Status:
UNKNOWN
A Prospective Evaluation of the Catheter Science M3 "Mini Catheter" for Patients With Prostatic
Lead Sponsor:
Dr. Gaines W. Hammond Jr. MD FACS
Conditions:
Urinary Retention
Eligibility:
MALE
50+ years
Phase:
NA
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 contr...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03339076
Start Date
July 7 2017
End Date
March 1 2018
Last Update
November 21 2017
Active Locations (1)
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1
Watson Clinic Llp
Lakeland, Florida, United States, 33805