Vulvodynia and Pain
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Detail Report
Supplemental Update Report CR Number: 2012319113 Implementation Date: 16-Jan-19 Related CR: 2012319113 MedDRA Change Requested Add a new SMQ Final Disposition Final Placement Code # Proposed SMQ Infusion related reactions Rejected After Suspension MSSO The proposal to add a new SMQ Infusion related reactions is not approved after suspension. The ICH Advisory Panel did approve this SMQ topic to go into the development phase and it Comment: underwent testing in three databases (two regulatory authorities and one company). However, there were numerous challenges encountered in testing and the consensus decision of the CIOMS SMQ Implementation Working Group was that the topic could not be developed to go into production as an SMQ. Most notably, in contrast to other SMQs, this query could not be tested using negative control compounds because it was not possible to identify suitable compounds administered via infusion that were not associated with some type of reaction. In addition, there is no internationally agreed definition of an infusion related reaction and the range of potential reactions associated with the large variety of compounds given by infusion is very broad and heterogenous. Testing was conducted on a set of around 500 terms, the majority of which was already included in Anaphylactic reaction (SMQ), Angioedema (SMQ), and Hypersensitivity (SMQ). It proved difficult to identify potential cases of infusion related reactions in post-marketing databases where the temporal relationship of the event to the infusion is typically not available. In clinical trial databases where this information is more easily available, users are encouraged to provide more specificity about the event, e.g., by reporting “Anaphylactic reaction” when it is known that this event is temporally associated with the infusion. -
Localised Provoked Vestibulodynia (Vulvodynia): Assessment and Management
FOCUS Localised provoked vestibulodynia (vulvodynia): assessment and management Helen Henzell, Karen Berzins Background hronic vulvar pain (pain lasting more than 3–6 months, but often years) is common. It is estimated to affect 4–8% of Vulvodynia is a chronic vulvar pain condition. Localised C women at any one time and 10–20% in their lifetime.1–3 provoked vestibulodynia (LPV) is the most common subset Little attention has been paid to the teaching of this condition of vulvodynia, the hallmark symptom being pain on vaginal so medical practitioners may not recognise the symptoms, and penetration. Young women are predominantly affected. LPV diagnosis is often delayed.2 Community awareness is low, but is a hidden condition that often results in distress and shame, increasing with media attention. Women can be confused by the is frequently unrecognised, and women usually see a number symptoms and not know how to discuss vulvar pain. The onus is of health professionals before being diagnosed, which adds to on medical practitioners to enquire about vulvar pain, particularly their distress and confusion. pain with sex, when taking a sexual or reproductive health history. Objective Vulvodynia The aim of this article is to inform health providers about the Vulvodynia is defined by the International Society for the Study assessment and management of LPV. of Vulvovaginal Disease (ISSVD) as ‘chronic vulvar discomfort, most often described as burning pain, occurring in the absence Discussion of relevant findings or a specific, clinically identifiable, neurologic 4 Diagnosis is based on history. Examination is used to support disorder’. It is diagnosed when other causes of vulvar pain have the diagnosis. -
Impact of a Multidisciplinary Vulvodynia Program on Sexual Functioning and Dyspareunia
