Prospective Registry for Patients Undergoing Surgery for Male Stress Urinary Incontinence

Condition(s) studied

Study summary

This will be a prospective collection of pre-defined parameters on the treatment of male stress urinary incontinence by an artificial urinary sphincter (AUS) and male sling. The data collection will be undertaken from multiple centers in Europe. The participation will be by open invitation to all members of the Female \& Functional Section of the EAU (ESFFU) along with other urologists undertaking these procedures. There will be a call via the European Association of urology (EAU) to all European Urologists to register for database entry. There will be no restriction on the number of patients enrolled as long as they are consecutive. The aim is to have a long term collection of the data set from as many centers as possible. An initial assessment for the robustness of the data collection will be undertaken at 3 months by a nominated steering committee. However, the first clinical evaluation of the data collected will commence at 1 year by the steering committee. Thereafter, the evaluations will be performed after every 2 years.

Eligibility

Primary outcome measure(s)

• Cure rate — 10 years after surgery
  Cure rate will be the main endpoint of the study, and is defined as urinary continence with no need for use of pads or the use of 1 light security pad. The cure rate after 10 years of study follow up will be calculated together with its 95% Confidence Intervals, for the total patient group as well as for each device subtype.

Trial sites (28)

More European Association of Urology Research Foundation trials in Germany