Perioperative Post-Prostatectomy Incontinence Home Telehealth Program
Phase: NA
Conditions: Urinary Incontinence, Prostate Cancer
Sponsor: VA Office of Research and Development

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July 25, 2016 
 
 
 
 
 
 
 
Protocol 
 
“Perioperative Post-Prostatectomy Incontinence Home Telehealth Program" 
 
Funded by Department of Veterans Affairs,  
Veterans Health Administration, Office of Research and Development,  
Rehabilitation Research and Development Service 
 
PI: Patricia S Goode, MSN, MD 
Co-PI: Kathryn L Burgio, PhD 
Atlanta Site PI: Theodore M. Johnson, II, MD, MPH 
Philadelphia Site PI: Diane K. Newman, DNP 
 
NCT01960998 
 
 
 

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July 25, 2016 
 
 
 
 
 
 
SPECIFIC AIMS 
 
 
Prostate cancer affects 1 in 6 men in the United States.1 Prostate cancer treatment, particularly radical 
prostatectomy, results in persistent incontinence that in patient surveys is significant enough to require pads in 
1of 3 of men undergoing surgery.2 However, there are several randomized, controlled trials of perioperative 
pelvic floor muscle training, including our own work,3 demonstrating clinically and statistically significant 
improvement in post-prostatectomy bladder control.3-8 Despite this strong evidence, most men undergoing 
radical prostatectomies do not receive pelvic floor muscle training. Preoperatively, men are counseled about 
the probability of incontinence and its usual course which is to improve and then resolve. They are discharged 
from the hospital with a urinary catheter. One to two weeks after surgery their catheter is removed during a 
clinic visit, the urine begins to drip out, they are reassured it is temporary, and they may be briefly verbally 
instructed in pelvic floor muscle exercises. However, they receive no formal pelvic floor muscle training. One 
barrier to translation of pelvic floor rehabilitation into urology practices, including those in the VA, is the lack of 
therapists or other interventionists with expertise in pelvic floor muscle training. Rather than training sufficient 
numbers of therapists VA-wide, a more cost-effective approach could be a telehealth-administered 
perioperative pelvic floor muscle training program.   
 
Telehealth is the use of medical information exchanged from one site to another via electronic 
communications to improve patients' health status. Telehealth has been shown to be an effective means to 
deliver care to Veterans in rural settings or in VA Medical Centers without expertise in specific disciplines. The 
VA Care Coordination Home Telehealth (CCHT) Program has been highly successful with implementing 
patient education and monitoring programs for a wide variety of chronic as well as subacute conditions with 
over 300,000 Veterans receiving care through CCHT in FY2010.14 Although most of the clinical trials of 
perioperative pelvic floor muscle training involved in-clinic training, a randomized controlled trial11 and our own 
work outlined in the preliminary studies section, have demonstrated the effectiveness of a written program of 
pelvic floor muscle training, supplemented with initial in-person contact.  
 
We are proposing to use home messaging units and telehealth as the means to deliver an evidence-based 
perioperative protocol of pelvic floor muscle training directly to Veterans in their homes. This would enable all 
Veterans undergoing radical prostatectomy to benefit from this training. Our perioperative program has already 
been developed and pilot tested in our VA Rehabilitation R&D-funded study (F6938R) Perioperative Telehealth 
Program for Post-Prostatectomy Incontinence. The program was highly rated by Veteran participants 
undergoing radical prostatectomy. The next step in this line of research is to test the efficacy of the 
perioperative rehabilitation program in a randomized, controlled trial. 
• The primary objective of our proposed randomized, controlled trial is to demonstrate the effectiveness of 
a telehealth-administered, evidence-based perioperative rehabilitation program for Veterans undergoing 
prostate cancer surgery to reduce post-prostatectomy incontinence and improve quality of life compared to 
current care.  
• The hypothesis to be tested is that a telehealth-administered, evidence-based, perioperative rehabilitation 
program including education, pelvic floor muscle training, progressive exercises, and bladder control 
techniques will be effective in reducing post-operative incontinence compared with current care. 
The primary outcome measure will be time to continence following surgery based on the International 
Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF), a brief, reliable questionnaire that has been 
validated in men and shown sensitivity to change with treatment in men with post-prostatectomy 
incontinence.24,26 Time to continence is extremely important to the Veteran who wants to recover bladder 
control as soon as possible after surgery, and is the outcome in most clinical trials in this population. 
Secondary outcome measures include: total score on the Urinary Incontinence Subscale of the Expanded 
Prostate Cancer Index Composite (EPIC), a validated health-related quality of life tool specific to prostate 
cancer survivors,30 pad use as measured by the EPIC, the Incontinence Impact Questionnaire Short Form,35 
the International Prostate Symptom Score Quality of Life Question,36 and three validated global patient ratings: 
the Estimated Percent Improvement, the Global Perception of Improvement, and the Patient Satisfaction 
Question.34 All outcome measures will be obtained using the telehealth program. The current care group will 

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July 25, 2016 
 
 
 
 
 
 
also receive the telehealth program, but without the pelvic floor muscle training component to control the use of 
technology. 
If proven efficacious, the program could be rapidly disseminated across VA through the Care Coordination 
Home Telehealth Program so that all Veterans undergoing radical prostatectomy can have evidenced-based 
perioperative pelvic floor muscle training and improved continence outcomes. 
 
 
 

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July 25, 2016 
 
 
 
 
 
 
RESEARCH STRATEGY 
 
OVERVIEW 
 
This will be a randomized controlled trial of telehealth administration of an evidence-based perioperative 
pelvic floor muscle training program versus an attention control condition to reduce the severity and duration of 
post-prostatectomy urinary incontinence. The primary outcome will be time to continence (date of surgery until 
no leakage reported for 3 weeks in a row). Related symptoms, severity of incontinence, condition-specific 
quality of life, and patient assessment of outcome and satisfaction will be measured as secondary outcomes.  
The telehealth program was developed and pilot tested with RR&D grant funding and was well accepted by 
Veterans. The telehealth device used in the pilot study was a Health Buddy™ (Bosch Inc. – Figure 4) which is 
used widely throughout the VA in the Care Coordination / Home Telehealth (CCHT) program.11 Bosch is exiting 
the telehealth industry as of May 15, 2015 but has agreed to follow research participants currently in the 
program until March 15, 2016. The program, with the branching logic will be transferred to similar technology 
with another VA approved telehealth vendor. One of the advantages of telehealth programs is the capability to 
have branching logic, so that the program is individualized depending on the progress and symptoms of the 
Veteran as he is progressing through each day’s session. 
 
The control group is designed to control for the daily use of a telehealth program (an attention control) as 
well to equate basic information about urinary incontinence between groups. The control program matches the 
number of interactions but is limited to general prostate cancer information; perioperative care; wetness, odor 
and skin care management but no content on pelvic floor muscle training and bladder control strategies. 
Outcome measures will be administered by the telehealth program in both groups. For the Health Buddy, data 
are stored on the telehealth program and transmitted each night via toll-free telephone lines to a database 
behind a secure VA firewall as they are in the CCHT program. This was proven to be feasible and practical in 
our pilot study. For the web-based program, the data will be stored on a secure website with VA-approved 
encryption. Both groups will have use of the telehealth program monitored and quantitated. Preoperatively and 
2 months postoperatively, telehealth sessions will be daily. After 2 months postoperatively, both groups will log-
in weekly for outcomes measurement until 6 months postoperatively and two more times at 9 & 12 months 
postoperatively. If we cannot obtain a response through the telehealth program, the questionnaires will be 
mailed to the participants along with a postage-paid return envelope. These measures are delineated in detail 
in the Outcome Measures section and in Table 5. The telehealth content for each session for both groups ends 
with a “fun fact” including sports and other trivia, famous men who have done well after prostate cancer 
diagnosis, etc. which have been successfully implemented in the pilot study and promoted adherence to the 
daily home telehealth program, in our pilot study as well as in the CCHT programs VA wide. At 12 months, 
Veterans still incontinent in both groups will be offered treatment in the GRECC Continence Clinics or the VA 
Urology Clinic. 
 
