Trial Information

Global Performance Evaluation of the AMS CONTINUUM™ Device in Facilitating Vesico-Urethral Anastomosis Following a Radical Prostatectomy

Radical prostatectomy (RP) is the most utilized surgical treatment option for localized
prostate cancer due to the multi-focal nature of the disease. RP is most suitable for
otherwise healthy men whose cancer is limited to a small area. The RP procedure involves
removing the prostate gland, seminal vesicles and nearby lymph nodes. One of the most
technically challenging and critical aspects in all of these surgical approaches is
reconstruction of the interrupted urinary tract by hand sewing the vesico-urethral
anastomosis. This is where the bladder neck is sewn to the urethra after the prostate has
been removed.

CONTINUUM™ (study Device) is to be used as part of the RP procedure by facilitating the
approximation of the bladder neck and urethral stump. The Device brings together and holds
the tissue in place until adequate natural healing of the vesico-urethral anastomosis occurs
thereby minimizing extravasation. The Device also provides a conduit for drainage of urine
from the bladder out the urethra during tissue healing.

The concept of the CONTINUUM™ device and the feasibility of its operation have been
successfully tested in animal and human studies. Pilot clinical studies in the United
States (G060095) found that the majority of subjects who received and were discharged with
the Device demonstrated a water-tight vesico-urethral anastomosis at the first Device
removal visit. Additionally, no unanticipated adverse device effects (UADEs) were reported.
The focus of the proposed study is to further verify the performance of the Device in
global research centers.