Surgery for Male Stress Urinary Incontinence

Condition(s) studied

Investigational drug(s) / intervention(s)

Artificial urinary sphincter: Implantation of peri-urethral artificial urinary sphincter

Male sling: Retrourethral implantation of male sling

Study summary

The purpose of this observational prospective study is to evaluate the success rate (cure plus improvement) of procedures for treatment of male stress urinary incontinence (artificial urinary sphincter or male slings) at 5 years of study follow-up and to determine other outcomes of surgical treatment for each of the devices and, to perform a prognostic factor analysis to identify clinical and surgical variables that correlate with (in)continence or revisions for each of the device subtypes. Cure is defined as urinary continence with no need for use of pads or the use of 1 light security pad; the improvement is defined as the reduction of≥ 50% of the number of pads with use of no more than two pads.

Eligibility

Primary outcome measure(s)

• Success rate (cure plus improvement) — 5-years after surgery
  Will be obtained through patient 24-hour pad use. Cure rate is defined as urinary continence with no need for use of pads or the use of 1 light security pad.

Trial sites (1)

More Fondazione Policlinico Universitario Agostino Gemelli IRCCS trials in Italy