A Prospective Evaluation of the Catheter Science M3 "Mini Catheter" for Patients With Prostatic
Status unconfirmed · Not applicable
Conditions studied: Urinary Retention
In brief
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.
Key facts
- Study ID
- NCT03339076
- Run by
- Dr. Gaines W. Hammond Jr. MD FACS
- People needed
- 50
- Starts
- 2017-07-07
- Expected to finish
- 2018-03-01
- Last updated by the study team
- 2017-11-21
Who can join
Age: 50 and older. Sex: male. Healthy volunteers: accepted.
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
- Inclusion will start once the M3 is placed and a functioning bladder is demonstrated.
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).
Where it is running
- Watson Clinic Llp — Lakeland, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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