Danny Lovatsis

Safety and efficacy of sacrospinous vault suspension.

Abstract The objective of the study was to determine the success rate and complications of sacrospinous vault suspension when performed by an experienced surgeon. Retrospective data collection was performed for 293 women who had undergone sacrospinous vault suspension at Mount Sinai Hospital, Toronto, between November 1993 and 19 December 1998. Primary outcome measures were complication rates (acute and long term) and success rate, with failure defined as any degree of vault prolapse requiring repeat operation, any degree of symptomatic isolated vault prolapse, or any vault prolapse at or beyond the introitus. Statistical analysis was performed using simple descriptive techniques. During the study period, 305 sacrospinous vault suspensions were performed; however, 12 cases were excluded because of inaccessible records. This study therefore comprised the remaining 293 cases: 129 at the time of vaginal hysterectomy, 5 with transvaginal cervical stump excision, 155 for post-hysterectomy vault prolapse, and 4 without hysterectomy. Two hundred had follow-up of 1 year or more, with maximum follow-up 5 years. Of these 200, there were 6 failures (3%). There were no acute hemorrhages and no deaths. There was a complaint of postoperative right buttock pain in 18 of the 293 procedures (6.1%), with this persisting on a chronic basis in 3 patients. Eight patients complained of new-onset postoperative dyspareunia. Nine patients had postoperative stress urinary incontinence, and 14 patients had de novo anal incontinence. Postoperatively, there were 17 patients with a cystocele and 7 with a rectocele. There were three other complications: one pelvic hematoma at the sacrospinous suspension site, one right foot drop which spontaneously resolved, and one case of pain in the right sciatic nerve distribution which spontaneously resolved. Forty-three patients complained of anal incontinence preoperatively, and 38 (88.4%) had the symptoms resolved postoperatively. It was concluded that, when performed by a surgeon experienced in the procedure, sacrospinous vault suspension is safe and effective, with a successful result at 1 year in more than 90% of cases, and rare major complications.

Recurrent Urinary Tract Infection

OBJECTIVE to provide an update of the definition, epidemiology, clinical presentation, investigation, treatment, and prevention of recurrent urinary tract infections in women. OPTIONS continuous antibiotic prophylaxis, post-coital antibiotic prophylaxis, and acute self-treatment are all efficient alternatives to prevent recurrent urinary tract infection. Vaginal estrogen and cranberry juice can also be effective prophylaxis alternatives. EVIDENCE a search of PubMed and The Cochrane Library for articles published in English identified the most relevant literature. Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies. There were no date restrictions. VALUES this update is the consensus of the Sub-Committee on Urogynaecology of the Society of Obstetricians and Gynaecologists of Canada. Recommendations were made according to the guidelines developed by the Canadian Task Force on Preventive Health Care (Table 1). OPTIONS recurrent urinary tract infections need careful investigation and can be efficiently treated and prevented. Different prophylaxis options can be selected according to each patients characteristics.

Effect of childhood dysfunctional voiding on urinary incontinence in adult women.

OBJECTIVE: To determine whether a history of childhood dysfunctional voiding is associated with urinary incontinence in adulthood. METHODS: Using a case-control study, we surveyed patients presenting with or without urinary incontinence. Cases were patients referred to a tertiary urogynecology clinic, and controls were patients referred to a general gynecology clinic. Patients completed a validated childhood questionnaire about dysfunctional voiding. A total score of 6 or more in girls is indicative of dysfunctional voiding, a condition characterized by urgency, frequency, constipation, urinary or fecal incontinence, and/or urinary tract infections. Using an alpha of 0.05, a power of 80%, and a baseline prevalence of dysfunctional voiding of 8%, we determined that 170 patients were needed to show a 3-fold difference between groups. RESULTS: Cases (n = 84) and controls (n = 86) had similar baseline characteristics except for body mass index and incidence of previous pelvic surgery. Although the total dysfunctional voiding score was higher in cases than controls (7.3 versus 5.0, respectively; P = .001), the difference in the number (%) of patients with history of childhood dysfunctional voiding between the 2 groups was not significant (47 [56%] versus 36 [42%], respectively; odds ratio 1.76, 95% confidence interval 0.96–3.24; P = .07). When all patients from both groups were combined, there was a higher prevalence of a history of childhood dysfunctional voiding in women with or without current urinary frequency (P = .004), urgency (P = .03), stress incontinence (P = .01), and urge incontinence (P = .009). CONCLUSION: Women with adult lower urinary tract symptoms may have a higher prevalence of history of childhood dysfunctional voiding. LEVEL OF EVIDENCE: II-2

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).

