| Abstract: | Overactive bladder (OAB) imposes a burden on many aspects of a patient's life. The health-related quality of life (HRQOL) of OAB patients has been shown to be lower than healthy or control patients. A goal of successful treatment is to improve the HRQOL of OAB patients. With newer OAB treatments becoming available, HRQOL is an important outcome to measure. Thus, the objective of this study was to compare the HRQOL of patients being treated with tolterodine immediate-release (IR) versus placebo for OAB. The King's Health Questionnaire (KHQ) and the Medical Outcomes Study Short Form 36 (SF-36) were administered at baseline and end of treatment (12 weeks) in a randomized, parallel groups, placebo-controlled, double-blind, multinational study designed to compare the clinical efficacy and safety of tolterodine to placebo in the treatment of OAB. At end of treatment KHQ domains selected a priori as primary HRQOL endpoints (incontinence impact and role limitations) significantly improved (PА.0001) with tolterodine IR. Domains selected a priori as secondary HRQOL or symptom endpoints (physical limitations, emotions, sleep and energy, severity (coping) measures, and symptom severity) were also significantly improved (PА.0074) following treatment with tolterodine IR. The tolterodine IR group had less severity of individual symptoms and significantly better patient rating of bladder control than the placebo group at end of treatment. As expected, the SF-36 did not detect treatment differences. In conclusion, many aspects of HRQOL, as measured by the KHQ, significantly improved with tolterodine IR treatment. These HRQOL improvements were consistent with clinical efficacy results. The findings demonstrate that tolterodine IR patients experience overall improvement in their condition that resulted in important impacts on their HRQOL. |
