Impact of Atkinson Product Design Urinary Slide Valve Versus Standard Catheter Drainage System on Social Functioning
NCT01063452 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2017-01-05
Summary
The primary objective of this study is to evaluate the impact of the Atkinson Product Design urinary slide valve on patient morbidity and freedom as measured by impact on activities of daily living (ADL) and quality of life (QOL). Secondary objectives include assessing the impact of the device on bacteruria and evaluating the impact of the primary treatment on ADL and QOL.
Conditions
- Urinary Catheterization
- Urinary Tract Infections
Interventions
- DEVICE
-
Truvalve
Atkinson Product Design urinary slide valve
- OTHER
-
Control (catheter drainage bag)
urinary catheter drainage bag
Sponsors & Collaborators
-
The Cleveland Clinic
lead OTHER
Principal Investigators
-
Manoj Monga, MD · University of Minnesota
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-02-28
- Primary Completion
- 2010-02-28
- Completion
- 2010-02-28
Countries
- United States
Study Locations
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