THEORETICAL FOUNDATION 
The major theoretical underpinnings for this proposal are drawn from the Health Belief Model (Table 1), 
which describes four factors influencing health efforts, adherence and a person’s readiness to take action:  
perceived threats, benefits, barriers and cues to action.22 Developed to improve adherence among TB patients, 
the Health Belief Model is ideally suited to management of post-prostatectomy incontinence. Both conditions 
are associated with stigma in those affected, can be treated with resulting cure in many of those affected, can 
become a chronic condition in others, and require daily adherence to therapy to improve the probability of cure 
or control. The daily interaction with the telehealth curriculum should prompt the participant to take the steps 
necessary to increase the probability of recovering continence. Telehealth technology is extremely well suited 
to provide education on the health problem, and to guide patients in their rehabilitation program with daily 
interaction, thus increasing adherence. Patients who encounter barriers with the telehealth curriculum as 
guidance will trigger calls from the monitoring center to problem solve through telephone contact with a nurse 
practitioner skilled in management of post-prostatectomy incontinence. Telehealth is not the intervention, but 
 

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July 25, 2016 
 
 
 
 
 
 
a means to administer the intervention, which is an evidence-based set of skills to improve pelvic floor strength 
and bladder control. Table 1 outlines the application of the concepts of the Health Belief Model in the design of 
this proposal. 
  
 
Table 1 - Health Belief Model22 Applied to Telehealth-Administered Perioperative  
Rehabilitation Program for Patients Undergoing Radical Prostatectomy 
Concept 
Application 
Perceived 
Susceptibility/ 
Severity 
Patients considering radical prostatectomy for treatment of prostate cancer often do not 
completely comprehend the risk of postoperative urinary incontinence, despite a thorough 
explanation by their urologist. The education provided preoperatively through the telehealth 
program will increase awareness of susceptibility to and consequences of incontinence, but 
even more importantly will focus them on an action plan with the potential to decrease the 
severity of postoperative incontinence. This rehabilitation program will be started 
preoperatively and continues when they are free from postoperative discomfort.  
Perceived 
Benefits 
The telehealth-administered curriculum will reinforce the urologist’s discussion of the 
probability of postoperative incontinence, lessening the possibility of patients believing that 
they were not fully informed when they confront the realities of loss of bladder control 
postoperatively. The telehealth curriculum will educate the patient about the demonstrated 
benefit of the evidence-based, perioperative rehabilitation program in terms of reduction in 
severity and duration of incontinence. It will specify how, where and when to take action 
and set expectations about potential benefits. 
Perceived 
Barriers 
Preoperatively, when not incontinent, many patients have trouble overcoming the barriers to 
initiating a rehabilitation program and integrating it with daily routines. The telehealth 
program, with its educational program and its daily prompting can help overcome these 
barriers. Postoperatively, when confronted with leakage, patients will be prompted to 
participate in a step-by-step program to decrease their leakage. The nature of stress urinary 
incontinence with variability leakage volume depending on activity can lead to days with 
more leakage, which could discourage the Veteran and cause abandonment of the 
rehabilitation program. This is best counteracted in clinic with frequent contact with a 
therapist, and daily interaction with the telehealth program will serve in this role, with back-
up by a nurse practitioner if needed as determined by the Veterans answers to the 
telehealth administered questions or by lack of daily use of the program. 
Cues to 
Action 
The telehealth curriculum will serve to provide information, promote awareness and remind 
or cue the participant to action on a daily basis. The branching logic of the system allows 
customization of the rehabilitation program depending on individual barriers and progress.  
Self-Efficacy 
While our data establish the usability of the intervention, confidence in one’s ability to 
engage, adhere and gain benefit from the intervention will be supported by providing 
training and support, the reinforcing motivational aspects of the intervention, and feedback 
specific to goal attainment/ progress to foster confidence. 

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METHODS 
Overview and Timeline 
The overall timeline is shown in Table 2.  
Table 2 – Project Timetable 
Activities 
Year 1 
Year 2 
Year 3 
Year 4 
Q1 Q2 Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q4 
Q1 
Q2 
Q3 
Q
4 
Q
1 
Q2 Q3 Q4 
Convert Placebo 
Program to telehealth 
format. 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Add additional outcome 
measures to 
Intervention module. 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Finalize Procedure 
Manual 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Set up Recruitment 
Procedures in BHM and 
ATL VAMC Urology 
Clinics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
In-person training 
sessions for Atlanta 
Team 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Newly Enrolled 
 
15 
15 
15 
15 
16 
18 
18 
20 
20 
20 
 
 
 
 
 
Cumulative Enrollment  
 
15 
30 
45 
60 
76 
94 
112 
132 
152 
172 
 
 
 
 
 
12-month Follow-up 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Monitored Participants 
 
15 
30 
45 
45 
46 
47 
48 
48 
48 
48 
48 
32 
16 
 
 
Collect Outcome 
Measures 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Data Entry 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
Data analysis 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Prepare and present 
findings at national 
meeting 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
Prepare and submit 
manuscripts for 
publication 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X 
X 
Implement 
Dissemination Plan 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
X* 
*On-going into the next year under direction of investigators in the GRECC 
 
Based on our experience in the developmental study, it will require 1 month to get the contract with the 
telehealth vendor established, during which time we will do final edits to the intervention and control telehealth 
programs. Dr. Muta Issa, Chief of Urology at the Atlanta VAMC will review the perioperative care content. This 
will further assure the generalizability of the program that we developed in collaboration with Dr. Janet Colli, 
who was Chief of Urology at the Birmingham VAMC during the early pilot/ developmental study. We also have 
added Dr. Katharina Echt, who contributes expertise in aging, health literacy, training and technology usability 
to the study team; she will further revise the content for optimal presentation. 
Once the content is finalized, the telehealth vendor will translate it into the telehealth program with 
branching logic. The branching logic system allows each participant to have a customized rehabilitation 
program according to his needs. For example, how to locate the proper muscles to exercise is a skill not well 

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July 25, 2016 
 
 
 
 
 
 
taught in most urology practices. The telehealth curriculum will start with the method that is usually successful: 
Screen 1 – “Practice stopping your urine steam each time you urinate until your next session.” Screen 2 – 
“Even if you can’t completely stop your urine stream, if you can slow it down, you are using the right muscles.” 
The next day, the telehealth program will inquire about their success in stopping the stream. If they could do it, 
they will be instructed in pelvic floor muscle exercise technique using the same muscles. If they couldn’t stop 
their stream, the telehealth program will present another technique to locate the pelvic floor muscles. If that 
method is unsuccessful, a third technique will be tried. If all 3 techniques still result in uncertainty, a phone call 
from the nurse practitioner will be triggered.  
It will take 2 months to edit the final screens for the active intervention telehealth program, and to edit the 
attention control program as it is converted to telehealth format. 
The telehealth program monitors the participants’ progress each day and the study coordinator takes 
appropriate action the next business day. Another example of the manner in which the curriculum is 
individualized is that almost 100% of men have early stress leakage (leak when they cough, sneeze, bend 
over, lift) following radical prostatectomy, but only about 50% of men have urge incontinence (“gotta go, gotta 
go”).3 The telehealth program will ask the participant if he is having leakage accompanied by urgency on the 
way to the bathroom and then guide him to the appropriate urgency control strategy training only if needed. An 
outline of the entire rehabilitation program content is in Table 3 in the Intervention Section below. 
Enrollment will begin when both the treatment and control home telehealth programs have been further 
refined by our additional experts. A combined estimated 90 prostatectomies per year are performed at the 
Birmingham and Atlanta VAMCs. Based on our pilot study, 85% of Veterans approached will be eligible and 
agree to participate. Of our first 21 pilot study patients, 2 decided to have radiation therapy instead or their 
prostatectomy and 1 surgery was aborted due to positive lymph nodes. Therefore, it will take 3 years to enroll 
all participants, and 12 more months for final outcomes assessment. Data cleaning and entry will be ongoing. 
The enrollment, data collection, manuscript preparation, and dissemination schedules are in the Timeline in 
Table 2. Dissemination of successful clinical demonstration programs is a mission of the GRECC and 
dissemination of this intervention will be designed during this clinical trial, but disseminated in the following 
year with GRECC effort. 
 
Participants 
Participants will be recruited from among men who are scheduled to undergo radical prostatectomy for 
treatment of prostate cancer at the Birmingham, Philadelphia, and Atlanta VA Medical Centers. Patients who 
are seen in the VA Medical Centers who elect to have their surgery outside of the facility can still participate in 
the study. In addition to recruitment at the above VA Medical Centers and in order to reach our targeted 
enrollment, beginning in 2015, recruitment will also take place in the Urology Clinic at the UAB Kirklin Clinic 
(Birmingham), the Urology Clinic at Emory St. Joseph’s Hospital (Atlanta), and at the University of 
Pennsylvania Urology Clinic. 
 
Inclusion and Exclusion Criteria 
 
Inclusion criteria:  
1. Patients who are seen in the Birmingham, Philadelphia, or Atlanta VA Medical Centers or University 
affiliated Urology clinics who are scheduled to undergo a radical prostatectomy for treatment of prostate 
cancer 7-28 days after possible enrollment. 
2. Ability to read English. This is essential to use the telehealth program and would exclude very few of 
our participants in Birmingham and Atlanta. Other language versions of the telehealth program, such as 
Spanish, will be developed at the dissemination phase. 
3. Home internet service. If the patient does not have a computer or does not wish to use their personal 
computer for the study, a tablet will be loaned to them.  
 
 
 
 

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Exclusion criterion: 
1. Self-report of significant incontinence in the 6 months prior to prostatectomy. Based on data from the 
Prostate Cancer Outcomes Study,2 we would expect about 14% of potential participants to have any 
pre-existing incontinence, 10% with minor leakage. In our pilot study of a clinic-based intervention at 
the Birmingham VAMC (Preliminary studies Section - Study #5), 2 of 30 men scheduled for 
prostatectomy (7%) had minor incontinence prior to prostatectomy and none of them had severe 
incontinence. In our prior clinical trial of preoperative pelvic floor muscle training for men undergoing 
radical prostatectomy, we operationalized this exclusion as “no more than 2 incontinence episodes in 
the last 6 months, not including post-void dribbling” and will do the same for the current proposal.4  Men 
who are excluded will be offered referral to the VA Continence Clinic for perioperative rehabilitation. 
Sample size 
 
Given the primary outcome is time to event, survival analyses will be used to conduct the analyses. A one-
sided log rank test with an overall sample size of 156 subjects (of which 78 are randomized to standard care 
and 78 are randomized to Telehealth) achieves 80% power using a one-tailed 0.05 significance level to detect 
a difference of 0.2000 between 0.55 and 0.35 - the proportions remaining incontinent in the two groups 
surviving in standard care and Telehealth respectively. This effect corresponds to a hazard ratio of 1.756. 
These results are based on the assumption that the hazard rates are proportional. The proposed effect size is 
based on our earlier research.4 Power and sample size has been calculated using the Log-Rank procedures 
within PASS 11.0 (Hintze, J. (2011). PASS 11. NCSS, LLC. Kaysville, Utah, USA. www.ncss.com).  
 
In our pilot study, after randomization, 10% of Veterans decided to have radiation instead of radical 
prostatectomy or were found to have positive lymph nodes during surgery and their prostatectomy aborted. 
These men ended participation in the study because they no longer had the risk factor for incontinence. To 
recruit sufficient numbers of Veterans so that we obtain the full 156 subjects indicated by our power calculation 
above, we will plan to randomize 10% more Veterans for a total of 172. When we reach the total of 156 
Veterans having had a radical prostatectomy, we will end recruitment. 
Recruitment Procedures at the VAMC 
The study coordinators at each site will attend all VA urology clinic sessions in which men could be 
scheduled for radical prostatectomy. In our pilot study, we have found that having a recruiter in clinic is 
essential for optimal enrollment, as busy urologists forget to call us to enroll patients. The study will be 
introduced to patients scheduled for radical prostatectomy by the urologist, and then the study coordinator will 
obtain informed consent from willing patients. Consenting participants will then complete the brief baseline 
assessment in clinic. Access to the telehealth program will be given to the participant after a brief training 
session. Our pilot study has shown that participants who were mailed a telehealth device had no trouble setting 
it up. The simple set-up instructions are very clear and have been performed successfully by hundreds of 
Veterans and their families across the U.S. If they prefer, participants can return for a separate appointment to 
complete baseline assessment.  
 
Our goal will be to enroll as many participants in person as possible. However, the study coordinator will 
check the surgery schedule weekly, and if a patient appears on the surgery schedule for radical prostatectomy 
and has not been enrolled in the study, the patient will be telephoned by Urology Clinic staff and if interested, 
then contacted by study staff. They will be invited to come in for an enrollment visit. As a back-up, or if the 
patient prefers, the study can be explained by telephone, a consent form mailed to the patient, any questions 
answered by telephone, and the consent form signed and mailed back. Once the consent form is returned, the 
baseline data can be completed by telephone, and when complete data has been received, the patient will be 
sent his telehealth program access.  
 
