Updating the Female Nomenclature: ICSM, ISSWSH, and ICD-11 Classification. Sharon J. Parish, MD, IF, NCMP 2017 Annual Scientific Program May 12, 2017

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1 Updating the Female Nomenclature: ICSM, ISSWSH, and ICD-11 Classification Sharon J. Parish, MD, IF, NCMP 2017 Annual Scientific Program May 12, 2017

2 Disclosures Advisory Board Palatin, Valeant Speaker AMAG, Pfizer Inc. Writing Support Allergen, Pfizer Inc.

3 Audience Pretest Which of the following is not included in the ISSWSH Nomenclature and is not proposed for ICD-11 Female Sexual Dysfunction Codes? a) Persistent Genital Arousal Disorder b) Female Orgasm Illness Syndrome c) Female Sexual Interest-Arousal Disorder, Subjective Type d) Female Genital Arousal Disorder

4 Objectives Report ICSM 4 th Consultation Definitions for Female Sexual Dysfunctions Describe ISSWSH Nomenclature for Female Sexual Disorders Discuss proposed ICD 11 chapter: Conditions Related to Sexual Health Describe proposed FSD categories and codes for ICD-11 Conditions Related to Sexual Health chapter

5 ICSM 4: Definitions of Female Sexual Dysfunctions International Consultation on Sexual Medicine (ICSM) ICSM 4 Consensus Process Draft definitions and rational presented to Fourth ICSM (ISSM) June, 2015 Final definitions approved and adopted, published in JSM and as chapters *Clinical principle: statement very widely agreed upon by clinicians and/or researchers for which there might or might not be evidence in literature Hypoactive Sexual Desire Dysfunction (clinical principle) Persistent or recurrent deficiency or absence of sexual/erotic thoughts or fantasies and desire for sexual activity Female Sexual Arousal Dysfunction (clinical principle) Persistent or recurrent inability to attain or to maintain until the completion of the sexual activity, an adequate subjective assessment of her genital response Female Orgasmic Dysfunction (grade B) (i) Marked delay in, marked frequency of, or absence of orgasm and/or (ii) marked decreased intensity of orgasmic sensation. McCabe et al. J Sex Med 2016;13:

6 Incidence & Prevalence of Desire and Arousal Definitions at variance with DSM-5 High level of overlap between different types of sexual dysfunction High level of variability in what is defined as a sexual dysfunction, disorder, problem HOWEVER, disorders are experienced differently: Low sexual desire has different prevalence rates and risk factors and is distinguished from low arousal. Low sexual desire is the most prevalent dysfunction, followed by low arousal (and orgasm problems). McCabe et al. J Sex Med 2016;13:

7 ICSM 4: Female Genital-Pelvic Pain Dysfunction Persistent or recurrent difficulties with at least one of the following: 1) Vaginal penetration during intercourse 2) Marked vulvovaginal pain during genital contact* 3) Marked fear or anxiety about vulvovaginal or pelvic pain in anticipation of, during, or as a result of genital contact* 4) Marked hypertonicity or overactivity of pelvic floor muscles with or without genital contact* *Changed from penetration in DSM 5 terminology Some research and clinical studies have separated vaginismus from dyspareunia, which may have a identifiable organic etiology McCabe et al. J Sex Med 2016;13:

8 ISSWSH Nomenclature Consensus Meeting: Mission Statement To develop consensus among experts, with experience in diagnosis, evaluation, treatment and/or research in sexual medicine for women, who used evidence for appropriate nomenclature and definitions of female sexual dysfunctions. These definitions must be applicable across disciplines and useful in both clinical and research settings, serve as the basis of International Classification of Diseases (ICD) codes, and provide regulatory guidance for women's sexual problems. Derogatis et al. J Sex Med Dec;13(12): Parish et al. J Sex Med Dec;13(12):

11 ISSWSH Sexual Disorders Nomenclature and Definitions including Level of Evidence Hypoactive Sexual Desire Disorder (grade B, level of evidence 2-3) Female Genital Arousal Disorder (grade B, level of evidence 2-3) Persistent Genital Arousal Disorder (expert opinion) Female Orgasm Disorder (grade B, level of evidence 2-3) Frequency diminished; anorgasmia Intensity muted Timing delayed; spontaneous; premature Pleasure anhedonic; pleasure dissociative orgasm disorder (PDOD) (expert opinion) Female Orgasm Illness Syndrome (expert opinion) Parish et al. J Sex Med 2016;13(12):

12 Hypoactive Sexual Desire Disorder (HSDD) Sexual desire is a construct that is not specifically event-related. Grade B: level of evidence 2-3 Manifests as any of the following for a minimum of six months: Lack of motivation for sexual activity as manifested by either: Reduced or absent spontaneous desire (sexual thoughts or fantasies) Reduced or absent responsive desire to erotic cues and stimulation or inability to maintain desire or interest through sexual activity Loss of desire to initiate or participate in sexual activity, including behavioral responses such as avoidance of situations that could lead to sexual activity, that is not secondary to sexual pain disorders AND is combined with clinically significant personal distress that includes frustration, grief, incompetence, loss, sadness, sorrow, or worry Parish et al. J Sex Med 2016;13(12):

