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A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder

This study has been completed.
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center Identifier:
First received: June 16, 2008
Last updated: January 6, 2016
Last verified: January 2016
The purpose of this study is to explore additional benefit of solifenacin after 12-week treatment, compared with alpha blocker monotherapy in men with residual OAB symptoms.

Condition Intervention Phase
Urinary Bladder, Overactive Drug: Alpha blocker Drug: placebo Drug: solifenacin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Comparison of the Efficacy and Safety of Any Alpha Blocker Monotherapy and Any Alpha Blocker Plus Solifenacin in Men With Residual Overactive Bladder Symptoms of Urinary Frequency and Urgency With/Without Urgency Incontinence After Previous Monotherapy With Any Alpha Blocker

Resource links provided by NLM:

Further study details as provided by KYU-SUNG LEE, Samsung Medical Center:

Primary Outcome Measures:
  • Achievement level of patients' individual satisfaction [ Time Frame: At weeks 4 and 12 ]

Secondary Outcome Measures:
  • Changes in urgency episodes [ Time Frame: At weeks 4 and 12 ]
  • Changes in OAB symptom scores [ Time Frame: At weeks 4 and 12 ]
  • Changes in QoL score by OAB-q [ Time Frame: At weeks 4 and 12 ]

Enrollment: 94
Study Start Date: June 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Alpha blocker and placebo Drug: Alpha blocker
Drug: placebo
Experimental: Alpha blocker and solifenacin Drug: Alpha blocker
Drug: solifenacin
Other Names:
  • Vesicare
  • YM905


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Persistent symptoms of OAB as verified by the 3 day voiding diary, defined by:

    • symptoms of urinary urgency (defined as a level of >=3 in a 5 point urgency scale) at least two episode per 24 hours and
    • symptoms of urinary frequency ( >8 micturitions per 24 hours)
  • On a stable dose of tamsulosin for at least 1 month

Exclusion Criteria:

  • Previous history of acute urinary retention
  • Patients have a baseline post-void residual (PVR) which exceeded 50% of voided urine volume
  • Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
  • Symptomatic acute urinary tract infection (UTI) during the screening period
  • Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder
  • A 5-alpha reductase inhibitor if started less than 3 months prior to screening
  • Patients with previous urethral, prostate or bladder neck surgery
  Contacts and Locations
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Please refer to this study by its identifier: NCT00699049

Korea, Republic of
Cheonan, Korea, Republic of
Pusan, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Korea, Inc.
Study Chair: Central Contact Astellas Pharma Inc
  More Information

Responsible Party: KYU-SUNG LEE, professor, Samsung Medical Center Identifier: NCT00699049     History of Changes
Other Study ID Numbers: SMK-1
Study First Received: June 16, 2008
Last Updated: January 6, 2016

Keywords provided by KYU-SUNG LEE, Samsung Medical Center:
Alpha blocker
Overactive Bladder
Urgency incontinence

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin Succinate
Adrenergic alpha-Antagonists
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Adrenergic Antagonists
Adrenergic Agents processed this record on September 21, 2017