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Completed

NCT Number: NCT00884104

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

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

45 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Cheonju, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

solifenacin

Drug

Oral

Other names: Vesicare

Primary outcomes

  1. Percentage of patients with "add-on" solifenacin treatment

    Time frame: Weeks of 12, 24 and 52 of combination therapy

Secondary outcomes

  1. Change from baseline in micturition efficacy parameters

    Time frame: Weeks of 12, 24 and 52 of combination therapy

Sponsors and collaborators

Lead sponsor

KYU-SUNG LEE

Other

Collaborators

  • Astellas Pharma Korea, Inc.

Registry information

Official study title

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.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 20, 2009
Registry last updated
Jan 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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