Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms

Sponsor

Astellas Pharma Taiwan, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02715024

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the clinical efficacy and safety of tamsulosin alone or in combination with solifenacin for the treatment in men with lower urinary tract symptoms (LUTS) including overactive bladder (OAB) symptoms in Taiwan.

Condition or Disease	Intervention/Treatment	Phase
Lower Urinary Tract Symptoms Overactive Bladder Benign Prostatic Hyperplasia (BPH)	Drug: Tamsulosin Drug: Solifenacin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Randomized, Parallel Study to Evaluate the Clinical Efficacy and Safety of Tamsulosin Alone or in Combination With Solifenacin for the Treatment in Men With Lower Urinary Tract Symptoms Including Overactive Bladder Symptoms

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Apr 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tamsulosin alone	Drug: Tamsulosin Oral Other Names: Harnalidge® D
Experimental: Tamsulosin + solifenacin	Drug: Tamsulosin Oral Other Names: Harnalidge® D Drug: Solifenacin Oral Other Names: Vesicare®

Arm

Intervention/Treatment

Experimental: Tamsulosin alone

Drug: Tamsulosin

Oral

Other Names:

Harnalidge® D

Experimental: Tamsulosin + solifenacin

Drug: Tamsulosin

Oral

Other Names:

Harnalidge® D

Drug: Solifenacin

Oral

Other Names:

Vesicare®

Outcome Measures

Primary Outcome Measures

Change in International Prostate Symptoms Score (IPSS-(S)) from baseline to the end of treatment [Baseline and end of treatment (up to 12 weeks)]

Secondary Outcome Measures

Change in mean number of urgency episode per 24 hours from baseline to the end of treatment [Baseline and end of treatment (up to 12 weeks)]
Change in mean number of micturitions per 24 hours from baseline to the end of treatment [Baseline and end of treatment (up to 12 weeks)]
Change in Quality of life index (I-PSS-(L)) from baseline to the end of treatment [Baseline and end of treatment (up to 12 weeks)]
Change in maximum flow rate (Qmax) and voided volume determined by uroflowmetry from baseline to the end of treatment [Baseline and end of treatment (up to 12 weeks)]
Safety as assessed by adverse events [Up to 12 weeks]
Safety as assessed by postvoid residual volume (PVR) [Up to 12 weeks]
Measured by bladder scan
Safety as assessed by vital signs [Up to 12 weeks]
Safety as assessed by laboratory parameters [Up to 12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical signs and symptoms of frequency and urgency related to benign prostatic hyperplasia for at least 3 months
I-PSS(S) score of ≥ 12
Maximum flow rate (Qmax) of 4 to15 mL/sec
Mean urinary frequency of ≥ 8 micturitions per 24 hours and ≥ 1 episode of urgency per 24 hours as verified by the 3-day micturition diary
Benign digital rectal examination (DRE) result

Exclusion Criteria:

Clinically significant outflow obstruction
Significant post void residue volume (PVR >100ml)
Prostate specific antigen (PSA) ≥10 ng/mL
Previous or planned prostate surgery, including transurethral resection of the prostate (TURP)
Transurethral microwave treatment (TUMT), transurethral needle ablation (TUNA), laser, or other invasive or minimally invasive procedures within 12 months
Patient with a neurological cause for abnormal detrusor activity
Patients with urinary tract infection, chronic inflammation, bladder stones, bladder neck, sclerosis, urethral stricture, prostatic cancer, severe vesical diverticulum
Uncontrolled narrow angle glaucoma, urinary or gastric retention or any other medical condition which in the opinion of the investigator makes the use of anticholinergics contra-indicated
Patients with any other complication which may cause voiding dysfunction
Patients with severe hepatic dysfunction, severe renal dysfunction, severe cardiovascular disorder, orthostatic hypotension, or senile dementia
Patients receiving any medication therapy for LUTS/BPH 2 weeks prior to the study
Use of drugs to treat incontinence currently
Hypersensitivity to tamsulosin and/or solifenacin or to any component of the formulation
Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial
Patients had taken any investigational drug in the previous 3 months prior to this study