A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks

KYU-SUNG LEE

Status and phase

Completed

Phase 4

Conditions

Overactive Bladder

Treatments

Drug: Solifenacin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00884104

SMK-3

Details and patient eligibility

About

The purpose of this study is to evaluate the rate of "add-on" solifenacin treatment and its persistency in men with over active bladder symptoms after tamsulosin monotherapy for 4 weeks.

Full description

This is a multi-center study to evaluate the efficacy, safety, and persistency of solifenacin treatment in male patients with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence who are receiving tamsulosin monotherapy for LUTS at a stable dose for 4 weeks in real life practice. Also proportion of patients and predictive factors with persistent OAB symptoms after tamsulosin monotherapy will be investigated.

Enrollment

307 patients

Sex

Male

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

IPSS ≥ 12
Symptoms of OAB as verified by the V8 (≥8)
Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
- Mean urinary frequency ≥8 times/24 hours
- Mean number of micturition-related urgency episodes ≥3 episode/24 hours (with a Urinary Sensation Scale rating of ≥3 marked for the corresponding micturition in the bladder diary)

Exclusion criteria

Treatment within the 14 days preceding treatment with any alpha blocker drugs
A known history of bladder outlet obstruction due to: bladder neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor