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Completed

NCT Number: 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

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.

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Key information

Conditions

Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia (BPH) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Male Urogenital Diseases Overactive Bladder Pathological Conditions, Signs and Symptoms Prostatic Diseases Prostatic Hyperplasia Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Site

Taipei, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin

Drug

Oral

Other names: Harnalidge® D

solifenacin

Drug

Oral

Other names: Vesicare®

Primary outcomes

  1. Change in International Prostate Symptoms Score (IPSS-(S)) from baseline to the end of treatment

    Time frame: Baseline and end of treatment (up to 12 weeks)

Secondary outcomes

  1. Change in mean number of urgency episode per 24 hours from baseline to the end of treatment

    Time frame: Baseline and end of treatment (up to 12 weeks)

  2. Change in mean number of micturitions per 24 hours from baseline to the end of treatment

    Time frame: Baseline and end of treatment (up to 12 weeks)

  3. Change in Quality of life index (I-PSS-(L)) from baseline to the end of treatment

    Time frame: Baseline and end of treatment (up to 12 weeks)

  4. Change in maximum flow rate (Qmax) and voided volume determined by uroflowmetry from baseline to the end of treatment

    Time frame: Baseline and end of treatment (up to 12 weeks)

  5. Safety as assessed by adverse events

    Time frame: Up to 12 weeks

  6. Safety as assessed by postvoid residual volume (PVR)

    Time frame: Up to 12 weeks

    Measured by bladder scan

  7. Safety as assessed by vital signs

    Time frame: Up to 12 weeks

  8. Safety as assessed by laboratory parameters

    Time frame: Up to 12 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Taiwan, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Mar 22, 2016
Registry last updated
Mar 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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