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

NCT03339076 | Unknown FDA Device

• 1 other identifier: Study # 17/10/04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Retention

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Failure of the M3 as a choice of bladder drainage over Foley Catheter or Self Intermittent Catheter drainage

  From time of Placement up to 28 days.

Study Arms (1)

For a single-arm trial

OTHER

Inclusion Criteria with intervention replacing either a foley catheter or self intermittent catheter with the M3 "Mini Catheter" 1. Males \> 50 years of age 2. Signed subject informed consent 3. Patients with actual urinary retention dependent on Foley Catheter or Intermittent Catheter 4. Inclusion will start once the M3 is placed and a functioning bladder is demonstrated. Exclusion Criteria 1. 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) 2. Gross hematuria 3. 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"

Interventions

M3 "MINI CATHETER" DEVICE

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."

For a single-arm trial

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males \> 50 years of age
• Signed subject informed consent (see Appendix "A")
• Patients with actual urinary retention dependent on Foley Catheter or Intermittent Catheter

You may not qualify if:

• 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).

Sponsors & Collaborators

• Dr. Gaines W. Hammond Jr. MD FACS: lead

Study Sites (1)

Watson Clinic Llp

Lakeland, Florida, 33805, United States

RECRUITING

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• GAINES W HAMMOND, MD

  Watson Clinic Center for Research, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GAINES W HAMMOND, MD

CONTACT

863-687-1322; GHAMMOND@WATSONCLINIC.COM

ELAYNE HALL

CONTACT

863-680-7300; EHALL@WATSONCLINIC.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: INVESTIGATOR - SPONSOR

Model Details: This single arm prospective study is designed to produce valid scientific evidence regarding safety and efficacy of the M3 in establishing urinary drainage and allowing the control of micturition when indwelling for \<28 days in male patients. The total study population will initially include 50 subjects with open enrollment of additional subjects. 1\. Study Timeline and Calendar The maximum indwelling time for the DEVICE should be \<28 days, at which time the DEVICE will be removed, and the patient will be offered the option of insertion of a new M3 Catheter or return to the bladder drainage technique used prior to M3 Catheter insertion. All patients will be followed until patient is off study or until end of study, whichever occurs first.

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 13, 2017
• Study Start: July 7, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: November 21, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After completion of the study anticipated to be in March 2018 for a 2 year period of time.
• Access Criteria: Appropriate credentials to access material with the identifying markers of patients identity withheld.

Locations

US (1)