Protocol for Patient-Centered Versus Physician-Centered Counseling Video for Midurethral Slings an RCT
Phase: NA
Conditions: Stress Urinary Incontinence, Satisfaction
Sponsor: University of New Mexico

PROTOCOL TITLE: Protocol for Patient-Centered versus Physician-Centered Counseling Video for 
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Protocol for Patient-Centered versus Physician-
Centered Counseling Video for Midurethral Sings An 
RCT:  MU-Vi: MidUrethral Sling Videos 
 
 
 
 
Acronym: MU-Vi 
 
Principal Investigator: 
Yuko M. Komesu MD 
Associate Professor Obstetrics & Gynecology 
University of New Mexico Health Sciences Center 
 
 
Total Revision History:  
Version Number: 5 
Version Date: 9/25/17 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL TITLE: 
Protocol for Patient-Centered versus Physician-Centered Counseling Video 
for Midurethral Sings An RCT: MidUrethral Sling Videos 
PRINCIPAL INVESTIGATOR: 

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Name: Yuko Komesu, MD 
Obstetrics & Gynecology, Division of Urogynecology 
VERSION NUMBER: 
 
4 
 
DATE: 
5/3/17 
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) 
 
HHS (Department of Health and Human Services) 
 
VA 
 
Other:       
 
Is this a clinical trial under ICH-GCP E6?   
 Yes   
 No 
If yes, please confirm that the research team is familiar with and agrees to comply 
with the investigator requirements cited in ICH-GCP E6.  
 Yes   
 No  
ICH-GCP E6 can be accessed by copying and pasting this URL into your 
browser: http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf 
 
 
 

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Table of Contents 
1. 
Objectives .................................................................................................................... 4 
2. 
Background .................................................................................................................. 5 
3. 
Study Design................................................................................................................ 6 
4. 
Inclusion and Exclusion Criteria ................................................................................. 6 
5. 
Number of Subjects ..................................................................................................... 7 
6. 
Study Timelines ........................................................................................................... 7 
7. 
Study Endpoints ........................................................................................................... 8 
8. 
Research Setting .......................................................................................................... 8 
9. 
Resources Available .................................................................................................... 8 
10. 
Prior Approvals ...................................................................................................... 10 
11. 
Multi-Site Research ................................................ Error! Bookmark not defined. 
12. 
Study Procedures ................................................................................................... 10 
13. 
Data Analysis ......................................................................................................... 12 
14. 
Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 13 
15. 
Withdrawal of Subjects .......................................................................................... 13 
16. 
Data Management/Confidentiality ......................................................................... 13 
17. 
Data and Specimen Banking .................................................................................. 14 
18. 
Risks to Subjects .................................................................................................... 14 
19. 
Potential Benefits to Subjects ................................................................................ 15 
20. 
Recruitment Methods ............................................................................................. 15 
21. 
Provisions to Protect the Privacy Interests of Subjects .......................................... 16 
22. 
Economic Burden to Subjects ................................................................................ 16 
23. 
Compensation ........................................................................................................ 17 
24. 
Compensation for Research-Related Injury ........................................................... 17 
25. 
Consent Process ..................................................................................................... 18 
26. 
Documentation of Consent .................................................................................... 19 
27. 
Study Test Results/Incidental Findings ................................................................. 19 
28. 
Sharing Study Progress or Results with Subjects .................................................. 19 
29. 
Inclusion of Vulnerable Populations ...................................................................... 19 
30. 
Community-Based Participatory Research ............................................................ 20 
31. 
Research Involving American Indian/Native Populations ..................................... 20 
32. 
Transnational Research .......................................................................................... 20 
33. 
Drugs or Devices.................................................................................................... 20 
Checklist Section .............................................................................................................. 21 
 

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1. Objectives 
 
Management of Pelvic Floor Disorders (PFDs) is individualized according to a patient’s 
symptomatology and quality of life.  Although conservative measures exist, patients may 
elect for surgical management.  The decision making process for surgery is complex. It is 
well documented that patient’s lack understanding prior to their surgical procedures1, 2. 
Preparedness for MUS surgery is related to a patient’s comprehension of the purpose, 
risks, benefits, and complications3.  Patients who are more prepared prior to surgery have 
been proven to have greater postoperative satisfaction3. Therefore, it is essential to 
improve patients’ preparedness and enhance patients’ understanding of realistic 
expectations of post-operative outcomes.    
 
