Funding for this research was provided by:
Dr. R. Pfleger GmbH
Article History
Received: 25 January 2018
Accepted: 2 September 2018
First Online: 14 September 2018
Ethics approval and consent to participate
: All procedures performed in this study were in accordance with the German Drug Law, with the joint recommendations of the Federal Institute for Drugs and Medical Devices (BfArM) and the Paul-Ehrlich-Institute relating to the conduct of non-interventional trials [CitationRef removed], and with the recommendations for assuring Good Epidemiological Practice [CitationRef removed]. Written informed consent regarding data protection was obtained from all patients before being included in the study. The Ethics Committee of the Medical Chamber Westphalia-Lippe and the Westphalian Wilhelm University Münster, Germany, approved the study protocol. This decision was provided to each urologist within the regulatory jurisdiction of the Ethics Committee. No further Ethics Committee was involved as ethics approval in general was not mandatory and all participating urologists were satisfied with the vote of the Ethics Committee of the Medical Chamber Westphalia-Lippe and Westphalian Wilhelm University Münster.This NIS was registered with the number DRKS00007109 at the German Register of Clinical Studies (DRKS) on October 29, 2014.
: Not applicable.
: Alexander Ivchenko received cost reimbursement of travel expenses by Dr. R. Pfleger GmbH. Rolf-Hasso Bödeker is paid-consultant (statistical planning and analysing) to Dr. R. Pfleger GmbH, Andreas Wiedemann is a consultant of Dr. R. Pfleger GmbH, Claudia Neumeister is employee (Senior Project Manager Clinical Research) of Dr. R. Pfleger GmbH.
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