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

Phase 4

Completed

• Conditions: Urinary Bladder, Overactive
• Interventions: Drug: Alpha blocker; Drug: solifenacin; Drug: placebo

• Registration Number: NCT00699049
• Lead Sponsor: KYU-SUNG LEE

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-16
• Study First Submitted QC: 2008-06-16
• Study First Posted: 2008-06-17
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alpha blocker and solifenacin	solifenacin	-
Alpha blocker and placebo	Alpha blocker	-
Alpha blocker and placebo	placebo	-
Alpha blocker and solifenacin	Alpha blocker	-

Primary Outcome Measures

Name	Time	Method
Achievement level of patients' individual satisfaction	At weeks 4 and 12

Secondary Outcome Measures

Name	Time	Method
Changes in QoL score by OAB-q	At weeks 4 and 12
Changes in urgency episodes	At weeks 4 and 12
Changes in OAB symptom scores	At weeks 4 and 12