Our long-term goal is to improve patient-centered preparedness and satisfaction when 
considering surgery.  Previous studies by the Preliminary Study of Peer Support Groups 
and Pelvic Floor Disorders have demonstrated trends in improvement for preparedness 
and decision conflict with the use of peer focus groups.  However, peer support groups 
are a costly process and there may be many barriers to participate.  
 
A key gap in the literature is how to improve patient preparedness for surgery and 
improve satisfaction through the use of peer counseling in a manner that is convenient 
for patients, reproducible and low cost.  Technological advances with multimedia may 
assist in bridging this gap. With ease-of-access to mobile electronic devices, videos are 
effective tools to prepare patients for surgery. The purpose of this randomized controlled 
clinical trial is to determine if a patient-centered video improves satisfaction and 
preparedness compared to a physician-centered video.   
 
The first objective of this research is to develop two videos to counsel patients who have 
elected to undergo a MUS procedure. One video will be created from a physician-
centered approach. The second video will be a patient-centered perspective. The second 
objective of this research is to compare the impact of video counseling between women 
randomized to a physician-centered versus a patient-centered video. Our central 
hypothesis is that women randomized to a patient-centered video will report higher scores 
of satisfaction and preparedness than women randomized to the physician-centered video. 
 
Specifically, our aims for this study are: 
Aim #1: To create two videos to be used to counsel patients who have elected to undergo 
a MUS procedure.  One video will present the risks, benefits and alternatives to MUS 
surgery by a physician, mimicking traditional counseling prior to surgery. The second 
video will also explain the risks, benefits and alternatives to the MUS surgery utilizing a 
patient mentor who has undergone the MUS procedure will describe the patients’ 
perception of the information. The patient-centered video will also include topics that 
have previously been identified by focus groups as important patient-centered aspects of 
pre-surgical counseling. 
 

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Aim #2: To compare the impact of video counseling between women randomized to a 
physician-centered video and a patient-centered video. Hypothesis: Women randomized 
to a patient centered-video will report higher satisfaction and preparedness as measured 
by validated scales. They will have higher scores on the Post-operative preparedness 
questionnaire (PPQ), Preparedness Scale and the Surgical Decision Satisfaction (SDS-
PFD) questionnaire; and lower scores on the Decision Regret Scale (DRS-PFD) 
questionnaire than women randomized to view the physician-centered video prior to 
undergoing midurethral sling surgery. 
 
Aim #3: To compare a women’s decisional conflict post-operatively in women 
randomized to the physician-centered video and the patient-centered video. Hypothesis: 
There is a reduction of decisional conflict in women randomized to the patient-centered 
video. 
 
Aim #4: To determine if there are differences in anxiety scores in women who watch the 
patient-centered video versus the physician centered video.  Hypothesis:  Anxiety scores 
measured by the State Trait Anxiety Inventory (STAI: Y-6 Item) questionnaire are 
decreased by a pre-operative patient-centered counseling video. 
 
2. Background 
 
Patients poorly understand or retain information given to them by physicians.  Patient 
preparedness for surgery has been shown to influence a patient’s perception of 
surgical success4. Patient satisfaction is of increasing importance and is likely linked 
to preparedness. Realistic surgical expectations have been shown to be associated 
with higher postoperative satisfaction5. In addition, what patients feel is important to 
know about surgery may not correlate with what physicians feel is important. 
Recognizing inconsistencies, which may exist between a patient-based versus a 
physician-based framework for comprehension, may improve a patient’s 
preparedness and ultimate satisfaction with surgical care.  
 
Previous work from the Preliminary Study of Peer Support Groups and Pelvic Floor 
Disorders indicates that women desire peer support in the peri-operative period.  
Group shared appointments before sacral nerve stimulation showed a greater 
likelihood of preparedness preoperatively, which was associated positively with the 
patient’s perception of outcome6.  Furthermore, pilot peer support groups have 
indicated an improvement in preparedness.  
 
Stress urinary incontinence, or loss of urine with cough and sneeze, affects nearly 13 
million women in the US7. Mid-urethral (MUS) slings are an effective treatment and 
are the standard surgical treatment for stress urinary incontinence (SUI)8.  
Approximately 30% of women with SUI in the United States select surgical 
treatment. The risks, benefits and alternative to MUS are well described9-12, 
nonetheless patients do not recall key steps in the procedure or long-term risks of the 
procedures. Poor risk recall of MUS surgery was associated with increased decision 

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regret from the procedure9. Length of counseling prior to surgery did not improve 
recall of the procedure or its risks9.  
 
