Status:
TERMINATED
Efficacy And Safety Of The Uro-Ease® Urinary Catheter During Clean Intermittent Catheterization
Lead Sponsor:
Lahey Clinic
Collaborating Sponsors:
Spirus Medical, Inc.
Conditions:
Urinary Retention
Urinary Catheterization
Eligibility:
MALE
18+ years
Brief Summary
To evaluate the ease of use and comfort of a new urinary catheter, the Uro-Ease, as used in the Clean Intermittent Catheterization (CIC)process.
Detailed Description
Urinary retention can occur among men with Benign Prostatic Hypertrophy(BPH) or Neurologic co-morbidities. Many of these men are treated with Clean Intermittent Catheterization(CIC. For some, this ca...
Eligibility Criteria
Inclusion
- Male patients
- Urinary retention defined as \>150cc retained in bladder on post void residual
Exclusion
- Female patients
- Known urethral stricture
- Active symptomatic Urinary Tract Infection
- History of pelvic fracture or urethral disruption
- History of previous urethroplasty(urethral reconstructive surgery)
- Known Latex allergy
- Unable to physically perform CIC
- Unable to provide follow up
- Unable to give consent
- Currently taking chronic narcotic pain medication
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00804557
Start Date
October 1 2008
End Date
August 1 2010
Last Update
May 6 2011
Active Locations (1)
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1
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805