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

Sponsor:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00699049

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 IV

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:

MedlinePlus related topics: Urinary Incontinence

Drug Information available for: Solifenacin Solifenacin succinate

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 February 09, 2012