Ethical Issues Associated With the Introduction of New Surgical Devices, or Just Because We Can, Doesn’t Mean We Should

Surgical devices are often marketed before there is good evidence of their safety and effectiveness. Our paper discusses the ethical issues associated with the early marketing and use of new surgical devices from the perspectives of the six groups most concerned. Health Canada, which is responsible for licensing new surgical devices, should amend their requirements to include rigorous clinical trials that provide data on effectiveness and safety for each new product before it is marketed. Industry should comply with all Health Canada requirements to obtain licenses for new products. Until Health Canada requires effectiveness and safety data, industry should cooperate with physicians in appropriate studies before releasing new products and should make balanced presentations of all the available evidence. Surgeons should, before using a new surgical device, assess the evidence on its effectiveness and safety and ensure they are properly trained and competent in using the device. Surgeons should provide their patients with an evaluation of the available evidence and inform them about possible complications and the surgeons level of experience with the new device. Patients, who should be given an honest evaluation of the available evidence, possible complications, and the surgeons experience, should be encouraged to evaluate the evidence and information to their own satisfaction to ensure that fully informed consent is given. Health institutions, responsible for regulating practice within their walls, should review new devices for safety, effectiveness, and economic impacts, before allowing their use. They should also limit the use of new surgical devices to surgeons trained and competent in the new technology. Professional societies should provide guidance on the early adoption of new surgical devices and technologies. We urge all those involved in the development, licensing, and use of new surgical devices to aim for higher ethical standards to protect the health and safety of patients requiring surgery. The lowest acceptable ethical standard would require device manufacturers to provide surgeons with accurate and timely information on the efficacy and safety of their products, allowing surgeons and patients to evaluate the evidence (and the significance of information not yet available) before surgery.

Vaginal delivery and pelvic floor dysfunction: current evidence and implications for future research

Vaginal delivery is the major risk factor for the development of pelvic organ prolapse and urinary and fecal incontinence, resulting from damage to the pelvic floor muscles, nerves and connective tissue. This article reviews the perineal trauma mechanism during vaginal delivery and discusses implications of current and future research projects.

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).

Conservative Management of Urinary Incontinence

OBJECTIVE To outline the evidence for conservative management options for treating urinary incontinence. OPTIONS Conservative management options for treating urinary incontinence include behavioural changes, lifestyle modification, pelvic floor retraining, and use of mechanical devices. OUTCOMES To provide understanding of current available evidence concerning efficacy of conservative alternatives for managing urinary incontinence; to empower women to choose continence therapies that have benefit and that have minimal or no harm.

Randomized Trial of Oxybutynin Extended Versus Immediate Release for Women Aged 65 and Older with Overactive Bladder: Lessons Learned from Conducting a Trial

OBJECTIVE This trial was designed to investigate the effectiveness of extended release versus immediate release oxybutynin in reducing symptoms of overactive bladder in a community-dwelling female population over the age of 65. METHODS This was a prospective randomized 12-week, open-label study. The primary outcome was number of micturitions per 24 hours, 12 weeks after treatment. The a priori sample size estimate was 60 patients per group. RESULTS Of the 318 women approached, only 72 women (23%) were enrolled over 34 months (33 in the immediate release group, and 39 in the extended release group). The study was stopped prematurely because of recruitment difficulties and an interim analysis revealing the need for a much larger sample than had been estimated to show a significant difference between treatments. After 12 weeks of treatment, there was no difference between the oxybutynin extended release and immediate release groups in the number of micturitions per 24 hours or in other outcomes. CONCLUSION This study did not demonstrate differences between oxybutynin extended release and immediate release and in reducing symptoms of overactive bladder or quality of life, possibly because the study did not reach the necessary sample size. The difficulty in recruiting subjects for the trial likely resulted from the onerous study requirements (4 study visits required over 12 weeks) and the downtown location of the study centres: these factors would cause particular difficulties for women over age 65 with overactive bladder, for whom travelling may be a problem. Evidence is needed to guide prescribing for older patients, but designing research to obtain adequate sample sizes is difficult. Studies in older subjects should ensure that a much larger budget is allocated for recruitment than would be allocated for studies in younger subjects, that meticulous attention is paid to issues of transport and access, and that support is provided for subjects who agree to take part research.

Efficacy and Safety of Tension-Free Vaginal Tape Compared With Transobturator Tape Among Obese Women With Stress Urinary Incontinence: A Retrospective Cohort Study

OBJECTIVE To determine the efficacy and safety of tension-free vaginal tape (TVT) compared with transobturator tape (TOT) in obese women with stress urinary incontinence (SUI). METHODS We performed a retrospective chart review of patients who underwent insertion of TVT or TOT for stress urinary incontinence between January 2003 and October 2009. Women were excluded if they had had previous surgery for SUI or had a diagnosis of intrinsic sphincter deficiency. RESULTS One hundred eighty obese women (BMI > 30 kg/m²) with SUI and with follow-up for at least one year were identified (90 had TVT and 90 had TOT). The rates of success on the objective criteria were 91% for the TVT group and 88% for the TOT group (P = 0.46) and 87% versus 80% (P = 0.23) on subjective assessment. CONCLUSION Our retrospective cohort study demonstrated similar rates of cure for obese women with SUI who underwent insertion of TVT and TOT.