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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.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00699049
First received: June 16, 2008
Last updated: April 8, 2010
Last verified: April 2010
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Achievement level of patients' individual satisfaction [ Time Frame: At weeks 4 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in urgency episodes [ Time Frame: At weeks 4 and 12 ] [ Designated as safety issue: No ]
  • Changes in OAB symptom scores [ Time Frame: At weeks 4 and 12 ] [ Designated as safety issue: No ]
  • Changes in QoL score by OAB-q [ Time Frame: At weeks 4 and 12 ] [ Designated as safety issue: No ]

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
oral
Drug: placebo
oral
Experimental: Alpha blocker and solifenacin Drug: Alpha blocker
oral
Drug: solifenacin
oral
Other Names:
  • Vesicare
  • YM905

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00699049

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

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00699049     History of Changes
Other Study ID Numbers: SMK-1
Study First Received: June 16, 2008
Last Updated: April 8, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Alpha blocker
Tamsulosin
Solifenacin
Overactive Bladder
Urgency incontinence

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Adrenergic alpha-Antagonists
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Adrenergic Antagonists
 Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on June 17, 2013