To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH) with tamsulosin hydrochloride for at least 6 weeks
Study drugs are administered for 14 weeks in total, including a 2-week run-in period (single blind) and a 12-week treatment period (double blind). After written informed consent, study drugs for the run-in period are orally administered once daily after breakfast for two weeks to subjects who fulfill the inclusion and exclusion criteria. Then, subjects are randomized and orally treated with study drugs for the treatment period once daily after breakfast for 12 weeks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
638
oral
oral
Unnamed facility
Chugoku, Japan
Unnamed facility
Chūbu, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kansai, Japan
Unnamed facility
Kantou, Japan
Change from baseline in mean number of urgency episodes per 24 hours
Time frame: at 4, 8, 12 week
Mean number of micturitions per 24 hrs
Time frame: at 4, 8, 12 week
Mean number of incontinence episodes per 24 hours
Time frame: at 4, 8, 12 week
Mean number of micturitions per night
Time frame: at 4, 8, 12 week
Adverse Events, Laboratory Tests
Time frame: end of study
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Kyushu, Japan
Unnamed facility
Shikoku, Japan
Unnamed facility
Tōhoku, Japan