This is a Phase IV, prospective, randomized, multi-center study to find risk factors of OAB symptoms relapse in patients who showed therapeutic benefits after 1, 3, or 6 months of treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month. Patients who have OAB symptoms for 6 or more than 6 months and who show successful treatment response to 1 month of treatment with Tolterodine SR 4mg will be enrolled and randomized to 1, 3 or 6 months of treatment group. After completion of the treatment, subjects will be evaluated for changes in OAB symptoms and retreatment rate will be assessed.
Primary Objective: * To investigate the risk factors of OAB symptom relapse and retreatment in patients who showed therapeutic benefits after 1, 3 or 6 months of treatment with Tolterodine SR and who then discontinued these antimuscarinics for 3 month. Secondary Objective: * To investigate the change of the patient perception and quality of life after antimuscarinic discontinuation * To find the rate of patients who have OAB symptom relapse. * To find the risk factors of patients who want retreatment. * To find the rate of patients who want retreatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
173
Extended release tolterodine tartrate 4 mg, once daily, for 1 months
Extended release tolterodine tartrate 4 mg, once daily, for 3 months
Extended release tolterodine tartrate 4 mg, once daily, for 6 months
Samsung Medical Center
Irwon-dong, Seoul, South Korea
Holy Family Hospital, The Catholic University of Korea
Gyeonggi-do, South Korea
Asan Medical Center, Ulsan College of Medicine
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Risk factors and relapse rate of the OAB symptoms after drug discontinuation
Time frame: from baseline (treatment completion) to 1, 3 month after drug discontinuation
Micturition diary efficacy parameters
Time frame: from baseline (treatment completion) to 1, 3 month after drug discontinuation
Quality of life parameters: change in total score and subscale scores of OAB-questionnaire
Time frame: from baseline (treatment completion) to 1, 3 month after drug discontinuation
Patient perceptions: change in patient perception of urgency, change in patient perception of bladder condition and percentage of patients who wants retreatment
Time frame: from baseline (treatment completion) to 1, 3 month after drug discontinuation
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