Outpatient Visits Versus Telephone Interviews for Postoperative Care: A Randomized Controlled Trial
Phase: NA
Conditions: Satisfaction, Postoperative Complications, Pelvic Floor Disorder
Sponsor: University of New Mexico

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PROTOCOL TITLE:
Outpatient Visits versus Telephone Interviews for Postoperative Care: A 
Randomized Controlled Trial (OPTIONs)
PRINCIPAL INVESTIGATOR:
Name: Yuko Komesu, MD
Department: Urogynecology
VERSION NUMBER:
4
DATE:
2/10/17
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)
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.....................................................................................................................3
2.
Background ..................................................................................................................4
3.
Study Design ................................................................................................................6
4.
Inclusion and Exclusion Criteria ..................................................................................7
5.
Number of Subjects......................................................................................................8
6.
Study Timelines............................................................................................................9
7.
Study Endpoints ...........................................................................................................9
8.
Research Setting.........................................................................................................10
9.
Resources Available...................................................................................................11
10.
Prior Approvals.......................................................................................................13
11.
Multi-Site Research ................................................................................................13
12.
Study Procedures ....................................................................................................13
13.
Data Analysis..........................................................................................................17
14.
Provisions to Monitor the Data to Ensure the Safety of Subjects...........................20
15.
Withdrawal of Subjects...........................................................................................22
16.
Data Management/Confidentiality..........................................................................22
17.
Data and Specimen Banking...................................................................................25
18.
Risks to Subjects.....................................................................................................25
19.
Potential Benefits to Subjects .................................................................................27
20.
Recruitment Methods..............................................................................................27
21.
Provisions to Protect the Privacy Interests of Subjects ..........................................28
22.
Economic Burden to Subjects.................................................................................29
23.
Compensation .........................................................................................................30
24.
Compensation for Research-Related Injury............................................................31
25.
Consent Process......................................................................................................31
26.
Documentation of Consent .....................................................................................36
27.
Study Test Results/Incidental Findings ..................................................................36
28.
Sharing Study Progress or Results with Subjects...................................................37
29.
Inclusion of Vulnerable Populations ......................................................................38
30.
Community-Based Participatory Research.............................................................39
31.
Research Involving American Indian/Native Populations .....................................39
32.
Transnational Research...........................................................................................39
33.
Drugs or Devices ....................................................................................................40
Checklist Section ...............................................................................................................41

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1. Objectives
1.1. Describe the purpose, specific aims, or objectives.
Healthcare in the United States is costly, does not result in high patient 
satisfaction and is in need of reform. It is well known that the current state of 
healthcare delivery is trapped in a paradox with higher spending and poorer 
outcomes compared to other countries.[1] To bring American healthcare back on 
course, the focus must shift to value. Health care value relies on quality and cost 
with the following equation: value = quality ÷ cost.[2] Quality incorporates clinical 
outcomes, safety, and patient satisfaction.[2] Routinely, hospitals and providers 
are rated on their postoperative care using the Consumer Assessment of 
Healthcare Providers and Systems (S-CAHPS) endorsed by the Agency for 
Healthcare Research and Quality (AHRQ). (https://cahps.ahrq.gov)  In this 
equation, value increases by improving quality with increasing patient satisfaction 
and/or lowering costs without negatively impacting outcomes and maintaining 
safety. All healthcare stakeholders including patients, payers, providers, and 
suppliers benefit from working towards improving value.[3]
 
The value of routine, interval post-operative visits is unknown. Post-operative 
clinical visits are considered a “gold standard” based solely on tradition. 
Postoperative care of patients over the telephone has been utilized in place of 
traditional outpatient postoperative visits in the pediatric and adult surgery 
literature.[4-10] Retrospectively, this form of postoperative care has proven to be 
safe, effective, and reduces patients’ nonmedical costs with improvements in 
patient satisfaction as measured on non-validated global scales.[5-10] However, 
a prospective trial evaluating patient satisfaction and the safety of phone call 
postoperative visits has not been undertaken. A key gap in assessing the 
value of Urogynecologic care is assessing the value of routine 
postoperative visits. 
Our specific aims for this study include the following:
1. Compare patient satisfaction with their postoperative care among 
women randomized to telephone calls versus routine outpatient visits at 3 
months as measured by the postoperative domain of the S-CAHPS. 
Hypothesis: We hypothesize that patients receiving postoperative care with 
telephone calls will report non-inferior satisfaction on the S-CAHPS as women 
who have in-person postoperative clinic visits.
2. Compare adverse events at 3 months between patients randomized to 
telephone calls versus postoperative visits. Hypothesis: We hypothesize that 
adverse events will not differ between the two groups.
3. Determine the cost-effectiveness of postoperative care with telephone 
calls versus visits at 3 months using patient and societal perspectives.  

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Hypothesis:  We hypothesize that postoperative care with phone calls is more 
cost-effective than in-person visits from both the patient and societal 
perspectives.
1.2. State the hypotheses to be tested.
Ultimately, our long-term goal is to institute novel approaches to postoperative 
care that adds value to healthcare delivery. Our overall objective here, which is 
the next step in pursuit of that goal, is to replace routine postoperative visits with 
telephone follow-up in a non-inferiority randomized controlled trial of 
postoperative patients after surgery for a pelvic floor disorders. Our central 
hypothesis is this novel use of telephone follow-up calls versus clinic visits in 
uncomplicated post-operative patients after surgery for pelvic floor disorders will 
result in non- inferior satisfaction for their care as well as significantly reduce 
patients’ direct and indirect nonmedical costs for postoperative care. Our 
hypothesis has been formulated on the basis of other retrospective, 
observational studies in the pediatric and adult surgery literature.[4-10] The 
rationale for the proposed research is that, once it is established that 
postoperative care with telephone calls offers similar  rates of satisfaction among 
patients for their postoperative care, that this new approach for healthcare will 
offer an alternative to routine postoperative care.
2. Background
2.1. Describe the relevant prior experience and gaps in current knowledge.
One in four women suffer from incontinence or prolapse and 1 in 5 women will 
undergo surgery for these disorders in their lifetime.[11] In the United States, 
more than 300,000 procedures are performed each year for pelvic organ 
prolapse with up to 25% undergoing reoperations.[12] The total annual medical 
cost for surgery alone is substantial, estimating more than one billion dollars.[13] 
Routine postoperative care visits consume health care resources as well as 
patients’ time and their nonmedical cost. The contribution of the proposed 
research is expected to provide evidence for a new model of postoperative care 
with the potential to increase value in our health care delivery to women with 
pelvic floor disorders. 
Based solely on tradition, physicians recommend routine, postoperative visits. 
The intervals of these visits vary depending on the type of surgery and by 
surgeon preference but have no real evidence indicating that these visits add 
value to postoperative care. While direct medical cost for a postoperative visit is 
covered through insurance since the 1992 National Global Surgery Policy, the 
patient still carries financial burdens and inconvenience to come to their 
postoperative visits.[14] Patients’ nonmedical direct and indirect costs must be 
considered—examples of nonmedical direct costs include transportation and 

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childcare expenses and indirect cost includes income lost from time off work for 
either the patient themselves or for someone who accompanies them to their 
postoperative visit. This financial burden has a real impact from a societal 
perspective as low-income patients estimate spending nearly 10% of their 
monthly income for a postoperative visit.[15] Recognizing this burden and 
developing a new, convenient, safe approach to postoperative care has the 
potential to maintain patient satisfaction as well as decrease costs, thereby 
increasing value.
2.2. Describe any relevant preliminary data.
No preliminary data are currently available regarding patient satisfaction or cost 
effectiveness with postoperative care comparing clinic visits and telephone 
follow-up using standardized questionnaires.  
A previous retrospective chart review of patients at the UNM Urogynecology 
office showed that patients travel 42.4 miles on average (SD +/- 91.5 miles) for 
their appointments. [16]  In addition, Albuquerque is the only city in New Mexico 
with board certified Urogynecologists.  Patients carry a significant burden of cost 
and time required for routine postoperative visits.  
2.3. Provide the scientific or scholarly background for, rationale for, and 
significance of the research based on the existing literature and how will it add 
to existing knowledge.
Retrospective studies have evaluated telephone evaluation in place of traditional 
outpatient visits in the pediatric and adult surgery literature including general 
surgery, urology, and orthopedic surgery.[4-10] Although validated measures 
were not used, global satisfaction scores were high, patients’ indirect costs 
reduced, and, on the side of the providers, increased time available for new 
patients or other follow-up visits was created. Importantly, surgical outcomes 
were similar.  These factors—outcomes and satisfaction improvement, cost 
reduction, clinical efficiency—have the potential to improve healthcare value in 
the postoperative setting and overall achieve the National Quality Strategy aims. 
Telephone follow-up for postoperative care has not been evaluated using a 
randomized controlled study design with validated measures and has not been 
rigorously evaluated in the Urogynecologic literature. The British medical system 
has adopted the use of telephone follow-up by a clinical nurse after 
Urogynecologic procedures. One retrospective study using the British Society of 
Urogynaecology database showed 90% of women who underwent a midurethral 
sling received telephone follow-up and did not require an outpatient visit.[17] 
Using this same database, a retrospective observational study showed a trend 
toward self-directed care, in which patients self-present if complications 
occur.[18] These results along with the retrospective studies from other surgical 

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fields provide the rationale behind a randomized controlled study for 
postoperative telephone follow-up after surgery for pelvic floor disorders.
The contribution is significant because telephone follow-up has the potential to 
increase value in Urogynecologic postoperative care and meet the National 
Strategic Goals regarding quality. Presently no standard guidelines are available 
to recommend routine post-operative visits and this trial will allow us to evaluate 
the status quo—costly face-to-face visits versus inexpensive telephone calls. By 
minimizing patients’ burden while delivering high quality care, we expect to 
maintain patient satisfaction as well as decrease cost. The Agency for Healthcare 
Research and Quality (AHRQ) through the U.S. Department of Health and 
Human Services sets the framework for providers and hospitals to assess 
value.[19] The AHRQ leads the National Quality Strategy which encompasses 3 
aims: better care, healthy people, and affordable care.[19] The pursuit of 
improved healthcare value is the focus of this proposal and incorporates the aims 
of the National Quality Strategy. 
The proposed research is innovative, in our opinion, because it represents 
a substantive departure from the status quo by replacing these 
postoperative visits with telephone calls. Telephone follow-up is a novel, 
simple, cost-reducing approach to postoperative care for women undergoing 
elective surgery for pelvic floor disorders. Currently, no randomized trials have 
evaluated satisfaction, safety and cost in an Urogynecology population using 
telephone follow-up for postoperative care. Evidence for this mode of 
postoperative care as safe and affordable with high satisfaction, will break down 
the barriers in reaching a new horizon for postoperative care with increased 
value. The establishment of phone calls as a safe, patient-centered way to 
conduct post-operative care would allow for a more efficient and effective 
healthcare delivery. This research may be generalizable to other surgical 
practices as well. 
3. Study Design
3.1. Describe the study design (e.g., observational; randomized placebo-controlled 
clinical trial, etc.)
We will conduct a randomized trial to compare patient satisfaction between 
outpatient visits and telephone calls for post-operative care. We will recruit 
women pre-operatively at the UNM Urogynecology clinic who are undergoing 
surgery for pelvic floor disorders including urinary and/or anal incontinence 
and/or pelvic organ prolapse and/or pelvic pain, and/or mesh 
exposure/complications.  All women will give written informed consent. Patients 
will be randomized at the time of discharge to either telephone follow-up or 
outpatient visits. Computer generated randomization will be assigned by 
research staff uninvolved with recruitment and will be stored in opaque, 

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sequentially numbered envelops. Follow-up for both randomization arms will be 
scheduled at 1-2 weeks, 6 weeks, and 3 months post-operatively, as these are 
common timeframes for routine postoperative visits in our practice. 
3.2. Describe blinding, if applicable
Blinding is not applicable to this study.
4. Inclusion and Exclusion Criteria
4.1. Describe how individuals will be screened for eligibility.
Patients presenting to the UNM Urogynecology office who choose to undergo 
surgery for a pelvic floor disorder will be eligible for this study.  These pelvic floor 
disorders include urinary and/or anal incontinence and/or pelvic organ prolapse 
and/or pelvic pain, and/or mesh exposure/complications .  
4.2. Describe the criteria that define who will be included or excluded in your final 
study sample.
The inclusion criteria are the following: 
1. Subjects ≥ 18 years of age 
2. Women undergoing surgery for a pelvic floor disorder
3. Able to give informed consent
4. Has a reliable phone number for contact postoperatively
5. Able to speak and understand English or Spanish.  Spanish forms will be 
submitted after initial review of English materials. 
The exclusion criteria are the following: 
1. Any patient whose physician decides medical necessity for the patient to 
have postoperative follow-up in the clinic
2. Unable to give written informed consent
3. Does not have a reliable phone number
4. Inability to speak and understand either English or Spanish.  As noted 
above, Spanish forms will be submitted after initial review of English 
materials.
5. Those who specifically request postoperative clinic visits
6. Pregnant patients
4.3. Indicate specifically whether you will include each of the following special 
populations: (You may not include members of the above populations as subjects 
in your research unless you indicate this in your inclusion criteria.)

Adults unable to consent

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
Individuals who are not yet adults (infants, children, teenagers)

Pregnant women

Prisoners
Special populations such as adults unable to consent, individuals who are not yet 
adults, pregnant women, and prisoners will not be included in this study.
4.4. Indicate if you excluding any particular populations (e.g., women, children, 
persons not fluent in English, a particular racial or ethnic group, etc.) and 
provide justification. 
We will be excluding women who are unable to speak and understand either 
English or Spanish.  The justification for this is the satisfaction surveys (S-
CAHPS by the U.S. Agency for Healthcare Research and Quality) are only 
available in English and Spanish.  And because this is our primary objective, it is 
important to use these standardized surveys. 
5. Number of Subjects
5.1. If this is a multicenter study, indicate the total number of subjects to be accrued 
across all sites.
This is a randomized controlled trial at a single site—the University of New 
Mexico’s Urogynecology department.
5.2. Indicate the number of subjects to be recruited at this site.  
The recruitment goal for this study is 120 patients to allocate 60 patients in the 
clinic visit group and 60 patients in the telephone follow-up group.
5.3. Provide sample size justification
The sample size for this study is determined by our primary objective, patient 
satisfaction measured by the Consumer Assessment of Healthcare Providers 
and Systems (S-CAHPS) survey. We will conduct a non-inferiority patient 
satisfaction study comparing postoperative care with clinic visits versus 
telephone calls.
We have been able to identify two publications that have used the S-CAHPS; 
both of these reported scores for individual items, as well as composites of “top 
box” responses for individual items.  For example, responses for the question, 
“After your surgery did the surgeon listen carefully to you?” has three responses: 
1. Yes, definitely, 2. Yes, somewhat, and 3. No.  A top box response is “Yes, 
definitely”.  The global satisfaction with their surgeon is a single item, ranging 
from 0 (worst surgeon possible) to 100 (best surgeon possible), with “top” box 
responses of 100.  “Top” box responses in prior studies ranged from 56-100% 
with the majority of responses about 90%.  Assuming both the control and 
experimental groups are equivalent in patient satisfaction, a non-inferiority 
calculation can be applied using 90% as the percentage “success” in the control 
group and experimental groups with 80% power, an alpha of 0.05, and 15% non-

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inferiority limit.  In this equation, if there is truly no difference between the control 
and experimental groups, then 100 patients for total sample size are required to 
be 80% sure that the upper limit of a 90% two-sided confidence interval will 
exclude a difference in favor of the control group of more than 15%. Our primary 
outcome measure is the global composite for the surgeon rating, which has been 
used in the previous studies.  This sample size will provide similar power for 
comparison of other items and scale of the S-CAHPS between groups.  We 
anticipate that up to 10% of women who are recruited will have complications 
that preclude them from participation after consent and prior to randomization, 
such as poorly controlled pain, complications or surgeon concerns.  In addition, 
we anticipate that 10% of women will be lost to follow-up.  Therefore we plan to 
recruit a total of 120 women, 60 per group.  
6. Study Timelines
6.1. Describe:

The duration of an individual subject’s participation in the research

The duration anticipated to enroll all subjects

The expected duration for the investigators to complete the study (complete 
analysis)
It is anticipated that approximately two years will be needed to complete this 
entire project.  We expect that patients will be enrolled starting in August 2016.  
We anticipate recruitment to take one year and be complete by August 2017. 
Data entry will be ongoing during this time and should also be complete by 
November to December of 2017 (or 3 months after last patient is enrolled). Data 
analysis will be completed by February 2018.  Our final goal is to submit the 
abstract for the AUGS 2018 fall meeting.
7. Study Endpoints
7.1. Describe the primary and secondary study endpoints.
The primary endpoint of our study is to compare patient satisfaction between 
postoperative follow-up with clinic visits versus telephone calls in a randomized, 
non-inferiority controlled trial.  
7.2. Describe any primary or secondary safety endpoints.
Timeline
August 2016- Sept 2016
Aug 2017-Dec 2017
Jan 2018-Feb 2018
Subject recruitment, surgery, 
through 3 month follow up
Data analysis
Manuscript preparation

