Urethral Catheter Immobilization Device to Reduce Catheter-Related Discomfort

NCT ID: NCT03341468

Last Updated: 2021-05-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2018-08-31

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 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.

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 following radical prostatectomy. Currently, catheters are secured to the patient's leg using tape or an elastic leg strap. This point of securing, however, allows the tip of the penis and the urethral meatus to move in different vectors from the catheter. Data demonstrating urethral catheter hypermobility as an etiology of pain and discomfort have not been reported. However, clinical experience suggests that this type of catheter mobility is associated with significant discomfort.

It is predicted that the use of an external urethral catheter immobilization device (Patent: Simpson et al., US8500719, 2013) designed to secure/minimize catheter movement relative to the tip of the penis will greatly improve catheter associated pain and discomfort in men undergoing radical prostatectomy. The catheter immobilization device is an FDA-approved, 510(k) exempt, pliant tubular structure comprised of Suprazote Foam (Zotefoams) that surrounds the penile shaft. The foam support has a rigidity greater than that of the flaccid penis. It is bi- lobed (i.e., two identical halves) that hinge together to close around the tip of the penis with an aperture aligned with the urethra. The catheter extends through this opening and is secured to the device does not alter the urethral catheter in any fashion. The device limits catheter movement radial to the axis of the catheter. This, in turn, keeps the catheter in line with the urethra, reducing abrasion and traction to the meatus and urethra.

To test the hypothesis, a randomized-controlled trial will be performed in male patients who underwent radical prostatectomy. These men will be randomized to two arms: one arm will have the device fitted around their catheter after surgery is complete while the other will not have the device fitted. Outcome measures involving catheter-related pain and discomfort will then be assessed until the urethral catheter is removed per standard of care after radical prostatectomy.

Conditions

Urinary Catheter-Related Discomfort

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Urethral catheter immobilization

Intervention Type: DEVICE

Subjects assigned 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.

Subjects will be asked to fill out a symptom-based questionnaire prior to leaving the office. This will conclude their participation in the study.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Urethral catheter immobilization

Subjects assigned 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.

Subjects will be asked to fill out a symptom-based questionnaire prior to leaving the office. This will conclude their participation in the study.

Intervention Type: DEVICE

Other Intervention Names

Indwelling urethral catheter support

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shahin Tabatabaei

Assistant Professor of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shahin Tabatabaei, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital, Department of Urology

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2017P001343

Identifier Type: -

Identifier Source: org_study_id