Solifenacin Succinate With Tamsulosin HCl in Males With Lower Urinary Tract Symptoms and Bladder Outlet Obstruction

Astellas

Status and phase: Completed; Phase 2

Conditions: Lower Urinary Tract Symptoms; Bladder Outlet Obstruction

Treatments: Drug: tamsulosin hydrochloride; Drug: solifenacin succinate; Drug: Placebo to tamsulosin; Drug: Placebo to solifenacin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00507455

905-CL-058

2007-001268-57 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 222 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with Lower Urinary Tract Symptoms (LUTS) and Bladder Outlet Obstruction (BOO)
• BOO indication by a Bladder Outlet Obstruction Index (BOOI) ≥ 20
• Patient has a total International Prostate Symptom Score (IPPS) score of ≥ 8 (Inclusion criteria for Baseline also)
• Patient had a maximum urinary flow rate of ≤ 12 mL/sec, with a voided volume of ≥ 120 mL during free flow in a representative assessment of uroflowmetry.

Exclusion criteria

• History of urinary retention in preceding 12 months
• Current urinary tract infection (UTI) or symptomatic and recurrent UTI of > 3 episodes within 12 months.
• Known clinical history or diagnosis of chronic inflammation, stone in bladder or ureter, or other causes of outflow tract obstruction
• Known diagnosis or history of carcinoma or previous pelvic radiation therapy, except non-metastatic basal or squamous cell carcinoma of the skin that had been treated successfully
• Clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to Visit 1

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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222 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.

Treatment:

Drug: Placebo to solifenacin

Drug: Placebo to tamsulosin

6 mg Solifenacin + 0.4 mg Tamsulosin

Experimental group

Description:

Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.

Treatment:

Drug: solifenacin succinate

Drug: tamsulosin hydrochloride

9 mg Solifenacin + 0.4 mg Tamsulosin

Experimental group

Description:

Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.

Treatment:

Drug: solifenacin succinate

Drug: tamsulosin hydrochloride