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

KYU-SUNG LEE

Status and phase

Completed

Phase 4

Conditions

Urinary Bladder, Overactive

Treatments

Drug: placebo

Drug: solifenacin

Drug: Alpha blocker

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00699049

SMK-1

Details and patient eligibility

About

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.

Enrollment

94 patients

Sex

Male

Ages

50+ years old

Volunteers

No 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