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

A Prospective, Open-label, Observational, Multi-center Study for the Identification of Predictive Factors for the Solifenacin Treatment in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks and Evaluation of Efficacy and Persistency of Add on Solifenacin in Men With Residual Overactive Bladder Symptoms After Previous Monotherapy With Tamsulosin.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00884104

Enrollment

307

Registered

2009-04-20

Start date

2009-03-31

Completion date

2010-12-31

Last updated

2016-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

Keywords

Solifenacin, Tamsulosin, OAB

Brief summary

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.

Detailed 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.

Interventions

DRUGSolifenacin

Oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

45 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Percentage of patients with add-on solifenacin treatment	Weeks of 12, 24 and 52 of combination therapy

Secondary

Measure	Time frame
Change from baseline in micturition efficacy parameters	Weeks of 12, 24 and 52 of combination therapy

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026