In 2009 the European Association of Urology Research Foundation (EAU-RF) started a European registry project to evaluate the impact and management of Lower Urinary Tract Symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH) in five Western European countries.From February 2010 until April 2011 exactly 2072 eligible patients were registered in 5 European countries (the United Kingdom, France, Germany, Italy and Spain) across 86 urological and general practitioner’s centres. So far, the drop-out rate is low, with 91 patients discontinuing participation for several reasons. The aim of the registry is to identify potentially unmet medical needs in a contemporary real-life setting by describing the extent of symptom persistence, worsening and improvement in patients with LUTS/BPH under pharmacological treatment.
The registry will also provide an understanding as to how much current management practices respond to patient needs both in terms of satisfaction with treatment, and improvement in the different domains of quality of life. Satisfaction with treatment as assessed by patients and physicians will be correlated and clinical progression events will be collected as well. The PI of this registry is Prof. Andrea Tubaro (IT).
Two patient populations were studied in the registry:1) patients with LUTS-BPH who presently/recently are untreated with pharmacological agents for LUTS-BPH and start BPH pharmacological treatment at or directly after the baseline visit, and 2) patients with LUTS-BPH presently/recently treated with BPH pharmacological treatment who will continue their BPH pharmacological treatment.
After baseline, the presently/recently untreated patients come for three follow-up visits at 6-, 12 and 24-months. Presently/recently treated patients come for two follow-up visits, at 12 and 24-months. During the visits, patient data (including clinical progression events) and outcomes of the questionnaires are collected in a web-based data management system. The registry also collects data on how physicians follow existing guideline recommendations.
Currently, the patients which started with the registry in the beginning of 2010 are coming for their last, 24-month visit. In April 2013 we expect that the last registered patients will come for the last visit.
After statistical analysis, final publication will follow in December 2013.
Contact details EAU Research Foundation:
• Wanda De Raadt, MSc,Clinical Project ManagerEAU CRO, Arnhem, The Netherlands,Tel: +31 263 890 firstname.lastname@example.org
• Wim Witjes, MD, PhD,Scientific and Clinical Research DirectorEAU CRO, Arnhem, The Netherlands,Tel: +31 263 890 677
This article, including all relevant illustrations, is featured in the March/May issue of European Urology Today.