A Prospective Evaluation of the Catheter Science M3 "Mini Catheter" for Patients With Prostatic
A Prospective Evaluation of the Catheter Science M3 "Mini Catheter" for Patients With Prostatic
The Catheter Science M3 "Mini Catheter" has been developed for management of urinary
 retention. This temporary device allows for normal functioning of the external striated
 sphincter. The design contributes to its atraumatic insertion and removal. It is a short
 catheter segment which is attached to a monofilament suture which runs thru the lumen of the
 urethra and is attached to a small plastic "bobber". This study is designed to validate the
 reduction in these adverse effects: The suture to the outside allows for repositioning should
 the device slip back into the bladder and facilitates removal. With volitional voiding and
 competent external sphincter, patients are able to void spontaneously without the need of a
 collection device and are continent. The design enhances the flow characteristics and reduces
 post void residual. Since the M3 does not have a tubular segment thru the tip of the penis or
 sphincter, biofilm production is eliminated.
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).