The principal aim of this pilot study is to directly compare both approaches and analyze the failure rate after one year of follow-up. These data will serve as the basis to design a larger phase II or III trial in the future with failure rate as the primary end-point. Other study objectives are thoroughly described underneath.
Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations.
Age ≥ 18 years.
Male patient.
Fit for operation, upon surgeon's discretion.
Absence of signed written informed consent.
Age < 18 years.
Female patients.
Transgender patients.