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

Astellas

Status and phase

Completed

Phase 4

Conditions

Benign Prostatic Hyperplasia (BPH)

Lower Urinary Tract Symptoms

Overactive Bladder

Treatments

Drug: Tamsulosin

Drug: Solifenacin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02715024

HAURO-0605-TW

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

Male

Ages

45+ years old

Volunteers

No 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