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Objectives: To evaluate the cost effectiveness of onabotulinumtoxinA (BOTOX(®), 200 units [200 U]) for the management of urinary incontinence (UI) in adults with neurogenic detrusor overactivity (NDO) due to subcervical spinal cord injury or multiple sclerosis that is not adequately managed with anticholinergic drugs (ACHDs)., Perspective: UK National Health Service (NHS) perspective., Methods: A Markov state-transition model was developed, which compared onabotulinumtoxinA + best supportive care (BSC) with BSC alone (comprising behavioural therapy and pads, alone or in combination with clean intermittent catheterization and possibly with ACHDs). Non-responders were eligible for invasive procedures. Health states were defined according to the reduction in UI episodes. Efficacy data and estimates of resource utilization were pooled from 468 patients on onabotulinumtoxinA in two phase III clinical trials. Drug costs (2013) and administration costs (NHS Reference Costs 2011-2012) were obtained from published sources. The time horizon of the model was 5 years, and costs and benefits were discounted at 3.5%. Scenario, one-way and probabilistic sensitivity analyses (PSAs) were conducted to explore uncertainties around the assumptions., Results: In the base case, treatment with onabotulinumtoxinA + BSC over 5 years was associated with an increase in costs of £1,689 and an increase in quality-adjusted life-years (QALYs) of 0.4, compared with BSC alone, resulting in an incremental cost-effectiveness ratio of £3,850 per QALY gained. Sensitivity analyses showed that utility values had the greatest influence on model results. PSA suggests that onabotulinumtoxinA + BSC had a 100 % probability of being cost effective at a willingness to pay of <£20,000., Conclusion: For adult patients with NDO who are not adequately managed with ACHDs, onabotulinumtoxinA + BSC appears to be a cost-effective use of resources in the UK NHS.

Overactive bladder (OAB) is characterised by the storage symptoms of urgency, with or without urge incontinence, and usually with urinary frequency and nocturia. OAB is a common condition that affects people of all ages within society. It has an estimated prevalence of 16% and is known to adversely affect quality of life (QOL). Assessment of the QOL of patients is important to understanding both the burden of disease and improvement after treatment. In clinical practice, the physician's assessment of the disease burden of OAB has been shown to be inaccurate and non-reproducible. Psychometrically robust self-completion questionnaires provide a valid, reproducible and rapid assessment of patient-reported disease impact that can elicit the impact of symptoms, and they are also useful for the evaluation of the efficacy of an intervention. Many different questionnaires have been developed to assess the QOL impact of OAB. Generic instruments measure very broad aspects of health and are suitable for a wide range of patient groups and general population screening. They can be applied to patients with any medical condition and provide a measure of morbidity but are less sensitive to clinically relevant change in conditions such as OAB. Condition-specific questionnaires offer greater sensitivity and responsiveness to change in the assessment of QOL of specific patient groups. Single-item global assessment questionnaires are useful in conditions such as OAB that have multiple and varied symptoms, and reflect an individual's needs, concerns and values. Patient-derived outcome measures are used in real-world clinical practice, clinical trials, health economic research and healthcare planning.

Overactive bladder is a common condition, with recent findings estimating the prevalence in adults at about 15%. Symptoms, including urinary urgency, high voiding frequency and urge incontinence, have been shown to decrease patients' quality of life. Given its high prevalence, the economic burden of overactive bladder is also substantial, with a recent estimate placing the annual cost in the US at 9.1 billion US dollars (year 2000 values). The objective of this review is to provide a critical appraisal of published economic evaluations of pharmacological and non-pharmacological treatments for overactive bladder. Published economic evaluations of treatments for overactive bladder have focused entirely on pharmacological treatments -- mainly on the two most commonly used drugs, oxybutynin and tolterodine, each of which is available in immediate- and extended-release formulations. Ten economic evaluations (more than half are cost-effectiveness studies) have been published. Modelling with decision trees or Markov models has been the predominant method. Evaluations comparing drug therapy with no treatment have concluded that drug therapy is cost effective. Analyses comparing the formulations of oxybutynin and tolterodine have produced highly inconsistent results, largely due to the sources of data employed for effectiveness and treatment discontinuation rates. There are no evaluations of drugs relative to non-pharmacological treatment, and there are other significant gaps in the economic evaluations of treatment to date. These include gaps resulting from a lack of reliable data on the performance of these drugs in real-world settings, particularly data on long-term persistence with treatment. A more definitive pharmacoeconomic comparison of oxybutynin and tolterodine formulations, incorporating all available clinical data, and other treatment options would help direct treatment.

