Clinical trial NCT03341468: Urethral Catheter Immobilization Device to Reduce Catheter-Related Discomfort
Official title: Use of a Urethral Catheter Immobilization Device to Reduce Pain and Discomfort Associated With Catheter Mobility in Post-Prostatectomy Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
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
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Urethral catheter related pain/discomfort
timeFrame: At follow-up visit for foley removal (10 days after surgery)
Secondary outcomes:
measure: Adverse events secondary to urethral immobilization
timeFrame: Through post-operative day # 1 and at follow-up visit for foley removal (10 days after surgery)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital, Department of Urology
name: Shahin Tabatabaei, MD
role: PRINCIPAL_INVESTIGATOR
References: