Marianne Pierce

Technical Update on Pessary Use

OBJECTIVE To review the use, care, and fitting of pessaries. OPTIONS Pessaries are an option for women presenting with prolapse and/or urinary incontinence. OUTCOMES Pessaries can be successfully fitted in the majority of women with excellent satisfaction rates and minimal complications. EVIDENCE PubMed and Medline were searched for articles published in English to September 2010, using the key words pessary, prolapse, incontinence, fitting, and complications. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. Searches were updated on a regular basis, and articles were incorporated in the guideline to May 2012. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES The quality of evidence was rated with use of the criteria described by the Canadian Task Force on Preventive Health Care. Recommendations for practice were ranked according to the method described by the Task Force (Table 1). BENEFITS, HARMS, AND COSTS Women may choose a pessary for management of their prolapse and/or stress incontinence rather than opt for surgery. Major complications have been seen only with neglected pessaries. Minor complications such as vaginal discharge, odour, and erosions can usually be successfully treated. SUMMARY STATEMENTS AND RECOMMENDATION: Summary Statements 1. Most women can be successfully fitted with a pessary when they present with prolapse. (II-2) 2. Complications of pessary use are usually minor, and vaginal discharge is the most common complaint. (II-3) 3. Vaginal erosions can be treated with removal of the pessary and optional vaginal estrogen supplementation. (II-2) 4. Satisfaction rates with pessary use are very high. (II-2) Recommendation 1. Pessaries should be considered in all women presenting with symptomatic prolapse and/or urinary stress incontinence. (II-1A).

Female Genital Cosmetic Surgery

OBJECTIVE To provide Canadian gynaecologists with evidence-based direction for female genital cosmetic surgery in response to increasing requests for, and availability of, vaginal and vulvar surgeries that fall well outside the traditional realm of medically-indicated reconstructions. EVIDENCE Published literature was retrieved through searches of PubMed or MEDLINE, CINAHL, and The Cochrane Library in 2011 and 2012 using appropriate controlled vocabulary and key words (female genital cosmetic surgery). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to May 2012. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table). Recommendations 1. The obstetrician and gynaecologist should play an important role in helping women to understand their anatomy and to respect individual variations. (III-A) 2. For women who present with requests for vaginal cosmetic procedures, a complete medical, sexual, and gynaecologic history should be obtained and the absence of any major sexual or psychological dysfunction should be ascertained. Any possibility of coercion or exploitation should be ruled out. (III-B) 3. Counselling should be a priority for women requesting female genital cosmetic surgery. Topics should include normal variation and physiological changes over the lifespan, as well as the possibility of unintended consequences of cosmetic surgery to the genital area. The lack of evidence regarding outcomes and the lack of data on the impact of subsequent changes during pregnancy or menopause should also be discussed and considered part of the informed consent process. (III-L) 4. There is little evidence to support any of the female genital cosmetic surgeries in terms of improvement to sexual satisfaction or self-image. Physicians choosing to proceed with these cosmetic procedures should not promote these surgeries for the enhancement of sexual function and advertising of female genital cosmetic surgical procedures should be avoided (III-L) 5. Physicians who see adolescents requesting female genital cosmetic surgery require additional expertise in counselling adolescents. Such procedures should not be offered until complete maturity including genital maturity, and parental consent is not required at that time. (III-L) 6. Non-medical terms, including but not restricted to vaginal rejuvenation, clitoral resurfacing, and G-spot enhancement, should be recognized as marketing terms only, with no medical origin; therefore they cannot be scientifically evaluated. (III-L).