238 Impact of a Multidisciplinary Vulvodynia Program on Sexual Functioning and Dyspareunia Lori A. Brotto, PhD, Paul Yong, MD, Kelly B. Smith, PhD, and Leslie A. Sadownik, MD Department of Gynaecology, University of British Columbia, Vancouver, BC, Canada DOI: 10.1111/jsm.12718 ABSTRACT Introduction. For many years, multidisciplinary approaches, which integrate psychological, physical, and medical treatments, have been shown to be effective for the treatment of chronic pain. To date, there has been anecdotal support, but little empirical data, to justify the application of this multidisciplinary approach toward the treatment of chronic sexual pain secondary to provoked vestibulodynia (PVD). Aim. This study aimed to evaluate a 10-week hospital-based treatment (multidisciplinary vulvodynia program [MVP]) integrating psychological skills training, pelvic floor physiotherapy, and medical management on the primary outcomes of dyspareunia and sexual functioning, including distress. Method. A total of 132 women with a diagnosis of PVD provided baseline data and agreed to participate in the MVP. Of this group, n = 116 (mean age 28.4 years, standard deviation 7.1) provided complete data at the post-MVP assessment, and 84 women had complete data through to the 3- to 4-month follow-up period. Results. There were high levels of avoidance of intimacy (38.1%) and activities that elicited sexual arousal (40.7%), with many women (50.4%) choosing to focus on their partner’s sexual arousal and satisfaction at baseline. With treatment, over half the sample (53.8%) reported significant improvements in dyspareunia. Following the MVP, there were strong significant effects for the reduction in dyspareunia (P = 0.001) and sex-related distress (P < 0.001), and improvements in sexual arousal (P < 0.001) and overall sexual functioning (P = 0.001). -
COVID-19 Mrna Pfizer- Biontech Vaccine Analysis Print
COVID-19 mRNA Pfizer- BioNTech Vaccine Analysis Print All UK spontaneous reports received between 9/12/20 and 22/09/21 for mRNA Pfizer/BioNTech vaccine. A report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the different vaccines. All reports are kept under continual review in order to identify possible new risks. Report Run Date: 24-Sep-2021, Page 1 Case Series Drug Analysis Print Name: COVID-19 mRNA Pfizer- BioNTech vaccine analysis print Report Run Date: 24-Sep-2021 Data Lock Date: 22-Sep-2021 18:30:09 MedDRA Version: MedDRA 24.0 Reaction Name Total Fatal Blood disorders Anaemia deficiencies Anaemia folate deficiency 1 0 Anaemia vitamin B12 deficiency 2 0 Deficiency anaemia 1 0 Iron deficiency anaemia 6 0 Anaemias NEC Anaemia 97 0 Anaemia macrocytic 1 0 Anaemia megaloblastic 1 0 Autoimmune anaemia 2 0 Blood loss anaemia 1 0 Microcytic anaemia 1 0 Anaemias haemolytic NEC Coombs negative haemolytic anaemia 1 0 Haemolytic anaemia 6 0 Anaemias haemolytic immune Autoimmune haemolytic anaemia 9 0 Anaemias haemolytic mechanical factor Microangiopathic haemolytic anaemia 1 0 Bleeding tendencies Haemorrhagic diathesis 1 0 Increased tendency to bruise 35 0 Spontaneous haematoma 2 0 Coagulation factor deficiencies Acquired haemophilia -
Faculty Meeting August 9Th, 2011
Review of Systems is a process that includes a review of body systems. It is carried out through a series of questions regarding signs and symptoms. The Review of Systems (ROS) includes information about the following 14 systems. Constitutional: description of general appearance; growth and development, recent weight loss/gain, malaise, chills weakness, fatigue, fever, vital signs, head circumference for a baby, appetite, sleep habits, insomnia, night sweats. Integumentary: (skin and/or breast) rashes, color, sores, dryness, itching, flaking, dandruff, lumps, moles, color change, changes in hair or nails, sweating, hives, bruising, scratches, scars, swelling., acne. Eyes: vision, no change in vision, glasses or contact lenses, last eye exam, eye pain, “eye” redness, excessive tearing, double vision, blurred vision, spots, specks, flashing lights, photophobia, glaucoma, cataracts. Ears, Nose, Mouth/ Throat Ears: hearing loss, tinnitus, vertigo, earaches, ear infections, ear discharges; if hearing is decreased, use of hearing aids. Nose and sinuses: frequent colds, stuffiness’, discharge drainage, nasal itching, hay fever, nosebleeds sinusitis, sinus trouble, sinus pressure, nasal congestion, nasal discharge, nasal infection Mouth/Throat condition of teeth and gums bleeding gums dentures, (how they fit) last dental exam, dry mouth, frequent sore throats, difficulty swallowing, no posterior pharynx pain, hoarseness, sores/ulcers, hoarseness, pyorrhea. Respiratory: cough, sputum, (color, quantity) shortness of breath, pleuritic chest pain, wheezing, asthma, bronchitis, TB, emphysema, pneumonia, hemoptysis, CXR. Cardiovascular: heart trouble; high blood pressure; CV hypertension, heart murmurs, chest pain/ pressure palpitations, dyspnea, orthopnea,, rheumatic fever, paroxysmal nocturnal dyspnea, edema; past EKG or other heart tests. Peripheral Vascular; intermittent claudication, leg cramps, varicose veins, past clots in the vein, syncope, edema. -