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The primary safety endpoint of our study is to determine the difference in 
adverse events, emergency room visits, primary care physician visits between 
patients with postoperative follow-up in the clinic versus telephone calls.
Our secondary endpoint is to compare the patients’ nonmedical costs (gas 
money, time from work, child care, etc) between those who follow-up 
postoperatively in the clinic versus telephone calls.
7.3. Describe any exploratory endpoints.
Our exploratory endpoint is to determine if there is a difference in pain and 
pelvic floor symptoms in patients with follow-up with clinic visits versus telephone 
calls.  The pain assessment will be measured by the Surgical Pain Scales.  The 
pelvic floor symptoms will be measured by the Pelvic Floor Disorder Inventory 
(PFDI-20).
8. Research Setting
8.1. Describe the sites or locations where your research team will conduct the 
research.
The study will be performed at the University of New Mexico Hospital (UNMH), 
Sandoval Regional Medical Center (SRMC), and the associated Urogynecology 
clinics.
8.2. Identify where your research team will identify and recruit potential subjects.
Potential subjects will be recruited in the UNM, SRMC, and Westside 
Urogynecology clinics.  All patients planning to undergo surgery will have a 
complete history and physical taken and undergo a pelvic exam, as is standard 
practice.  After written consent to participate in the study, women will complete 
initial questionnaires in the outpatient offices.  
8.3. Identify where research procedures will be performed including any laboratory 
analytics
Surgeries will be undertaken in either UNMH, the Outpatient Surgery and 
Imaging Services (OSIS), or SRMC hospital. All other follow up after surgery will 
be performed again in the above mentioned outpatient clinics.
There are no laboratory tests in this trial other than what would routinely collected 
prior to surgery. 
8.4. Describe the composition and involvement of any community advisory board
NA.  There will be no involvement of a community advisory board.
8.5. For research conducted outside of UNM HSC and its affiliates describe:
NA.  No research will be conducted outside of UNMHSC and its affiliates.

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9. Resources Available
9.1. Describe the qualifications of the PI and study staff (e.g., training, experience, 
oversight) as required to perform the research. When applicable describe their 
knowledge of the local study sites, culture, and society. 
9.2. When applicable, describe which licensed physicians/providers will be 
responsible for medical decision-making and ordering and evaluation of 
necessary diagnostics and therapeutics. 
9.3. Describe other resources available to conduct the research: For example, as 
appropriate:

Justify the feasibility of recruiting the required number of suitable subjects 
within the agreed recruitment period. For example, how many potential 
subjects do you have access to? What percentage of those potential subjects 
do you need to recruit?

Describe the time that will be devoted to conducting and completing the 
research.

Describe the facilities available to conduct the research.

Describe the availability of medical or psychological resources that subjects 
might need as a result of an anticipated consequences of the human research.

Describe the process to ensure that all persons assisting with the research are 
adequately informed about the protocol, the research procedures, and their 
duties and functions.

If CTSC resources are being accessed, the signed CTSC resources attachment 
must be uploaded on the CTSC Submission page in Click.
Dr. Rebecca Rogers and Dr. Yuko Komesu are board certified subspecialists in 
urogynecology and will serve as the PI for this study.  They are  experienced 
researchers at UNM.  They have been the PI on multiple research trials and have 
successfully completed randomized control trials as senior faculty members at 
UNM. 
The University of New Mexico (UNM) urogynecology division operates at two 
main locations. UNM Women’s Health Urogynecology Center (UNMH) located in 
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. 
Based on the current surgical volume in the UNM division of Urogynecology, 
there are approximately 400-500 surgeries performed each year for pelvic floor 
disorders. Hence, assuming 25% recruitment, it will take 12 months to recruit the 

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120 patients necessary. Additionally, they are going to be followed for 3 months 
after surgery, so in total, to recruit subjects, perform their surgery and to collect 
all 3 month follow up data, we expect this will take 15 months. Then, for data 
analysis and composition of the manuscript, we estimate that this will take 6 
months.
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 one research nurse 
through our NIH-funded Clinical and Translational Research Center and one 
nurse directly through the Department. 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. Rebecca Rogers and Dr. Yuko Komesu have 
mentored and have been the PI on multiple clinical trials and contribute multiple 
publications in peer-reviewed journals. Their Curriculum Vitaes are 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, 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 Dr. Yuko Komesu, and the signed 
Departmental Review Form can be found in the “supporting documents” section. 

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This study does not include any ionizing radiation, biological specimens, or 
drugs.
11.Multi-Site Research
NA. This is not a multi-site study.
12.Study Procedures 
This is a randomized non-inferiority controlled clinical trial to determine the value 
of postoperative care by measuring patient satisfaction, safety, and cost-
effectiveness.  Patients will be randomized postoperatively to either follow-up in 
the clinic or with telephone calls at 1-2 weeks, 6 weeks, and 3 months.  The 
target population is women with a pelvic floor disorder (urinary and/or anal 
incontinence and/or pelvic organ prolapse and/or pelvic pain, and/or mesh 
exposure/complications) who are planning surgical management.  
Before Surgery: 
Patients who meet inclusion criteria will be invited to participate in the study.  All 
patients who agree will give written consent prior to their surgery.  All patients will 
complete baseline questionnaires including the following: Surgical Pain Scales, 
Pelvic Floor Disorder Inventory (PFDI-20), the Preoperative S-CAHPS 
questionnaire, and the European Quality of Life-5 Dimensions (EQ-5D).  Data 
collected in addition to the above outcome measures will include Patient 
Demographics: age; self-reported race and ethnicity; primary language, marital 
status, education, health insurance, annual income estimate, and living 
arrangements.  Also, Medical/Surgical History: medical comorbidities; prior 
surgeries for pelvic floor disorders.  The physician’s physical exam will include 
the following: Pop-Q stage, height, weight, and pelvic floor disorder diagnoses.  
The Patient Contact form will be completed for all patients enrolled.  
Day of Surgery: 
On the day of the patient’s surgery, the operation that was decided between the 
patient and her physician will be performed.  Information including the indications 
for surgery, procedures performed, length of surgery, and any intraoperative 
adverse events will be collected.  This information will be recorded by the 
surgeon immediately postoperative in the Surgeons Report form.
Immediately Postoperative: 
The Immediately Postoperative S-CAHPS questionnaire will be completed before 
discharge.  If the patient stays overnight in the hospital after surgery, the S-
CAHPS questionnaire will be completed on postoperative day #1.  For women 

