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 Overview
=================
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.

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

Conditions
-----------------
Lower Urinary Tract Symptoms, Overactive Bladder, Benign Prostatic Hyperplasia (BPH)

Intervention / Treatment
-----------------
* Drug: Tamsulosin
* Drug: Solifenacin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamsulosin alone<br> | Drug: Tamsulosin<br>* Oral<br>* Other names: Harnalidge® D;|
| Experimental: Tamsulosin + solifenacin<br> | Drug: Tamsulosin<br>* Oral<br>* Other names: Harnalidge® D;Drug: Solifenacin<br>* Oral<br>* Other names: Vesicare®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Measured by bladder scan | Up to 12 weeks | 
| Safety as assessed by vital signs |  | Up to 12 weeks | 
| Safety as assessed by laboratory parameters |  | Up to 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tamsulosin, Solifenacin, Lower urinary tract symptoms, Overactive bladder