DOCSLIB.ORG

Step-By-Step Approach to Managing Pelvic Organ Prolapse Information for Physicians

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Step-By-Step Approach to Managing Pelvic Organ Prolapse Information for Physicians Surveillance médicale FP Watch Step-by-step approach to managing pelvic organ prolapse Information for physicians Risa Bordman MD CCFP FCFP Deanna Telner MD MEd CCFP Bethany Jackson MD CCFP D’Arcy Little MD CCFP Definition of pelvic organ prolapse Step 4: Medical therapy Descent of pelvic organs into the vagina Use estrogen (oral or vaginal) for mild cystocele. • Anterior: cystocele (bladder most common), urethro- Consider a pessary. cele (urethra) • A pessary is a shaped device usually made of silicone • Middle: uterus, vault (after hysterectomy) and left in the vagina. • Posterior: rectocele (rectum), enterocele (small bowel, omentum) Tips on pessaries Grades of uterine prolapse • There are 2 types: supportive for milder prolapses I Descent of the uterus to above the hymen and space-occupying for more serious prolapse. II Descent of the uterus to the hymen • Cost is $88 (Canadian) delivered to your office. III Descent of the uterus beyond the hymen • For women with atrophic changes, the vagina can IV Total prolapse be prepared with topical estrogen 2 to 3 times a week for a month before insertion. Step 1: Presentation and history • Aim for the largest pessary that fits comfortably. Prevalence: The prevalence of pelvic organ pro- • Examiner’s fingers should pass easily between the lapse among parous women is 50%. Most women are pessary and the vagina wall. asymptomatic. • After fitting the pessary in the office, have patients History: Physicians should ask about urinary frequency walk around and then try to urinate or defecate. and urgency, bulges or lumps in the vagina, pelvic pres- • Women can remove, wash with mild soap and sure or heaviness, incontinence of urine or stool, diffi- water, and replace the pessary weekly or monthly culty with defecation or constipation, dyspareunia, and (or it can be cleaned by a health care professional whether patients insert their fingers in the vagina to void every 3 to 6 months). or defecate. • There is no evidence or consensus on which pes- Risk factors: Childbirth, constipation, age, pelvic sur- sary is best, how often to clean it, or how often to gery, chronic cough, raised intra-abdominal pressure, visit a health professional. and obesity. • You can try to keep the vagina lubricated with estrogen or Trimo-San vaginal jelly. Step 2: Physical examination and investigations • Adverse effects include discharge, odour, pain, Physical examination: Bimanual, including speculum bleeding, failure to reduce prolapse, and expulsion. examination at rest and with straining. If prolapse is not • Long-term use carries a risk of vaginal erosion, so vagi- obvious, repeat with patient standing with 1 foot on a nal examinations should be done every 3 to 6 months. chair. To help with speculum examination, turn the regular • If forgotten, pessaries might become fixed in place. speculum 90º (watch the urethra) to see the anterior and To loosen fixed pessaries before removal, apply 2 g posterior walls or remove 1 blade from a double speculum of estrogen cream every second day for 2 weeks. and apply the single blade anteriorly and posteriorly. • Change a pessary after about 5 years or when it Investigations: Urine culture. If you are unsure of the wears out. diagnosis, use pelvic ultrasonography or cystography. Pessary companies Step 3: Treatment principles Most women are asymptomatic so no treatment is Milex (Cooper Surgical), 800 243-2974, needed. A trial of lifestyle modification might be www.coopersurgical.com beneficial: Kegel exercises, weight loss, smoking ces- Mentor, 800 668-6069, www.mentorcorp.com sation, treatment of constipation, electrical stimula- Superior, 800 268-7944, www.superiormedical.com tion, or biofeedback. VOL 53: MARCH • MARS 2007 Canadian Family Physician • Le Médecin de famille canadien 485 FP Watch Surveillance médicale -Ìi«ÃÊÌÊ>>}i\ Pelvic Organ Prolapse ÌÌÊi\ÊÊ7iÊ>ÀiÊvÌiÊÀiÕVÌ>ÌÊÌÊ`ÃVÕÃÃÊ«À>«ÃiÊÃÞ«ÌðÊÊ7 iÊÊ, /½ÃÊiÝÃÌÊvÀÊÌÀi>ÌiÌ]Ê«iÃÃ>ÀiÃÊ >ÀiÊ>Ê}`Ê«ÌÊvÀÊÌ ÃiÊÜ ÊÜà ÊÌÊÀi>ÊviÀÌiÊÀÊ>Û`ÊÃÕÀ}iÀÞ° iwÌ\Ê iÃViÌÊvÊ«iÛVÊÀ}>ÃÊÌÊÌ iÊÛ>}>° ÊÊÊÊ Ê UÊ ÌiÀÀ\ÊVÞÃÌViiÊ­L>``iÀ]ÊÃÌÊV®]ÊÕÀiÌ ÀViiÊ­ÕÀiÌ À>® ÊÊÊÊ Ê UÊ ``i\ÊÕÌiÀÕÃ]ÊÛ>ÕÌÊ­«ÃÌÊ ÞÃÌiÀiVÌÞ®]Ê ÊÊÊÊ Ê UÊ *ÃÌiÀÀ\ÊÀiVÌViiÊ­ÀiVÌÕ®ÊiÌiÀViiÊ­Ã>ÊLÜi]ÊiÌÕ® *ÀiÃiÌ>ÌÉÃÌÀÞ *ÀiÛ>>ViÊzÊxä¯ÊvÊ«>ÀÕÃÊÜi°ÊÊÃÌÊ>ÃÞ«Ì>ÌV° 1 ÃÌÀÞ ,ÃÊv>VÌÀà U Ê1À>ÀÞÊvÀiµÕiVÞ]ÊÕÀ}iVÞ U Ê vwVÕÌÞÊÜÌ Ê`iviV>ÌÉÊ U Ê `LÀÌ U Ê ÀVÊVÕ} U Ê Õ}iÉÕ«ÊÊÛ>}> ÊÊÊÊVÃÌ«>Ì U Ê ÃÌ«>Ì U Ê"LiÃÌÞ U Ê*iÛVÊ«ÀiÃÃÕÀiÉ i>ÛiÃà U Ê Þë>ÀÕ> U Ê}} U Ê,>Ãi`ÊÌÀ>>L`> U ÊVÌiViÊvÊÕÀi U ÊÃiÀÌ}Êw}iÀÃÊÊÛ>}>ÊÌÊÊ U Ê*iÛVÊÃÕÀ}iÀÞ ÊÊÊÊ«ÀiÃÃÕÀi ÊÊÊÊÀÊÃÌ ÊÊÊÊÛ`É`iviV>Ìi * ÞÃV>Ê Ý>ÉÌ>ÊÛiÃÌ}>Ìà /«ÃÊvÀÊëiVÕÕÊiÝ> U ÊÊÊ >Õ>ʳÊëiVÕÕÊiÝ>Ê>ÌÊÀiÃÌÊ>`ÊÜÌ ÊÃÌÀ>} U ÊÊÊvÊ«À>«ÃiÊÌÊLÛÕÃ\ÊÀi«i>ÌÊÜÌ Ê«>ÌiÌÊÃÌ>`}ÊÜÌ ÊÊ vÀÊ«À«>«Ãi\ UÊÊÊ/ÕÀÊÀi}Õ>ÀÊëiVÕÕÊäc 2 ÊÊÊÊÊÊiÊvÌÊÊV >À ÊÊÊÊÊÊ­Ü>ÌV ÊÕÀiÌ À>®ÊÌÊÃii U ÊÊÊ1ÀiÊVÕÌÕÀi ÊÊÊÊÊÊ>ÌiÀÀÉ«ÃÌiÀÀ U ÊÊÊvÊÕÃÕÀiÊvÊ`>}ÃÃÊ«iÛVÊÕÉÃÊÀÊVÞÃÌ}À>« Þ UÊÊÊ,iÛiÊiÊL>`iÊvÀ ÊÊÊÊÊÊÌ iÊ`ÕLiÊëiVÕÕ ÊÊÊÊÊÊ>`ÊÕÃiÊÃ}iÊL>`i /Ài>ÌiÌÊ*ÀV«ià ÊÊÊÊÊÊ>««i`Ê>ÌiÀÀÞ U ÊÊÊÃÌÊ>ÃÞ«Ì>ÌVÊ>`ÊÊÌÀi>ÌiÌÊii`i` ÊÊÊÊÊÊ>`Ê«ÃÌiÀÀÞ U ÊÊÊ/À>ÊvÊviÃÌÞiÊ`wV>ÌÊ>ÞÊLiÊLiiwV> 3 ÊÊÊÊÊÊÊÊ i}iÊiÝiÀVÃià ÊÊÊÊÊÊÊ 7i} ÌÊÃà ÊÊÊÊÊÊÊ -Ì«ÊÃ} ÊÊÊÊÊÊÊ /Ài>ÌÊVÃÌ«>Ì ÊÊÊÊÊÊÊ iVÌV>ÊÃÌÕ>ÌÉLvii`L>V "* i`V>Ê/ iÀ>«Þ L}ÊV`iÊvÀÊ U ÊÊÊ ÃÌÀ}iÊ­À>]Û>}>®ÊvÀÊ`ÊVÞÃÌVii U ÊÊÊ Ã`iÀÊ>Ê«iÃÃ>ÀÞ «iÃÃ>ÀÞÊwÌÌ}Ê 4 U ÊÊÊ- >«i`Ê`iÛViÊÕÃÕ>ÞÊ>`iÊvÊÃViÊ>`ÊivÌÊÊÌ iÊÛ>}> În U ÊÊÊ vviÀiÌÊÌÞ«iÃÊvÀÊVÞÃÌVii]ÊÃÌÀiÃÃÊVÌiVi]ÊÕÌiÀiÊ«À>«Ãi]ÊÀiVÌViiÊÀÊVL>Ìà ­«iÀÊ£ÓÊÌ Ã® ÊÊÊÊÊÊ­ÌÊ>ÃÊ}`ÊvÀÊ«ÃÌÊ ÞÃÌiÀiVÌÞÊÛ>ÕÌÊ«À>«Ãi® U ÊÊÊÌÊLÞÊÌÀ>Ê>`ÊiÀÀÀÊÜÌ ÊwÌÌ}ÊÀ}ÃÊÃ>ÀÊÌÊ`>« À>}ÊwÌÌ} U ÊÊÊÃÌÊVÊÃÊÀ}ÊÜÌ ÊÃÕ««ÀÌÊ­ÌÀi>ÌÃÊÀ>`iÃÊÊ>`ÊÊÕÌiÀiÊ«À>«ÃiÊ>`ÊVÞÃÌVii® U ÊÊÊ,iÛi`ÊÀi}Õ>ÀÞÊvÀÊVi>}ÊLÞÊ«>ÌiÌÊÀÊ i>Ì ÊV>ÀiÊ«ÀviÃÃ> U ÊÊÊ-iiÊ«>ÌiÌÊiÛiÀÞÊÎÊÊÈÊÌ ÃÊÌÊV iVÊvÀÊÛ>}>ÊiÀÃà À>`iÃÊvÊ1ÌiÀiÊ*À>«Ãi\ ÕÀÌ iÀÊ Û>Õ>ÌÃÉ-ÕÀ}V>Ê/Ài>ÌiÌ £°ÊÊ iÃViÌÊvÊÕÌiÀÕÃÊ>LÛi U ÊÊÊ*iÛVÊÀ}>Ê«À>«ÃiÊÃÕÀ}iÀiÃÊ >ÛiÊ>ÊÃÕVViÃÃÊÀ>ÌiÊÈxä¯]ÊÀi«iÀ>ÌÊÀ>ÌiÊÎä¯ ÊÊÊÊÊÌ iÊ Þi U ÊÊÊ7 iÊÀiÊÌ >ÊiÊV«>ÀÌiÌÊÛÛi`]Êii`Ê>ÊVL>ÌÊvÊÃÕÀ}iÀià ӰÊÊ iÃViÌÊÌÊÌ iÊ Þi 5 U ÊÊÊ ÀÀiVÌ}ÊVÞÃÌViiÊV>ÊÕ>ÃÊÃÌÀiÃÃÊVÌiViÊ­ÕÊL>``iÀmi>ÃiÀÊÌÊi>® ΰÊÊ iÃViÌÊLiÞ`ÊÌ iÊ Þi ÊÊÊÊÊÊ ÊÊV>ÊV iVÊvÀÊÌ ÃÊ«ÀÀÊÌÊÃÕÀ}iÀÞÊLÞÊVÀÀiVÌ}Ê«À>«ÃiÊÜÌ Ê>Ê«iÃÃ>ÀÞ {°ÊÊ/Ì>Ê«À>«Ãi U ÊÊÊ-iÊ«iÀ>ÌÃÊ>ÞÊ«Ài`ëÃiÊÌÊ«À>«ÃiÊÊ>Ì iÀÊV«>ÀÌiÌ U ÊÊÊ >ÊÕÃiÊv>ÃV>Éià ÉÌ>«iÉÃÕÌÕÀiÊÌÊÃÕëi`ÊÀ}>ÃÊÌ ÀÕ} Ê>L`i]ÊÛ>}>ÊÀ ÊÊÊÊÊÊ>«>ÀÃV«VÊ>««À>V U ÊÊÊÀÊÕÌiÀiÊ«À>«Ãi]ÊÛ>}>Ê ÞÃÌiÀiVÌÞÊÃÊÌÀi>ÌiÌÊvÊV ViÊ ÊÊÊÊÊÊ ÊÊÌÊVÃiÀÛiÊÕÌiÀÕÃ\Ê->VÀ ÞÃÌiÀ«iÝÞÊÕÃiÃÊ9à >«i`Ê}À>vÌÊÌÊ>ÌÌ>V ÊÕÌiÀÕÃÊÌÊÃ>VÀÕ U ÊÊÊ «V>ÌÃÊVÕ`iÊ iÀÀ >}i]Ê i>Ì>]ÊiÀÛiÊ`>>}i]ÊÛ`}Ê`vwVÕÌiÃ] ÊÊÊÊÊÊÀiVÕÀÀiViÊvÊ«À>«Ãi]Ê`Þë>ÀÕ>]Êià ÊiÀà Page 14 486 Canadian Family Physician • Le Médecin de famille canadien VOL 53: MARCH • MARS 2007 Surveillance médicale FP Watch • Different pessaries are used for cystocele, stress incon- Complications include hemorrhage, hematoma, nerve tinence, uterine prolapse, rectocele, and combinations damage, voiding difficulties, recurrence of prolapse, of these (pessaries are not as good for vault prolapse dyspareunia, and mesh erosion. after hysterectomy). • Fit by trial and error with fitting rings, similar to dia- Bottom line phragm fitting. Women are often reluctant to discuss prolapse symp- • The most used pessary is the ring with support (treats toms. While there are no randomized controlled tri- grades I and II uterine prolapse and cystocele). als of treatment, pessaries are a good option for • Pessaries should be removed regularly for cleaning by those who wish to remain fertile or avoid surgery. patient or health care professional. • Patients should be seen every 3 to 6 months to check Resources for vaginal erosions. An Approach to Diagnosis and Management of Benign Uterine Conditions in Primary Care is available on-line Step 5: Further evaluations and surgical treatment with patient handouts and other useful resources at • Pelvic organ prolapse surgery has a success rate of www.benignuterineconditions.ca. Printed copies can be 65% to 90%; repeat operation rate is 30%. obtained from the Ontario College of Family Physicians • When more than 1 compartment is involved, patients on their website at www.ocfp.on.ca, by e-mail at need a combination of surgeries. [email protected], and by telephone at 416 867-8646. • Correcting cystocele can unmask stress incontinence (unkinking the urethra makes it easier to leak). You Dr Bordman is a family doctor at North York General could check for this before surgery by correcting the Hospital in Toronto, Ont, and an Assistant Professor in the prolapse with a pessary. Department of Family and Community Medicine at the • Some operations predispose patients to prolapse in University of Toronto. Dr Telner is a family physician at the another compartment. Toronto East General Hospital and an Assistant Professor in • Surgery can be via the abdomen (open or laparo- the Department of Family and Community Medicine at the scopic) or the vagina using fascia, mesh, tape, or University of Toronto. Dr Jackson completed a fellowship in sutures to suspend the organs. women’s health and is currently a family physician in Ottawa, • To conserve the uterus, sacrohysteropexy uses a Ont. Dr Little is a Lecturer in the Department of Family and Y-shaped graft to attach the uterus to the sacrum. Community Medicine at the University in Toronto. ✶ ✶ ✶.
Load more

Recommended publications
  • OVESTIN PESSARY (0.5Mg)
    NEW ZEALAND DATA SHEET 1. OVESTIN PESSARY (0.5mg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pessary contains 0.5 mg Estriol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Pessary 0.5 mg - white, torpedo formed pessary. One pessary (2.5 g weight) contains 0.5 mg oestriol. Length 26.5 mm; largest diameter 14 mm. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Atrophy of the lower urogenital tract related to oestrogen deficiency, notably • for the treatment of vaginal complaints such as dyspareunia, dryness and itching. • for the prevention of recurrent infections of the vagina and lower urinary tract. • in the management of micturition complaints (such as frequency and dysuria) and mild urinary incontinence. Pre- and postoperative therapy in postmenopausal women undergoing vaginal surgery. A diagnostic aid in case of a doubtful atrophic cervical smear. 4.2 Dose and method of administration Dosage OVESTIN is an oestrogen-only product that may be given to women with or without a uterus. Atrophy of the lower urogenital tract 1 pessary per day for the first weeks, followed by a gradual reduction, based on relief of symptoms, until a maintenance dosage (e.g. 1 pessary twice a week) is reached. Pre- and post-operative therapy in postmenopausal women undergoing vaginal surgery 1 pessary per day in the 2 weeks before surgery; 1 pessary twice a week in the 2 weeks after surgery. A diagnostic aid in case of a doubtful atrophic cervical smear 1 pessary on alternate days in the week before taking the next smear. Administration OVESTIN pessaries should be inserted intravaginally before retiring at night.
