A Prospective Evaluation on the Catheter Science M3 “Mini Catheter” for Patients with Prostatic Obstruction
The Catheter Science M3 “Mini Catheter” has been developed for management of urinary obstruction. The M3 is a short catheter segment which is attached to a monofilament suture which runs thru the lumen of the urethra. The device tip is a Coude tip with a guide wire channel and 3 wings to stabilize the device and prevent expulsion. This temporary device by bridging the obstructive prostate, allows for normal volitional voiding with a functioning bladder and external urinary sphincter.
This is an IRB approved 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 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 anticipated infection rate for patients with a Foley in place over a similar period of time. 3. Monitor the following: Voluntary Micturition Post Void Residual Continence Migration of the device Ease of removal Comfort C. To determine the rate of each anticipated Urinary Tract Adverse Event requiring intervention and unanticipated adverse device effects through 2 weeks post removal of the device.
From June 2017 thru November 2017, 45 M3 Catheters we’re placed in 28 patients who were in chronic urinary retention managed with either Foley Catheter or CIC. This group represents a cumulative experience with the M3 Mini Catheter > 500 catheter days. The average duration of device was placed was > 20 days. 12 patients had the device for a complete 28 days. Weekly evaluation of the presence or absence of infection with independent analysis of UA and Culture and Sensitivity revealed a 72 % infection rate prior to placement of a M3 “Mini Catheter.” In patients with the device in place for 28 continuous days of M3 drainage revealed a 18% infection rate. The Foley Catheter expected infection rate at 28 days is > 95%. This represents a 77% reduction from the expected infection rate for a Foley Catheter.. The Voided Volume, Peak Flow Rate (Qmax) and post placement Post Void Residual avearage revealed: Voided Volume 385 cc Qmax. 13 cc/sec PVR. 15 cc No encrustations were observed at removal. All devices were placed and removed in the office with comfort and ease of placement. No significant adverse Events were noted during the study.
The M3 “Mini Catheter” demonstrated a substantial reduction in infection rate over the 28 day period as compared to expected infection rates with either a Foley or CIC. (>95% vs 18%) The device is easy to place and remove and does not require an external collection device. The device was not spontaneously expelled or retrograde migration back into the bladder. The device was reported as comfortable with improvement on IPSS scores. No devices were removed due to discomfort, irritation, hematuria, encrustations, or inability to drain the bladder. No incintinence was reported in patients with a device placed proximal to the urinary sphincter. In conclusion: The M3 “Mini Catheter” has demonstrated in this pilot study, to be an attractive alternative device to either a Foley Catheter or Clean Intermittent Catheter for managing urinary retention in this group of patients.