Quality‐of‐life aspects of the overactive bladder and the effect of treatment with tolterodine

more to issues relevant to the patient and the clinician, Introduction and can thus be used to determine whether a desired treatment eCect has been achieved or not. Several The overactive bladder (OAB) is a multisymptomatic problem that aCects people of both sexes and all ages, instruments have been developed specifically for urinary incontinence, including the Incontinence Impact although it is more prevalent in the elderly [1–5]. The OAB is defined as urgency and frequency with or without Questionnaire (IIQ) and the Urinary Distress Inventory (UDI) [16], the York Incontinence Perception Scale urge incontinence. Urinary incontinence and urgency/ frequency have been shown to aCect a patient’s physical, (YIPS) [17], the Incontinence Quality of Life (IQoL) [18], the Incontinence Quality of Life Index (IQoLI) [19] social and emotional well-being [6–12]; the eBcacy of any treatment is generally measured as a decrease in and the King’s Health Questionnaire (KHQ) [20]. The two types of instruments are complementary and the frequency of incontinence. While such clinical eBcacy measures (often surrogate endpoints) are of great generally, they are combined in QoL research. The objective of this review is to discuss the impact value and particularly important in clinical trials, they fail to address the patients’ concept of disease burden on QoL of the OAB and analyse the improvements that can be achieved with an eCective and well-tolerated drug and the consequences of treatment from the patients’ perspective. Measuring these patient-derived values is such as tolterodine. We used the SF36 and the EuroQol to assess the impact of the OAB on patients’ well-being, therefore important, as patients are paying a larger part of treatment costs and health outcomes are increasingly and the IQoLI and the KHQ to investigate the eCect of treatment with tolterodine. The IQoLI was tested for use evaluated from the patients’ view. The benefits of specific treatments and of the healthcare delivery system in in a clinical trial setting and the KHQ, so far only validated with female patients, was also validated for general will be judged in terms of the extent to which changes in patients’ functioning or well-being meet their use in men. needs and expectations. Subjective quality of life (QoL) can be objectively Disease impact measured and several instruments have been developed, validated and used extensively. Generic instruments The SF36, a generic instrument, was used both in crosssuch as the MOS Short Form (SF) 36 [13] provide a sectional surveys and in clinical trials. The instrument profile of the patients’ QoL covering several health includes 36 questions with multiple answers that are concepts, generally grouped in physical, mental and grouped into eight subscales measuring eight health social domains. Instruments such as the EuroQol EQ-5D concepts or domains. Each subscale is scored individually [14,15] measure QoL as an index and provide a healthbetween 0 (worst) and 100 (best). It was integrated in state classification system that allows their use in costtwo large ‘willingness-to-pay’ (WTP) surveys in Sweden utility analyses. The advantage of generic measures is [21] and in the USA [22] of patients with urge and/or that they are more comprehensive and allow comparimixed incontinence. Scores were correlated with selfson across populations and diseases. However, they are reported symptoms of frequency and incontinence, and generally not sensitive enough to detect small changes to the amounts that patients were willing to pay for caused by treatment. Specific measures are targeted symptom relief, to estimate the impact of the syndrome on patients’ QoL. It was also used in a clinical study comparing tolterodine with oxybutynin and placebo over Accepted for publication 3 December 1998