:10.1016/j.jpain.2014.11.002
xv K.J. Propert, R.D. Mayer, Y. Wang,  et al. Responsiveness of symptom scales for interstitial cystitis. Urology, 67 
(2006), pp. 55-59
xvi Julian LJ. Measures of anxiety: state-trait anxiety inventory (STAI), beck anxiety inventory (BAI), and hospital 
anxiety and depression scale-anxiety (HADS-A). Arthritis Care Res. 2011; 63: S467- S472.
xvii Balestroni, Gianluigi, and Giorgio Bertolotti. "EuroQol-5D (EQ-5D): an instrument for measuring quality 
of life." Monaldi Archives for Chest Disease 78.3 (2012).
xviii O'Leary MP, Sant GR, Fowler FJ, Jr., Whitmore KE, Spolarich-Kroll J. The interstitial cystitis symptom index 
and problem index. Urology 1997 May;49(5A Suppl):58-63.
xix Kanter G, Komesu YM, Qaedan F, et al. Mindfulness-based stress reduction as a novel treatment for interstitial 
cystitis/bladder pain syndrome: a randomized controlled trial. Int Urogynecol J. 2016;27(11):1705-1711. 
doi:10.1007/s00192-016-3022-8