Urethral Catheter Immobilization Device to Reduce Catheter-Related Discomfort

Withdrawn before enrolling · Not applicable

Conditions studied: Urinary Catheter-Related Discomfort

In brief

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 males. Movement of a catheter within the urethra is a source of discomfort for patients. The investigators hypothesize that this discomfort can be reduced by using an external device designed to securely fasten the catheter to the penis.

Key facts

Study ID

NCT03341468

Run by

Massachusetts General Hospital

People needed

0

Starts

2018-04-01

Expected to finish

2018-08-01

Last updated by the study team

2021-05-26

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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