A Prospective Evaluation of the Catheter Science M3 "Mini Catheter" for Patients With Prostatic

This single arm, prospective study is designed to produce valid scientific evidence
regarding:

1. Safety and efficacy of the Catheter Science M3 "Mini Catheter" in establishing urinary
drainage and allowing the control of micturition when indwelling for a period of time up
to but less than 28 days in male patients with prostate outlet obstruction who have been
dependent on either a Foley catheter or Intermittent Catheterization.

2. The study purpose is to measure the rate of catheter-related urinary tract infections in
patients with the M3 in place as compared to the known infection rate for patients with
a Foley catheter in place over the same period of time.

A single arm study design was chosen because there is no alternative treatment to serve as an
appropriate control. The M3 de-obstructs the prostatic urethra, allows volitional voiding
function in patients with a contractile bladder. A Foley catheter, a pre- amendment device,
was considered for a control treatment. Although a Foley catheter is used to establish
urinary drainage initially with close to 100% efficacy, it does not allow for voluntary
micturition as defined with the coordination of contraction of the bladder with the
relaxation of the striated external sphincter. The ability of the bladder to fill and
contract with a Foley is altered. The M3 allows for the bladder to fill since the sphincter
is not bridged. Volitional micturition is initiated with bladder contraction coordinated with
a relaxation of the external striated sphincter. The flow of urine is thru and around the M3
rather than only intraluminal in the Foley. The direction of urine flow with the M3 is in one
direction in contrast to the Foley catheter and external collection device which is
bi-directionally. The flow of urine back into the bladder has long been viewed as a
significant contributor to the CAUTI. The Foley is a passive drainage device which simply
drains the bladder with negative pressure produced in a closed system aided with gravity. The
laterally placed intake eyes of the Foley are vulnerable to occlusion of the bladder mucosa
being pulled into the lumen by the negative pressure of the closed system. The requirement of
an external collecting bag coupled with the Foley traversing the entire length of the
Urethra, severely impairs activities of daily life. The comparative lifestyle changes between
the Foley Catheter, Intermittent Catheter and M3 group is not the focus of this study of the
Safety and Efficacy characteristics of the M3 vs Foley comparison, but will be obvious to
patients and clinicians.

The retention balloon inflation channel impacts the internal diameter of the Foley. The
Balloon prevents complete emptying of the bladder with resultant residual of 10-100cc
reported. Since there is no consistent flow of urine around a Foley to help "wash out
bacteria" the formation of biofilm is accelerated. The Foley violates the anatomical
protective points (penile meatus, sphincter, prostatic urethral and bladder neck) which help
prevent bacterial contamination. The M3 CAUTI reduction as compared to the Foley and
Intermittent Catheter Group is due to a series of important design features. The removal of a
retention balloon allows for the internal diameter to be enlarged. The 3 wings Malecott
promotes retention of the device as well as preventing bladder mucosal plugging of the lumen
during voiding contractions. This design also promotes an improved post void residual
compared to a Foley device. The residual urine in the bladder with a Foley as well a slow
flow rate promotes encrustations and occlusion of the Foley.

Inclusion Criteria:

- Males > 50 years of age

- Signed subject informed consent (see Appendix "A")

- Patients with actual urinary retention dependent on Foley Catheter or Intermittent
Catheter

- Inclusion will start once the M3 is placed and a functioning bladder is demonstrated.

Exclusion Criteria:

- Inability to undergo bladder catheterization with the M3 due to anatomical challenges
(i.e. urethral stricture, bladder neck contracture, false passage or false passages or
other history of urethral stricture)

- Gross hematuria

- Hypotonic Neurogenic Bladder (the placement of the M3 may isolate the cause of the
retention with the bridging of the prostate as bladder dysfunction rather than
prostate obstruction).