Urethral Catheter Immobilization Device to Reduce Catheter-Related Discomfort
Urethral Catheter Immobilization Device to Reduce Catheter-Related Discomfort
This is a randomized controlled study to determine the efficacy and safety of a patented
 urethral catheter support device designed to reduce discomfort associated with urethral
 catheter mobility in males.

 Movement of a catheter within the urethra is a source of discomfort for patients. The
 investigators hypothesize that this discomfort can be reduced by using an external device
 designed to securely fasten the catheter to the penis.
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