Study on Clinical Effectiveness and Safety of Oxybutynin Chloride Oral Osmotic Therapeutic System (OROS) at Different Dosage in Korean Patients

Inclusion Criteria:

• Patients who fulfilled all of the following criteria in their micturition charts for the 3 days prior to the 2nd visit (Baseline): Average Urination Frequency = 8 times / 24 hours, Average Frequency of Urgent Urination = 2 times / 24 hours (Definition of Urgent Urination: That of a Urination Sensation Scale score = 3 on the micturition chart)
• Patients who had over 3 months of OAB symptoms prior to the commencement of the trial
• Patients who were capable of, and agreed to, recording a micturition chart and some questionnaires
• Patients who understood the potential risks and benefits of the trial sufficiently, after listening to an explanation of it, and who are capable of signing the Trial Agreement.

Exclusion Criteria:

• Patients with Stress Urinary Incontinence (SUI) or patients with Mixed Urinary Incontinence (MUI), of which SUI was the superior part, assessed in terms of the past disease history of the patient
• Patients whose creatinine or the following liver enzyme concentrations were at least 2 times the upper limit of normal: aspartate aminotransferase (AST [SGOT]), alanine aminotransferase (ALT [SGPT]), and alkaline phosphatase
• Patients suffering from kidney disease
• Patients who were prohibited from taking anti-cholinergics due to symptoms of uncontrolled narrow angle glaucoma, urinary retention, or gastric retention
• Patients who had urinary tract infections (UTI) during the run-in period
• Patients with recurrent UTI, and who were treated on 5 occasions or more during the past year due to these UTI symptoms
• Patients who had been diagnosed with, or assumed to have, Interstitial Cystitis (IC)
• Patients with significant Bladder Outlet Obstruction found in clinical trials or with lower urinary tract functions, determined by the researcher according to clinical symptoms and treatment standards
• Patients who had had prostate surgery / intervention, (including minimal invasive therapy), or with a history of surgery on major sections of the urethra and/or the bladder. (Patients who had had an SUI operation more than 6 months prior to the trial were not excluded from the clinical trial.)
• Male patients over 50 years old who were found to have 10ng/ml or more serum prostate specific antigen (PSA) levels, had past disease histories, or were assumed to presently have prostate cancer
• Patients with a history of radiotherapy to their pelvic organs or external genitals, (external or epileptic), regardless of the reasons
• Patients who exhibited lower urinary tract neuropathological symptoms of multiple sclerosis (MS), Parkinson's disease, or spinal cord damage
• Patients with notable cystocele or clinically significant pelvic organ prolapse
• Patients who had a history of malignant tumors, including bladder cancer, uterine cancer, or cervical cancer in the past 2 years
• Patients expected to have the following medication during the trial period after the 1st visit (Trial Commencement): All anti-cholinergics excepting the trial doses, All treatment medications for OAB. (However, estrogen treatment begun more than 2 months prior to the start of the clinical trial was allowed)
• Patients who were taking, prior to the 1st visit (Trial Commencement), or who were expected to take medicines during the trial period, with anti-cholinergic side effects, at unstable dosage levels
• Patients who took tricyclic antidepressants (TCA), diuretic or a-blocker, but who did not take doses in a stable manner for at least 1 month prior to the 1st visit (Trial Commencement)
• Patients who took selective serotonin reuptake inhibitors (SSRI) but who did not take doses in a stable manner for at least 3 month prior to the 1st visit (Trial Commencement). (This means that patients who took SSRI at stable dosages were allowed to participate in the trial.)
• Patients who were scheduled for, after the 1st visit (Trial Commencement), or were expected to have, during the trial period, electrical stimulation or bladder training
• Patients who suffered had an indwelling urethral catheter or intermittent self-catheter
• Patients who were medicated under another clinical trial within 1 month prior to the 1st visit (Trial Commencement)
• Patients who had chronic constipation or a history of serious constipation
• Female patients who were pregnant or breast-feeding
• Sexually active, reproductive age female patients not using adequate contraception methods for at least 1 month prior to the start of this trial, and who were unwilling to continue to use such contraception methods during the trial period. Definite contraception methods refer to the use of intrauterine devices (IUDs), combined contraceptive pills, transdermal contraceptive systems, hypodermic transfer hormone drugs, injectable contraceptives, operative methods, (tubal ligation or vasectomy), and abstinence
• Patients who, as ascertained by the investigator, were otherwise unsuitable for participation in this trial