If participants are enrolled more than 28 days before their surgery date, they will not begin the program 
until 28 days before surgery. As in the inclusion/exclusion criteria section, if a participant cannot start the 
telehealth program at least 7 days before surgery, he will be excluded. He and the urologist could decide to 
delay his surgery so that he could participate if the participant desires. This would not affect his prostate cancer 

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July 25, 2016 
 
 
 
 
 
 
outcome and might improve his continence outcome. Every effort will be made to enroll participants at least 14 
days before their surgery. 
Recruitment Procedures at the University Affiliate Urology Clinics 
 
Birmingham site - Patients who are planning to undergo a prostatectomy at UAB will be informed of the 
study by their urologist at their pre-operative appointment at The Kirklin Clinic. The urologist will put a sentence 
in his clinic note that the patient has been informed about the study and agreed to have a study coordinator call 
him with more information. The urology nursing staff will email the study coordinator (secure UAB email to 
secure UAB email) with the names, MR numbers, and phone numbers of all patients who agree to be called.  
We will not be conducting any study procedures in The Kirklin Clinic. Our study coordinator will call the patient 
and explain the study to him. If he agrees to participate, she will conduct an informed consent discussion, 
answer all the patient’s questions and mail the VA consent form, the VA HIPAA and the UAB HIPAA form - 
Authorization for Use/Disclosure of Health Information for Research form. Should the patient wish to meet in 
person rather than do a telephone consent, we will meet with them at the TKC Urology Clinic during an already 
scheduled appointment or at the BVAMC (whatever the patient prefers). If the patient has questions once he 
receives the consent form in the mail, he can call and have a second discussion with the study coordinator 
and/or arrange an in-person visit. Should the patient request an in-person visit and provide us with a signed 
consent form at that visit, we will transport the consent form in a locked bag from The Kirklin Clinic to the 
Birmingham VAMC.  
 
Philadelphia and Atlanta sites – Recruitment at the Affiliate Urology Clinics at Philadelphia and Atlanta will 
be developed by the site and approved by their VA and University IRBs as appropriate with local regulations. 
Stratification and Randomization 
In order to assure between-group comparability, subjects will be stratified on two dimensions with 
possibility of impacting outcome:  
1. Age (<65 years and 65 or older) – older men are more likely to have post-operative incontinence. 
2. Gleason Score (<7 and 7 or greater) - named after Donald Gleason, a pathologist at the Minneapolis 
VAMC who developed this important tool with other colleagues in the 1960s, to classify the differentiation 
of the cancer cells in the prostate biopsy; the higher the score, the more anaplastic the tumor pattern, and 
the more likely that the tumor has spread beyond the prostate. The Gleason score serves as an indication 
of the likely extent of prostate cancer and serves as a surrogate for the surgical margins that will be 
necessary to resect the cancer, which will occur after randomization. The more extensive the resections 
are associated with worse continence outcomes, contingent particularly on whether one or both 
neurovascular bundles could be preserved. Seven is considered the cut point for higher risk disease. 
Within each stratum, blocked randomization will be performed using a variable block size and a table of 
random numbers to avoid inequity in the total number of subjects assigned to each group. Stratification will be 
used only to ensure that the treatment groups are similar on severity and treatment factors, not to compare 
groups. Each site will have a separate randomization schedule to avoid unequal distributions between sites.  
Also, blocking is used not to create comparison groups but only to ensure that the groups are similar in size. 
Intervention 
 
This telehealth technology allows for daily guidance via a series of interactive screens. At the time of his 
choosing each day, the participant interacts with a 10-minute session. Informational screens are interspersed 
with screens that pose questions. Some questions are on understanding of a technique, some on adherence to 
the rehabilitation program. Depending on the participant’s answers, the telehealth program’s branching logic 
permits different paths. For example, if the participant answers that he has not yet resumed his exercises 
postoperatively, the next screen will inquire about the reason. Four common reasons are listed, and 
appropriate information and instructions are provided depending on his endorsement of a reason. Some 
responses, such as repeated failure to resume exercises postoperatively, a lapse in adherence to exercises 
preoperatively once adherence is established, failure to master a specific skill such as urgency suppression, or 

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July 25, 2016 
 
 
 
 
 
 
a week without using the telehealth program at all will trigger an alert to the site study coordinator so that a 
nurse practitioner skilled in perioperative pelvic floor muscle training can call the patient to target perceived 
barriers. However, most common problems have been anticipated and already integrated into the telehealth 
program dialogues.  
 
The Health Buddy is connected to the telehealth program via an analog telephone line (“land line”) or a 
cellular modem and a new interactive dialogue is downloaded each night via an automatic toll-free call. For 
participants with cell phones, there is no additional cost, since the cellular modem is independent of the 
participant's cell service. The study pays an additional fee for the service as well as purchasing the cellular 
modems. The device can be taken anywhere in the United States, plugged into a telephone line or accessing a 
cellular signal, and the rehabilitation program and data collection will proceed. A green light on the Health 
Buddy alerts the participant that a session is waiting. For the web-based program, the participant will access 
the telehealth program with their own computer or tablet or a loaned tablet. The purpose of the telehealth 
program dialogues is to improve adherence to the rehabilitation program through regular monitoring and 
proactive problem solving. In addition, the participant will need to do 5 minutes of three times daily exercises 
and practice his bladder control skills. 
 
The core content of telehealth-administered, evidence-based, perioperative rehabilitation program is 
administered daily via 5-10-minute sessions 2 weeks preoperatively and 2 months postoperatively. If the 
participant has more time before surgery, he will have slightly longer to practice his exercises (within the 7-28-
day window). Program content includes education, pelvic floor muscle training, progressive exercises, and 
bladder control techniques and is based on the programs described in seven randomized, controlled trials of 
perioperative pelvic floor muscle rehabilitation that have successfully decreased post-prostatectomy 
incontinence, including our own clinical trial.4-10 The outline of the content is shown in Table 3. Some 
redundancies are built into the curriculum for reinforcement. With the branching logic, if a participant has 
mastered a technique, the content will not be repeated. Real-life patient stories illustrate the teaching points in 
many of the sessions and function to increase personal relevance of the material and thus learner 
engagement. Moreover, these patient stories support skill acquisition by demonstrating or modeling the 
everyday application of the teaching points in the lives of the participants. 
Table 3 - Outline of Telehealth-Administered, Evidence-Based  
Perioperative Rehabilitation Program Content 
Preoperative 
1) General Information about prostate 
cancer** 
2) Information about post-prostatectomy 
incontinence, prevalence and course** 
3) Goals of the rehabilitation program 
 4) Locating the pelvic floor muscles and  
     proper contraction/relaxation technique 
5) Building muscle strength and control 
6) Treatment adherence 
7) Each session ends with a Fun Fact – 
including examples of famous men who 
have done well after prostate cancer 
diagnosis.** 
 
 
 
Postoperative 
1) Resuming exercises and building strength and control 
2) Leakage management – absorbent products, skin care 
and odor control** 
3) Building muscle strength 
4) Bladder control techniques  
      – stress, urge, post-void dribbling 
5) Fluid management – drinking  
    adequate fluid and avoiding caffeine 
6) Maintaining control once continence  
    is attained 
7) Each session ends with a Fun Fact – including examples 
of famous men who have done well after prostate cancer 
diagnosis.** 
** Shared content with attention control program 

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The written content of the telehealth program will be supplemented only by an anatomy diagram for 
participants using a Health Buddy. The diagram will be incorporated into the web-based program. We had 
planned a very brief booklet, based on the book “Staying Dry: A Practical Guide to Bladder Control,” authored 
by the Co-PI, Dr. Kathryn Burgio, et al. and published by The Johns Hopkins University Press,22/23 which is the 
basis for much of the behavioral content of the telehealth program. However, we decided not to use the 
booklet. We wanted to see if the telehealth program would be sufficient alone, and indeed it has been. The 
only supplementation that our pilot participants recommended was an anatomy diagram of the pelvic floor 
muscles and related anatomy, which we did not supply initially, but are now using. That no participant 
expressed a need for written materials, which would probably surprise many academicians. However, the daily 
reinforcement of the behavioral program by the telehealth program is actually much more intense than the 
teaching patients receive in our in-clinic training, with visits once a month. Also, each daily telehealth module 
can be repeated as many times as the participant desires on that particular day. Most of the pilot participants 
liked the daily brief telehealth sessions and information "bites," and felt it was better than a self-help manual 
would have been.  
 
Using telehealth to administer an evidence-based, perioperative rehabilitation program to participants 
undergoing prostate cancer surgery is an innovative use of this technology. The telehealth programs have 
proven to be a feasible and effective means of health monitoring for chronic conditions.12-17 It has also been 
used in other surgical populations: post organ transplant and post coronary artery bypass surgery. 
Unfortunately, no research exists to evaluate these types of telehealth programs, only the more chronic care 
models such as diabetes and congestive heart failure.17 Our proposed study will begin to help fill that gap in 
the literature. 
Treatment Fidelity 
 
Intensive protocol training will be done for the project managers at both sites as well as for the nurse 
interventionist. This will occur on-site for both the Atlanta and Birmingham sites, and then be supplemented by 
weekly VANTS calls to prevent procedure drift and discuss problems as they arise, The PI is also available any 
time by cell phone to answer more urgent questions. On the weekly calls, we will review results of the 
interventions by the study coordinators for participants who are non-adherent to conducting their daily 
telehealth sessions. The nurse interventionist in Birmingham will be conducting all telephone interventions for 
participants at all sites who are completing their telehealth session, but not meeting learning goals. A formal 
monthly meeting will be conducted with the PI and nurse interventionist to review all telephone support, 
including content and results. Because the nurse interventionist's and the PI’s offices are close together in the 
Birmingham office of the GRECC, we also anticipate being able to discuss these calls immediately after they 
occur as well.  
Follow-Up 
 
After completing the daily 2-month post-operative program, participants will complete an outcome 
assessment once a week until 6 months after their surgery, and then again at 9 and 12 months. Weekly, this 
will be the ICIQ-UI short form, and every 4 weeks the EPIC-UI and the EPI, GPI, and PSQ will be added as 
outlined in Table 4. Specifics for these measures are in the following section on Outcome Measures. For the 9- 
and 12-month outcomes assessment, a questionnaire will be mailed with a post-paid, pre-addressed envelope 
only if the patient does not respond to the telehealth session. If participants in either group do not do a weekly 
assessment, they will be called to prompt them to complete the assessment or offered the opportunity to 
complete it on the telephone.    
 
 

12 
July 25, 2016 
 
 
 
 
 
 
Table 4 – Data Collection Schedule 
 
Pre-op 
Visit 
1 Month 
After 
Discharge 
Ongoing in the 6-
Month Post-op 
period 
At 6 
Months 
Post-op 
At 9 
Months 
Post-op 
At 12 
Months 
Post-op 
CPRS 
Abstraction 
H & P 
Hospital 
Record 
 
 
 
CPRS Clinic 
Notes and 
Medication 
Profile 
Continence 
History 
X 
 
 
 
 
 
ICIQ-UI-SF     
[4 items] 
X 
 
WEEKLY via 
telehealth program 
X 
X 
X 
EPIC-UI  
[4 items] 
X 
 
MONTHLY via 
telehealth program 
X 
X 
X 
IIQ-SF, 
IPSS QoL 
question, 
other QoL 
questions      
[11 items] 
X** 
 
MONTHLY via 
telehealth program 
 
X 
X 
Exercise 
Adherence 
Measure 
[3 items] 
 
 
MONTHLY via 
telehealth program - 
intervention group 
only 
X 
X 
X 
Bladder 
Control 
Strategy 
Adherence 
[3 items] 
 
 
MONTHLY via 
telehealth program - 
intervention group 
only 
X 
X 
X 
PSQ, EPI, 
GPI            
[1 item 
each] 
** 
 
At 2 MONTHS post-
op and then 
MONTHLY via 
telehealth program 
X 
X 
X 
CPRS = Computerized Medical Record System; EPI = Estimated Percent Improvement;                     EPIC-UI = 
Expanded Prostate Cancer Index Composite Urinary Incontinence Subscale;                     GPI = Global 
Perception of Improvement; H & P = History and Physical; ICIQ-SF = International Consultation on Incontinence 
Questionnaire – Short Form; IIQ-SF - Incontinence Impact Questionnaire Short Form; IPSS QoL- International 
Prostate Symptom Score Quality of Life; PSQ = Patient Satisfaction Question  
**Note that the PSQ, EPI, and GPI are patient global impressions of improvement and satisfaction and cannot 
be collected at baseline. Same with return to work after surgery and return to usual activities after surgery (other 
QoL items) 
 
Participants who have not achieved continence by 12 months after their surgery will be offered treatment in 
the GRECC Continence Clinics.  
 
 

13 
July 25, 2016 
 
 
 
 
 
 
Telehealth Equipment Return 
Once the participant has completed the telehealth portion of the study, the study coordinator will check for 
any upcoming appointments in CPRS. If they have been loaned a tablet, it is optimal to have it returned in 
person. If no appointments are scheduled in the near future, the participant will be provided with a box and a 
postage-paid, return mailing label. The participant will be responsible for packaging the tablet in the provided 
box and dropping it off at the nearest UPS store. If the participant does not wish to deliver the telehealth device 
to the nearest UPS store or there is not a store nearby, a UPS pick-up at their home will be scheduled with the 
participant’s permission. 
Outcome Measures 
 
The International Consultation on Incontinence Questionnaire Short-Form (ICIQ-SF) is one of a 
series of International Consultation on Incontinence questionnaires that have been meticulously developed and 
tested.24-27 The ICI questionnaires are becoming the outcome measures of choice in incontinence clinical trials 
internationally,28-29 allowing comparability between studies. The ICIQ-SF is a brief (4 items), reliable 
(Cronbach’s alpha = 0.95), questionnaire that quantifies both symptom burden and impact of incontinence and 
has been validated in men and women. We have piloted the ICIQ-SF and patients have found it very quick and 
easy to complete. The ICIQ-SF correlated well with urodynamic outcomes in men and women,25 and 24-hour 
pad tests, the International Prostate Symptom Score (IPSS), and Postoperative Patient Global Impression of 
Improvement (PGI-I) Score in men undergoing surgical treatment for post-prostatectomy incontinence.26  
The primary patient outcome is time to continence as measured by the ICIQ-SF. The ICIQ-SF is 
designed, in part, to screen for incontinence and is completely appropriate to determine if a person no longer 
has incontinence. We used time to continence in our previous clinical trial of preoperative training to prevent 
post-prostatectomy incontinence.4 Time to continence also has face validity since it is extremely important to 
the patient who wants to regain continence as soon as possible after his surgery. The ICIQ-SF will be 
completed weekly for 6 months post-operatively via the telehealth program. Each telehealth screen related to 
the ICIQ-SF will be prefaced with “During the last week” to make the timeframe clear. When a participant 
reports no incontinence on the ICIQ-SF (an answer of “never” to “In the last week, how often did you leak 
urine?”) for 3 weeks in a row, we will consider him continent. We successfully used the definition of no reported 
leakage for 3 weeks based on weekly bladder diaries in our prior study of preoperative training to prevent post-
prostatectomy incontinence.4 Although it is likely that participants who achieve this endpoint may still have 
occasional leakage, such as with heavy lifting or a good laugh, experience has shown that these men do not 
consider themselves incontinent. The total score of the ICIQ-SF will also be used to evaluate patient outcomes. 
The ICIQ-SF score has shown sensitivity to change with treatment in men with post-prostatectomy 
incontinence.26 We will also compare continence rates at 9 and 12 months. 
Secondary Outcome Measures 
 
Expanded Prostate Cancer Index Urinary Incontinence Subscale (EPIC-UI): This measure, validated 
as a stand-alone assessment, consists of 4 questions from the EPIC,30 a health-related quality of life (HRQOL) 
assessment tool. The EPIC was developed based on advice from an expert panel and prostate cancer 
survivors, expanding the 20-item University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) to 50 
items that quantify symptoms and bother associated with urinary, sexual, bowel, and hormonal domains. 
Summary and subscale scores were derived by content and factor analyses. Reliability and validity of the total 
and subscales were assessed by test-retest correlation, Cronbach's alpha coefficient, inter-scale correlation, 
and EPIC correlation with other validated instruments. Test-retest reliability and internal consistency were high 
for the EPIC-UI with (r = 0.87 and Cronbach's alpha = 0.89). In addition to the subscale score, the EPIC-UI 
question on pad use will be used as descriptive data. Although more valid measures are now recommended, 
pad use is an outcome that has been used in many post-prostatectomy incontinence trials and is important for 
comparability across trials. 
 
Incontinence Impact Questionnaire - Short Form (IIQ-SF) This measure, validated in men with post-
prostatectomy incontinence, measures the impact of incontinence on regular activities.31 It is a condition-

14 
July 25, 2016 
 
 
 
 
 
 
specific quality of life measure that has been widely used in incontinence clinical trials. It is sensitive to pre-
post changes after treatment. See Figure 1. 
 
 
 
 
 
 
 
 
 
 
IPSS Quality of Life Question.32 Frequently administered with the AUA Symptom Index, this validated 
quality of life measure has been shown to be sensitive to change after treatment in clinical trials including our 
own work. It is shown in Figure 2.  
 
 
 
 
Other Quality of Life Questions: We have supplemented the validated questionnaires with additional 
quality of life questions in much of our past research.4,18-21 These additional data points provide additional 
information of the impact of incontinence. We plan to ask the participants the following questions each month 
1-6 months post-operatively and again at 9 & 12 months post-operatively: 
• 
How disturbing is the urine leakage problem to you? (not at all, somewhat, or extremely disturbing) 
• 
How much does leakage of urine restrict your activities? (not at all, some of the time, most of the 
time, all of the time). 
• 
Have you been able to return to work since your surgery? (yes, no, retired or disabled) 
• 
Have you been able to resume your usual activities since your surgery? (yes, no) 
 
Exercise Adherence Questionnaire: We will measure adherence to exercises monthly, more frequently 
as the exercise routine is being established, with a brief questionnaire used in our NIH-funded incontinence 
research since 1989, including our trial of pelvic floor rehabilitation for post-prostatectomy incontinence,4 
Figure 1 
Incontinence Impact Questionnaire – Short Form 
Has urine leakage affected your: 
Not at all Slightly Moderately Greatly 
1.   Ability to do household chores 
(cooking, housecleaning, laundry)? 
❑ 
❑ 
❑ 
❑ 
2.   Physical recreation such as walking, 
swimming, or other exercise? 
 
❑ 
❑ 
❑ 
❑ 
3.   Entertainment activities (movies,  
      concerts, etc)? 
❑ 
❑ 
❑ 
❑ 
4.   Ability to travel by car or bus more 
than 30 minutes from home? 
❑ 
❑ 
❑ 
❑ 
5.   Participation in social activities 
outside your house? 
❑ 
❑ 
❑ 
❑ 
6.   Emotional health (nervousness, 
      depression, etc)? 
❑ 
❑ 
❑ 
❑ 
7.   Feeling frustrated? 
❑ 
❑ 
❑ 
❑ 
Figure 2 - IPSS Quality of Life Question: If you were to spend the rest of your life 
with your urinary problem the way it is now, how would you feel about that?  
⁭ 
Delighted, Pleased, Mostly satisfied, Mixed (about equally satisfied and dissatisfied), 
Mostly dissatisfied, Unhappy, Terrible 

15 
July 25, 2016 
 
 
 
 
 
 
and also, the VA Rehab R&D-funded study of pelvic floor rehabilitation for overactive bladder in men.18 The 
questionnaire is shown in 
Figure 3. If the participant 
answers “No” to “Are you 
doing the pelvic floor 
muscle exercises?” the 
next two questions would 
not appear. Instead, the 
participant will see 
screens designed to help 
him surmount barriers to adherence. Participants in the experimental group will also get monthly measures of 
bladder control strategy adherence – i.e., using the pelvic floor muscles to prevent stress and urge leakage. 
Patient Satisfaction Question (PSQ), Estimated Percent Improvement (EPI), and Global Perception 
of Improvement (GPI): As in the most recent publication by the International Consultation on Incontinence 
conducted in 2009, the International Scientific Committee recommended that urinary incontinence clinical trials 
include one or more high quality, validated instruments representing the viewpoint of the patient.33 Subjective 
patient assessments have been deemed so important that in one trial of pelvic floor muscle rehabilitation in the 
NIH Pelvic Floor Disorders Network, it was the consensus of the expert panel to use a single global patient 
rating of improvement as the primary outcome measure.34,35 We propose three patient perception assessments 
developed by the investigators to capture patient perceptions of improvement and satisfaction (Figure 4).33  
The Estimated Percent Improvement (EPI) and 
Global Perception of Improvement (GPI) are 
two simple questions that allow the patient to 
estimate his improvement after treatment; 
response on one is continuous and the other 
categorical. The Patient Satisfaction Question, 
on the other hand, captures patient satisfaction 
with treatment on a visual analog scale from 0 
to 100%. This outcome is very important since 
there can be different levels of satisfaction with 
similar degrees of improvement and vice 
versa.20,21 We used these measures in our 
Rehab R&D-funded project, “Behavioral 
Treatment for Overactive Bladder in Men,” 
(Merit Award B02-2489R, PI - Dr. Burgio).18 
During validation of these assessment questions, convergent validity was established by examining the 
relationship between each measure and reduction of incontinence episodes (based on bladder diary), change 
on the Incontinence Impact Questionnaire (IIQ), a validated incontinence-specific quality of life tool, and 
patients’ desire for another treatment.  Discriminant validity was tested by examining the relationship of the 
global ratings to five measures not expected to be related to outcome (age, race, BMI, education level, and 
change in perceived pain). The PSQ, EPI and GPI demonstrated acceptable convergent and discriminant 
validity for measuring outcomes in studies of treatment for urinary incontinence.33 The schedule of data 
collection is shown in Table 4 (above).  
 
