Conditions: Lower Urinary Tract Symptoms Bladder Outlet Obstruction
Keywords: Lower Urinary Tract Symptoms Bladder Outlet Obstruction Treatment Solifenacin Succinate Tamsulosin hydrochloride
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 222
Healthy volunteers: no

Brief summary:
A study to evaluate the safety of the co-administration of solifenacin succinate with tamsulosin hydrochloride in men with lower urinary tract symptoms (LUTS) and bladder outlet obstruction (BOO).

Detailed description:

Arms:
arm 1: Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks. arm 2: Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks. arm 3: Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.

Interventions: intervention 1: solifenacin succinate intervention 2: tamsulosin hydrochloride intervention 3: Placebo to solifenacin intervention 4: Placebo to tamsulosin
Intervention descriptions: intervention 1: Solifenacin succinate tablets intervention 2: Tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets intervention 3: None intervention 4: None

Protocol document: