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

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ClinicalTrials.gov Identifier: NCT00699049
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : January 7, 2016
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Urinary Bladder, Overactive Drug: Alpha blocker Drug: placebo Drug: solifenacin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
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
Study Start Date : June 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

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Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699049


Locations
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Korea, Republic of
Cheonan, Korea, Republic of
Pusan, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
KYU-SUNG LEE
Astellas Pharma Korea, Inc.
Investigators
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Study Chair: Central Contact Astellas Pharma Inc
More Information
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Responsible Party: KYU-SUNG LEE, professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00699049    
Other Study ID Numbers: SMK-1
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: January 7, 2016
Last Verified: January 2016
Keywords provided by KYU-SUNG LEE, Samsung Medical Center:
Alpha blocker
Tamsulosin
Solifenacin
Overactive Bladder
Urgency incontinence
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
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