Urethral Catheter Immobilization Device to Reduce Catheter-Related Discomfort

NCT03341468 | Withdrawn FDA Device

• 1 other identifier: 2017P001343
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Catheter-Related Discomfort

Keywords

Urethral catheter discomfort; Urethral catheter pain; Urethral catheter immobilization device; Prolonged urethral catheterization; Foley catheter; Urinary catheter; Indwelling urethral catheter support

Outcome Measures

Primary Outcomes (1)

• Urethral catheter related pain/discomfort

  To be assessed via a proprietary questionnaire that is multiple choice and designed to determine the nature of catheter related pain/discomfort. Pain is to be measured on a scale of 1 to 10. Subsequent descriptions of the pain (location, aggravating factors, relieving factors, etc.) and impact are to be answered as multiple choice questions so as to structure the responses without limiting the response.

  At follow-up visit for foley removal (10 days after surgery)

Secondary Outcomes (1)

• Adverse events secondary to urethral immobilization

  Through post-operative day # 1 and at follow-up visit for foley removal (10 days after surgery)

Study Arms (2)

Urethral catheter immobilization

EXPERIMENTAL

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.

Device: Urethral catheter immobilization

No urethral catheter immobilization

NO INTERVENTION

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.

Interventions

Urethral catheter immobilization 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.

Also known as: Indwelling urethral catheter support

Urethral catheter immobilization

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Shahin Tabatabaei, MD

  Massachusetts General Hospital, Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urology

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: November 14, 2017
• Study Start: April 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)