While we have found that patients feel that peer counseling improves their 
preparedness for surgery, and others have published similar results, peer to peer 
counseling is difficult and costly to arrange. Barriers to participate in peer support 
include transportation and scheduling conflicts.  One-on-one counseling is costly and 
difficult to arrange. A key gap in the literature is how to improve patient preparedness 
for surgery and improve satisfaction through the use of peer counseling, in a manner 
that is convenient for patients, reproducible and low cost.   
 
Digital videos are inexpensive, reproducible, can be easily displayed, and are time 
regulated. With ease-of-access to mobile electronic devices, videos are effective tools 
to prepare patients for surgery. A previous study by Ellet et al. has demonstrated that 
patients prefer a consent process that is enriched with multimedia presentations as 
preferred to solely receiving information from the physician13. A study evaluating 
educational videos created for radiation treatment for prostate cancer noted that 
increased patient satisfaction, preparedness, and reduced anxiety14.  
 
3. Study Design 
 
This is a randomized controlled clinical trial to 
determine if a patient centered-video improves 
satisfaction and preparedness compared to a 
physician centered-video.  The target population is 
women with stress urinary incontinence who are 
planning to have a mid-urethral sling performed. 
Women will be randomized during their pre-
operative visit to watch the physician centered-
video or patient centered-video before they are 
counseled regarding their upcoming MUS surgery 
in the usual manner during the clinic visit and prior 
to signing surgical consent.   
 
 
 
 
 
 
4. Inclusion and Exclusion Criteria 
We will recruit patients who present to the University of New Mexico 
Urogynecology practice at UNMH, Sandoval Regional Medical Center, or the 
UNM Westside clinic with stress urinary incontinence who elect to undergo a 
MUS procedure.  We selected a MUS procedure because there is well-described 

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literature of the risks, benefits, and alternatives to MUS that we will utilize to 
create the videos.  Patients who have elected to proceed with a MUS procedure 
will be offered study enrollment if they meet the inclusion and do not meet the 
exclusion criteria. 
The inclusion criteria are: 
1. Subjects are ≥ 18 years of age 
2. Planning to undergo a midurethral sling procedure 
3. Either stress urinary incontinence (SUI) or mixed urinary incontinence (MUI) 
with a positive cough stress test or SUI documented on urodynamic testing 
4. English speaking 
 
Exclusion criteria are as follows: 
1. Those who desire a concomitant POP Surgery 
2. Inability to speak/understand English  
3. Prior midurethral sling performed 
5. Number of Subjects  
 
Power Analysis: We will compare the percent of patients that feel completely prepared 
(strongly agree on the Patient Preparedness Questionnaire, a 1-6 Likert scale) between 
the two intervention groups, those randomized to a Physician-centered vs Patient-
centered video. Firoozi et al. found 30% were “completely prepared” in the standard 
office counseling group.6 However, we expect a “floor effect” where a higher percentage 
of completely prepared at 40%. As there is high satisfaction in this population that will be 
undergoing mid-urethral sling surgery. A sample size of 24 patients per group would be 
adequate to detect a difference of 40% (Physician-centered video) versus 78% (Patient-
centered video) in those being “completely prepared” with 80% power and an alpha of 
0.05.  This is a feasible power analysis since Firoozi et al found an improvement to 79% 
using the shared appointments.6 Therefore our recruitment goal will be to increase 
randomization to a total of 60 subjects, 30 patients per group, which will also allow for a 
20% loss to follow up.  
 
 
6. Study Timelines 
Based on the current surgical volume in the UNM division of urogynecology, it will take 
12 months to recruit the 43 patients; it would take 18 months to recruit~ 60 patients. 
Then, for data analysis and composition of the manuscript, we estimate that this will take 
6 months. 

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7. Study Endpoints 
First, the physician-centered and patient-centered video will be created.  Once 
developed, the primary endpoint of our study is to determine if there is a difference 
in patient preparedness and satisfaction in those women undergoing a MUS procedure 
who have watched a patient-centered versus a physician-centered video watched at 
their pre-operative visit. Our secondary endpoints include differences in 
preparedness, satisfaction and decisional conflict scores.  Our exploratory endpoint is 
to investigate differences in anxiety 6 weeks after corrective MUS surgery in those who 
undergo a pre-operative patient-centered video compared to a physician-centered 
video.  
 
Given that a MUS surgery is routinely performed currently, we do not have any safety 
endpoints. 
 
 
8. Research Setting 
The study will be performed at the University of New Mexico (UNMH), Sandoval 
Regional Medical Center (SRMC)urogynecology clinics in Albuquerque, New 
Mexico.   
All patients planning to undergo surgery will have a complete history and 
physical taken and undergo a physical exam. After recruitment, they will undergo 
the consent process, and fill out initial questionnaires in the outpatient offices.   
There are no laboratory tests in this trial other than what would be routinely 
collected prior to surgery 
There will be no involvement of any community advisory board. 
9. Resources Available 
 
Yuko Komesu, MD is a board subspecialist in Urogynecology and will serve as the PI 
for this study.  She is an experienced researcher at UNM. She has been the PI on 
multiple research trials and has successfully completed multiple randomized control 
trials at UNM.   
 
The University of New Mexico (UNM) urogynecology division operates at two main 
locations. UNM Women’s Health Urogynecology Center (UNMH) located in 

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downtown Albuquerque provides a full range of services for women with pelvic floor 
disorders. At UNM, the clinic at University of New Mexico’s Health Sciences Center 
consists of 8 exam rooms, 2 treatment rooms and 3 consult rooms with a separate 
entrance for urogynecology patients. Our second location is at Sandoval Regional 
Medical Center (SRMC), a community based facility located in Rio Rancho, New 
Mexico, a large suburb located outside of Albuquerque.  The UNM Westside clinic is 
located in the western side of Albuquerque where there are 3 examination rooms 
devoted to urogynecologic patients 
 
 
 
Clinical Research Nurse Coordinator/Research Staff: The Urogynecology Division 
employs 5 research coordinators, two student research assistants and a full time 
research administrative assistant. We also employ two research nurses through our 
NIH-funded Clinical and Translational Research Center. 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 had consistently met or exceeded recruitment goals on time. We are 
currently members of the NICHD-sponsored PFDN, and have met recruitment goals 
with high rates of follow-up and accurate data collection. In addition to PFDN 
research, Dr. Komesu is currently funded with an R01 through NCCAM (National 
Center of Complementary and Alternative Medicine), an NIH Institute. She is 
evaluating hypnotherapy versus medications in the treatment of urgency urinary 
incontinence and is evaluating their effect on brain activation and connectivity on 
fMRI. The Division has collaborated with investigators both as the coordinating and a 
contributing site; recent work includes the IUGA-sponsored Sexual Function Group 
as well as collaboration with Brown University. 
 
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 

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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, however as the 
patients are getting surgery, the urogynecology physicians are available on a 24-hour 
basis, 7 days per week for their patients requiring emergency care. 
 
10. Prior Approvals 
There will not be any approvals obtained prior to commencing the research. The 
study was presented for approval by the Departmental Chair. The signed 
Departmental Review form can be found in the “supporting documents” 
This study does not include any ionizing radiation, biologic specimens, or 
drugs. 
 
11. Study Procedures  
1. First, two videos will be created to counsel patients who have decided to undergo 
a MUS procedure.  One video, the physician-centered video, will be developed 
with well-described literature involving the risks, benefits, and alternatives to 
MUS.  Physicians from the urogynecology division will be videotaped explaining 
these risks. The second video will be the patient-centered video.  We will meet 
with the patient mentors who were a mentor in the Preliminary Study of Peer 
Support Groups and Pelvic Floor Disorders.  We will create a script with the 
patient mentors that will include the risks, benefits, and alternatives in lay terms 
as well as topics that have previously been identified by focus groups as important 
patient-centered aspects of counseling.  This will include aspects of quality of life 
factors such as catheterization and when patients can return back to work. Once 
we have created the script with the mentors who agree to be filmed; the mentors 
will be videotaped explaining these topics. All participants involved in the 
creation of the video will sign an informed consent prior to the development of 
the video.  The participants will include the physicians counseling on the video 
and women acting as mentors on the video. 
 
2. Once the videos are complete, we will perform a randomized clinical trial clinical 
trial to determine if a patient-centered versus a physician-centered video will 
increase preparedness and satisfaction.  The target population is female subjects 
with stress urinary incontinence who are planning to have a MUS procedure.  All 
subjects will be given written study consents during their clinic visit when they 
are scheduled for their MUS.  After enrollment, subject’s data collected include 
Patient Demographics: Age; self-reported race and ethnicity; body mass index 
(BMI); vaginal parity, education level, socio-economic status. Also, 
Medical/Surgical History: Medical comorbidities; prior POP surgeries or 
incontinence procedures, prior hysterectomy. They will also perform a health 
literacy assessment utilizing the validated REALM-SF questionnaire. They will 
also complete the PGI-I and STAI: Y6 questionnaire at the baseline clinic visit. 

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Once this is performed, patients will return for their standard pre-operative clinic 
visit. Patients will then be randomized once they check-in to the waiting room.   
 
Randomization:  Randomization assignment will be generated by a computer 
based randomization table and assigned by a research coordinator not otherwise 
involved in the study.  Assignments will be kept in sealed opaque envelopes 
numbered sequentially.  As an adjunct to standard pre-operative counseling, the 
physician will call the research coordinator and the next envelope in the sequence 
will be opened randomizing the patient to the patient-centered or physician 
centered video. 
 
Once randomized, patients will view the video they are assigned to in the waiting 
room utilizing video viewing devices with headphones. Once the video is 
complete, patients will receive standard pre-operative counseling for the 
midurethral sling procedure by their provider. The pre-operative counseling will 
be scripted. They will then complete the PPQ, preparedness scale, SDS-PFD, 
DCS. 
 
At the 6 week post-operative visit, they will fill out the questionnaires: SDS-PFD, 
DRS-PFD, and STAI: Y6, UDI-6, PGI-I will be completed (Table 1). The physician 
will also complete an adverse events form at that time. 
 
               Table 1: Outcomes collected at various time points 
 
 
 
The primary outcome is preparedness for surgery with an adjunct patient-
centered versus a physician-centered video at their pre-operative visit. After 
they watch the video in the waiting room, all patients will receive standard pre-
operative counseling for the midurethral sling procedure by their provider. They 
will then fill out the preparedness questionnaires. Our secondary outcome is 
satisfaction, which will also be evaluated using the SDS-PFD at her pre-
operative visit after consents and the video as well as their 6 week visit. 
The midurethral sling will be performed by surgeons in the standard fashion.   
 
Baseline 
Clinic Visit 
Immediately 
after consents 
and video 
6 weeks 
postoperatively 
PPQ 
 
X 
X 
Preparedness 
Scale 
 
X 
 
DCS 
 
X 
 
DRS-PFD 
 
 
X 
SDS-PFD 
 
X 
X 
UDI-6 
X 
 
X 
Demographics 
X 
 
 

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Outcome Measures: 
1. Patient Preparedness Questionnaire (PPQ): Assess the level of pre-operative 
preparedness according to each preparedness question.  Measured by question 
11 on the Patient Preparedness Questionnaire (PPQ): “Overall, I feel prepared 
for my upcoming surgery.” The 11-question PPQ contains questions on both 
knowledge and preparedness for the planned surgical procedure.  The PPQ has 
demonstrated construct validity properties in previous studies. 
2. Decision Regret Scale- Pelvic Floor Disorders (DRS-PFD): Validated pelvic 
floor disorder questionnaire.  It is designed to measure regret after health care 
decisions. This is a modified scale that is specific for women making decisions 
regarding surgical therapy for PFDs. 
3. Satisfaction with Decision Scale-Pelvic Floor Disorders (SDS-PFD): 
Validated pelvic floor disorder questionnaire. This is a modified 6-item 
questionnaire with a 5-point response scale to measure patient satisfaction.  
4. Urinary Distress Inventory 6 (UDI-6): This is a validated shortened version 
of the UDI questionnaire to assess symptom distress and the impact of daily life 
of urinary incontinence.  It is a 6-question instrument that correlates well with 
the longer version. 
8.  Decisional Conflict Scale (DCS): A questionnaire that has been adapted and 
validated for Pelvic Floor Disorders. This contains 16 questions with a five-
point response scale.  The mean score is multiplied by 25 to report it on a 100-
point scale with 0 correlating to no decisional conflict and 100 with extremely 
high decisional conflict. 
9. Preparedness Scale: Measures extent to which a subject that she was prepared 
pre-operatively for their surgery on a 0 to 10 scale. 
12. Data Analysis 
Data Analysis:  The main comparison is of the overall preparedness questionnaire item on 
the patient preparedness questionnaire (PPQ) between the two intervention groups of 
patients (physician- vs. patient- centered videos) using the Chi-Squared test for categorical 
data, since the questionnaire item responses are on a Likert scale. Other analyses will be 
done by a 2-way ANOVA with both intervention groups and the item members considered 
to be 2 grouping factors. 
 
Power Analysis: We will compare the percent of patients that feel completely prepared 
(strongly agree on the Patient Preparedness Questionnaire, a 1-6 Likert scale) between 
the two intervention groups, those randomized to a Physician-centered vs Patient-
centered video. Firoozi et al. found 30% were “completely prepared” in the standard 
office counseling group.6 However, we expect a “floor effect” where a higher percentage 
of completely prepared at 40%. As there is high satisfaction in this population that will be 
undergoing mid-urethral sling surgery. A sample size of 24 patients per group would be 

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adequate to detect a difference of 40% (Physician-centered video) versus 78% (Patient-
centered video) in those being “completely prepared” with 80% power and an alpha of 
0.05.  This is a feasible power analysis since Firoozi et al found an improvement to 79% 
using the shared appointments.6 Therefore our recruitment goal will be to increase 
randomization to a total of 60 subjects, 30 patients per group, which will also allow for a 
20% loss to follow up.  
 
