Trial | NCT00884104  Report issue

Title

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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    307
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.
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.
Study Started
Mar 31
2009
Primary Completion
Dec 31
2010
Study Completion
Dec 31
2010
Last Update
Jan 07
2016
Estimate

Drug Solifenacin

Oral

  • Other names: Vesicare

1.tamsulosin + solifenacin Experimental

Criteria 

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
No Results Posted