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undergoing day surgery the form will be completed in the postoperative holding 
area.
Randomization: 
Computer generated randomization will be assigned by research staff uninvolved 
with recruitment and will be stored in opaque, sequentially numbered envelops. 
On the day of the patient’s discharge following surgery, the Urogynecology team 
will call the research coordinator and the patient will be randomized to either 
clinic visits or telephone calls for postoperative follow-up.  Both the clinic visits 
and telephone calls will be scheduled with specific dates and times.  These 
intervals are at 1-2 weeks, 6 weeks (+/-2 weeks), and 3 months (+/-3 weeks) as 
this is our current practice.  See table 1.
Patients randomized to telephone calls: 
Patients will be scheduled to receive a telephone call from qualified medical staff 
from the Urogynecology office at 1-2 weeks, 6 weeks (+/-2 weeks), and 3 months 
(+/-3 weeks).  A scripted interview (See forms: 1-2 Week Interview, 6 Week 
Interview, and 3 Month Interview) will be conducted to evaluate the patient’s 
postoperative status.  The information gathered from the telephone interview will 
be entered into their medical record.  If the medical staff person has any concern 
regarding a patient’s postoperative status, the patient will be called by one of the 
Urogynecology physicians and/or a clinic visit will be scheduled immediately, as 
is standard practice for patients who are called postoperatively.  If the patient 
requests a postoperative appointment in the clinic, this will also be scheduled 
immediately.  This process is already a standard practice for patient phone calls 
to our clinic.  
In addition to evaluating the patient’s postoperative status, the Patient Cost 
Survey will evaluate primary care and emergency room visits, new prescriptions, 
hospital admissions, estimated travel time, and nonmedical costs.
After the 3 month phone call, each patient will return to the Urogynecology office 
and meet with a research assistant for a research visit. The patient will then 
complete the following questionnaires: PFDI-20, EQ-5D, Surgical Pain Scales, 
and the Postoperative S-CAHPS questionnaire. 
Patients randomized to clinic visits: 
Patients will be scheduled to receive clinic visits with a physician at the 
Urogynecology office at 1-2 weeks, 6 weeks, and 3 months.  The same scripted 
interview (See forms: 1-2 Week Interview, 6 Week Interview, and 3 Month 
Interview) will be obtained to evaluate the patient’s postoperative status.  This 
clinical encounter will also be entered into the medical record.  The Patient Cost 
Survey will be completed by the patient at each postoperative visit as well.

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These patients will have physical exams performed.  The Adverse Events 
Physical Exam form will be completed by the physician performing the 
postoperative exam.
After the 3 month clinic visit, the patients will meet with the research assistant for 
a research visit.  At this time, the PFDI-20, the EQ-5D, the Surgical Pain Scales, 
and the Postoperative S-CAHPS questionnaire will be administered.  After 
completion, the patient will be compensated $50.
 
Table 2: Study forms at each interval
Pre-op 
Immediately 
post-op
Time of 
Discharge
1-2 weeks 
post-op
6 weeks 
post-op
3 months 
post-op
Demographics
X
S-CAHPS
X
X
X
EQ-5D
X
X
PFDI-20
X
X
Physical Exam
X
Surgeons Report
X
Patient Cost 
X
X
X
X

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For Clinic Phone Calls other than the calls scheduled at 1-2 weeks, 6 weeks 
and 3 months:
At the time of discharge, patients receive the contact information for the 
Urogynecology clinic and on-call staff for after-hours concerns.  These calls may 
be patients from both arms of this study.  The qualified medical staff receiving 
these calls will have a scripted form (the Interview form) to complete and added 
to the medical record, as is standard practice in our clinics.  The number of 
additional phone calls will be calculated.  The medical staff will determine if the 
treatment plan is sufficient over the phone or if a clinic visit is necessary.  This 
process is already standard practice in the Urogynecology clinic.
If a patient randomized to the telephone calls requires a clinic visit, the Interview, 
Patient Cost survey, Adverse Events Physical Exam forms will be completed.
Outcome Measures:
1. Surgical-Consumer Assessment of Healthcare Providers and Systems (S-
CAHPS) survey: The “gold standard” for healthcare quality, developed by 
the Surgical Quality Alliance including the American college of Surgeons 
and overseen by the U.S. Agency for Healthcare Research and Quality 
(AHRQ).  Incorporates six composites: information to prepare for surgery, 
communication before surgery, attentiveness on the day of surgery, 
information to help recovery, communication after surgery, staff at 
surgeon’s office and the overall surgeon rating. [19]
2. Adverse Events: Using a Clavien-Dindo scale, a validated measure of the 
severity of adverse events associated with surgery. [20]
3. European Quality of Life-5 Dimensions (EQ-5D): Preference-based utility 
index algorithm used to calculate each subject’s utility index and compare 
change in QALYs between the two treatment groups. [21]
4. Pelvic Floor Distress Inventory (PFDI-20): This is a validated, reliable and 
responsive 20-question form with 3 scales (Urinary Distress Inventory, 
Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress 
Inventory) assessing women with pelvic floor disorders. [22]
5. Surgical Pain Scales: Four visual analog scales that measure pain at rest, 
pain during normal activities, pain during work or exercise, and pain 
unpleasantness. [23]
13.Data Analysis
Data Analysis:  Between and within group differences will be evaluated using 
Fisher’s exact test for categorical variables and t-tests for continuous variables.  
Adverse Events
X
X
X
X

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If there are any baseline differences between groups, and multivariate analysis 
will determine the contribution of these differences to observed differences (if 
any) between groups.
Power Analysis: Our power calculation is based on our primary outcome—patient 
satisfaction.  We have been able to identify two publications that have used the 
S-CAHPS; both of these reported scores for individual items, as well as 
composites of “top box” responses for individual items.  For example, responses 
for the question, “After your surgery did the surgeon listen carefully to you?” has 
three responses: 1. Yes, definitely, 2. Yes, somewhat, and 3. No.  A top box 
response is “Yes, definitely”.  The global satisfaction with their surgeon is a single 
item, ranging from 0 (worst surgeon possible) to 10 (best surgeon possible), with 
“top” box responses of 10.  “Top” box responses in prior studies ranged from 56-
100% with the majority of responses about 90%.  Assuming both the control and 
experimental groups are equivalent in patient satisfaction, a non-inferiority 
calculation can be applied using 90% as the percentage “success” in the control 
group and experimental groups with 80% power, an alpha of 0.05, and 15% non-
inferiority limit.  In this equation, if there is truly no difference between the control 
and experimental groups, then 100 patients for total sample size are required to 
be 80% sure that the upper limit of a 90% two-sided confidence interval will 
exclude a difference in favor of the control group of more than 15%. Our primary 
outcome measure is the global composite for the surgeon rating, which has been 
used in the previous studies.  This sample size will provide similar power for 
comparison of other items and scale of the S-CAHPS between groups.  We 
anticipate that up to 10% of women who are recruited will have complications 
that preclude them from participation after consent and prior to randomization, 
such as poorly controlled pain, complications or surgeon concerns.  In addition, 
we anticipate that 10% of women will be lost to follow-up.  Therefore we plan to 
recruit a total of 120 women, 60 per group.  All data will be entered into REDcap 
and undergo data cleaning.  Data analysis will be performed as instructed by the 
CAHPS Analysis Program using the CAHPS41.SAS macro program provided by 
the AHRQ. Analysis will be performed using Fisher’s Exact test for categorical 
variables, t-tests for continuous variables, and Wilcoxon Rank test for ordinal 
variables with significance set at P<0.05. Evaluation of potential confounders 
(e.g. age, baseline questionnaire) will be performed using regression methods, if, 
by chance there are differences between groups.
Cost-Effectiveness Analysis
The cost-effectiveness analysis will be conducted from a societal and patient 
perspective and will be expressed as incremental cost required to produce one 
additional unit of quality-adjusted life year (QALY). Data on each subject’s use of 
medical and non-medical resources related to postoperative care will be 
collected during the follow up period. Direct and indirect costs of postoperative 
care with telephone calls compared to in-person visits and women’s preference 
will be estimated. 

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We plan to capture incremental direct health care, direct non-medical, and 
indirect resource use related to study interventions and postoperative 
complications. Costs will be estimated using the resource costing method.  Direct 
medical service use collected from each study case report form and direct non-
medical and indirect costs collected from patient questionnaires are monetized 
by multiplying the number of units of each resource use by the average unit cost 
of this item in dollars. Detailed individual cost data will not be collected.  This 
method allows a consistent capture of resource use when costs are incurred 
across multiple health systems or payers. Detailed case report forms, that 
include the interventions performed (e.g. phone calls, in-person visits) and 
clinical events (e.g. complications) will be completed at study calls and visits. 
Patient questionnaire on direct non-medical costs (e.g. transportation) and 
indirect costs (e.g. time, lost productivity) will be completed at study calls and 
visits.  Data from medical resource types (physician visits, medications, hospital 
admissions and emergency room visits) will be collected. Cost for each direct 
medical service use, direct non-medical items, and indirect items will be assigned 
based on national Medicare reimbursement rates or other standardized unit costs 
as indicated in Figure 3. 
Rationale for using the EQ-5D to measure Utility Values
The European Quality of Life-5 Dimensions (EQ-5D) (EuroQol Group, 
http://www.euroqol.org), preference-based utility index algorithm will be used to 
calculate each subject’s utility index. [21] This instrument will be collected at 
baseline and 3 months. The EQ-5D has 5 attributes (mobility, self-care, usual 
activities, pain/discomfort and anxiety/depression) with 3 levels each for a 
possible 243 unique health states.  The EQ-5D scoring Function is based on the 
time-tradeoff method with UK Scores ranging from -0.59 to1.00 and US Scores 
from -0.11 to 1.00.   This instrument has been previously validated in women with 
pelvic floor disorders. [24, 25] These data will be used to compare change in 
QALYs between the two treatment groups. We are choosing to use a general 

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scale to calculate change in utilities (rather than condition-specific) to allow for 
comparison of cost-effectiveness results with other interventions and diseases. 
Statistical Analysis:  Differential mean costs and differential mean QALYs 
between the two treatment groups will be estimated using multiple regression 
analysis. Specifically, a generalized linear model with appropriate link function 
(e.g., log-link) and response probability distribution (e.g., gamma distribution) will 
be used to analyze costs due to the potential skewness and heteroscedasticity of 
medical expenditure data, while an ordinary least squares regression will be used 
for analyzing QALY data. The models will account for treatment group, 
stratification factors, as well as other characteristics of the subjects that are found 
to differ significantly between the groups.[26] When estimating QALYs, we will 
also adjust for subjects’ baseline utility scores to account for potential imbalance 
in baseline utility between the two treatment groups. [26]  We will calculate the 
incremental cost-effectiveness ratio (ICER), which is the differential mean costs 
divided by the differential mean QALYs between the two groups, to assess the 
additional costs associated with each additional QALY gained. Our base case 
analysis will be conducted based on subjects with complete data. Sensitivity 
analysis will be conducted to include subjects with incomplete data using the 
multiple imputation method.  Non-parametric bootstrapping resampling technique 
will be used to derive the 95% confidence interval for the ICER.  In addition, cost-
effectiveness acceptability curve (CEAC) will be generated to illustrate the 
likelihood that one treatment is more cost-effective than the other with various 
ceiling cost-effectiveness ratios. The cost-effectiveness evaluations will be 
conducted as within-trial comparisons.  We plan to conduct supplemental 
analyses using other outcome measures including incremental cost per patient 
satisfaction.
14.Provisions to Monitor the Data to Ensure the Safety of Subjects
We have formed a DSMB of individuals not participating in the study but expert in 
pelvic surgery.  The DSMB chair is Dr. Sara Popek, MD and members are Drs. 
Rameet Singh, MD and Dr. Nathan Blue, MD.  Biannually, the board will meet and 
discuss study recruitment, attrition, and adverse events that have occurred.   The 
intervention in this study is low risk and although surgery is inherently risky, surgery 
is not part of the intervention of this study, as women have already decided to 
proceed with surgery for their pelvic floor dysfunction apart from the interventions 
of this trial.  The DSMB will determine whether or not adverse events are related 
to the intervention in this study or not related, and determine if it is safe to continue 
recruitment of patients. 
The DSMB will review the adverse events forms that are collected with each 
patient encounter for both the telephone follow-up and outpatient visit groups.  
This adverse events form includes queries for emergency room visits or primary 
care physician office visits since the last postoperative encounter.  If a serious 
adverse event is identified, the DSMB will be notified immediately to meet and 
review the case.  In addition to asking the patient during the encounter, the 

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patient’s chart will be reviewed at each follow-up interval (1-2 weeks, 6 weeks, 3 
months).  If the patient received care at an outside facility, records will be 
requested.  
Privacy concerns are taken into account with every patient seen at the UNM or 
SRMC clinics. Participants approached and/or interviewed in the clinic setting will 
be in private offices or examination rooms in the UNM, Westside, or SRMC 
clinics, 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 and SRMC 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. 
15.Withdrawal of Subjects
15.1.
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 

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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 discharge 
from the hospital following their surgery. 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.
16.Data Management/Confidentiality
16.1.
 
Randomization assignment will be generated by 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 surgery, 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, 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.

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Electronic data entry will be performed in the OBGYN administrative offices, 
using the de-identified subject study number.  The electronic data 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. 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.
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 data will be transported to outside locations. There will be no audio 
or video recordings or photographs taken.
17.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. All data will be entered into REDCap which is password protected 
and will only be accesed by investigators.  The data will be maintained for 5 
years after completion of the study and then destroyed.
No specimens will be archived for future use. Additionally, this is neither a multi-
center study nor will any information be banked or archived elsewhere.
18.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. 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. 

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The link identifying patients and their study numbers will be also stored in a 
locked cabinet.
Additionally, each patient who will be offered enrollment will already have agreed 
to surgery for one or more pelvic floor disorders. There are risks inherent to these 
surgical procedures including bleeding, risk of infection, injury to surrounding 
organs, especially if an intraperitoneal surgery is performed (bowel, rectum, 
bladder, ureters, nerves vessels, vagina, uterus, cervix). 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. If the patient opts for a surgery that involves mesh, she will be made 
aware of the risks of transvaginal mesh included in the FDA warning (e.g. mesh 
erosion, pelvic pain, and pain with intercourse). 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 risk of not presenting for postoperative checks are small, and include that 
the patient may have problems that are not recognized by the patient or medical 
staff during phone calls, and could potentially lead to delay of diagnosis.  We 
believe that these risks are small, as women do not routinely undergo a physical 
exam at all in person postoperative visits if she does not express having any 
specific problems.  In addition, if concerns are raised during calls, women will be 
scheduled to be seen in the clinic as is our current practice.  
Questionnaires will be provided preoperatively, immediately postoperative, and 3 
months postoperatively.  There is a risk of patient discomfort with completing 
these questions.
There are no known additional risks to the form of postoperative care.  Each 
patient will receive instructions and contact information prior to discharge.  This 
contact information will include after-hours phone numbers, so a member of the 
Urogynecology team may be contacted at any time postoperatively.  The patients 
who are randomized to the telephone follow-up will be asked at every interval if 
they feel a postoperative clinic visit is necessary.  This question will be asked 
regardless if the patient is asymptomatic.  If the patient desires a clinic visit, an 
appointment will be scheduled as soon as possible.  ALL patients, regardless of 
their randomization visits are also welcome to call the clinic if they have any 
questions or concerns regarding their postoperative care.  If the medical staff 
decides a follow-up appointment is necessary, an appointment will be made as 
soon as possible.  These measures are already part of our clinical practice
There are no additional risks to those who are not subjects of this study.
19.Potential Benefits to Subjects

