Clinical trial NCT02715024: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lower Urinary Tract Symptoms
Overactive Bladder
Benign Prostatic Hyperplasia (BPH)
Keywords: Tamsulosin
Solifenacin
Lower urinary tract symptoms
Overactive bladder
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2016-03-22
Enrollment: 52
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in International Prostate Symptoms Score (IPSS-(S)) from baseline to the end of treatment
timeFrame: Baseline and end of treatment (up to 12 weeks)
Secondary outcomes:
measure: Change in mean number of urgency episode per 24 hours from baseline to the end of treatment
timeFrame: Baseline and end of treatment (up to 12 weeks)
measure: Change in mean number of micturitions per 24 hours from baseline to the end of treatment
timeFrame: Baseline and end of treatment (up to 12 weeks)
measure: Change in Quality of life index (I-PSS-(L)) from baseline to the end of treatment
timeFrame: Baseline and end of treatment (up to 12 weeks)
measure: Change in maximum flow rate (Qmax) and voided volume determined by uroflowmetry from baseline to the end of treatment
timeFrame: Baseline and end of treatment (up to 12 weeks)
measure: Safety as assessed by adverse events
timeFrame: Up to 12 weeks
measure: Safety as assessed by postvoid residual volume (PVR)
timeFrame: Up to 12 weeks
measure: Safety as assessed by vital signs
timeFrame: Up to 12 weeks
measure: Safety as assessed by laboratory parameters
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Site
Study officials:
affiliation: Astellas Pharma Taiwan, Inc.
name: Therapeutic Area Lead of Medical Affairs (Asia-Oceania)
role: STUDY_DIRECTOR
References: