Pilotstudy with prototype of Casto Button for catherisable urinarystomas

In patients who are not able to empty the bladder properly, in selected cases a
catheterisable stoma (CS) is created made of appendix, ileum or bladder wall.
The CS is inserted in the bladder with a valve, and to other end it is fixated
in the skin of the right lower abdomen or in the umbilicus. Four to 8 times a
day the bladder is emptied by inserting a catheter through the CS into the
bladder. In the University Medical Center Utrecht, more than 50 adult patients
with CS are under surveillance. The conjunction between stoma and skin has a
tendency to become stenotic. Stenosis of the skin accounts for a high surgical
revision rate. For prevention of stenosis, an ACE stopper is commonly used.1
Disadvantages of the ACE-stopper include allergy, falling out, and insufficient
prevention of stenosis. The ACE stopper needs to be removed before
catheterization.
In cooperation with the Department of Medical Technology and Clinical Physics,
a new device was developed to prevent stenosis of the skin in patients with CS.
The prototype is made of titanium. Prototypes with different diameters were
made for a try out.
The goal of this study is to evaluate the use of the Casto Button in a small
group of patients with help of a self-developed questionnaire.
Based on the results of the questionnaire, adjustments to the Casto Button can
be made.

Is the Casto Button an easy to use, comfortable device capable of preventing
stenosis in patients with CS?

Patients with a CS in the lower right abdomen who are under surveillance in the
University Medical Center Utrecht will be asked to participate.
After informed consent, they will be invited for a visit to determine the
proper size of the Casto Button and fill out a baseline self-developed
questionnaire. A sterile prototype Casto Button will be provided on loan, and
oral and written instructions for use will be given. After 4 weeks the use of
the Casto Button will be evaluated by a self-developed questionnaire.

Catheterisable stomas of the bladder have a tendency to become stenotic at skin
level. The Casto Button is designed to prevent stenosis. Patients will use a
prototype made of titanium. Based on results of the questionnaire, eventual
adjustments will be made and in the end a synthetic version of the Casto Button
will be manufactured. So the benefit for the patient is prevention of stenosis
of their catheterisable stoma. The expected risk is minimal. The burden on the
patient is to fill out a questionnaire.