    [Show full text]
  • UK Clinical Guideline for Best Practice in the Use of Vaginal Pessaries for Pelvic Organ Prolapse
    UK Clinical Guideline for best practice in the use of vaginal pessaries for pelvic organ prolapse March 2021 Developed by members of the UK Clinical Guideline Group for the use of pessaries in vaginal prolapse representing: the United Kingdom Continence Society (UKCS); the Pelvic Obstetric and Gynaecological Physiotherapy (POGP); the British Society of Urogynaecology (BSUG); the Association for Continence Advice (ACA); the Scottish Pelvic Floor Network (SPFN); The Pelvic Floor Society (TPFS); the Royal College of Obstetricians and Gynaecologists (RCOG); the Royal College of Nursing (RCN); and pessary users. Funded by grants awarded by UKCS and the Chartered Society of Physiotherapy (CSP). This guideline was completed in December 2020, and following stakeholder review, has been given official endorsement and approval by: • British Association of Urological Nurses (BAUN) • International Urogynecological Association (IUGA) • Pelvic Obstetric and Gynaecological Physiotherapy (POGP) • Scottish Pelvic Floor Network (SPFN) • The Association of Continence Advice (ACA) • The British Society of Urogynaecology (BSUG) • The Pelvic Floor Society (TPFS) • The Royal College of Nursing (RCN) • The Royal College of Obstetricians and Gynaecologists (RCOG) • The United Kingdom Continence Society (UKCS) Review This guideline will be due for full review in 2024. All comments received on the POGP and UKCS websites or submitted here: [email protected] will be included in the review process. 2 Table of Contents Table of Contents ................................................................................................................................
    [Show full text]
  • Pessary for Management of Pelvic Organ Prolapse
    Pessary for management of Pelvic Organ Prolapse Cathy Davis Clinical Nurse Specialist Department of Urogynaecology King’s College Hospital, London Definition of Prolapse The descent of one or more of the anterior vaginal wall, posterior vaginal wall, uterus (cervix) or vaginal vault (cuff scar after hysterectomy). The presence of any such sign should be correlated with relevant POP symptoms. (Haylen et al 2016) Risk Factors • Increased intra-abdominal pressure • Chronic cough • Chronic constipation • Weight lifting • Presence of abdominal tumours - fibroids & ovarian cysts • High impact exercise • Age/ Menopause • Obesity Risk Factors contd.... • Smoking • Multiparity • Congenital weakness – rare; due to deficiency in collagen metabolism • Injury to pelvic floor muscles • Iatrogenic/ pelvic surgery - hysterectomy Symptoms of POP • May be asymptomatic – a small amount of prolapse can often be normal • Sensation of a lump or bulge " coming down" - most common • Backache • Heaviness • Dragging or discomfort inside the vagina – often worse on standing /sitting for prolonged periods • Seeing a lump or bulge Symptoms of POP contd.... • Bladder / Urinary symptoms -Frequency -Difficulty initiating voids, low-flow, incomplete bladder emptying -Leakage on certain movements or when lifting heavy objects -Recurrent urinary tract infections • Bowel symptoms -Constipation - Incomplete bowel emptying - May have to digitate to defecate/use aides • Symptoms related to Sex – uncomfortable, lack of sensation Diagnosis of Prolapse • Vaginal examination •
    [Show full text]
  • Combi Soft Gel Pessary & External Cream
    Combi Soft Gel Pessary Canesten & External Cream 500mg vaginal capsule & 2% w/w cream Clotrimazole Read all of this leaflet carefully because it contains important To treat internal thrush, your doctor may recommend that you use the information for you. pessary without the help of an applicator. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. HOW TO USE CANESTEN® COMBI • This medicine has been prescribed for you. Do not give it to anyone else 3. under any circumstances. The Soft Gel Pessary: • If you have any unusual effects after using this product, tell your doctor. Unless directed otherwise by your doctor, the Soft Gel Pessary should be inserted as high as possible into the vagina, preferably before going to sleep IN THIS LEAFLET at night for convenient and comfortable treatment. Wash your hands before removing the foil from the blister pack and again 1. What is Canesten Combi and what is it used for? afterwards when you have used the applicator. 2. Before you use Canesten Combi 3. How to use Canesten Combi 1. Remove the applicator from the packaging. Pull out the plunger A until it 4. Possible side effects stops. Remove the pessary from the foil blister pack and place firmly into the 5. How to store Canesten Combi applicator B. 6. Further information 1. WHAT IS CANESTEN® COMBI AND WHAT IS IT USED FOR? Canesten Combi Soft Gel Pessary & External Cream is a full course of treatment for vaginal thrush (candidiasis) because it treats both the internal cause and external symptoms.
