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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KYU-SUNG LEE
• Collaborator: Astellas Pharma Korea, Inc.
• Treatments: Adrenergic alpha-Antagonists; Solifenacin Succinate

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