13. Provisions to Monitor the Data to Ensure the Safety of Subjects 
There is no DSMB or individual that will be monitoring safety as these procedures, 
MUS is a common surgical procedures included in the standard of care for stress 
urinary incontinence. Additionally, there will be a form to report all adverse events 
throughout the study so this can be reported on. 
 
We do not anticipate any conditions that would trigger a suspension or termination of 
the research. 
 
14. Withdrawal of Subjects 
Any participant 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. 
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 the planned surgical procedure performed in the 
usual fashion.  
 
To minimize withdrawal from the study, patients will be randomized just before the 
procedure. According to the 2010 CONSORT guidelines, we will analyze all 
participants assessed for eligibility within the study. We will document reasons for 
withdrawal from the study including failure to meet eligibility criteria or participant 
declining enrollment into the study. We will report eligibility criteria not met or reasons 
for declining participation in the study. The withdrawal procedure is clearly 
documented in the study consent. 
 
15. Data Management/Confidentiality 
Randomization assignment will be generated by a computer based randomization table 
and assigned by a research coordinator not otherwise involved in the study.  
Assignments will be kept in sealed opaque envelopes numbered sequentially, and on 
the day of the patient’s pre-operative visit, the surgeon will call a research coordinator 
who will open the next envelope in the sequence. This de-identified study subject 
number will then be assigned to the patient. All data collection sheets and 
questionnaires will contain the subject number and day of the hospital or clinic visit. 
No other patient identifiers will be collected.  PHI including patient name, date of birth, 

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phone number, medical record number will need to be collected to track for 
appointments.  
 
The data collection, HIPAA and consent forms will be maintained in a locked file 
cabinet in the OBGYN administrative area. A separate folder will be designated for 
each participant. The offices have the additional security of being badge-access only 
for OBGYN department employees. A key matching study number to subject’s name 
will be secured in a locked file cabinet in the OBGYN research administrative area.  
 
The only PHI collected will be patient name, date of birth, medical record number and 
telephone number for site use only and to ensure patient follow up. This will not be 
entered into the database, but it will be kept with the other identifying information. 
 
The data does not include sensitive information or information requiring additional 
protection. 
 
All data will be kept in a locked file 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 in the OBGYN administrative offices at UNM 
A REDCAP database will be created through UNM to collect, store and manage the 
data. REDCAP databases are reposed securely. The REDCAP database is only 
accessible using a individual unique login and password and access is only provided to 
co-investigators.  Access is restricted to co-investigators and will be protected using 
the unique REDCAP login and password provided to each co-investigator. 
 
A Certificate of Confidentiality will not be used to protect data from forced release. No 
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 OBGYN administrative area. A separate folder will be 
designated for each participant. A key matching study number to subject’s name will 
be secured in a locked file cabinet in the OBGYN 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. The data will be 
maintained for 5 years after completion of the study and then destroyed. 
 
No specimens will be collected. . 
 
17. Risks to Subjects 
Risks of enrollment in the study include the risk of breach of confidentiality. We will take 
every measure to try to ensure the security and confidentiality of participants. This may 

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result in stigmatization or hardship. Participants will be recruited in a private room and will 
have ample time to consider whether they want to participate in the study. Also, locked 
filing cabinets will be used to protect patient consent information and collected data. The 
link identifying patients and their study numbers will be also stored in a locked cabinet. 
There are risks of stress, emotional distress, and inconvenience. There are unknown risks 
of being randomized to either a physician-centered video or a patient-centered video. 
 
 
Additionally, each patient who will be offered enrollment will already have agreed to 
a MUS surgery. There are risks inherent to these surgical procedures including 
bleeding, risk of infection, injury to surrounding organs, especially bladder perforation. 
We attempt to minimize the possibility of unrecognized injuries by performing 
cystoscopy with all of these procedures to ensure bladder integrity and to note efflux 
from each ureteral orifice. Each patient will be provided with informed consent 
regarding these risks and offered a blood transfusion in the event of life-threatening 
blood loss. Giving informed consent for these procedures is our practice’s standard of 
care and will not be altered in the study population. The patient and physician-centered 
videos are an adjunct to routine pre-operative visits.  
 
Pregnant women will not be included in the study, so there is no risk to 
embryos/fetuses. All women who are of reproductive age routinely get a pregnancy test 
the day of surgery. If they are pregnant, the patient meets exclusion criteria.  
 
There are no risks to those who are not subjects. 
 
18. Potential Benefits to Subjects 
The patients enrolled are already opting for surgical correction of their stress urinary 
incontinence. 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. Participation in this study may provide information that may help other people 
who have a similar medical problem in the future. It is unknown as to whether watching 
the physician-centered or patient-centered videos will increase satisfaction, 
preparedness, knowledge, knowledge-recall, and decrease anxiety. 
 
19. Recruitment Methods 
. 
 
The urogynecology clinic at UNMH, Westside, SRMC have a large referral population 
of patients with pelvic organ prolapse. Participants will be identified in the clinics at 
investigators. The patients will be counseled about possible treatment options for stress 
urinary incontinence including non-surgical and surgical techniques. If the patients 
surgical management by a midurethral sling procedure, 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, 

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and primary health care providers, as well as communicate any questions they may 
have before beginning the written consent process.  
 
If a woman is withdrawn from the study either by her desire or that of the research staff, 
or does not desire to participate, she will be offered the same treatment options, but she 
will not watch the videos during her pre-operative visit. Her follow up times for after 
surgery are the same regardless of participation in the study. 
 
There will be no other additional materials to recruit subjects. 
 
20. Provisions to Protect the Privacy Interests of Subjects 
Privacy concerns are taken into account with every patient. Participants approached 
and/or interviewed in the clinic setting will be in private offices or examination rooms 
where 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.  
 
Additionally, the operating rooms at UNM, SRMC, and SMCA hospital are places 
where patient privacy is respected and observed. 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 is required to be signed. All 
documents containing personal health information (screening logs, consent documents, 
data forms) are maintained in locked file 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 in locked files with access limited to authorized 
research staff and investigators. This information is only to be used at the study center.  
 
21. Economic Burden to Subjects 
 
Research Procedures 
Number of 
Samples/Procedures 
Responsible Party 
Study 
3rd Party Payer 
or Participant 
Midurethral Sling Surgery 
1 
 
 
      
      
 
 
      
      
 
 

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Standard of Care Procedures 
Number of 
Samples/Procedures 
Responsible Party 
Study 
3rd Party Payer 
or Participant 
Midurethral Sling Surgery 
1 
 
 
Pre-operative visit 
1 
 
 
Urodynamics 
1 
 
 
1-2 week post-operative visit 
1 
 
 
6 week post-operative visit 
1 
 
 
3 month post-operative visit 
1 
 
 
      
      
 
 
      
      
 
 
 
A Midurethral Sling (MUS) surgery is the most common type of surgery to correct stress 
urinary incontinence. The sling is a narrow strap made of synthetic mesh that is placed 
under the urethra and acts as a hammock to lift or support the urethra.  
 
There are no study related costs to the participants. Whether enrolled in the physician-
centered video or the patient-centered arm of the study, participants will not be billed for 
the study materials. They have already chosen to undergo surgery, and they will receive 
prior authorization from their 3rd party payers, or they will have worked out financial 
assistance, if needed, with the hospital prior to their surgical date. These costs will be billed 
to their insurance provider and costs may range from copay only to full cost of treatment. 
 
 
22. Compensation 
For enrollment in the study, each patient will be compensated with a $60 merchandise 
card. They will receive a $20 merchandise card at their pre-operative evaluation and a 
$40 merchandise card at their 6-8 week post-operative visit. The merchandise card is 
reasonable compensation for the inconvenience of participating in a research study 
due to the multiple questionnaires evaluating preparedness, satisfaction, knowledge, 
and anxiety after watching a physician or patient-centered video.  
 
 
23. Compensation for Research-Related Injury 
If participants are injured or become sick as a result of this study, 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 

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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 may also be directed toward 
the HRPO. This language will be stated in the written consent document, and reviewed 
during the informed consent process. Again, the patient undergoes an informed consent 
process for the surgical procedure regardless of enrollment in the study; hence, there is 
no additional risk to participate in this study. 
 
24. Consent Process 
Patients will be approached about the research study at the urogynecology clinics 
during a discussion for the management of stress urinary incontinence. Each patient 
undergoes counseling in a private room with a closed door to ensure privacy. All of the 
physicians in the urogynecology division will obtain consent, given that they are the 
ones providing the surgical care. They routinely perform this procedure and thus are 
highly qualified to counsel patient regarding the risks, benefits, and alternatives to the 
procedure. Those recruited will have already decided to undergo a corrective mid 
urethral sling procedure. Study consent will be obtained by one of the research team 
members. Additionally, care will not be withheld if they decide not to participate.   
 
The patients who would like to participate in the study will be consented during their 
pre-operative visit in the urogynecology clinic. There is a variable amount of time 
between the decision to undergo surgery and their next visit for their pre-operative 
assessment, but it ranges from a few days to months. Hence, the patient will be 
counseled on the study upon the decision to undergo surgery, during their pre-operative 
visit, and again during the day of surgery. They will have these multiple opportunities 
to ask any questions that they may have, 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.  Subject will all be encouraged to take as much time as they need.  
 
This study will obtain HIPAA authorization prior to enrollment. HIPAA authorization 
is embedded within the study consent form, which will be reviewed with all participants 
by the physician 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. 

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Subjects not fluent in English 
Given that the primary outcome is measurement with the PPQ questionnaire 
and it is only validated in English, non-English speaking patients will be 
excluded. 
Cognitively Impaired Adults/Adults Unable to Consent/Use of a Legally 
Authorized Representative 
Cognitively Impaired Adults will not be included in the study. 
Subjects who are not yet adults (infants, children, teenagers) 
All subjects will be 18 years of age or older. No infants, children or teenagers will 
be enrolled in the study. 
25. Documentation of Consent 
We plan to document consent, and the Consent form is attached. We do not plan on 
collecting/storing tissue samples. We will not obtain consent verbally. We will not be 
using a script, information sheet, or other mechanism. 
 
26. Study Test Results/Incidental Findings 
26.1. Individual Results: Patients will be randomized to watch either a physician-
centered or patient-centered video.  Therefore, the patients will be aware which 
study arm they are randomized to.  Study results for individual participants will 
not be shared.  
26.2. Incidental Findings:  
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 a 
pre-operative work up, which may include different laboratory tests and 
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 
The patients will be aware which arm of the study they are randomized to.  Therefore, 
we will not require to provide subjects with a summary of the trial. 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 
There will not be any vulnerable populations included in this study. Those electing 
for surgery will not be coerced into doing so, nor will they be coerced into 
participating in this trial. 
 

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29. Community-Based Participatory Research 
There will be no involvement of the community in this research. 
 
30. Research Involving American Indian/Native Populations 
This research does not specifically target this population. If a Native American 
female is a candidate for this study she will be offered participation. 
 
31. Transnational Research 
This study is not transnational 
 
32. Drugs or Devices 
No drugs or devices will be utilized in this study. 
 
 

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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. 
 
I. Waivers or Alterations of Consent, Assent, and HIPAA Authorization 
A. Partial Waiver of Consent for Screening/Recruitment 
We are not requesting a partial waiver of consent 
Partial Waiver of HIPAA Authorization for Screening/Recruitment 
We will not be reviewing records to identify potential subjects  
B. Waiver of Documentation of Consent 
NA, We are not requesting a waver of documentation of consent. We do not intend to 
obtain consent verbally.  We will be obtaining signatures from subjects on a consent 
form to document consent. 
C. Alteration of Consent 
NA. We are not intending to obtain consent by eliminating or altering one or more of 
the required elements of consent. 
D. Full Waiver of Consent/Parental Permission 
We are not requesting a full waiver of consent for all subject or certain subject 
groups. 
E. Full Waiver of Consent/Parental Permission (Public Benefit or Service 
Programs) 
We are not requesting a full waiver of consent for all subjects or certain subject 
groups 
F. Full Waiver of HIPAA Authorization 
We are not requesting a full waiver of the requirement to obtain HIPAA authorization 
for all subjects or certain subject groups. 
G. Other Waiver Types 
 
We are not requesting alterations of consent, assent, or HIPAA authorization. 
 
II. Vulnerable Populations 
A. Adults with Cognitive Impairments 
Adults with cognitive impairments will not be included in this study.  
B. Children 
The subject population will not include children 

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C. Pregnant Women and Fetuses 
The subject population does not include pregnant women or fetuses. 
D. Neonates of Uncertain Viability or Nonviable Neonates 
The subject population does not include neonates of neonates of uncertain viability 
E. Nonviable Neonates 
 
The subject population does not include nonviable neonates 
 
F. Biomedical and Behavioral Research Involving Prisoners 
The subject population will not include prisoners 
 
III. Medical Devices 
 
A medical device will not be utilized in this study 
 
 
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10.  US Food and Drug Administration. FDA Public Health Notification: Serious Complications 
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