Qualitative Assessment 
 
At 6 months postoperatively, after completing the core curriculum, 30 participants in the active treatment 
group will complete an in-person or telephone assessment of their experience using a semi-structured 
interview guide developed by Dr. Woodby and our research team (Table 5). The telephone or in-person 
interview will be conducted by Dr. Katharina Echt in Atlanta to evaluate any suggestions participants have and 
as well as gather any suggestions for changes to the telehealth program. The session is recorded, with the 
participant’s permission. To optimize patient feedback from those who can best express their critique and 
Figure 4 – Global Patient Perception Assessments 
 
PSQ:  How satisfied are you with your progress in 
controlling your bladder? 
     Completely // Somewhat // Not at All 
 
GPI:  Overall, do you feel that you are: Much better // 
Better // About the same // Worse // Much worse 
 
EPI:  Estimate how much better you are on a scale from: 
 0% (no better) to 100% (completely better).    
________%   
Figure 3 - Exercise Adherence Questionnaire 
Are you doing the pelvic floor muscle exercises? (Yes or No) 
If yes: How many days did you do the exercises in the last week? ______ 
How many exercises do you do in a typical day?  _______ 

16 
July 25, 2016 
 
 
 
 
 
 
suggestions on paper, this option will be available to participants as well. Based on participant input, 
modifications will be made to the telehealth curriculum. 
 
Table 5 - Semi-Structured Interview Guide 
 
I. Technology Issues 
a. If you used a Health Buddy, can you tell me about your experience with setting up the 
telehealth device in your home? 
i. How easy or difficult was the initial set-up? 
ii. Where did you place the telehealth device in your house? 
iii. Was this location someplace convenient to your daily routine?  
iv. Did anyone notice the telehealth device and ask questions about it? How was it 
answering their questions? 
b. Can you tell me about how it was to use the telehealth program? 
i. What time of day did you usually do your telehealth sessions? 
ii. How convenient or challenging was it to find the time each day to do the 
telehealth session?  
iii. Did you usually do this alone or was someone with you when you used the 
telehealth program? If someone helped: How did that work for you? 
iv. If you used a Health Buddy or loaner tablet, did you experience any problems 
with the telehealth equipment? 
II. Module Content 
a. What did you think about the information you received through the telehealth program? 
i. Was the print size easy or hard to read? 
ii. Was the information easy or challenging to understand? 
iii. Did the information flow in an order that made sense or was it confusing? 
iv. Overall, did the program move at the right speed? Or was it too slow or too fast? 
v. Was the information helpful? 
vi. What in particular was most helpful? 
vii. What was the least helpful? 
viii. What did you think about the patient stories? 
ix. What did you think about the fun facts? 
b. Can you tell me about what it was like for you to do the pelvic muscle exercises? 
i. How difficult was it for you to locate your pelvic muscles? 
ii. How easy or challenging is it for you to practice the exercises each day? 
iii. What reminders do you use to help you to remember to do your exercises? 
III. Overall Evaluation 
a. Overall, did you like the telehealth Program?  
b. Did it meet the expectations you had when you signed up for the program? 
c. Does it make sense to you to learn this information using the telehealth program or 
would you prefer learning it another way? (like in the clinic or from a booklet) 
IV. Suggestions 
a. What suggestions do you have for improving the telehealth Program? 
b. Is there anything else you would like to share about your experience with this 
equipment or information that you think we ought to know that would be helpful for 
other patients? 
c. Would you recommend this to other men who are planning to have prostatectomy 
surgery? 
 

17 
July 25, 2016 
 
 
 
 
 
 
 
We have been successfully using this Interview Guide during the pilot study. We will continue to collect 
qualitative data in the RCT. A sample size of 30 will ensure that important characteristics of participants' 
experiences are not overlooked and that there is sufficient variation in participants’ perceptions and 
experiences to identify most, if not all, of the relevant themes. 
As shown in Table 6, an N of 30 reduces the probability of missing a perspective with a 10%-incidence to 
less than 5%. This translates into 95% confidence of identifying any qualitative insight that will contribute to our 
characterization of participants experiences with the intervention.36 This data is assisting us with improvements 
in the telehealth program now as a result of being used in the pilot study and will be quite useful in description 
of the telehealth modules development and in dissemination. 
Table 6. The probability of missing a population subgroup in a random sample 
Number of Respondents 
Population 
Incidence 
10 
20 
30 
40 
50 
60 
100 
200 
========= ======= ======= ======= ======= ======= ======= ======= ======= 
.50 
.001 
<.001 
<.001 
<.001 
<.001 
<.001 
<.001 
<.001 
.33 
.018 
<.001 
<.001 
<.001 
<.001 
<.001 
<.001 
<.001 
.25 
.056 
.003 
<.001 
<.001 
<.001 
<.001 
<.001 
<.001 
.20 
.107 
.012 
.001 
<.001 
<.001 
<.001 
<.001 
<.001 
.10 
  .349* 
.122 
  .042* 
.015 
  .005* 
.002 
<.001 
<.001 
.05 
.599 
.358 
.215 
.129 
.077 
.046 
  .006* 
<.001 
.01 
.904 
.818 
.740 
.669 
.605 
.547 
.366 
.134 
 
Data Management 
 
The telehealth programs use encrypted data with a proprietary 128-bit encryption technology that has been 
approved by VA security audits and is downloaded nightly from the Health Buddy to the VA Austin Automation 
Center or stored on the secure vendor website. Bosch also maintains a duplicate failover facility in the VA 
facility at Hines IL. Both databases are synced daily so the chance of data loss is extremely low. The transfer 
of data is via a toll-free call at no expense to the participant. If the call is interrupted, the Health Buddy recalls 
the center and retransmits all of the data. Data downloads to our research site will be via a shared-access VA 
server, other than the programmed alerts based on patients’ replies to the Health Buddy dialogues, which will 
be transmitted the day received to prompt a call to the patient from a nurse practitioner at our center. If a 
participant has not completed the telehealth outcome measures for 1 week, they will be administered in-person 
or by telephone and barriers will be problem solved to increase adherence. All adherence and nurse 
practitioner time will be tracked. We will differentiate contact necessary for the participant to master the content 
of the rehabilitation program from contact necessary to collect study outcome measures on time. This will be 
important to dissemination planning. 
 
For the data collected at the Birmingham and Atlanta VAMCs by in-person or telephone interviews and 
CPRS audit, the research documents will be scanned and uploaded to a SharePoint site behind a VA firewall. 
The paper copies will be kept in a secure and locked location in the Geriatric Research, Education, and Clinical 
Center (GRECC). The data will be entered into a SPSS database and stored on a secure VA server by the 
data manager. Information abstracted from the VA Computerized Patient Record System (CPRS) will be 
entered onto paper forms that will then be entered into the same SPSS database. A back-up SPSS database 
will be stored on a different VA server in a different location. The databases will be deidentified. The name and 
study number key will be stored in separate files on each of the servers. To ensure the accuracy of the data, a 
percentage of the data entered from paper records will be subject to dual entry with the percentage adjusted 

18 
July 25, 2016 
 
 
 
 
 
 
up or down depending on the error rate detected.  Manual inspection of the forms will be done to resolve 
differences in the dually entered data. The principal investigator and statistician will meet with the database 
manager to review accrual, data entry, and examine the database for outliers or data base entry errors 
monthly. 
 
Data Analysis 
Preliminary Analyses 
 
Although subjects will be stratified and randomized, the equivalency of the two groups will be evaluated on 
selected variables that might influence treatment outcome:  study site, age, nerve sparing surgery, body mass 
index. The chi square statistic will be used for the categorical variables and the two-sample t test for 
continuous variables.  Normality will be carefully assessed for continuous outcomes and if the assumption is 
violated, non-parametric methods will be used. 
Outcome Variables Analysis 
Primary outcome analysis: duration of incontinence (time to achieve continence after surgery). Participants will 
be considered continent if they answer that they leak urine “never” on the ICIQ-SF for 3 weeks in a row. Please 
see Methodology section for complete explanation of this measure. Baseline time for this measure will be the 
day of surgery. Median time until continence and its 95% confidence interval will be calculated per group. The 
duration of incontinence will be examined using the Kaplan-Meier procedure, in which all protocol eligible 
participants are analyzed. Men who did not have a prostatectomy – either due to positive lymph nodes during 
surgery or because they changed their mind and selected another treatment after randomization but before 
surgery will not be included in the analysis. All other men randomized will be included. The duration of 
incontinence will be compared between the 2 groups using the log rank test. We will also compare continence 
rates at 9 and 12 months. 
Secondary outcome analyses (severity of incontinence, impact on quality of life, and patient reported 
evaluations of improvement and satisfaction with treatment) will be measured by: 
1. ICIQ-SF total score 
2. EPIC-UI total score 
3. Pad use from the EPIC-UI 
4. Patient estimation of improvement measured by the GPI and EPI 
5. Patient satisfaction as measured by the PSQ 
6. IIQ – total and subscale scores 
7. IPSS Quality of Life Question (IPSS QoL) 
8. Questions on activity restriction, amount of disturbance caused by incontinence 
9. Return to work or normal activities after surgery. 
 
Our hypothesis for the secondary outcomes is that total ICIQ-SF, EPIC-UI total Score, Pad use, GPI, EPI, 
PSQ, IIQ, IPSS QoL, return to work or normal activity, and amount of disturbance caused by incontinence will 
be better in the pelvic floor muscle rehabilitation group. 
Initially, descriptive analyses will be conducted to examine distributions of the frequency of symptoms and 
possible covariates. Extreme values will be checked for accuracy and recoded as indicated. Transformations 
may be employed to correct for skewness or heterogeneity as needed.  
The ICIQ-SF total score and the EPIC-UI total score will be analyzed using multiple regression analysis to 
regress the 6 and 12-month scores on treatment group, while controlling for baseline score (first score after 
catheter removal post-operatively). Pad use will be dichotomized into no pad use and any pad use. Pad use 
will also be analyzed descriptively as no pads, 1 pad, or 2 or more pads. The chi square statistic and the t test 
for independent samples will be used. Both measures are necessary for comparison with earlier studies. 
Multiple regression will used for the GPI, EPI, and PSQ at 6 and 12 months. There is no baseline for these 
measures as they are the patients’ evaluations of their improvement and treatment satisfaction. For the IPSS 
QoL question, questions on activity restriction, disturbance, and return to work or normal activity, the chi 
square statistic and the t test for independent samples will be used. 

19 
July 25, 2016 
 
 
 
 
 
 
Qualitative Analysis 
To ensure analytic rigor, the following procedures will be followed: (1) data immersion (reading/listening 
and re-reading/listening to the text); (2) thematic identification and articulation (discovering, naming, defining 
codes/variables); (3) data categorization (developing a coding scheme); (4) pattern articulation (identifying 
connections within and between codes; (5) data interpretation (recognizing how the patterns transcend 
individual experiences and reflect larger social processes). As an analytical process, content analysis involves 
sorting and making sense of written and narrative data. The goal is not to generalize across a population, but 
rather to provide understanding and explanation from the respondent’s perspective. 
 
DISSEMINATION PLAN 
Before dissemination, data from the qualitative analysis of the semi-structured interviews with participants 
in the active treatment group as well as any themes that arose in our debriefing meetings regarding the nurse 
practitioner "rescue calls" will be used for final modifications to the program.  
We will be using a theoretical framework to guide dissemination, the Promoting Action on Research 
Implementation in Health Services (PARIHS) framework.37140 The PARIHS model is ideal for dissemination of a 
telehealth-administered program because it focuses on systems of care rather than individual provider or 
patient response to proposed change. The PARIHS framework proposes that successful implementation of 
evidence in practice is dependent on the inter-relationship of three key elements: the nature of the evidence, 
the quality of the context, and expert facilitation. For successful implementation, evidence needs to be robust, 
the context receptive to change, and appropriate facilitation provided. This RRD-funded grant will provide the 
evidence and the successful context. The investigators will be actively involved in the dissemination process to 
facilitate implementation.  
The dissemination will be through the VA Care Coordination/Home Telehealth (CCHT) program. As per the 
PARIHS framework, to establish the nature of the evidence, teaching sessions via teleconference will be done 
for the CCHT staff to describe the burden on Veterans as a result of a diagnosis of prostate cancer, the 
excellent prognosis, but the resulting incontinence in men electing surgical treatment. Further, evidence of the 
effectiveness of perioperative pelvic floor rehabilitation and specifically that the telehealth program is effective 
to assist Veterans undergoing prostate cancer surgery to recover continence sooner and that it also improves 
their quality of life will be presented. We will include patient testimonials from our patient debriefings and 
qualitative analysis. We will provide similar educational sessions for Urology Clinic nurses, nurse practitioners, 
and physicians assistants. Their assistance will be crucial to help identify Veterans about to have prostate 
cancer surgery so they can participate in the preoperative rehabilitation model. CCHT teams can also monitor 
the surgery schedules so that any patients missed pre-operatively can be enrolled immediately after surgery.  
Per the PARIHS framework, to establish the quality of the context and receptivity to this new program, input 
regarding any anticipated difficulties in implementation will be solicited after each teleconference so that they 
can be addressed.  
To provide expert facilitation during implementation, we will provide telephone support as CCHTs start 
using this new module and continue as long as necessary. So far in the pilot study, patient telephone support 
beyond a phone call to encourage a few Veterans to start the program has not been necessary. If this proves 
to be so in the RCT, then the CCHT personnel would not need additional expertise to monitor patients enrolled 
in the program. The training as described above will be sufficient for them to implement the program. 
Unlike many treatment protocols developed and proven effective by research teams that average 10 years 
to become common practice, the delivery system for this intervention has a strong existing infrastructure, the 
CCHT program. As mentioned earlier in the grant proposal, there has been a 30-fold growth in the CCHT 
program from 10,000 Veterans served in FY2006 to 300,000 in FY2010. There are 3 major reasons for this 
growth: 1) the CCHT program is mandated in every VA, 2) funding to each VAMC is based on the number of 
Veterans enrolled, so there is motivation to enroll Veterans into the program, and 3) the Veterans really like 
these simple home messaging devices and take pride in the improvements in their knowledge and health. This 
completely fits into the Health Belief Model, which is our theoretical framework for the study. The home 

20 
July 25, 2016 
 
 
 
 
 
 
messaging units cue the Veterans to action, provide the information they need for an action plan, and help 
them achieve benefits that are clinically meaningful.  
Done optimally, dissemination will take the better part of a year and will be performed as part of the 
GRECC mission of disseminating successful clinical dissemination projects. GRECC investigators will also 
revise the content of the program as necessary in the future as guided by new science and practice. 
To assist in dissemination, we will also present the results of the clinical trial at the American Urological 
Association annual meeting and publish the manuscripts in prominent medical journals such as JAMA or the 
Journal of Urology, with an article describing the development of the program in the Federal Practitioner.