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

Primary Purpose

Urinary Bladder, Overactive

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Alpha blocker
placebo
solifenacin
Sponsored by
KYU-SUNG LEE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring Alpha blocker, Tamsulosin, Solifenacin, Overactive Bladder, Urgency incontinence

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Alpha blocker and placebo

Alpha blocker and solifenacin

Arm Description

Outcomes

Primary Outcome Measures

Achievement level of patients' individual satisfaction

Secondary Outcome Measures

Changes in urgency episodes
Changes in OAB symptom scores
Changes in QoL score by OAB-q

Full Information

First Posted
June 16, 2008
Last Updated
January 6, 2016
Sponsor
KYU-SUNG LEE
Collaborators
Astellas Pharma Korea, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00699049
Brief Title
A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder
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 Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
KYU-SUNG LEE
Collaborators
Astellas Pharma Korea, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive
Keywords
Alpha blocker, Tamsulosin, Solifenacin, Overactive Bladder, Urgency incontinence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alpha blocker and placebo
Arm Type
Placebo Comparator
Arm Title
Alpha blocker and solifenacin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Alpha blocker
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral
Intervention Type
Drug
Intervention Name(s)
solifenacin
Other Intervention Name(s)
Vesicare, YM905
Intervention Description
oral
Primary Outcome Measure Information:
Title
Achievement level of patients' individual satisfaction
Time Frame
At weeks 4 and 12
Secondary Outcome Measure Information:
Title
Changes in urgency episodes
Time Frame
At weeks 4 and 12
Title
Changes in OAB symptom scores
Time Frame
At weeks 4 and 12
Title
Changes in QoL score by OAB-q
Time Frame
At weeks 4 and 12

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Cheonan
Country
Korea, Republic of
City
Pusan
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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