Use of a Urethral Catheter Immobilization Device to Reduce Pain and Discomfort Associated With Catheter Mobility in Post-Prostatectomy Patients

Status: Withdrawn
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
Boston
Time Frame
Start Date: 2018-04-01
Completion Date: 2018-08
Treatments
Experimental: Urethral catheter immobilization
Subjects randomized to the intervention group will undergo radical prostatectomy with placement of the urethral catheter per the standard of care. The urethral catheter immobilization device will be applied in the operating room prior to the patient being transported to the recovery room. Subjects will be informed on safe use of the device and must demonstrate competency in removing and replacing the device prior to discharge. Subjects will also be given an elastic leg strap, which they may use concurrently with the device. Subjects will attend routine follow up appointments with their surgeon for removal of the urethral catheter and void trial per standard of care, at which the device will no longer be needed.
No_intervention: No urethral catheter immobilization
Subjects randomized to the control group will undergo radical prostatectomy with placement and securing of the urethral catheter per the standard of care. The catheter will be secured to the leg using cloth tape. Subjects will also be given an elastic leg strap that they may use following discharge, as is routine. Subjects will attend routine follow up appointments with their surgeon for removal of the urethral catheter and void trial per standard of care.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov