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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00699049
Enrollment
94
Registered
2008-06-17
Start date
2008-06-30
Completion date
2010-03-31
Last updated
2016-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder, Overactive

Keywords

Alpha blocker, Tamsulosin, Solifenacin, Overactive Bladder, Urgency incontinence

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.

Interventions

DRUGAlpha blocker

oral

DRUGplacebo

oral

DRUGsolifenacin

oral

Sponsors

Astellas Pharma Korea, Inc.
CollaboratorINDUSTRY
KYU-SUNG LEE
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Achievement level of patients' individual satisfactionAt weeks 4 and 12

Secondary

MeasureTime frame
Changes in urgency episodesAt weeks 4 and 12
Changes in OAB symptom scoresAt weeks 4 and 12
Changes in QoL score by OAB-qAt weeks 4 and 12

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026