Introduction: Oxybutynin and tolterodine are two drugs widely used for the management of overactive bladder and urge urinary incontinence. The once-daily, extended-release formulations benefit from being well tolerated and efficacious. However, their costs, compared with generic immediate-release (IR) oxybutynin, are significantly greater. This study compared the cost effectiveness of oxybutynin extended-release (Oxy-XL), tolterodine extended-release (Tol-ER), tolterodine immediate-release (Tol-IR) and oxybutynin immediate-release (Oxy-IR)., Study Design: A cost-effectiveness model., Methods: A systematic review that identified appropriate randomised clinical trials provided evidence on efficacy. Empirical models of drug effects (number of incontinent-free weeks) and persistence (proportion of patients still on therapy) were constructed in order to determine clinical effectiveness which was combined with cost data (direct medical costs to the UK NHS, year 2001 values) to calculate the drugs' cost-effectiveness from the perspective of the NHS. Univariate sensitivity analyses were conducted to test the robustness of the results., Patients: Hypothetical cohort of patients with urge incontinence associated with overactive bladder., Main Outcome Measures and Results: The incremental cost per incontinent-free week for Oxy-IR (versus no treatment) ranged from pound sterling 2.58 to pound sterling 16.59. Oxy-XL and Tol-ER were more effective than Oxy-IR but at additional costs per incontinent-free week. Tol-IR did not appear to be a cost-effective option as it was less effective and more costly than the extended-release formulations. Uncertainty surrounding the health and cost consequences of early discontinuation affected these results, although the model results were robust to parameter uncertainty., Conclusion: Oxy-IR, Oxy-XL and Tol-ER appear to be cost-effective options for the management of urge incontinence from the NHS perspective. A decision among the treatments depends on the acceptable cost per additional incontinent-free week.

Objective: To offer cost estimates of urinary incontinence (UI) in the general population based on prospectively collected data., Design: We analyzed individual costs in a sample of women with UI who were identified in the framework of a cross-sectional study on the prevalence of UI in women aged > 40 years., Setting: Six areas in Italy., Intervention: Home interview., Patients and Participants: Women were identified among the patients registered with a network of general practitioners operating in each area using computer-generated random number lists., Results: A total of 2767 women were identified. Of these, 408 (14.7%) reported UI during the year before the interview and 229 underwent a detailed interview on UI-related costs. On the basis of this information, we estimated the direct costs associated with UI from the perspective of the Italian National Health Service (INHS). The lifetime cost per patient of diagnosis was 80,131 Italian lire (L) (exchange rate: $US1 = L1618). Consultations accounted for only 20% of the diagnostic cost, diagnostic tests for 36% and hospital admissions for diagnostic procedures accounted for 44%. The diagnosis cost estimate seems low, partly because several women did not request either consultations or diagnostic tests (the overall rate per patient was 0.76 for consultations and 0.39 for diagnostic tests). The only appreciable treatment cost, according to the INHS perspective, was for diapers. The annual cost per patient for diapers was L255,519. The prevalence of UI in women aged > 40 years in Italy is estimated in the study at 9.3%. Thus, combining this information with the cost estimates, the annual treatment cost of UI in Italian women aged > 40 years is L351,800 billion, considering diapers and drugs only., Conclusion: This study has estimated the individual cost of UI in the general population. These figures may be useful when designing economic evaluations of UI.

Urinary incontinence (UI) is prevalent and costly, occurring in 15 to 30% of the US population over the age of 60 years. Among people aged 15 to 64 years, UI occurs in 1.5 to 5% of men and 10 to 25% of women. Severe incontinence occurs in 6% of the general US population, and it is estimated that $US10 billion per year is spent in direct costs alone on care for these patients. This review presents a description of the various types of UI and describes the prevalence and costs of the condition. In addition, 3 approaches to assessing the impact of UI on quality of life are discussed, namely generic measures, disease-specific measures and qualitative approaches. We also review papers on UI and sexual functioning, UI in men, and some aspects of treatment. The review was conducted in the process of developing a new disease-specific measure for urinary urge incontinence (UUI). In general, the literature suggests that UUI has a greater impact than stress incontinence on quality of life, and that UI affects social and psychological functioning more than physical functioning. Only in a minority of individuals is the impact of UI disabling; however, most individuals with UI show significant reduction in their social functioning. Several studies suggest that the impact of UI is not solely a function of its severity, but also depends on individual coping abilities. Some studies also indicate that the social problems associated with UI grow with time, but it is not clear if that is a function of increasing severity of the condition, or the particular adaptations required for coping with this problem. An important distinction appears to be the ability of individuals to avoid public notice of their condition because of uncontrolled accidents. In summary, there is a need for a new measure of the quality-of-life impact of UUI that is based on the literature and on in-depth interviews with patients.