Jane Schulz

A population‐based study of urinary symptoms and incontinence: the Canadian Urinary Bladder Survey

To ascertain the prevalence of lower urinary tract symptoms (LUTS) and urinary incontinence (UI) in Canada, using a cross‐Canada telephone survey, as there is a wide discrepancy in the reported prevalence of these conditions.

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.

Correlation of Urethral Closure Pressure, Leak-Point Pressure and Incontinence Severity Measures

The aim of this study was to determine whether water perfusion maximum urethral closure pressure (MUCP) correlates with Valsalva leak-point pressure (LPP), and which of these best correlates with subjective and objective incontinence severity measures. Fifty-two women with previously diagnosed genuine stress incontinence (n= 46), or mixed incontinence with a minor and controlled urge component (n= 6), were assigned an incontinence status grade based on interview and diary review. These women then completed visually observed standing LPPs at 250 ml bladder capacity, supine water perfusion MUCP determinations, pad tests and quality of life questionnaires. The urodynamic and severity measures were compared with correlation analysis or analysis of variance. A modest correlation exists between LPP and MUCP (r= 0.50–0.62, P<0.001). Both MUCP and LPP demonstrated significant decreases (P<0.01) with increasing severity of assigned incontinence grade. A very low and insignificant correlation existed for these urodynamic parameters and pad loss or quality of life measures. MUCP and LPP correlate modestly with each other and both are comparable in predicting incontinence severity. Either can be used as the urodynamic measure to assess intrinsic sphincter deficiency.

Prevalence and risk factors for urinary and fecal incontinence four months after vaginal delivery.

OBJECTIVE To determine the prevalence of and risk factors for urinary and fecal incontinence four months after vaginal delivery. METHODS All patients who had vaginal deliveries at a tertiary care hospital over a three-month period were approached during their postpartum hospital stay regarding participation in the study. Participants underwent a telephone interview at four months after their delivery to determine the presence and type of any incontinence. RESULTS Of 632 patients, 145 (23%) had stress incontinence, 77 (12%) had urge incontinence, 181 (29%) had any urinary incontinence and 23 (4%) had fecal incontinence. In univariate analysis, stress incontinence was found to be increased in patients>or=30 years of age (26.2%) compared with patients<30 years of age (19.3%) (RR 1.4; 95% CI 1.0-1.8, P=0.05). Urge incontinence was increased in patients who had a forceps delivery (21%) compared with no forceps delivery (9%) (RR 2.2; 95% CI 1.4-3.6, P=0.005), an episiotomy (32.4%) compared with no episiotomy (18.7%) (RR 1.9; 95% CI 1.2-2.9, P<0.01) and a longer second stage of labour (108 min vs. 77 min, P=0.01). The prevalence of any urinary incontinence was increased with forceps delivery (15.5%) compared with no forceps delivery (8.7%) (RR 1.5; 95% CI 1.1-2.1, P=0.01) and maternal age of >or=30 years (34.1%) compared to <30 years (23.5%) (RR 1.5; 95% CI 1.1-1.9, P=0.003). In multivariate analysis, the two variables that remained significant for any urinary incontinence were maternal age>or=30 years (P<0.01) and forceps delivery (P<0.01). There were no identified risk factors for fecal incontinence. CONCLUSION Urinary incontinence is common in women at four months post partum. Fecal incontinence is less common. Maternal age and forceps assisted delivery were risk factors for urinary incontinence.

Tolerability of 5 mg Solifenacin Once Daily Versus 5 mg Oxybutynin Immediate Release 3 Times Daily: Results of the VECTOR Trial

PURPOSE Although antimuscarinic treatment is indicated for overactive bladder, many patients discontinue it because of dry mouth. Of available antimuscarinics oxybutynin is associated with the highest dry mouth rate. We compared the safety and tolerability of 5 mg solifenacin vs 15 mg oxybutynin immediate release. MATERIALS AND METHODS At 12 Canadian centers a total of 132 patients with overactive bladder symptoms (greater than 1 urgency episode per 24 hours, and 8 or greater micturitions per 24 hours) were randomized to 5 mg solifenacin once daily or 5 mg oxybutynin 3 times daily for 8 weeks. The primary end point was the incidence and severity of dry mouth reported after direct questioning. Efficacy end points (3-day diary documented changes in urgency, frequency, incontinence, nocturia and voided volume), and changes on the Patient Perception of Bladder Condition scale and the Overactive Bladder Questionnaire were evaluated secondarily. RESULTS Of patients on solifenacin vs oxybutynin immediate release 35% vs 83% reported dry mouth (p <0.0001). Of patients reporting dry mouth severity was graded moderate by 13% and 42% of those on solifenacin and oxybutynin immediate release, and severe by 13% and 28%, respectively (p = 0.001). Patients in each group showed improvements in efficacy end points, and Patient Perception of Bladder Condition scale and Overactive Bladder Questionnaire scores from baseline to treatment end. CONCLUSIONS Significantly fewer patients on 5 mg solifenacin once daily reported dry mouth vs those receiving 5 mg oxybutynin immediate release 3 times daily. Significantly fewer patients on solifenacin reported moderate/severe dry mouth. Significantly fewer patients on solifenacin withdrew from study due to dry mouth and there were significantly fewer overall adverse events. Solifenacin and oxybutynin immediate release were efficacious in decreasing efficacy end points, and improved Patient Perception of Bladder Condition scale and Overactive Bladder Questionnaire results from baseline to treatment end.

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.

Tolerability of solifenacin and oxybutynin immediate release in older (>65 years) and younger (≤65 years) patients with overactive bladder: sub-analysis from a Canadian, randomized, double-blind study

Abstract Objective: Overactive bladder (OAB) is a common condition whose prevalence increases with age. Antimuscarinic agents are the pharmacologic treatment of choice, but adverse events such as dry mouth may lead to early discontinuation. The purpose of this analysis was to compare the incidence and severity of dry mouth and other adverse events with solifenacin 5 mg/day and oxybutynin immediate release (IR) 15 mg/day in patients ≤65 years and >65 years in the Canadian VECTOR study (VEsicare in Comparison To Oxybutynin for oveRactive bladder patients). Research design and methods: VECTOR was a randomized, multicentre, prospective, double-blind, double-dummy study in 132 subjects with ≥1 urgency episode per 24 h, with or without urgency incontinence, and ≥8 micturitions per 24 h for ≥3 months. After a 2-week washout, patients received solifenacin 5 mg once daily or oxybutynin IR 5 mg tid for 8 weeks. For the current post-hoc analysis, adverse events were evaluated in subgroups of patients ≤65 years and >65 years, using a full logistic regression model, multinomial logit regression model and reduced model. Clinical trial registration: NCT00431041. Results: The incidence and severity of dry mouth and other adverse events with solifenacin were similar between younger and older patients. In both age subgroups, solifenacin 5 mg/day was associated with fewer episodes and lower severity of dry mouth, and a lower discontinuation rate, compared with oxybutynin IR 15 mg/day. Conclusions: Solifenacin 5 mg/day was better tolerated than oxybutynin IR 15 mg/day in younger (≤65 years) and older (>65 years) subgroups. Solifenacin was equally well tolerated in both age subgroups. Limitations of the analysis were that the study was not preplanned to perform post-hoc subgroup analysis, patients knew that dry mouth was a primary outcome, and the study used fixed doses of each drug.

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.