Ekbom Syndrome: a Delusional Condition of “Bugs in the Skin”
Curr Psychiatry Rep DOI 10.1007/s11920-011-0188-0 Ekbom Syndrome: A Delusional Condition of “Bugs in the Skin” Nancy C. Hinkle # Springer Science+Business Media, LLC (outside the USA) 2011 Abstract Entomologists estimate that more than 100,000 included dermatophobia, delusions of infestation, and Americans suffer from “invisible bug” infestations, a parasitophobic neurodermatitis [2••]. Despite initial publi- condition known clinically as Ekbom syndrome (ES), cations referring to the condition as acarophobia (fear of although the psychiatric literature dubs the condition “rare.” mites), ES is not a phobia, as the individual is not afraid of This illustrates the reluctance of ES patients to seek mental insects but rather convinced that they are infesting his or health care, as they are convinced that their problem is her body [3, 4]. This paper deals with primary ES, not the bugs. In addition to suffering from the delusion that bugs form secondary to underlying psychological or physiologic are attacking their bodies, ES patients also experience conditions such as drug reaction or polypharmacy [5–8]. visual and tactile hallucinations that they see and feel the While Morgellons (“the fiber disease”) is likely a compo- bugs. ES patients exhibit a consistent complex of attributes nent on the same delusional spectrum, because it does not and behaviors that can adversely affect their lives. have entomologic connotations, it is not included in this discussion of ES [9, 10]. Keywords Parasitization . Parasitosis . Dermatozoenwahn . Valuable reviews of ES include those by Ekbom [1](1938), Invisible bugs . Ekbom syndrome . Bird mites . Infestation . Lyell [11] (1983), Trabert [12] (1995), and Bak et al. -
Women's Health Concerns
WOMEN’S HEALTH Natalie Blagowidow. M.D. CONCERNS Gynecologic Issues and Ehlers- Danlos Syndrome/Hypermobility • EDS is associated with a higher frequency of some common gynecologic problems. • EDS is associated with some rare gynecologic disorders. • Pubertal maturation can worsen symptoms associated with EDS. Gynecologic Issues and Ehlers Danlos Syndrome/Hypermobility •Menstruation •Menorrhagia •Dysmenorrhea •Abnormal menstrual cycle •Dyspareunia •Vulvar Disorders •Pelvic Organ Prolapse Puberty and EDS • Symptoms of EDS can become worse with puberty, or can begin at puberty • Hugon-Rodin 2016 series of 386 women with hypermobile type EDS. • 52% who had prepubertal EDS symptoms (chronic pain, fatigue) became worse with puberty. • 17% developed symptoms of EDS with puberty Hormones and EDS • Conflicting data on effects of hormones on connective tissue, joint laxity, and tendons • Estriol decreases the formation of collagen in tendons following exercise • Joint laxity increases during pregnancy • Studies (Non EDS) • Heitz: Increased ACL laxity in luteal phase • Park: Increased knee laxity during ovulation in some, but no difference in hormone levels among all (N=26) Menstrual Cycle Hormonal Changes GYN Issues EDS/HDS:Menorrhagia • Menorrhagia – heavy menstrual bleeding 33-75%, worst in vEDS • Weakness in capillaries and perivascular connective tissue • Abnormal interaction between Von Willebrand factor, platelets and collagen Menstrual cycle : Endometrium HORMONAL CONTRACEPTIVE OPTIONS GYN Menorrhagia: Hormonal Treatment • Oral Contraceptive Pill • Progesterone only medication • Progesterone pill: Norethindrone • Progesterone long acting injection: Depo Provera • Long Acting Implant: Etonorgestrel • IUD with progesterone Hormonal treatment for Menorrhagia •Hernandez and Dietrich, EDS adolescent population in menorrhagia clinic •9/26 fine with first line hormonal medication, often progesterone only pill •15/26 required 2 or more different medications until found effective one. -
The Older Woman with Vulvar Itching and Burning Disclosures Old Adage
Disclosures The Older Woman with Vulvar Mark Spitzer, MD Itching and Burning Merck: Advisory Board, Speakers Bureau Mark Spitzer, MD QiagenQiagen:: Speakers Bureau Medical Director SABK: Stock ownership Center for Colposcopy Elsevier: Book Editor Lake Success, NY Old Adage Does this story sound familiar? A 62 year old woman complaining of vulvovaginal itching and without a discharge self treatstreats with OTC miconazole.miconazole. If the only tool in your tool Two weeks later the itching has improved slightly but now chest is a hammer, pretty she is burning. She sees her doctor who records in the chart that she is soon everyyggthing begins to complaining of itching/burning and tells her that she has a look like a nail. yeast infection and gives her teraconazole cream. The cream is cooling while she is using it but the burning persists If the only diagnoses you are aware of She calls her doctor but speaks only to the receptionist. She that cause vulvar symptoms are Candida, tells the receptionist that her yeast infection is not better yet. The doctor (who is busy), never gets on the phone but Trichomonas, BV and atrophy those are instructs the receptionist to call in another prescription for teraconazole but also for thrthreeee doses of oral fluconazole the only diagnoses you will make. and to tell the patient that it is a tough infection. A month later the patient is still not feeling well. She is using cold compresses on her vulva to help her sleep at night. She makes an appointment. The doctor tests for BV. -
Chronic Pain:Useful Terms Personal Injury
Chronic pain:useful terms Personal Injury Analgesic - (also known as a painkiller) is any member of the group of drugs used to relieve pain. Epidural - Epidurals are given for the relief of pain. A cocktail of drugs containing a corticosteriod and a local anaesthetic is injected into the epidural space, between the bone and the membrane that encloses the spinal cord. Fusion - Surgical procedure designed to abolish movement across a joint. Usually involves bone grafting and sometimes metal fixation. Gout - Gout is a type of arthritis that causes sudden and extremely painful inflammatory attacks in the joints – most commonly the big toe, ankles and knees but any other joint too. Guanethidine Blocks – Tourniquet is applied to the limb and guanethidine is injected into a vein to temporarily treat Complex Regional Pain Syndrome symptoms. Hydrotherapy - formerly called hydropathy involves the use of water for pain-relief and treating illness. Hyperalgesia - The perception of a painful stimulus as more painful than normal. Instability - A term used to describe an abnormal increase in the movement of one vertebrae to another. Local Anaesthetic Blocks – Local anaesthetic is injected around the sympathetic nerves from a temporary sympathetic block to treat Complex Regional Pain Syndrome. MRI Scan - Magnetic Resonance Imaging involves a highly technical scanner that uses magnetic fields and computer technology to generate images of the internal anatomy of the body, including discs and nerve roots. It is a painless procedure, although like CT scans, people with claustrophobia may find it difficult. Myelography - A water-soluble, radio-opaque dye is injected into the cerebro-spinal fluid. -
Vulvodynia: What We Know and Where We Should Be Going
SYSTEMATIC REVIEW,META-ANALYSIS,NARRATIVE REVIEW Vulvodynia: What We Know and Where We Should Be Going Logan M. Havemann, BA,1 David R. Cool, PhD,1,2 Pascal Gagneux, PhD,3 Michael P.Markey, PhD,4 Jerome L. Yaklic, MD, MBA,1 Rose A. Maxwell, PhD, MBA,1 Ashvin Iyer, MS,2 and Steven R. Lindheim, MD, MMM1 evolving definitions, and unidentified pathogenesis of disease. Objective: The aim of the study was to review the current nomenclature The pathogenesis of VVD remains largely unknown and is likely and literature examining microbiome cytokine, genomic, proteomic, and multifactorial. Recent research has focused largely on an inflam- glycomic molecular biomarkers in identifying markers related to the under- matory pathogenesis, and our current understanding suggests an standing of the pathophysiology and diagnosis of vulvodynia (VVD). initial vaginal insult with infection1 followed by an inflammatory Materials and Methods: Computerized searches of MEDLINE and response10 that may result in peripheral and central pain sensitiza- PubMed were conducted focused on terminology, classification, and tion, mucosal nerve fiber proliferation, hypertrophy, hyperplasia, “ ” omics variations of VVD. Specific MESH terms used were VVD, and enhanced systemic pain perception.11 With advancements in vestibulodynia, metagenomics, vaginal fungi, cytokines, gene, protein, in- our ability to measure transcriptomic markers of disease, as well flammation, glycomic, proteomic, secretomic, and genomic from 2001 to as the progress in mapping the human genome and how variations 2016. Using combined VVD and vestibulodynia MESH terms, 7 refer- affect disease states, new avenues of research in the pathogenesis ences were identified related to vaginal fungi, 15 to cytokines, 18 to gene, of VVD can now be explored including the potential role for 43 to protein, 38 to inflammation, and 2 to genomic. -
Reproductive Experiences Among Women with Vulvodynia Nora S
View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Springer - Publisher Connector Johnson et al. BMC Pregnancy and Childbirth (2015) 15:114 DOI 10.1186/s12884-015-0544-x RESEARCH ARTICLE Open Access “You have to go through it and have your children”: reproductive experiences among women with vulvodynia Nora S. Johnson, Eileen M. Harwood and Ruby H.N. Nguyen* Abstract Background: Vulvodynia is a potentially debilitating chronic pain condition affecting the vulva (external genitalia) in women, with typical age of onset during the early-to mid-reproductive years. Yet, virtually nothing is known about the thoughts, feelings and experience of vulvodynia patients regarding conception, pregnancy and delivery; including the effect that a hallmark symptom, dyspareunia (painful sex), can have on a couple’s physical and emotional ability to conceive. We sought to describe these experiences and beliefs among women with vulvodynia who were pregnant or who recently had delivered a child. Methods: The study used in-depth, qualitative exploratory interview methods to gain a deeper understanding of these experiences for 18 women with vulvar pain who were recruited from an existing, nationally-sampled prospective pregnancy cohort study. Results: Four major themes were reported by our participants. Women described their reaction to pain as volatile at first, and, over time, more self-controlled, regardless of medical treatment; once the volatility became more stable and overall severity lessened, many women began planning for pregnancy. Techniques described by women to cope with pain around pregnancy included pain minimization, planning pregnancy-safe treatment and timing intercourse around ovulation. -
Vulvodynia: a Self-Help Guide
Vulvodynia: A Self-Help Guide www.nva.org Table of Contents Introduction Introduction ..................................................................................... 1 Welcome to the NVA’s self-help guide for women with vulvodynia. We Section I: Learning the Basics ....................................................... 2 created this guide to answer many of your questions about vulvodynia and Gynecological Anatomy its treatment, and to offer suggestions for improving your quality of life. First Normal and Abnormal Vulvovaginal Symptoms we’d like to highlight a few important points. Vulvar Self-Examination Each woman’s experience with vulvodynia is unique, with symptoms ranging Section II: Understanding Vulvodynia ........................................... 9 from mild to incapacitating. If your pain level is mild, some of the information What is Vulvodynia? in this guide may not apply to you. What Causes Vulvodynia? How is Vulvodynia Diagnosed? Some doctors are still unfamiliar with vulvodynia. Many women spend a long Co-Existing Conditions time wondering what is wrong with them and see several doctors before How is Vulvodynia Treated? they are told they have vulvodynia. An accurate diagnosis is half the battle, Self-Help Strategies for Vulvar Pain so now you can focus your efforts on finding helpful treatments and feeling better. Section III: Understanding Chronic Pain ..................................... 17 How We Feel Pain When you start a new treatment, try to be patient and hopeful. There are When Pain Becomes Chronic many treatment options for vulvodynia and no single treatment works equally Coping with Chronic Pain well for all women. Sometimes progress is slow and you may only notice improvement on a monthly, rather than daily, basis. Section IV: Quality of Life Issues ................................................. 20 Overcoming Challenges in Your Intimate Relationship It is important to participate in treatment decisions and discuss your progress Keeping Sexual Intimacy Alive (or lack of it) with your doctor or other health care provider.