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

Sponsor

KYU-SUNG LEE (Other)

Overall Status

Completed

CT.gov ID

NCT00699049

Collaborator

Astellas Pharma Korea, Inc. (Industry)

Enrollment

Locations

Arms

Duration (Months)

31.3

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Jun 1, 2008

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

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

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

Primary Outcome Measures

Achievement level of patients' individual satisfaction [At weeks 4 and 12]

Secondary Outcome Measures

Changes in urgency episodes [At weeks 4 and 12]
Changes in OAB symptom scores [At weeks 4 and 12]
Changes in QoL score by OAB-q [At weeks 4 and 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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