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

Condition(s) targeted: Urinary Bladder, Overactive

Intervention: Alpha blocker (Drug); placebo (Drug); solifenacin (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Astellas Pharma Inc

Official(s) and/or principal investigator(s):
Central Contact, Study Chair, Affiliation: Astellas Pharma Inc

Overall contact:
Clinical Development Administration Department, Email: clinicaltrials_info@jp.astellas.com

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.

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Achievement level of patients' individual satisfaction

Secondary outcome:

Changes in urgency episodes

Changes in OAB symptom scores

Changes in QoL score by OAB-q

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Male.

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

Clinical Development Administration Department, Email: clinicaltrials_info@jp.astellas.com

Seoul, Korea, Republic of; Recruiting

Pusan, Korea, Republic of; Recruiting

Cheonan, Korea, Republic of; Recruiting

Starting date: June 2008
Ending date: February 2010
Last updated: September 8, 2009