OBJECTIVE: To assess the effects of tolterodine extended release (ER) plus behavioral intervention on urgency and other patient-reported outcomes in subjects with overactive bladder (OAB) who were previously dissatisfied with antimuscarinic treatment. METHODS: In this 16-week, multicenter, open-label study, eligible adults (aged > or = 18 y) reported dissatisfaction with their most recent antimuscarinic OAB medication; > or = 8 micturitions and > or = 2 urgency episodes per 24 hours and > or = 1 UUI episode in 5 day bladder diaries; and OAB symptoms for > or = 3 months. Subjects received tolterodine ER plus a behavioral educational handout with verbal reinforcement of behavioral intervention content for 8 weeks. Those satisfied with treatment at week 8 continued with this therapy; those dissatisfied received tolterodine ER plus individualized behavioral intervention (pelvic floor muscle training, tailored behavioral techniques) for 8 weeks. Endpoints were changes from baseline in daytime and nocturnal micturition-related urgency episodes and frequency-urgency sum (a measure of urgency severity and frequency) reported in 5 day bladder diaries at weeks 4, 8, 12, and 16; Patient Perception of Bladder Condition (PPBC), Overactive Bladder Questionnaire (OAB-q), and Urgency Perception Scale (UPS) scores at weeks 8 and 16. RESULTS:Daytime and nocturnal urgency episodes and frequency-urgency sum were significantly reduced at all time points (all p < 0.0001). Significant improvements were also observed in PPBC, OAB-q Symptom Bother and Health-Related Quality of Life, and UPS scores at weeks 8 and 16 (all p < 0.0001). CONCLUSIONS:Patients with OAB who are dissatisfied withantimuscarinic therapy may experience improved treatment outcomes by adding a self-administered behavioral intervention to their drug regimen.
RCT Entities:
OBJECTIVE: To assess the effects of tolterodine extended release (ER) plus behavioral intervention on urgency and other patient-reported outcomes in subjects with overactive bladder (OAB) who were previously dissatisfied with antimuscarinic treatment. METHODS: In this 16-week, multicenter, open-label study, eligible adults (aged > or = 18 y) reported dissatisfaction with their most recent antimuscarinic OAB medication; > or = 8 micturitions and > or = 2 urgency episodes per 24 hours and > or = 1 UUI episode in 5 day bladder diaries; and OAB symptoms for > or = 3 months. Subjects received tolterodine ER plus a behavioral educational handout with verbal reinforcement of behavioral intervention content for 8 weeks. Those satisfied with treatment at week 8 continued with this therapy; those dissatisfied received tolterodine ER plus individualized behavioral intervention (pelvic floor muscle training, tailored behavioral techniques) for 8 weeks. Endpoints were changes from baseline in daytime and nocturnal micturition-related urgency episodes and frequency-urgency sum (a measure of urgency severity and frequency) reported in 5 day bladder diaries at weeks 4, 8, 12, and 16; Patient Perception of Bladder Condition (PPBC), Overactive Bladder Questionnaire (OAB-q), and Urgency Perception Scale (UPS) scores at weeks 8 and 16. RESULTS: Daytime and nocturnal urgency episodes and frequency-urgency sum were significantly reduced at all time points (all p < 0.0001). Significant improvements were also observed in PPBC, OAB-q Symptom Bother and Health-Related Quality of Life, and UPS scores at weeks 8 and 16 (all p < 0.0001). CONCLUSIONS:Patients with OAB who are dissatisfied with antimuscarinic therapy may experience improved treatment outcomes by adding a self-administered behavioral intervention to their drug regimen.
Authors: Jeffrey P Weiss; Zhanna Jumadilova; Theodore M Johnson; Mary P Fitzgerald; Martin Carlsson; Diane L Martire; Atul Malhotra Journal: J Urol Date: 2012-11-15 Impact factor: 7.450