Genital Pain (GP) gathers complex multi-factorial conditions which create substantial personal distress to patients and partners and affect quality of life and sexuality. Only recently accurate descriptions of vulvar pain have been defined, highlighting that about 40% of women 20-40 y.o. suffer from pain during sexuality. Up to 16% of the female population is diagnosed with vulvodynia, but this prevalence is increasing. GP was strictly viewed as a medical problem, even if psychological issues and social aspects are central in that conditions. Literature showed that data on this issue are still controversial, demanding to a careful analysis of the problem. GP consequences are specific for each woman and are not related only to the sexual context. They include behavioral, emotional, cognitive, physiological and interpersonal aspects. There is the urgent need to identify the biopsychosocial factors involved in GP and to address more effective treatments conducted in controlled settings in order to identify evidence-based protocols.
General aim of proposed study is to better understand the biopsychosocial factors characterizing GP women, in order to improve the taking-care process. The project is divided in 2 phases: firstly, we will assess some biomedical, psychological, social and sexual factors describing these cohorts of women. After, a team of different specialist will be involved in the diagnosis process and the measure of ¿real-time¿ genital and sexual pain thanks to the use of new tools (Vulvalgesiometer and Tampon test). In the second part of the project, the research will focus on vulvodynia¿s treatment. The effectiveness of a medical and an integrated biopsychosocial protocol will be tested with a randomized controlled trial on 3 groups (Biopsychosocial integrated treatment, Medical treatment and Control group). ECM course for professionals (physicians, psychologists, and pelvic floor physiotherapists) will be organized to share the results.
Financial impact: GP has a deep impact not only on women¿s life, but even on economy and health care system. (Pukall et al., 2016). A recent survey indicated the costs of vulvodynia in the USA to be 31 to 72 billion dollars annually (Xie et al., 2012). This staggering amount includes direct health care costs (e.g., insurance payments and out-of-pocket expenses), direct non-health care costs (e.g., transportation), and indirect costs (economic loss owing to medical leave from work and employer payments to patients for medically related work loss). However, this research does not take into account the psychological burden of GP conditions, which increases the costs as well.
An unknown problem: Women spend a lot of money and time searching for a cure. Depending on etiology, patients can arrive very late to a clear diagnosis (when it is possible) after a long history of unimodal and/or non-effective treatments (Johnston et al., 2015; Hanno et al., 2015). In addition to that, those conditions have high rates of recidivism. Some women do not even ask for help because they think is normal to suffer and have painful sexual intercourses. In these cases, they go to consultation only when they want to conceive or to save their relationships. Psychologist and physician have usually no idea of what genital/sexual pain is and how to deal with it. For this reason, is important not only to improve the research, but to organize informative events to sensitize clinicians.
Overtaking DSM-5 classification: We agree with some criticism moved on the DSM-5 definition of GPPD. In our view, it could complicate research and clinical practice of GP. Researchers are aware that GP collected a lot of different profiles, even if there is still lack of data about their peculiarities. Clinicians¿ situation is harder: GPPD generalizes too much pain conditions, without giving a standard and efficient treatment. Our project is challenging and innovative because it wants to deepen the DSM-5 criteria in order to show more precise profiles of women with GP. Having a clear analysis of biopsychosocial components for each condition will help both diagnosis (evaluating protective and risk factors) and treatment process (giving clinicians indications for effective algorithms).
Methodology in line with gold standards and guidelines: Our project follows a clear methodology in order to generalize as much as possible the results. Questionnaires¿ selection and biological measures are based on the consensus statement from the 4th International Consultation on Sexual Medicine (Mc Cabe et al., 2015). To guarantee an optimal selection of the subjects involved, we will follow the standards for the diagnosis of GP conditions (Goldstein et al., 2016; Fugl-Meyer et al., 2013) with an integrated team of gynecologists, urologists, psychiatrists and psycho-sexologists. Moreover, we will test and standardize an integrated treatment protocol thanks to the randomized controlled trial (Fugl-Meyer et al., 2013).
Objective measure of ¿real-time¿ pain: Pain is an experience that lies in the body and in the mind. Experience of pain includes sensory (perception of pain characteristics, intensity, quality location), affective (negative emotion like anxiety, fear, unpleasant sensations), cognitive (interpretation of pain), behavioral (coping strategies used to express, avoid or control pain), and physiological aspects (nociceptive and stress responses) (Garland, 2012). Despite these evidence, many clinicians still think that chronic pain is just a psychological complaint. In our project, we inserted both subjective (Mc Gill Pain Questionnaire) that objective real-time measures (vulvalgesiometer and tampon test) to have a precise ¿pain map¿ together with biopsychosocial correlates.
Different biopsychosocial variables at the same time: The importance of using a pain-based system to characterize genital pain conditions is evident in literature. For example, information regarding pain location and eliciting situations have led to the appreciation of different subtypes of vulvodynia (Amalraj et al., 2009). In addition, GP conditions could have specific effects on biopsychosocial health (Sutton et al., 2009). The characterization of the pain is crucial to determining the most successful path for management: some treatments that could be appropriate for one condition, could be useless for others. Moreover, another innovation is that we will focus at the same time on numerous biopsychosocial factors that are implicated in the pain onset and maintenance. At our knowledge, it is also the first study assessing a wide range of GP conditions on the Italian population.