Long-term health-related quality of life of patients receiving extended-release tolterodine for overactive bladder.
OBJECTIVE
To evaluate the long-term effects of tolterodine on the health-related quality of life (HRQoL) of patients diagnosed with overactive bladder with incontinence.


METHODS
Patients who completed a 12-week randomized, double-blind, safety and efficacy trial comparing tolterodine with placebo were invited to enroll in a 12-month open-label continuation trial to assess the long-term safety and efficacy of tolterodine. This study reports the HRQoL results from the King's Health Questionnaire (KHQ) and the Short Form-36 (SF-36) that were administered at baseline, at the end of the 12-week trial, and 3 and 12 months following open-label treatment with tolterodine.


RESULTS
One thousand seventy-seven patients were included in the intent-to-treat (ITT(B)) population. KHQ translations were available for 838 patients (mean age, 61.1 years; 80.9% women) in the ITT(B) population. HRQoL, as measured by the KHQ, significantly improved from baseline to months 3 and 12 on the following domains: incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep and energy, severity (coping) measures, and symptom severity. Improvements were generally consistent across all analyses for the 3- and 12-month measurements and for the ITT(B) and completer (C(B)) populations. Patients receiving tolterodine in the double-blind study showed additional improvement at the 3-month open-label assessment on all but the general health domain. At 12 months from treatment rollover, all improvements from rollover to 3 months were sustained with additional improvement seen on the incontinence impact and role limitations domains. The general health perceptions domain showed a slight decline from rollover that might be attributable to a natural decline in patients' health status at this life stage. These findings were consistent with other efficacy results whereby efficacy was maintained over the 12-month open-label period. SF-36 results were consistent with previous experience of reduced sensitivity, as population groups were similar to the SF-36 Physical Component and Mental Component scores at various time points and with all populations.


CONCLUSIONS
Continued treatment with tolterodine provides additional benefits in HRQoL as measured by the KHQ. Of particular importance are improvements on the psychological aspects after longer-term treatment not detected after a short-term trial. Treatment effects on HRQoL are evident even after a 12-week placebo run-in supporting the true clinical effect of active treatment.
Kelleher
Con J
CJ
Guy's and St Thomas' NHS Trust, London, United Kingdom.
Kreder
Karl J
KJ
Pleil
Andreas M
AM
Burgess
Somali Misra
SM
Reese
Pat Ray
PR
D000368:Aged; D001315:Australia; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000627:therapeutic use; D003408:Cresols / Q000008:administration & dosage* / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use; D009520:New Zealand; D010665:Phenylpropanolamine; D011788:Quality of Life; D012426:Russia; D011795:Surveys and Questionnaires; D000068737:Tolterodine Tartrate; D014481:United States; D001745:Urinary Bladder Diseases / Q000188:drug therapy / Q000503:physiopathology; D014555:Urination Disorders / Q000188:drug therapy* / Q000503:physiopathology
D001559:Benzhydryl Compounds; D003408:Cresols; D003692:Delayed-Action Preparations; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate