Urethral Catheter Immobilization Device to Reduce Catheter-Related Discomfort

Indwelling urethral catheters are a source of discomfort and pain in males, particularly when
in place for extended periods of time. All patients require catheterization for a minimum of
10 days following radical prostatectomy. Currently, catheters are secured to the patient's
leg using tape or an elastic leg strap. This point of securing, however, allows the tip of
the penis and the urethral meatus to move in different vectors from the catheter. Data
demonstrating urethral catheter hypermobility as an etiology of pain and discomfort have not
been reported. However, clinical experience suggests that this type of catheter mobility is
associated with significant discomfort.

It is predicted that the use of an external urethral catheter immobilization device (Patent:
Simpson et al., US8500719, 2013) designed to secure/minimize catheter movement relative to
the tip of the penis will greatly improve catheter associated pain and discomfort in men
undergoing radical prostatectomy. The catheter immobilization device is an FDA-approved,
510(k) exempt, pliant tubular structure comprised of Suprazote Foam (Zotefoams) that
surrounds the penile shaft. The foam support has a rigidity greater than that of the flaccid
penis. It is bi- lobed (i.e., two identical halves) that hinge together to close around the
tip of the penis with an aperture aligned with the urethra. The catheter extends through this
opening and is secured to the device does not alter the urethral catheter in any fashion. The
device limits catheter movement radial to the axis of the catheter. This, in turn, keeps the
catheter in line with the urethra, reducing abrasion and traction to the meatus and urethra.

To test the hypothesis, a randomized-controlled trial will be performed in male patients who
underwent radical prostatectomy. These men will be randomized to two arms: one arm will have
the device fitted around their catheter after surgery is complete while the other will not
have the device fitted. Outcome measures involving catheter-related pain and discomfort will
then be assessed until the urethral catheter is removed per standard of care after radical
prostatectomy.

Inclusion Criteria:

- Patients scheduled to undergo radical prostatectomy at the Massachusetts General
Hospital

- Anticipated intra-operative placement of an 18 or 20 French, latex or silicone
urethral catheter at the conclusion of the operation (standard of care)

- At least 18 years of age

Exclusion Criteria:

- Inability to speak, read or understand English

- Apparent sore, rash, or infection on the penis

- Anatomic abnormalities that would prevent proper application and use of the device

- Patients with significant physical or mental disability that, in the opinion of the
treating surgeon, might prevent safe placement or removal of the device, or completion
of the symptom-based survey.

- Patients with fragile skin