Treatments for Overactive Bladder: Focus on Pharmacotherapy

OBJECTIVE To provide guidelines for pharmacotherapy to treat overactive bladder syndrome (OAB). OPTIONS Pharmacotherapy for OAB includes anticholinergic (antimuscarinic) drugs and vaginal estrogen. Both oral and transdermal anticholinergic preparations are available. OUTCOMES To provide understanding of current available evidence concerning safety and clinical efficacy of pharmacotherapy for OAB; to guide selection of anticholinergic therapy based on individual patient characteristics. EVIDENCE The Cochrane Library and Medline were searched for articles published from 1950 to the present related to individual anticholinergic drugs. Review articles on management of refractory OAB were also examined. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to 2010. VALUES The quality of evidence is rated and recommendations are made using the criteria described by the Canadian Task Force on Preventive Health Care (Table 1). BENEFITS, HARMS, AND COSTS Anticholinergics are the mainstay of pharmacotherapy for OAB. EVIDENCE for their efficacy is mostly derived from short-term phase III randomized drug trials. Placebo response is strong, and long-term follow-up and patient subjective outcome data are lacking. Care providers need to be well acquainted with the side effects of anticholinergics and select therapy based on individual patient parameters. Recommendations 1. Behavioural management protocols and functional electrical stimulation should be offered in the spectrum of effective primary treatments for overactive bladder syndrome. (I-A) 2. Oral oxybutynin, immediate and extended release, as well as transdermal oxybutynin, may be offered as treatment for overactive bladder syndrome, as they are associated with significant objective clinical improvement at 12 weeks. (I-A) Oxybutynin immediate release has superior cost-effectiveness but more side effects than other anticholinergics. (I-A) Adverse events associated with transdermal oxybutynin are fewer than with oral oxybutynin. (I-A) 3. Tolterodine, immediate and extended release, may be offered as treatment for overactive bladder syndrome, as it is associated with significant objective clinical improvement at 12 weeks. (I-A) 4. Trospium, immediate and extended release, may be offered as treatment for overactive bladder syndrome as it is associated with significant clinical improvement at 12 weeks. (I-A) Trospium is an adequate anticholinergic choice for overactive bladder syndrome patients with pre-existing cognitive impairment (II-B) and for overactive bladder syndrome patients taking concurrent CYP450 inhibitors. (III-B) 5. Solifenacin may be offered as treatment for overactive bladder syndrome, as it is associated with significant objective clinical improvement at 12 weeks. (I-A) Solifenacin may be an adequate anticholinergic choice for elderly overactive bladder syndrome patients or patients with pre-existing cognitive dysfunction. (I-B) 6. Darifenacin may be offered as treatment for overactive bladder syndrome, as it is associated with significant objective clinical improvement at 12 weeks. (I-A) Darifenacin is an adequate anticholinergic choice for overactive bladder syndrome patients with pre-existing cardiac concerns or cognitive dysfunction. (I-B) 7. Overactive bladder syndrome patients should be offered a choice between bladder training, functional electric stimulation, and anticholinergic therapy, as there is no difference in cure rates. Combination therapy does not have a clear advantage over one therapy alone. (I-A) 8. The choice of anticholinergic therapy should be guided by individual patient comorbidities, as objective efficacy of anticholinergic drugs is similar. (I-A) Dose escalation does not improve objective parameters and causes more anticholinergic adverse effects. It is, however, associated with improved subjective outcomes. (I-A) To decrease side effects, switching to a lower dose or using an extended release formulation or a transdermal delivery mechanism should be considered. (I-A) 9. Education on treatment efficacy, realistic expectations, and length of treatment should be offered to patients upon initiation of anticholinergic therapy, as continuation rates for anticholinergic therapy are low. (III-B) 10. Oral or transdermal estrogen supplementation should not be recommended for treatment of overactive bladder syndrome as its effects are comparable to placebo. (I-E) Vaginal estrogen can be suggested for subjective improvements in overactive bladder syndrome symptoms. (III-B) 11. Intravesical botulinum toxin injection and sacral nerve and posterior tibial nerve stimulation are clinically effective options for patients with overactive bladder syndrome unresponsive to conservative options, anticholinergics, or vaginal estrogen. (I-A).

Obstetrical Anal Sphincter Injuries (OASIS): Prevention, Recognition, and Repair

OBJECTIVE To review the evidence relating to obstetrical anal sphincter injuries (OASIS) with respect to diagnosis, repair techniques and outcomes. To formulate recommendations as to patient counselling regarding route of delivery for subsequent pregnancy after OASIS. OPTIONS Obstetrical care providers caring for women with OASIS have the option of repairing the anal sphincter using end-to-end or overlapping techniques. They may also be involved in counselling women with prior OASIS regarding the route of delivery for future pregnancies. OUTCOMES The outcome measured is anal continence following primary OASIS repair and after subsequent childbirth. EVIDENCE Published literature was retrieved through searches of Medline, EMBASE, and The Cochrane Library in May 2011 using appropriate controlled vocabulary (e.g., anal canal, obstetrics, obstetric labour complication, pregnancy complication, treatment outcome, surgery, quality of life) and key words (obstetrical anal sphincter injur*, anus sphincter, anus injury, delivery, obstetrical care, surgery, suturing method, overlap, end-to-end, feces incontinence). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational. There were no date or language restrictions. Searches were updated on a regular basis and incorporated in the guideline to September 2014. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. VALUES The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). BENEFITS, HARMS, AND COSTS Benefits from implementation of these guidelines include: improved diagnosis of OASIS, optimal functional outcomes following repair, and evidence-based counselling of women for future childbirth.

Pelvic Examinations by Medical Students

Ensuring the quality of medical education is important to ensuring that all Canadians have access to good health care today and in the future; however, patient autonomy should be respected in all clinical and educational interactions. When a medical student is involved in patient care, patients should be told what the student’s roles will be, and patients must provide consent. Patient participation in any aspect of medical education should be voluntary and non-discriminatory. PREAMBLE