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

NCT03339076 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2017-11-21

No results posted yet for this study

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

Interventions

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."

Sponsors & Collaborators

  • Dr. Gaines W. Hammond Jr. MD FACS

    lead INDIV

Principal Investigators

  • GAINES W HAMMOND, MD · Watson Clinic Center for Research, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-07
Primary Completion
2018-03-31
Completion
2018-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03339076 on ClinicalTrials.gov