A prospective observational study of the effects of treatment with extended-release tolterodine on health-related quality of life of patients suffering overactive bladder syndrome in Sweden

Abstract

Objective. Overactive bladder (OAB) is a chronic condition that has a profound impact on health-related quality of life (HRQoL). This study measured changes in bother of OAB symptoms and self-perceived HRQoL over 6 months in patients treated with extended-release (ER) tolterodine in a naturalistic setting. Material and methods. This was a prospective, single-cohort observational study of patients diagnosed with OAB, naïve to antimuscarinic treatment and prescribed tolterodine ER for the first time. Patients were asked to complete the Overactive Bladder Questionnaire (OAB-q) containing a symptom bother scale (0–100) and an HRQoL scale (0–100), which measures coping, social interaction, concern and sleep, at baseline and after 3 and 6 months. Results. In total, 235 patients (211 women and 24 men), with a mean age of 61 years (30–87), were recruited. The numbers of patients who completed the OAB-q were 220 and 169 at 3 and 6 months, respectively. The mean reductions in the symptom bother score from baseline were 19.6 and 19.3 at 3 and 6 months, respectively. Significant improvement (p < 0.0001) was seen in all HRQoL subscale scores. The proportion of responders who met the minimally important difference (change in the score of 10 or more units between baseline and 6 months) was 64% for the symptom bother score and 34–60% for the total HRQoL and subscale scores. Conclusions. OAB patients beginning treatment with tolterodine ER reported clinically significant improvement in OAB symptoms and self-perceived HRQoL over the 6 months of this observational study. The rate of discontinuation from treatment was 49%.

Key Words::

• Antimuscarinic
• health-related quality of life
• OAB-q
• overactive bladder
• tolterodine

Acknowledgements

This study was funded by Pfizer AB, Sweden. The authors would like to acknowledge Ann-Charlotte Åkerblad for excellent coordination of the study. The authors were involved in the design, conducted the project, analysed the data, and were involved in writing and reviewing the manuscript. They take full responsibility for the content.

Declaration of interest: Ralph Peeker collaborates with a number of pharmaceutical companies, including Astellas Pharma, Pfizer, Bayer Schering Pharma and AstraZeneca. The collaboration comprises lecturing, authoring books and book chapters, chairing workshops, participation in advisory boards and faculty membership at national as well as international expert meetings. Göran Samsioe received research grants from Pfizer, Bayer, Amgen, Orion Pharma and other pharmaceutical companies. He has participated in industry-sponsored symposia at international conferences. Jan Kowalski, Ann-Sofie Anderson and Agneta Bergqvist are Pfizer employees.