Benign Prostatic Hyperplasia (BPH), Lower Urinary Tract Symptoms, Overactive Bladder
Conditions
Keywords
Tamsulosin, Solifenacin, Lower urinary tract symptoms, Overactive bladder
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.
Interventions
DRUGTamsulosin
Oral
DRUGSolifenacin
Oral
Sponsors
Astellas Pharma Taiwan, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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) | — |
| 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 | — |
| Safety as assessed by adverse events | Up to 12 weeks | — |
Countries
Taiwan
Outcome results
None listed