Outcomes of a Longitudinal Multidisciplinary Program for the Treatment of Chronic Pelvic Pain, Incorporating Online and Mobile Applications to Promote Self Efficacy
Phase: NA
Conditions: Chronic Pelvic Pain Syndrome
Sponsor: Medstar Health Research Institute

Outcomes of a Longitudinal Multidisciplinary Program for the Treatment of Chronic 
Pelvic Pain, Incorporating Online and Mobile Applications to Promote Self Efficacy  
 
The purpose of the study is to determine the impacts of a structured multidisciplinary 
longitudinal program for the management of chronic pelvic pain with an emphasis on 
adjunctive web based and mobile applications on patient satisfaction; secondary 
objectives are to measure the impacts of the treatment plan on quality-of-life measures 
and pain. 
We hypothesize that those patients randomized to a structured chronic pelvic pain 
management program will demonstrate improved satisfaction with their care, and 
improved quality of life measures and pain scores as compared to those who receive 
standard care. 
 
Background: 
The diagnosis and treatment of conditions leading to chronic pelvic pain (CPP) is 
challenging for patients and providers alike. CPP is defined as pain perceived to originate 
from the pelvis, lasting greater than 6 months, often associated with negative cognitive, 
behavioral, sexual and emotional consequences. While CPP is estimated to affect 26% of 
the world’s female population, and accounts for 10% of gynecologic office visits, there is 
a lack of high-quality evidence to support the use of many well accepted therapeutic 
interventions1. It has, however, been well established that treatments should be 
multimodal in order to address the overlapping non-gynecologic pain disorders and 
biopsychosocial factors impacting many patients with CPP 1-3. A growing body of 
evidence has demonstrated improved pain severity and quality of life measures for 
patients receiving care in interdisciplinary centers, able to provide coordinated surgical, 
medical and/or pain management care in a centralized location6-9.  Other studies have 
examined care delivered in tertiary care center clinics, relying on a multidisciplinary 
approach in which patients received care from a variety of providers both central to the 
clinic and in their referral networks10. Although effective, the aforementioned approach 
dictates a specialized allocation of resources not widely available for the treatment of 
CPP in this moment. While the later multidisciplinary model may be more feasible in this 
current environment, it demands that patients are able to navigate care delivered from a 
variety of providers. Patients in turn may face financial constraints, time constraints, or a 
perceived lack of utility of the prescribed treatments leading to poor adherence4,5. With 
widely available access to smart phones and the internet, we may consider how to 
incorporate mobile and web-based applications to supplement the multidisciplinary 
treatment of CPP in a way that alleviates barriers to care. There already exist a variety of 
resources dedicated to patient education and self-management which have been found to 
effectively help individuals with chronic pain conditions11,12. Improvements in self 
efficacy and depression, as well as decreased health service usage have also been 
established when these apps are supplemented with proactive calls encouraging app 
compliance13,14.  Current practice at our tertiary care center relies upon a 
multidisciplinary model in which patients’ surgical and medical management of chronic 

pain is performed by clinic providers, and outside referrals are provided for complex pain 
management, pelvic floor therapy and psychotherapy services. We propose that 
formalizing the structure of our chronic pelvic pain management through the clear 
definition of available resources, supplemented with mobile and web-based applications 
supporting education and self-efficacy with the aim of reducing barriers to care, paired 
with a well-defined timeline for follow up, we will see improved patient satisfaction, 
improved quality of life and pain scores as opposed to patients enrolled in standard 
practice.  
 
Study Endpoints: 
The primary endpoint will be patient satisfaction scores related to their treatment for 
chronic pelvic pain. Secondary endpoints will be quality of life and pain scores.  
 
Study Intervention: 
Patients randomized to the intervention arm will receive standard care in addition to a 
Chronic Pelvic Pain Handbook which outlines their diagnoses and includes educational 
materials, an individualized treatment plan and follow up schedule.  
 
Procedures Involved: 
Patients meeting eligibility criteria will be approached regarding their interest in participating. 
Should they choose to participate they will be randomized using a random number generator- an 
odd number will designate randomization to the control group, while an even number will 
designate randomization to the intervention group. Those in the control arm will receive standard 
care which is individualized based on their specific needs and may include medical, procedural 
or surgical interventions. Those in the intervention arm will receive standard care in addition to 
our Chronic Pelvic Pain Handbook which includes educational resources pertinent to their 
specific diagnosis, defines available treatment resources, provides a clearly defined follow up 
schedule and points of contact. Resources included in the Chronic Pain Handbook were 
thoroughly reviewed by the study team and providers within the National Center for Advanced 
Pelvic Surgery team. They were screened to be sure that medically accurate information was 
being presented and that recommendations reflect best practices for the treatment of chronic 
pelvic pain based on expert consensus. The diagnoses designated on page 4 of the handbook will 
be filled out by the provider the patient is seeing in the office. Baseline demographics will be 
collected in addition to validated surveys measuring quality of life and pain scores for all 
participants. These surveys will be repeated at 3 months, 6 months and 12 months following 
initial enrollment. Patients’ satisfaction with their treatment will also be measured at 3 months, 6 
months and 12 months.  
 
 
 
 
 

Data Collected: 
Baseline demographic and pain related data including age, race/ethnicity, 
BMI, age when pain started, prior treatments, smoking status, history of 
anxiety/depression/sexual assault, current or prior engagement in 
psychotherapy, family history of chronic pain will be collected through chart 
review and patient interview at time of their scheduled visit. 
Measurements of pain and quality of life will be collected through previously 
validated questionnaires regarding pelvic pain (Yosef et al, 2016), in addition 
to the PHQ-9, GAD-7, Pain Catastrophizing Scale, and Pain Self Efficacy 
Questionnaire. 
Patient satisfaction data will be collected using the PSQ-18 with additional 
questions included regarding specific barriers they have experienced, what 
web based or mobile applications they have used and the degree to which they 
found them helpful.  
The number of visits outside of scheduled follow ups, as well as number of 
patient portal messages sent between visits will be obtained through chart 
review. 
 
Recruitment Methods: 
Subjects will be screened for eligibility based on chart review conducted 
prior to their scheduled appointment. If eligible they will be contacted in 
advance of their appointment to determine their interest in participation. If 
they are interested in participating, they will be verbally consented and 
randomized prior to the appointment. This will be performed remotely by 
the study coordinator. A message will be sent to the provider they are seeing 
and a note placed in the medical record to designate their participation and 
treatment arm. The patient will then be seen by their National Center for 
Advanced Pelvic Surgery provider, whom are listed as sub-investigators on 
the project.  
 
Consent Process: 
The consents will be performed over the phone in advance of the patient’s 
scheduled appointment. If they were not able to be contacted in advance of 
the appointment the consent may be performed in person.  
 
 
 
 

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