Recruiting

Catheter Science M3

Sponsor:

Dr. Gaines W. Hammond Jr. MD FACS

Code:

NCT03339076

Conditions

Urinary Retention

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Accepted

Interventions

M3 "MINI CATHETER"

Study Details

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

Study ID

NCT03339076

Start date

Jul 7, 2017

Status verified date

Nov, 2017

Completion date

Mar, 2018

Anticipated

Primary completion date

Mar, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 50+

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: For a single-arm trial

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).

Interventions

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."

Primary outcome measure

  • The percentage of Catheter Acquired Urinary Tract Infections with the M3 Mini Catheter. [ Time Frame: Time of placement up to 28 days. ]
  • The percentage of M3 removed due to encrustation and blockage of the M3. [ Time Frame: Weekly from time of placement up to 28 days. ]
  • Measurement of Bladder Drainage [ Time Frame: Weekly from time of placement up to 28 days. ]
  • Flow Rate after M3 placement [ Time Frame: At time of placement and weekly up to 28 days. ]

Central Contacts and Locations

Central contacts

GAINES W HAMMOND, MD

863-687-1322GHAMMOND@WATSONCLINIC.COM

ELAYNE HALL

863-680-7300EHALL@WATSONCLINIC.COM

Locations

Watson Clinic Llp

Recruiting

Lakeland, Florida, United States, 33805

Contacts

GAINES W HAMMOND, MD

863-680-7300GHAMMOND@WATSONCLINIC.COM

ELAYNE HALL

863-680-7300EHALL@WATSONCLINIC.COM

More Information

Sponsor

Dr. Gaines W. Hammond Jr. MD FACS

Last update posted

Nov 21, 2017

Last verified

Nov, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Gaines W. Hammond Jr. MD FACS on 2017-11-21.