Status:
WITHDRAWN
Urethral Catheter Immobilization Device to Reduce Catheter-Related Discomfort
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Urinary Catheter-Related Discomfort
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This is a randomized controlled study to determine the efficacy and safety of a patented urethral catheter support device designed to reduce discomfort associated with urethral catheter mobility in ma...
Detailed Description
Indwelling urethral catheters are a source of discomfort and pain in males, particularly when in place for extended periods of time. All patients require catheterization for a minimum of 10 days follo...
Eligibility Criteria
Inclusion
- Patients scheduled to undergo radical prostatectomy at the Massachusetts General Hospital
- Anticipated intra-operative placement of an 18 or 20 French, latex or silicone urethral catheter at the conclusion of the operation (standard of care)
- At least 18 years of age
Exclusion
- Inability to speak, read or understand English
- Apparent sore, rash, or infection on the penis
- Anatomic abnormalities that would prevent proper application and use of the device
- Patients with significant physical or mental disability that, in the opinion of the treating surgeon, might prevent safe placement or removal of the device, or completion of the symptom-based survey.
- Patients with fragile skin
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03341468
Start Date
April 1 2018
End Date
August 1 2018
Last Update
May 26 2021
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114