Post Marketing Study to Evaluate the Efficacy and Safety of Solifenacin in Patients With OAB (Overactive Bladder) After TURP (Trans-urethral Resection of Prostate) or PVP (Photoselective Vaporization of Prostate)

The BPH (benign prostate hyperplasia) patients who have OAB (overactive bladder) after TURP (trans-urethral resection of prostate) or PVP (photoselective vaporization of prostate) will participate in this study. The subjects will be randomized 1:1 to the solifenacin succinate group or to the placebo treatment group. The subjects shall take investigational product each night before sleeping from for four weeks and complete voiding diary. At Week-2 and Week-4 of the treatment, the subjects will be asked to complete the following activities: physical exam, vital signs test, IPSS, OABSS, post-void residual (PVR) test, and uroflowmetry, and will be asked to answer the BSW, (Benefit, Satisfaction and Willingness to Continue Questions) questionnaire.

Inclusion criteria

• Screening

• Patients who are willing and able to accurately complete the voiding diary, IPSS, and OABSS
• Patients who have been diagnosed with BPH and are scheduled to receive TURP or PVP
• Randomization (after TURP or PVP)

• Patients who have been diagnosed with OAB by the investigators
• Patients who underwent catheter removal 5±2 days beforehand and will have more than an average of three urgency episodes per 24 hrs and more than an average of eight micturitions per 24 hrs in a row before Visit 3, as recorded in the voiding diary
• Patients who will score more than 5 in questions 2, 4, and 7, which are on the storage symptoms in IPSS
• Patients who will score more than 4 in question 3 and more than 5 in the OABSS
• Patients who have not been treated with any medication for overactive bladder (OAB) symptoms 14 days before the randomization

Exclusion criteria

• Screening

• Patients who have been diagnosed with prostate cancer or bladder cancer and who have a present or resolved malignant disease in any pelvic organ
• Patients who have neurological diseases that affect micturition and can cause neurogenic bladder disease such as multiple sclerosis, Parkinson's disease, severe cerebral arteriosclerosis, dementia, stroke, or myelitis
• Patients who have had serious adverse events or are hypersensitive to anticholinergics
• Patients who have a severe gastrointestinal obstruction disease such as toxin megacolon, ulcerative colitis, intestinal atonia, paralytic ileus, and gastric retention
• Patients who have been diagnosed with severe myasthenia
• Patients who have been diagnosed with narrow-angle glaucoma
• Patients who have serious hepatic impairment (child class C)
• Patients who are being treated with a CYP3A4 inhibitor (e.g., Ketoconazole)
• Patients who have severe renal impairment or who are undergoing hemodialysis
• Patients who have diabetic neuropathy
• Patients who have a significant urinogenital disease such as UTI, interstitial cystitis, urothelial tumor, bladder stone, or urinary retention
• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
• Patients who have another medical or psychiatric condition that will make them inappropriate for participate in this study in the opinion of the investigators
• Patients who have participated in other clinical trials within 30 days before the screening visit
• Randomization

• Patients who have been diagnosed with clinically significant bladder outlet obstruction by investigators
• Patients whose PVR is greater than 100 mL
• Patients who have been diagnosed with prostate cancer or bladder cancer and who have a present or resolved malignant disease in any pelvic organ
• Patients who have neurological diseases that affect micturition and can cause neurogenic bladder disease such as multiple sclerosis, Parkinson's disease, severe cerebral arteriosclerosis, dementia, stroke, or myelitis
• Patients who have had serious adverse events or are hypersensitive to anticholinergics
• Patients who have a severe gastrointestinal obstruction disease such as toxin megacolon, ulcerative colitis, intestinal atonia, paralytic ileus, and gastric retention
• Patients who have been diagnosed with severe myasthenia
• Patients who have been diagnosed with narrow-angle glaucoma
• Patients who have serious hepatic impairment (child class C)
• Patients who are being treated with a CYP3A4 inhibitor (e.g., Ketoconazole)
• Patients who have severe renal impairment or who are undergoing hemodialysis
• Patients who experienced severe side effects after their operation
• Patients who have diabetic neuropathy
• Patients who have a significant urinogenital disease such as UTI, interstitial cystitis, urothelial tumor, bladder stone, or urinary retention
• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
• Patients who have another medical or psychiatric condition that will make them inappropriate for participate in this study in the opinion of the investigators
• Patients who have participated in other clinical trials within 30 days before the screening visit