Does a Patient Education Video Augment Pelvic Floor Physical Therapy Compliance?
Phase: NA
Conditions: Patient Compliance, Pelvic Floor Disorders
Sponsor: Elizabeth Mueller

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Title: Does a Patient Education Video Augment Pelvic Floor Physical Therapy 
Compliance? 
 
PI: Cynthia Brincat, MD 
 
Team: Colleen Fitzgerald, MD, Elizabeth Mueller, MD, Linda Brubaker, MD, Megan 
Brady, MD, William Adams, Ph.D., Neelam Balasubramanian, B.A., Elizabeth Billquest, 
B.S., Sana Iqbal, B.A., and Ketelynn Braggs, R.N. 
 
Department of Obstetrics & Gynecology, Division of Female Pelvic Medicine and 
Reconstructive Surgery, Loyola University Medical Center 
 
Version 2 
 
11.01.2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. Protocol Synopsis 
1.1. Study Premise 
 
Pelvic floor physical therapy (PFPT) is a widely accepted treatment for many 
urogynecologic diagnoses, such as stress and urge urinary incontinence, pelvic organ 
prolapse, and myofascial pain of the levator ani muscles1. This conservative treatment 
modality has virtually no risk, unlike medications or surgery2. It is especially useful for 
patients who are otherwise poor surgical candidates. This treatment consists of weekly 
one hour long physical therapy sessions with therapists specially trained in the pelvic 
floor musculature. Treatment length depends on severity of symptoms and patient 
progress, but is usually anywhere from five to fifteen visits at our practice. 
 
Many investigators worldwide have studied what factors influence patient compliance 
with this therapy1,3,4. Some barriers that have been identified including being too busy 
with work, being afraid of vaginal palpation, feeling ashamed, feeling too old to engage 
in such therapy, or having symptoms that are minor.5 Another analysis found that age, 
distance from home, and diagnosis necessitating PFPT were factors in compliance6. 
We have recently performed an IRB-approved retrospective chart review to determine 
PFPT compliance within our practice. We found that 66% of patients attended at least 
one therapy session. Of these women, 73% attended at least half of the recommended 
visits.  
 
Our practice wants to develop an educational tool to improve PFPT compliance. We 
designed and created a four minute patient education video with assistance of the 
marketing department. This video includes physicians, pelvic floor physical therapists, 
and one of our patients speaking to the most common questions and concerns patients 
have.  Now we aim to assess if patients who use this education tool will have improved 
compliance to therapy.  
 
1.2. Specific Research Question 
Does viewing an educational video augment patient compliance with PFPT compared to 
standard counseling? 
 
1.3. Study Objectives and Hypotheses 
Objective: To determine the impact on PFPT compliance in patients who view an 
educational compared to standard counseling 
 
Hypothesis:  Compared to patients receiving standard counseling, those who receive 
both the standard counseling and educational video intervention will  

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1) 
Be more likely to complete at least half of their recommended PT visits  
2) 
Be more likely to initiate PFPT 
3) 
Will have a shorter time to initiation of PFPT 
4) 
Be more likely to discharge from PFPT 
5) 
Will have greater improvement in urogenital distress following PFPT 
 
1.4. Summary of Study Design 
 
Study Design: Randomized controlled trial 
 
Population: Clinic-based patients seen at the Loyola University Medical Center 
Urogynecology outpatient clinic who have been prescribed PFPT as a treatment for 
their condition and agree to such therapy. 
 
Control group: Will read standard PFPT handout (see Appendix 4.1) 
 
Intervention group: Will read standard PFPT handout plus watch education video (see 
Appendix 4.2) 
 
Study Length: At least three months after the initial PFPT referral for each patient, 
medical record review will be performed to record therapy attendance, including date of 
first visit, number of visits recommended by the therapist, number of completed visits, 
and whether the patient was discharged from PFPT.  
 
Power-calculation: One goal of the proposed study is to test the null hypothesis that the rate 
of women attending at least half of their required PT visits is identical in the two populations:  
Those assigned to handout only and those assigned to handout and video intervention.  With 
proposed sample sizes of 96 assigned to handout only and 96 assigned to handout and video 
intervention, the study will have power of 80% to yield a statistically significant result. 
This computation assumes that the difference in proportions of compliance is 20% (specifically, 
70% versus 50% compliance for the intervention and control groups, respectively).  It also 
assumes that the criterion for significance (alpha) will be set at 0.05 and that the test will be 2-
tailed, meaning an effect in either direction will be interpreted.   
This effect was selected as the smallest effect that would be important to detect, in the sense 
that any smaller effect would not be of clinical or substantive significance.  It is also assumed 
that this effect size is reasonable, in the sense that an effect of this magnitude may be 
anticipated in this research. 
2. Protocol 
 

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Patients who have been interviewed, examined, and a plan has been made by the 
treating physicians in the Female Pelvic Medicine & Reconstructive Surgery practice will 
be invited to participate at the end of the visit if the patient and physician mutually agree 
that PFPT is the treatment modality to pursue. 
 
If she agrees to participate, she will be consented and randomized. If she is randomized 
to standard counseling, she will be given the standard handout to read. If she is 
randomized to the intervention, she will be both given the standard handout and then 
view the 4-minute educational video on a clinic iPad.  
 
At the conclusion of the counseling, patients will be asked if they have any additional 
questions, and these will be recorded and answered. The patient will also fill out a visual 
analog scale about how informed she feels. (See appendix 4.3 & 4.4) 
 
Follow-up: Patient chart will be monitored following enrollment in the study to measure 
time to PFPT attendance and PFPT compliance (See appendix 4.5).  
 
2.1. Eligibility criteria 
Inclusion criteria 
Patients who have prescribed PFPT by a treating physician in the Female Pelvic 
Medicine & Reconstructive Surgery practice 
 
Exclusion criteria 
Patients < 18 years old 
 
2.2. Consent Process 
Patients will be identified when they present to the Loyola Urogynecology out-patient 
clinic for management of their pessary.  Consent form will be read to them describing 
the nature of the trial and potential associated risks and benefits.  They will be informed 
that neither participation nor refusal will influence the care received at either Loyola 
University Medical Center. A copy of the consent form will be given to them.  
Participation is completely voluntary and they may discontinue participation in the study 
at any time. 
 
2.3. Trial Design 
Randomized controlled clinical trial 
 
2.4. Randomization 
Block randomization strategy will be developed based on a 1:1 allocation of patients in the 
intervention and control groups. The randomization procedure will take place after informed 
consent is completed and eligibility status is determined. 

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2.5. Confidentiality 
Following HIPPA guidelines, patient identifiable data will be coded to protect each 
patient’s identity.  A unique identification number will be assigned to designate each 
subject, and all identification numbers identifying information will be removed from the 
database and stored separately on a secure password-protected network drive in the 
office of the PI.   
Here is an overview of the security of the infrastructure: 
Physical 
- Servers kept in locked cage 
- Entry requires a passcard and biometric recognition 
- Digital surveillance equipment 
- Controls for temperature, humidity and smoke/fire detection 
- Staffed 24/7 
Network 
- Multiple independent connections to Tier 1 Internet access providers 
- Fully redundant OC-48 SONET Rings 
- Uptime monitored every 5 minutes, with escalation to SurveyMonkey staff 
- Firewall restricts access to all ports except 80 (http) and 443 (https) 
- QualysGuard network security audits performed quarterly 
Hardware 
- Servers have redundant internal power supplies 
- Data is on RAID 10, operating system on RAID 1 
- Servers are mirrored and can failover in less than one hour 
Software 
- Code in ASP, running on SQL Server 2000 and Windows 2000 Server 
- Latest patches applied to all operating system and application files 
- Data backed up every hour internally 
- Data backed up every night to centralized backup system, with offsite backups in 
event of catastrophe 
 
2.6. Statistical analysis 
 
Binary logistic regression will be used to compare the odds of PFPT initiation, 
PFPT discharge, completion of half of the recommended visits, and having any further 
questions after counseling between those assigned to the enhanced versus standard 
counseling groups. In these models, expected frequencies will be monitored and exact 
logistic regression models will be used when these values are sparse.  We will also 

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stratify the comparison of PFPT initiation by participants’ primary language.  Because 
few patients will have Spanish as their primary language, we will make an a-priori 
decision to use an exact binary logistic regression model to compare the two treatment 
groups among Spanish speaking participants.  Subsequently, a Breslow-day test may 
be used to compare the stratified English and Spanish speaking odds ratios for 
homogeneity. 
A binary logistic regression model will also be used to estimate the odds of being 
discharged from PFPT as a function of the number of completed visits, and a Kaplan-
Meier curve will be used to estimate the probability of not attending a PFPT visit 
following date of referral for those in the experimental and control cohorts.  Using this 
approach, elapsed time will be measured in days from referral date to date of first visit 
for those who attended PFPT.  Individuals who never attended PFPT will be censored 
at the last date they were known to be absent from therapy.  
For each patient, the change in UDI-6 will be calculated by subtracting the post-
treatment score from her pre-treatment score, and an independent samples t-test will be 
used to compare this change score between those assigned to the experimental group 
versus control group.  In this model, normality and influential outliers will be assessed 
using QQ plots and box plots, respectively.  A non-parametric Wilcoxon rank-sum test 
may be used if the data violate parametric assumptions.  Finally, though a Kaplan-Meier 
method is primarily used to compare days from date of referral to date of first visit 
between the experimental and control groups, a Wilcoxon rank-sum test will also be 
used to make this comparison as a sensitivity analysis among those who attend PFPT.  
All analyses will be completed using SAS version 9.4 (Cary, NC). 

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2.7. Anticipated findings and use of the data 
The findings from this project may result in a new standard counseling for PFPT that 
includes viewing of the educational video.  
 
2.8. Subject compensation 
There is no subject compensation.  
 
3. References 
1. Dumoulin C, Alewijnse D, Bo K, et al. Pelvic-floor-muscle training adherence: Tools, 
measurements and strategies-2011 ICS state-of-the-science seminar research paper II 
of IV. Neurourol Urodyn. 2015;34(7):615-621. 
2. Fitzgerald MP, Anderson RU, Potts J, et al. Randomized multicenter feasibility trial of 
myofascial physical therapy for the treatment of urological chronic pelvic pain 
syndromes. J Urol. 2013;189(1 Suppl):S75-85. 
3. Brown HW, Barnes HC, Giles D, McAchran S. Abstract: Compliance with prescribed 
pelvic floor physical therapy when patients consult with a physical therapist at their initial 
urogynecologic evaluation. Female Pelvic Medicine and Reconstructive Surgery. 
2015;21(5):S52. 
4. Farahani F, Calloway E, Gibson R, et al. Abstract: Patient compliance to pelvic floor 
physical therapy for urinary incontinence. Female Pelvic Medicine and Reconstructive 
Surgery. 2015;21(5):S52. 
5. Alewijnse D, Mesters I, Metsemakers J, Adriaans J, van den Borne B. Predictors of 
intention to adhere to physiotherapy among women with urinary incontinence. Health 
Educ Res. 2001;16(2):173-186. 

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6. Tibaek S, Dehlendorff C. Do women with pelvic floor dysfunction referred by 
gynaecologists and urologists at hospitals complete a pelvic floor muscle training 
programme? A retrospective study, 1992-2008. Int Urogynecol J. 2013;24(8):1361-
1369.  
4. Appendix 
4.1. Standard care handout 
The Role of Physical Therapy in the Treatment of Pelvic Floor Dysfunction: 
 
Physical therapists are trained to evaluate and treat dysfunctions in the joints, muscles, 
nerves and scar.  Physical therapists specifically trained in the area of pelvic health can 
identify the possible musculoskeletal causes of pelvic pain, bladder and bowel 
difficulties and develop a treatment plan specific to the individual suffering from this 
difficulties.   
 
What to expect at your first physical therapy appointment:   
Your first visit will include an initial evaluation in a comfortable, private room by a 
therapist who has undergone advanced education and training in the evaluation and 
treatment of pelvic muscle dysfunction. The therapist will obtain a detailed history of 
your health, pain and activity limitations. She will also ask you about any bowel, bladder 
and sexual difficulties as these are in part controlled by the pelvic muscles.  The 
therapist will then take a look at your posture, mobility of your spine and hips and 
strength and flexibility of pelvic girdle muscles.  She will examine any scar tissue and 
trigger points in the muscles of your pelvic region.   
 
The therapist will also specifically examine the pelvic floor muscles. Your pelvic floor 
consists of a group of muscles that attach behind the pubic bone in the front to the tail 
bone in the back. They are responsible for providing support to the pelvic joints and 
organs, relaxing to allow the passage of urine, stool and gas and contracting to prevent 
the loss of urine, stool and gas as appropriate.  In order to best examine these muscles 
you will be asked to undress from the waist down and be covered with a sheet.  The 
therapist will use a lubricated, gloved finger to identify painful muscles around and in 
your vagina or rectum then instruct you to contract and relax these muscles in order to 
determine how the muscles are functioning.  Care is taken to make you as comfortable 
as possible with the exam.   
 
Your therapist will discuss the evaluation results with you and provide you with 
education regarding your specific condition and the expectation of therapy.  She will 

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answer all of your questions and will work with you to establish a treatment plan based 
on the results of the evaluation and your goals for therapy. 
 
PAC can schedule for any of the locations and the phone number is 708-216-5300.  
 
Loyola Rehabilitation Services provides pelvic floor rehabilitation at the following 
locations: 
 
Loyola Outpatient Center Urogynecology at Loyola University Medical Center (708) 216-
2180  
 
Loyola Center for Rehabilitation on Roosevelt in Maywood (708) 216-5300 
 
Loyola Center for Health at Burr Ridge (708) 327-1050 
 
Loyola Center for Rehabilitation at Hickory Hills (708) 233-5395 (No PT at this location 
for now) 
 
Loyola Oak Brook and Oakbrook Terrace, 630-953-6778 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4.2. English Intervention video link: https://youtu.be/mDMVUQ-2wvY, and 
Spanish Intervention video link: https://youtu.be/R0x4ixhFCqo 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4.3. Patient information collected (in clinic) 
Circle one:  
 
Control  
 
 
Intervention (video) 
Age ______ 
 
Vaginal Parity _____________  
BMI  
 
 
Insurance type:  
Private  
Government sponsored  
Combined 
Other 
Race     
Caucasian 
Black 
  Asian      Eastern European 
   Hispanic 
Other  
Urogynecologic diagnoses (circle):  
SUI 
UUI 
MUI 
Urgency-frequency Syndrome   
Weak pelvic floor 
 Defecatory dysfunction   
POP 
 
Myofascial pain  
Other 
Stage of Prolapse  
0  
1  
2  
3  
4  
Not Assessed 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4.4   Patient questionnaire 
Do you have any further questions? No/Yes  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1) After your visit today, how well informed do you feel about the role of pelvic floor 
physical therapy in treating pelvic floor symptoms? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
No change 
 
 
 
 
 
 
 
 
 
Very Informed 
 
2) How do you rate the ease of understanding of information about pelvic floor physical 
therapy? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Very difficult  
 
 
 
 
 
 
 
 
Very easy 
 
3) How do you rate the amount of information about pelvic floor physical therapy that was 
presented to you? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Not enough information 
 
 
 
 
 
           Too much information 
 
 
 
 
 
 
 
 
 
 
 
 

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4.5 Patient information collected (from EMR < nine months later) 
 
Time to first PFPT visit from day of referral:  
 
  days 
 
Physician who referred: 
Fitzgerald 
Brubaker 
Mueller 
Brincat 
 
Number of recommended visits:  
 
 
 
Number of completed visits:  
 
 
 
 
Discharged from PFPT practice (circle): yes 
no