Efficacy and Safety of Tamsulosin/Solifenacin Combination therapy in Patients with voiding symptoms and moderate to severe storage symptoms due to Benign Prostate Hyperplasia : a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
588
Samsung medical center
Seoul, South Korea
RECRUITINGThe change of TUFS((Total Urgency and Frequency Score)/24h
Time frame: From baseline at week 12
The change of total IPSS(International prostate symptom score)
Time frame: From baseline at week 12
The change of urgency/24h
Time frame: From baseline at week 4, 8 and 12
The change of voiding frequency/24h
Time frame: From baseline at week 4, 8 and 12
The change of nocturnal frequency/24h
Time frame: From baseline at week 4, 8 and 12
The change of urge urinary incontinence frequency/24h
Time frame: From baseline at week 4, 8 and 12
The change of IPSS(International prostate symptom score)-sub score
Time frame: From baseline at week 4, 8 and 12
The change of PPBC(Patient perception of bladder condition)
Time frame: From baseline at week 4 and 12
The change of IPSS(International prostate symptom score) QoL(Quality of Life)
Time frame: From baseline at week 4, 8 and 12
PGIC(Patient Global Impression of change) and CGIC(Clinician Global Impression of change)
Time frame: From baseline at week 12
The ratio of subjects who are decreased total IPPS(International prostate symptom score) more than 4
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Time frame: From baseline at week 12