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The patients enrolled are already opting for surgical correction of their pelvic floor 
disorder. Participation in this study may help to increase the value of 
postoperative care by utilizing telephone follow-up instead of clinic visits, and 
decreasing the time and hassle of presenting for in person postoperative care. 
Participation in this study may show an increase in patient satisfaction and a 
decrease in patients’ nonmedical indirect costs.  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 improve our 
postoperative care for other women who have surgery for pelvic floor disorders in 
the future. 
20.Recruitment Methods
We will both recruit women from our Urogynecology clinical practice we do not 
plan to advertise for this study as only women already desiring surgery for a 
pelvic floor disorder will be recruited. 
The Urogynecology clinic at UNMH, Westside, and at SRMC has a large referral 
population of patients with pelvic organ prolapse. Subjects will be identified in the 
clinics at UNM/HSC and Sandoval Regional Medical Center by investigators. The 
patients will be counseled about their chosen surgery as well as their 
postoperative follow-up. 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. 
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 instead of undergoing randomization. She will have her 
postoperative follow-up in the clinic.  Her follow up times for after surgery are the 
same regardless of participation in the study.
A flyer with the study plan and outline will be given to each patient considering 
surgery for her pelvic floor disorder(s) evaluated in the Urogynecology clinic.  
This will allow patients time to consider enrollment before the surgery date.
21.Provisions to Protect the Privacy Interests of Subjects
21.1. . 
Privacy concerns are taken into account with every patient seen at the UNM or 
SRMC clinics. Participants approached and/or interviewed in the clinic setting will 
be in private offices or examination rooms in the UNM, Westside, or SRMC 
clinics, 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 

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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 and SRMC 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. 
22.Economic Burden to Subjects
Responsible Party
Research Procedures
Number of 
Samples/Procedures
Study
3rd Party Payer 
or Participant
Consent
1
Preoperative EQ-5D Questionnaire
1
Demographics Form
1
Preoperative S-CAHPS Questionnaire
1
Preoperative PFDI Questionnaire
1
Preoperative Pain scale
1
Immediate Postoperative S-CAHPS 
Questionnaire
1
Cost Survey at 1-2 weeks, 6 weeks, 3 
months
3
Adverse Events Physical Exam Form at 1-2 
weeks, 6 weeks, 3 months
3
3 Month Postoperative S-CAHPS 
Questionnaire
1
3 Month Postoperative Pain Scale
1
3 Month Postoperative PFDI-20
1
3 Month Postoperative EQ-5D 
1

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Questionnaire
Responsible Party
Standard of Care Procedures
Number of 
Samples/Procedures
Study
3rd Party Payer 
or Participant
Surgery for Pelvic Floor Disorder
1
x
Preoperative visit
1
x
Urodynamics  (bladder study)
1
x
1-2 week postoperative visit
1
x
6-8 weeks postoperative visit
1
x
3 month postoperative visit
1
x
     
     
     
     
There are no study related costs to the participants. Whether enrolled in the clinic 
visit or the telephone follow-up 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.  The postoperative follow-up is included in 
the patients’ surgical package for 90 days after surgery.  Therefore, the clinic 
visits do not pose any additional medical costs to the patients.  
23.Compensation
For enrollment in the study, each patient will be compensated $50 in the form of 
two gift cards. This payment is reasonable compensation for the inconvenience 
of participating in a research study due to the multiple questionnaires evaluating 
the importance of attempting to show any benefit in conducting postoperative 
care with telephone calls. 
The compensation of study subjects will be prorated.  Prior to discharge home, 
the patient will be compensated $20.  After the 3 month encounter, $30 will be 
compensated.  These payments will be provided as gift cards.  The clinic visits 
are the standard of care for our postoperative patients.  Therefore, these visits 
will not be compensated.  In addition, the telephone calls are the intervention to 
determine the value of postoperative clinic visits.  These telephone calls will not 
be compensated, because that would require the patient to return to the office 
which would defeat the purpose of the study.
24.Compensation for Research-Related Injury

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If participants are injured or become sick as a result of this study, UNMHSC will 
provide emergency treatment at the study participants’ 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 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 risks to participate in this study.
25.Consent Process
Patients will be approached about the research study at the Urogynecology clinic 
at UNM, Westside and at SRMC during a discussion for the management of 
pelvic organ prolapse. Each patient undergoes counseling in a private room with 
a closed door to ensure privacy. All of the physicians and research staff involved 
with this study will be responsible for obtaining written consent. Those recruited 
will have already decided to undergo surgery for a pelvic floor disorder at the 
discretion of the surgeon. Hence, they will not be coerced into performance of 
any “extra” procedures. Additionally, care will not be withheld if they decide not to 
participate.  Study consent will be obtained by one of the research team 
members.
The patients who would like to participate in the study will be consented prior to 
their surgery. 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 at the time 
of discharge. 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 

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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 imbedded 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, 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.
The HIPAA form is included with the study consent form which is also 
included in this submission.
Subjects not fluent in English
The primary outcome of this study is patient satisfaction measured by the Agency 
for Healthcare Research and Quality (AHRQ) surgical survey entitled, “Consumer 
Assessment of Healthcare Providers and Systems” (S-CAHPS).  This 
questionnaire is provided in both English and Spanish.  Therefore, the inclusion 
criteria states both English and Spanish speakers will be eligible for participation.  
The consent, demographics, and postoperative surveys will be available in both 
English and Spanish.  Non-English and non-Spanish speakers will be excluded.  
If the person obtaining consent does not speak Spanish, then a certified 
interpreter via in-person or telephone service will be available.
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.
26.Documentation of Consent

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We plan to document consent, and the consent form is attached. We do not plan 
on collecting/storing tissue samples.
27.Study Test Results/Incidental Findings

  
We do not intend to share study test or procedure results with study participants. 
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 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. 
28.Sharing Study Progress or Results with Subjects
The patients will not be masked to their study arm.  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. Once the study is complete if the patients desire they will be 
informed of what arm they were randomized to.  
29.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.
30.Community-Based Participatory Research
.
NA. There will be no involvement of the community in this research.
31.Research Involving American Indian/Native Populations
NA. This research does not specifically target this population.  If a Native 
American woman is a candidate for this study she will be offered participation.
32.Transnational Research
NA. This study is not transnational.

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33.Drugs or Devices
NA.  This research does not involve drugs or devices. 

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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.
NA.  None of the checklists were applicable to this study.
.

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