Effects of tolterodine extended release on patient perception of bladder condition and overactive bladder symptoms*.
OBJECTIVE
To evaluate the efficacy of tolterodine extended release (ER) versus placebo at 1 and 12 weeks using questionnaires and diary measures.


METHODS
Subjects with overactive bladder (OAB) were randomized to receive tolterodine ER (4 mg) or placebo for 12 weeks. This double-blind study is registered with ClinicalTrials.gov (identifier: NCT00143377).


METHODS
Subjects completed the Patient Perception of Bladder Condition (PPBC) and 3-day bladder diaries at baseline and weeks 1 and 12, and the Overactive Bladder Questionnaire (OAB-q) at baseline and week 12. PPBC score changes were analyzed using 2-category (improvement, no improvement), 3-category (improvement, no change, deterioration), and 4-category (>or=2-point improvement, 1-point improvement, no change, deterioration) stratifications. Categorical change in PPBC scores from baseline to week 12 was the primary endpoint.


RESULTS
A total of 617 subjects were randomized (tolterodine ER, n = 410; placebo, n = 207). At week 1, a significantly higher percentage of subjects receiving tolterodine ER reported improvement on the PPBC compared with placebo (p < 0.05). Subjects receiving tolterodine ER also had a significantly greater reduction in all OAB symptoms versus placebo (all p < 0.05). At week 12, a higher percentage of tolterodine ER subjects reported PPBC improvement versus placebo subjects. This was significant in the 3- and 4-category analyses (both p < 0.05) but not in the 2-category analysis (the prespecified method of analysis; p = 0.098). Compared with the placebo group, the tolterodine ER group reported significantly greater week 12 improvements in all bladder diary variables (all p < 0.01) as well as in OAB-q Symptom Bother, total Health-Related Quality of Life, Coping, and Concern scores (all p <or= 0.02).


CONCLUSIONS
Compared with placebo, subjects receiving tolterodine ER reported significantly greater improvements in nondiary patient-reported outcomes and OAB symptoms at week 12. Improvements in subjects' perception of their bladder-related problems and in OAB symptoms were observed as early as week 1. Further research is required to assess which aspects of subjects' bladder-related problems were improved. A large placebo effect may have prevented the prespecified 2-category analysis of PPBC improvement from reaching statistical significance at week 12, which was the primary endpoint.
Herschorn
Sender
S
Sunnybrook Health Sciences Center, University of Toronto, Toronto, ON, Canada. s.herschorn@utoronto.ca
Heesakkers
John
J
Castro-Diaz
David
D
Wang
Joseph T
JT
Brodsky
Marina
M
Guan
Zhonghong
Z
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D002170:Canada; D003408:Cresols / Q000008:administration & dosage* / Q000009:adverse effects; D003692:Delayed-Action Preparations / Q000008:administration & dosage / Q000009:adverse effects; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D010665:Phenylpropanolamine / Q000008:administration & dosage* / Q000009:adverse effects; D011795:Surveys and Questionnaires; D013997:Time Factors; D000068737:Tolterodine Tartrate; D014421:Turkey; D001743:Urinary Bladder / Q000503:physiopathology; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000503:physiopathology
D001559:Benzhydryl Compounds; D003408:Cresols; D003692:Delayed-Action Preparations; D018727:Muscarinic Antagonists; D010665:Phenylpropanolamine; D000068737:Tolterodine Tartrate