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

Phase 4

Completed

• Conditions: Lower Urinary Tract Symptoms; Overactive Bladder; Benign Prostatic Hyperplasia (BPH)
• Interventions: Drug: Tamsulosin; Drug: Solifenacin

• Registration Number: NCT02715024
• Lead Sponsor: Astellas Pharma Taiwan, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2016-03
• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-17
• Last Update Submitted: 2016-03-17
• Study First Posted: 2016-03-22
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tamsulosin alone	Tamsulosin	-
Tamsulosin + solifenacin	Tamsulosin	-
Tamsulosin + solifenacin	Solifenacin	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety as assessed by laboratory parameters	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 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
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 Quality of life index (I-PSS-(L)) 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

Trial Locations

Locations (1)

Site; 🇨🇳 Taipei, Taiwan