    [Show full text]
  • U.S. Medical Eligibility Criteria for Contraceptive Use, 2010
    Morbidity and Mortality Weekly Report www.cdc.gov/mmwr Early Release May 28, 2010 / Vol. 59 U.S. Medical Eligibility Criteria for Contraceptive Use, 2010 Adapted from the World Health Organization Medical Eligibility Criteria for Contraceptive Use, 4th edition department of health and human services Centers for Disease Control and Prevention Early Release CONTENTS The MMWR series of publications is published by the Office of Surveillance, Epidemiology, and Laboratory Services, Centers for Introduction .............................................................................. 1 Disease Control and Prevention (CDC), U.S. Department of Health Methods ................................................................................... 2 and Human Services, Atlanta, GA 30333. How to Use This Document ......................................................... 3 Suggested Citation: Centers for Disease Control and Prevention. [Title]. MMWR Early Release 2010;59[Date]:[inclusive page numbers]. Using the Categories in Practice ............................................... 3 Recommendations for Use of Contraceptive Methods ................. 4 Centers for Disease Control and Prevention Contraceptive Method Choice .................................................. 4 Thomas R. Frieden, MD, MPH Director Contraceptive Method Effectiveness .......................................... 4 Peter A. Briss, MD, MPH Unintended Pregnancy and Increased Health Risk ..................... 4 Acting Associate Director for Science Keeping Guidance Up to Date ...................................................
    [Show full text]
  • Regulations Governing the Classification of Medical Devices (Draft)
    Regulations Governing the Classification of Medical Devices (Draft) Article 1 These Regulations are enacted pursuant to Paragraph 2, Article 3 of the Medical Devices Act (hereinafter “this Act”). Article 2 Medical devices are classified into the following categories according to their function, intended use, operating instructions, and working principle, depending on the applicable medical specialty: 1. Clinical chemistry and clinical toxicology devices 2. Hematology and pathology devices 3. Immunology and microbiology devices 4. Anesthesiology devices 5. Cardiovascular devices 6. Dental devices 7. Ear, nose, and throat devices 8. Gastroenterology and urology devices 9. General and plastic surgery devices 10. General hospital and personal use devices 11. Neurological devices 12. Obstetrical and gynecological devices 13. Ophthalmic devices 14. Orthopedic devices 15. Physical medicine devices 16. Radiology devices Article 3 Medical devices are classified into the following classes according to their risk level: 1. Class I: Low risk 2. Class II: Medium risk 3. Class III: High risk 1 Article 4 Product items of the medical device classification are specified in the Annex. In addition to rules stated in the Annex, medical devices whose function, intended use, or working principle are special may have their classification determined according to the following rules: 1. If two or more categories, classes, or product items are applicable to the same medical device, the highest class of risk level is assigned. 2. The accessory to a medical device, intended specifically by the manufacturer for use with a particular medical device, is classified the same as the particular medical device, unless otherwise specified in the Annex. 3.
    [Show full text]
  • Vaginal Support Pessaries: Indications for Use and Fitting Strategies
    SERIES Vaginal Support Pessaries: Indications for Use and Fitting Strategies Shanna Atnip and Katharine O’Dell ESSARIES P elvic floor disorders are © 2012 Society of Urologic Nurses and Associates common in women, and as the population ages, Atnip, S., & O’Dell, K. (2012). Vaginal support pessaries: Indications for use and these disorders may be fitting strategies. Urologic Nursing, 32(3), 114-125. Pseen more frequently by health ERIES ON care providers (Nygaard et al., Flexible silicone vaginal support pessaries offer a low-risk, effective option for S 2008). When pelvic symptoms treatment of symptoms of pelvic organ prolapse. This first article in a three-part series summarizes clinical recommendations and current evidence related to are associated with loss of struc- pessary indications, choice, and fitting. tural support of the pelvic organs and vagina, vaginal support pes- PECIAL Key Words: Pelvic organ prolapse, pessary, indications, fitting. saries offer an important option S for relief (American College of Objectives: Obstetricians & Gynecologists 1. List the symptoms of pelvic organ prolapse that may be successfully treated [ACOG], 2007). with a vaginal support pessary. Historically, vaginal pessaries have been used to manage pelvic 2. Discuss the various types of pessaries and their uses to treat pelvic organ floor relaxation and were made prolapse. from a variety of materials, 3. Outline the pessary selection process and steps to pessary fitting. including fruit, metal, porcelain, rubber, and acrylic (Shah, Sultan, genic, and washable, and can gen- & Thakar, 2006). Modern pessaries erally be sterilized using an auto- are made from silicone, acrylic, clave, boiling water, or a cold ster- Shanna Atnip, MSN, WHNP-BC, is a Nurse latex, or rubber.
    [Show full text]
  • Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices
    September 12, 2006 NOTICE Our file number: 06-120629-368 Re: Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices Health Canada is pleased to announce the release of the revised Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices. This guidance document supersedes the January 14, 2000 version of the same document. The Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices is intended to assist manufacturers in confirming the classification of medical device products after application of the Classification Rules for Medical Devices set out in Schedule 1 of the Medical Devices Regulations. This guidance document has been revised to reflect changes to the risk- based classification of particular medical device groups. Specifically, the following major changes have been made to the document: • the reclassification of specific medical device groups; • the removal of redundant information; • the addition of medical device groups; and • the omission of product groups that do not fit the meaning of a medical device as defined in the Food and Drugs Act. To search for a medical device group within the Keyword Index to Assist Manufacturers in Verifying the Class of Medical Devices PDF file, go to Edit/Find and enter a keyword, preferred name code or description in the “Find” field. For instance, to verify the risk-based classification of dental burs, enter “bur” or “drill” in the “Find” field. Please note that this guidance document is provided only as a guide and that in the event of any discrepancy between this document and the Classification Rules for Medical Devices described in the Medical Devices Regulations, the latter shall prevail.
    [Show full text]
  • Treatment of Recurrent Vulvo-Vaginal Candidiasis with Sustained-Release Butoconazole Pessary
    C ase R eport Singapore Med J 2012; 53(12) : e269 Treatment of recurrent vulvo-vaginal candidiasis with sustained-release butoconazole pessary Ling Zhi Heng1, MBBS, Yujia Chen1, MBBS, Thiam Chye Tan1,2, MBBS, MMed ABSTRACT Vulvo-vaginal candidiasis (VVC) is a common infection among women. 5% of women with acute infection experience recurrent vulvo-vaginal candidiasis (RVVC). There is currently no optimal or recommended regime for RVVC. Although antifungal agents, such as imidazoles, have been successfully used as a first-line treatment for acute VVC, its effectiveness is limited in RVVC. This could be due to patient factors, drug application (such as leakage) or dosing factors. A sustained-release (SR) bioadhesive vaginal cream (2% butoconazole nitrate) has incorporated VagiSite technology, a topical drug delivery system that allows SR of the drug. We describe its efficacy and the successful use of a butoconazole-SR formulation in the treatment of two cases of RVVC. Keywords: butoconazole, candidiasis, recurrent vulvo-vaginal Singapore Med J 2012; 53(12): e269–e271 INTRODUCTION Table I. Risk factors for recurrent vulvo-vaginal candidiasis. Candidiasis is a common cause of infective vaginal discharge Risk factors Examples experienced by women. 75% of women experience at least Microbial • Candida albicans species one episode of vaginitis during their lifetime. Recurrent vulvo- • Non-albicans Candida species vaginal candidiasis (RVVC) is defined as four or more episodes Host • Uncontrolled diabetes mellitus • Oestrogen excess – oral contraceptive pills, hormone of symptomatic vulvo-vaginal cadidiasis (VVC) in one year. Up replacement therapy, local oestrogen administration, to 5% of women of childbearing age have experienced RVVC.(1) pregnancy Common symptoms include vaginal discharge, vulvar pruritus, • Antibiotic-induced dyspareunia and dysuria.
    [Show full text]
  • Drug-N-Therapeutics-Committee.Pdf
    Irrational use of medicines is a widespread problem at all levels of health care, but especially GUIDE DRUG AND THERAPEUTICS COMMITTEES: A PRATICAL in hospitals. This is particularly worrying as resources are generally scarce and prescribers in communities often copy hospital prescribing practices. Use of medicines can be greatly improved and wastage reduced if some simple principles of drug management are followed. But it is difficult to implement these principles because staff from many different disciplines are involved, often with no forum for bringing them together to develop and implement appropriate medicines policies. A drug and therapeutics committee (DTC) provides such a forum, allowing all the relevant people to work together to improve health care delivery, whether in hospitals or other health facilities. In many developed countries a well functioning DTC has been shown to be very effective in addressing drug use problems. However, in many developing countries DTCs do not exist and in others they do not function optimally, often due to lack of local expertise or a lack of incentives. Drug and Therapeutics Committees: A Practical Guide provides guidance to doctors, pharmacists, hospital managers and other professionals who may be serving on DTCs and/or who are concerned with how to improve the quality and cost efficiency of therapeutic care. It is relevant for all kinds of DTCs - whether in public or private hospitals and whether at district or tertiary referral level. This comprehensive manual covers a committee’s functions and structure, the medicines formulary process, and how to assess new medicines. The chapters on tools to investigate drug use and strategies to promote rational use are followed by a discussion of antimicrobial resistance and infection control.
    [Show full text]
  • Standard Terms: Introduction and Guidance for Use – V.2.1.3 – 16 November 2018 Contents
    Standard Terms Introduction and Guidance for Use Version 2.1.3 – 16 November 2018 GENERAL PRINCIPLES AND INSTRUCTIONS FOR USE OF THE LISTS OF STANDARD TERMS The lists of Standard Terms were initially drawn up by the European Pharmacopoeia (Ph. Eur.) Commission further to a request of the EU Commission, for use in marketing authorisation applications (MAAs), labelling (including the summary of product characteristics (SmPC)), and electronic communications. The first list was published as a special edition of Pharmeuropa in October 1996. The European Directorate for the Quality of Medicines & HealthCare (EDQM), a Directorate of the Council of Europe based in Strasbourg, France, is responsible for continuing this work. Standard Terms have the double purpose of bringing information to the patient/user/prescriber and distinguishing medicinal products having the same trade-name. Because of the labelling purposes it is imperative that any Standard Term is constructed with a view to the patient and the prescriber. It conveys essential information on the properties and uses of the particular medicinal products. To avoid a proliferation of over-complicated terms, complete information cannot always be included in a Standard Term, and should instead appear elsewhere in the labelling, in particular the package leaflet and SmPC. Since 2017 the scope of the Standard Terms database has also widened to allow the inclusion of certain additional terms that are not intended for use in MAAs, but are used for related purposes such as adverse event reporting (pharmacovigilance) and clinical trials. At the same time, in an effort to encourage greater global harmonisation of electronic communications, applications for terms to describe concepts that are not used in European Pharmacopoeia Commission member states but are used in other regions are also now accepted for consideration.
    [Show full text]
  • Induction of Labour This Is an Update of NICE Inherited Clinical Guideline D
    Issue date: July 2008 Induction of labour This is an update of NICE inherited clinical guideline D NICE clinical guideline 70 Developed by the National Collaborating Centre for Women’s and Children’s Health NICE clinical guideline 70 Induction of labour Ordering information You can download the following documents from www.nice.org.uk/CG070 • The NICE guideline (this document) – all the recommendations. • A quick reference guide – a summary of the recommendations for healthcare professionals. • ‘Understanding NICE guidance’ – information for patients and carers. • The full guideline – all the recommendations, details of how they were developed, and reviews of the evidence they were based on. For printed copies of the quick reference guide or ‘Understanding NICE guidance’, phone NICE publications on 0845 003 7783 or email [email protected] and quote: • N1625 (quick reference guide) • N1626 (‘Understanding NICE guidance’). NICE clinical guidelines are recommendations about the treatment and care of people with specific diseases and conditions in the NHS in England and Wales. This guidance represents the view of the Institute, which was arrived at after careful consideration of the evidence available. Healthcare professionals are expected to take it fully into account when exercising their clinical judgement. However, the guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer and informed by the summary of product characteristics of any drugs they are considering. Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity.
    [Show full text]