The purpose of this study is to demonstrate superiority of the solifenacin succinate (treatment) over the placebo (control) based on the change from the baseline in the mean number of urgency episodes per 24 hours after 2 weeks.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
68
Oral
Oral
Unnamed facility
Seoul, South Korea
Mean change from the baseline in the number of urgency episodes per 24 hrs in the voiding diary at Week 2
Time frame: Baseline and at week 2
Mean change from the baseline in the number of urgency episodes per 24 hrs in the voiding diary at Week 4
Time frame: Baseline and at week 4
Change from baseline in IPSS total score
IPSS: International Prostate Symptom Score
Time frame: Baseline, at week 2 and at week 4
Changes from baseline in IPSS storage subscale score
Time frame: Baseline, at week 2 and at week 4
Changes from baseline in IPSS voiding subscale score
Time frame: Baseline, at week 2 and at week 4
Changes from baseline in individual IPSS scores
Time frame: Baseline, at week 2 and at week 4
Changes from baseline in IPSS QOL
QOL: Quality of Life
Time frame: Baseline, at week 2 and at week 4
Changes from baseline in OABSS total score
OABSS: OverActive Bladder Sympton Score
Time frame: Baseline, at week 2 and at week 4
Change from baseline in average number of micturitions per 24 hrs for three days as recorded in the voiding diary
Time frame: Baseline, at week 2 and at week 4
Safety assessed by the incidence of adverse events, physical exam, and vital signs
Time frame: For 4 weeks of the treatment
Urinal post voiding residual volume
Measured by ultrasound or bladder scan
Time frame: Before treatment at week 2 and at week 4
Maximum flow rate of the urine
Assessment using uroflowmetry
Time frame: Before treatment at week 2 and at week 4
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