Health-related quality of life of patients receiving extended-release tolterodine for overactive bladder.
OBJECTIVE
To compare the health-related quality of life (HRQoL) of overactive bladder (OAB) patients foilowing treatment with tolterodine extended-release (ER) 4 mg once daily versus placebo.


METHODS
Multinational, placebo-controlled, randomized, double-blind 12-week study.


METHODS
Patients with urinary frequency ( > or = 8 micturitions/24 hours over a 7-day period), urge incontinence ( > or = 5 episodes/week), and symptoms of OAB for at least 6 months were eligible for inclusion. Patients (81% female) received oral therapy with tolterodine ER (n = 507) or placebo (n = 508) for 12 weeks.


METHODS
HRQoL was assessed using the King's Health Questionnaire (KHQ) and Medical Outcomes Study Short Form 36-item questionnaire (SF-36). Patients also rated their bladder condition. Assessments were performed at baseline and at the end of treatment.


RESULTS
At end of treatment, KHQ domains selected a priori as primary HRQoL end points (incontinence impact and role limitations) significantly improved (P < or = .001) with tolterodine ER. Domains selected a priori as secondary end points (physical limitations, sleep and energy, severity [coping] measures, and symptom severity) were also significantly improved (P < or = .006) following treatment with tolterodine ER. The tolterodine ER group had decreased symptom severity and statistically significant improvements in patient rating of bladder control compared with the placebo group at end of treatment. No treatment differences were detected using the SF-36.


CONCLUSIONS
Many aspects of HRQoL, as measured by the KHQ, showed statistically significant improvement following treatment with tolterodine ER. These HRQoL improvements were consistent with clinical efficacy benefits. Patients receiving tolterodine ER experienced overall improvement in their condition that was associated with an important impact on their HRQoL.
Kelleher
Con J
CJ
Guy's and St Thomas' NHS Trust, London, United Kingdom.
Reese
Pat Ray
PR
Pleil
Andreas M
AM
Okano
Gary J
GJ
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; D004311:Double-Blind Method; D005060:Europe; D005260:Female; D006302:Health Services Research; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000627:therapeutic use; D009520:New Zealand; D010665:Phenylpropanolamine; D010919:Placebos; D011788:Quality of Life; D012426:Russia; 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; D010919:Placebos; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate