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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT01747577
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Completed
Phase Phase 4
Start date December 4, 2012
Completion date October 24, 2013

See also
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