13 HSDD: Diagnostic Considerations Temporal relationship of diminished desire could be acquired or lifelong, but should be generalized for pharmacotherapy to be considered. If diminished desire is situational, locus of desire disorder outside the woman, therefore not generalized HSDD Physical and/or emotional abuse, dissatisfaction with one s partner, partner s sexual dysfunction, or intrusion of life stressors that can be diminished by lifestyle changes HSDD should be self-rated as mild, moderate, or severe Severity may relate to etiology, treatment response, more distress, treatment seeking, etc. Definition of HSDD incorporates bio-psycho-social context and can be used in both the somatic and psychiatric diagnostic systems Parish et al. J Sex Med 2016;13(12):

14 HSDD: Supporting Evidence Psychological tests measuring same construct (i.e. FSFI) were developed for and validated to HSDD and FSAD, but no validated measures available for DSM 5 Female Sexual Interest-Arousal Disorder (FSIAD) Genetic evidence from twin studies, studies of specific nucleotide polymorphisms, effects of serotonergic antidepressants, neuroimaging Predictor validators in treatment studies support separate diagnosis HSDD RX response: flibanserin, testosterone, investigational compounds, CBT FSAD Rx: estrogen, sildenafil, EROS, mindfulness No studies or algorithm for treatment of FSIAD Clayton et al. J Sex Med 2012;9: Clayton et al. J Sex Med 2012;9:

15 Subjective/Cognitive Arousal Some definitions of arousal include subjective awareness and enjoyment of genital and extragenital changes before and during sexual activity. Controversy about whether subjective awareness of physical changes of arousal is just one aspect of desire Also disconnect between perceived subjective awareness of arousal and presence or absence of genital vasocongestion Parish et al. J Sex Med 2016;13(12):

16 Female Genital Arousal Disorder (FGAD) Grade B (level of evidence 2-3) Defined as the inability to develop or maintain adequate genital response for a minimum of six months including Vulvovaginal lubrication Engorgement of the genitalia Sensitivity of the genitalia associated with sexual activity Disorders related to: Vascular injury or dysfunction and/or Neurological injury or dysfunction Usually generalized and acquired Traditional specifiers and causing or not causing significant intra or interpersonal distress apply. Parish et al. J Sex Med 2016;13(12):

17 Persistent Genital Arousal Disorder Expert opinion Characterized by persistent or recurrent, unwanted or intrusive, distressing feelings of genital arousal, or being on the verge of orgasm (genital dysesthesia), not associated with concomitant sexual interest, thoughts, or fantasies for a minimum of six months (expert opinion) May be associated with: Limited resolution, no resolution, or aggravation of symptoms by sexual activity with or without aversive and/or compromised orgasm Aggravation of genital symptoms by certain circumstances Despair, emotional lability, catastrophization, and/or suicidality Inconsistent evidence of genital arousal during symptoms Parish et al. J Sex Med 2016;13(12):

18 Female Orgasm Disorders Female Orgasmic Disorder (FOD) is characterized by a persistent or recurrent, distressing compromise of orgasm frequency, intensity, timing, and/or pleasure, associated with sexual activity for a minimum of six months (grade B; level of evidence 2-3) Frequency: orgasm occurs with reduced frequency (diminished frequency of orgasm) or is absent (anorgasmia) Intensity: orgasm occurs with reduced intensity (muted orgasm) Timing: orgasm occurs either too late (delayed orgasm) or too early (spontaneous or premature orgasm) than desired by the woman Pleasure: orgasm occurs with absent or reduced pleasure (anhedonic orgasm, pleasure dissociative orgasm disorder (PDOD expert opinion) Parish et al. J Sex Med 2016;13(12):

19 Female Orgasmic Illness Syndrome (FOIS) Expert opinion Characterized by peripheral and/or central aversive symptoms that occur prior to, during, or following orgasm not related, per se, to a compromise of orgasm quality. Peripheral: diarrhea, constipation, muscle aches, abdominal pain, diaphoresis, chills, hot flashes, fatigue, akathisia, genital pain Central: disorientation, confusion, decreased verbal memory, anxiety, insomnia, depression (post-coital tristesse), seizures, headache (coital cephalalgia) Orgasm-associated symptoms may last for minutes, hours, or days post-orgasm and vary widely in individuals. Farley SJ. Nature Reviews Urology. 2011;8:121. Waldinger MD, Schweitzer DHJ Sex Marital Ther. 2002;28: Ashby J, Goldmeier D. J Sex Med. May 2010;7: Rasmussen BK, Olesen J. Neurology, Jun 1992:42:

21 ICD 11: Proposed Chapter on Sexual Health World Health Organization (WHO) Departments of Mental Health and Substance Abuse and of Reproductive Health and Research proposed revisions; appointed joint Working Group on Sexual Disorders and Sexual Health to assist in development of recommendations. WHO Secretariat & Working Group proposed a new chapter: Conditions Related to Sexual Health Changes proposed based on research and practice advances, shifts in societal attitudes, and in relevant policies, laws, and human rights standards Reed et al. World Psychiatry 2016;15:

22 ICD 11: Proposed Chapter on Sexual Health Integrated classification encompassing sexual dysfunctions in ICD-10 chapters on Mental and Behavioural Disorders and Genitourinary System, overcoming mind-body separation inherent in ICD-10. Sexual response is a complex interaction of psychological, interpersonal, social, cultural, physiological, and gender-influenced processes; one or more factors may contribute to sexual dysfunctions, described as syndromes. ISSWSH and other international sexual medicine (SMSNA, ISSM) and sexology (WAS) societies co-sponsored WHO consultation meeting on classification of sexual dysfunctions and coding recommendations. Reed et al. World Psychiatry 2016;15:

23 ICD 11: Proposed Chapter on Sexual Health DSM 5 indicates that if sexual dysfunction is caused by non-sexual mental or medical disorder, substance, or medication, diagnosis not assigned ICD 11 allows for diagnosis when dysfunction represents independent focus of treatment; contributing factors may be coded using harmonized qualifiers: Temporal (lifelong vs. acquired), situational vs. generalized Etiological Disease classified elsewhere, medication/substance, lack of knowledge; psychological, behavioral, relationship, cultural factors Separation of desire and arousal into distinct dysfunctions based on epidemiological and biological evidence related to etiology and treatment response Sexual pain-penetration disorder includes vaginismus but not dyspareunia and vulvodynia, which have been retained in genitourinary chapter. These syndromes have different etiologies, occur in different populations, and have distinct treatment approaches. Reed et al. World Psychiatry 2016;15:

24 ICD 11: Proposed Chapter on Sexual Health Where possible, diagnostic categories apply to both men and women, emphasizing commonalities in sexual response without ignoring established sex differences HSDD, Orgasm Dysfunction CNS activation, deactivation, neuroplasticity Separate categories maintained where sex differences are related to distinct clinical presentations Female Arousal Dysfunction, Erectile Dysfunction Persistent over several months or sooner, occur frequently may fluctuate in severity, associated with clinically significantly distress Satisfactory rated by the individual Unrealistic expectations, discrepant desire, inadequate stimulation not valid bases for diagnoses of sexual dysfunction Boundary with other disorders and normality Reed et al. World Psychiatry 2016;15:

25 Sexual Dysfunctions: SXA SXA1 Sexual Desire Dysfunctions SXA1.1 Hypoactive Sexual Desire Dysfunction SXA1.2 Other Desire Dysfunctions SXA2 Sexual Arousal Dysfunctions SXA2.1 Female Sexual Arousal Dysfunction SXA2.2 Male Erectile Dysfunction SXA2.3 Other Sexual Arousal Dysfunctions SXA3 Orgasmic Dysfunctions SXA3.1 Anorgasmia SXA3.2 Other Orgasmic Dysfunction SXA4 Ejaculatory Dysfunctions SXA4.1 Male Early Ejaculation SXA4.2 Male Delayed Ejaculation SXA4.3 Other Ejaculatory Dysfunction SXA5 Other Sexual Dysfunction Reed et al. World Psychiatry 2016;15:

26 Other Arousal & Orgasm Dysfunctions SXA2.3 Other Arousal Dysfunctions Persistent genital arousal in women Restless genital syndrome in men and women SXA3.2 Other Orgasmic Dysfunction Post-orgasmic illness syndrome Hypohedonic orgasm Painful orgasm Reed et al. World Psychiatry 2016;15:

27 Sexual Pain Disorders: SXB SXB Sexual Pain Disorders SXB1 Sexual Pain-Penetration Disorder SXB2 Other Sexual Pain Disorder GB10 Dyspareunia ICCD-11 Beta test website: Reed et al. World Psychiatry 2016;15:

28 Key Points Scientific clinical trial data, biological evidence, and treatment outcomes support separation of desire and arousal as distinct clinical entities. Responsive desire & cognitive/subjective arousal reflect the ability to maintain desire throughout a sexual experience. PGAD, PDOD, Premature Orgasm D/O, FOIS are defined in the ISSWSH nomenclature. ICD-11 supports integration of biopsychosocial and cultural factors. ICD-11 overcomes mind-body split inherent in other classification systems. Organic causes of dyspareunia and vulvodynia are classified under genitourinary chapter in ICD-11. Future directions Adaptation of nomenclature into clinical practice and integration as research endpoints Field testing & approval of proposed ICD-11 codes

PSYCHOLOGICAL TREATMENT FOR HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD) IN MEN AND WOMEN

PSYCHOLOGICAL TREATMENT FOR HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD) IN MEN AND WOMEN MARITA McCABE PhD FAPS DIRECTOR INSTITUTE FOR HEALTH AND AGEING SMSNA 207 Annual Scientific Meeting May 2, 207 Boston,