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.

Study Overview

• Status: Unknown
• Conditions: Urinary Retention
• Intervention / Treatment: Device: M3 "MINI CATHETER"

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ELAYNE HALL; Phone Number: 863-680-7300; Email: EHALL@WATSONCLINIC.COM
• Study Contact Backup: Name: GAINES W HAMMOND, MD; Phone Number: 863-687-1322; Email: GHAMMOND@WATSONCLINIC.COM

Study Locations

• United States
  • Florida
    • Lakeland, Florida, United States, 33805
      • Recruiting
      • Watson Clinic LLP
      • Contact: GAINES W HAMMOND, MD; Phone Number: 863-680-7300; Email: GHAMMOND@WATSONCLINIC.COM
      • Contact: ELAYNE HALL; Phone Number: 863-680-7300; Email: EHALL@WATSONCLINIC.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: For a single-arm trial; Inclusion Criteria with intervention replacing either a foley catheter or self intermittent catheter with the M3 "Mini Catheter"; Males > 50 years of age; Signed subject informed consent; 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).

Device: M3 "MINI CATHETER"; Participants in the study are using either a foley catheter or Clean Intermittent Catheter devices to facilitate bladder drainage. The study is an alternative method of facilitating bladder drainage with the M3 "Mini Catheter."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of Catheter Acquired Urinary Tract Infections with the M3 Mini Catheter.	1.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.	Time of placement up to 28 days.
The percentage of M3 removed due to encrustation and blockage of the M3.	The percentage of M3 devices removed due to urinary retention caused by device encrustation.	Weekly from time of placement up to 28 days.
Measurement of Bladder Drainage	The Post Void Residual after M3 placement	Weekly from time of placement up to 28 days.
Flow Rate after M3 placement	The flow rate after M3 placement with a bladder volume of at least 120 cc.	At time of placement and weekly up to 28 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure of the M3 as a choice of bladder drainage over Foley Catheter or Self Intermittent Catheter drainage	The failure of the M3 to drain the bladder with the requirement to reinstitute Foley Drainage or Self Intermittent Catheter by choice versus M3 Mini Catheter	From time of Placement up to 28 days.

Collaborators and Investigators

• Sponsor: Dr. Gaines W. Hammond Jr. MD FACS
• Investigators: Principal Investigator: GAINES W HAMMOND, MD, Watson Clinic Center for Research, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: November 7, 2017
• First Posted (Actual): November 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 21, 2017
• Last Update Submitted That Met QC Criteria: November 18, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Urinary Retention
• Other Study ID Numbers: Study # 17/10/04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: There is a plan to make IPD and related data dictionaries available.
• IPD Sharing Time Frame: After completion of the study anticipated to be in March 2018 for a 2 year period of time.
• IPD Sharing Access Criteria: Appropriate credentials to access material with the identifying markers of patients identity withheld.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No