EAU Real Life Data Registry on TUNA® Therapy
Why this Real Life Data Registry?
TransUrethral Needle Ablation (TUNA®) Therapy is a minimally-invasive treatment for symptomatic BPH that relieves storage and voiding symptoms in men > 50 years old and with prostate sizes between 20 and 50cm3. It has recently been improved by Medtronic, resulting in the PrecisionTM Plus System. In order to evaluate the effects of the new PrecisionTM Plus System in a real life patient population a prospective, open source survey has been developed by the EAU clinical research office (EAU-CRO) in co-operation with Medtronic Europe Sarl.
What does the Real Life Data Registry Offer?
The Real Life Data Registry allow free access for the participating physicians to an advanced patient management system in which electronic data are stored and are accessible per centre. By participating, investigators will contribute to the European Real Life Data Registry on TUNA® Therapy and further research in benign prostatic hyperplasia (BPH) field. In this way they will help to improve the quality of care provided to patients suffering from BPH.
The EAU and the TUNA® Real Life Data Registry
The EAU Research Office has taken responsibility for the project implementation, registry steering and monitoring, software design, supervision of data monitoring and analysis, communication and publication. Though the EAU owns the registry data and its results, participating centres have full access to their patient data and maintain the right to disseminate and publish results after the publication of the multi-centric EAU Registry results.
Objectives
1. Offer an electronic procedure plan (enCapture® Advanced Patient Management System) with a non-limiting framework and guidelines for standardised data collection and facilitation of the decision making when treating patients with TUNA® Therapy with PrecisionTM Plus System.
2. Collect prospectively relevant real life patient data and treatment outcomes of patients treated in multiple centres in Europe.
3. Analyse the data in order to facilitate the knowledge exchange and expansion on efficacy and safety data of the TUNA® Therapy with PrecisionTM Plus System.
4. Provide relevant data and enable publication of results on a pooled European and individual level.
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