A Kinder Gentler
Solution for Post-Surgical
Catheterization
by Barry K. Jarnagin, MD
P
hysicians and their patients have been well served by the recent innovations that have
revolutionized the treatment of urinary incontinence and pelvic surgery; however, few developments have
dramatically improved post-operative (post-op) urinary management since the introduction of the Foley
catheter in 1935.1 There is scarcely better support for this position than the prevalence of cases in which
the patients’ predominant concerns are directed toward post-op care rather than the comparative risks
inherent to surgical intervention.
Ironically, apprehension regarding postsurgical catheters and urine bags typically overshadows what
would logically be far more serious mortality and morbidity concerns associated with general anesthesia,
significant blood loss, or other surgical complications.2,3
Figure 1. Optimal urinary-management decision process
Physical management modalities for urinary retention, whether the condition is post-procedural (e.g.,
female pelvic surgery) or otherwise occurring (e.g., benign prostatic hypertrophy, prostatitis), can be
classified as either intermittent or indwelling, with various catheter options available within each
classification. It is a reality of our healthcare delivery system that routine treatment of postoperative
urinary retention often defaults to utilizing a traditional Foley catheter with accompanying tube and bags.
However, selection of the optimal urinary management modality properly derives from consideration of
several important factors, and follows a decision process as shown in Figure 1.
Looking at these criteria with an understanding of their importance to patients shows that serious
consideration should often be given to urinary management using a valved catheter.
Valved urinary management
Practices approximating valved urinary management, including the use of Foley catheter plugs,
stopcocks, rubber bands, and other occlusion methods, have been commonly employed in the United
States despite the previous lack of devices cleared by the Food and Drug Administration (FDA) for valved
urinary management.
Recently, a series of valved urinary catheters (OPTION-v, Opticon Medical) was developed for this
indication. These catheters are available as gender-specific, 100% silicone disposable devices (Figures
2, 3).
Figure 2. OPTION-vf female catheter (reprinted with
permission from Opticon Medical)
OPTION-v valved urinary catheters incorporate many of the desirable attributes of both indwelling and
intermittent catheters because they eliminate the need for external urine collection bags while having the
benefit of not requiring multiple daily urethral reinsertions. Each catheter incorporates an external
drainage valve, integral with the distal end of the catheter, and a teardrop-shaped retention and sealing
balloon disposed just distal to the drainage eyelets at the proximal tip of the catheter. Upon insertion, the
teardrop-shaped balloon is inflated and seated so as to occlude the urethra at the bladder neck, allowing
urine to be stored normally in the bladder. Upon sensation of urge to void, or in compliance with a
prescribed voiding plan, the patient or caregiver manually actuates the catheter drainage valve to provide
on-demand drainage of the stored urine through the catheter (Figure 4).
Figure 3. OPTION-vm male catheter correct. (reprinted with permission from Opticon Medical)
When bladder emptying is complete, the drainage valve closes automatically upon release, and urine
begins to collect again in the bladder. The drainage valve design also protects against leaking and
accidental actuation so that urine drainage occurs only when intended. As with intermittent
catheterization, and contrary to continuous drainage using a Foley catheter, valved catheter management
preserves the detrusor cycling and bladder washout characteristics inherent to the normal bladder filling
and voiding cycle. While the importance of this remains controversial, many clinicians believe this
preservation is clinically important for rapid return of bladder function.4,5
Figure 4. Manually actuate valve for on-demand drainage.
For instances (e.g., immediately postop) when temporary continuous drainage would provide an added
convenience or treatment advantage, the OPTION-v series includes a continuous drainage adaptor
(CDA). While connected to the catheter, the CDA maintains the drainage valve in its open state and
allows a standard urine drain bag to be connected for the continuous drainage period (Figure 5). Once
valved management is desired, the CDA is simply unsnapped and disconnected from the catheter
drainage valve, allowing it to close, and the patient begins to collect urine in his/her bladder.
Clinical validation
Figure 5. Continuous drainage adaptor
To investigate the safety and efficacy of valved urinary management, a randomized, controlled clinical
trial compared valved urinary catheter management with silicone Foley catheterization in a population of
adult female patients, most requiring catheterization following incontinence or other pelvic surgery.6 The
incidence of significant
bacteriuria in both groups was equivalent and clinically typical of the intended-use population,7,8
compelling evidence that the external catheter drainage valve provides a system effectively closed
against microbial ingress. Post-void residual volumes were also shown to be equivalent and clinically
negligible in both groups, demonstrating the effectiveness of the valved catheter (and patient) in providing
complete clearance of the bladder upon intentional emptying.
Significant quality-of-life (QOL) differences between valved and Foley management cohorts were also
apparent in the study results. Patient responses from the valved catheter group were significantly more
favorable than from the Foley group regarding ease of mobility, patient comfort, freedom from sleep
disruption, social comfort or freedom from self-consciousness around others, and the ability to easily
shower and dress.
Patient satisfaction and quality of life
Ongoing clinical usage of OPTION-v catheters has provided additional validation of the clinical and
QOL benefits available through valved catheter management. Patients with previous Foley system
experience greatly appreciate the comfort of the valved catheter without tubing or bag and the mobility
that it affords. In brief consultation, it becomes intuitively obvious to patients that by the simple elimination
of cumbersome Foley system bags and tubes, a valved catheter would provide protection against
catheter traction discomfort and freedom from various urine bag problems such as spills, foul odors, and
the need for bag emptying and cleaning. It also offers an element of human dignity that cannot be
underestimated.
Less obvious, but arguably more significant in light of its pervasiveness throughout the perioperative
period, is the stress-relieving effect from the use of valved catheters for properly qualified patients, and
the freedom of increased mobility that the patients can enjoy. Consider a typical case in which a female
patient with incontinence and prolapse has been scheduled for surgery:
Pre-op: The patient’s principal concern is whether she will have to wear a catheter and urine bag
home following the procedure. You show her the valved catheter, describe how it functions, and explain
that she can avoid the Foley tubing and urine bag if she periodically actuates this catheter’s valve to drain
her bladder for several days after surgery. She demonstrates her understanding by squeezing the valve
as she would to drain, then enjoys the relief and peace of mind that come from having avoided her
greatest concern.
Post-op: Immediately post-op the patient can avoid the stress and often long delays associated with
voiding trials and focus upon preparing to return home to relax from the worries of surgery. With the
valved catheter she can get back to the simple activities of daily living, enjoy unfettered mobility and
untethered sleep. She can enjoy the dignity of near-normal voiding and receive visitors without concern
for urine bag visibility, odor, or leakage. She can also travel in social circumstances sooner and more
comfortably due to the lack of unsightly and uncomfortable tubing and bag.
Patients’ own comments are perhaps the most direct measure by which we can assess whether the
purported QOL benefits of a given product or therapy have been successfully delivered. The following
quotations are excerpts from the comment sections of valved-catheter clinical evaluation forms and
patient notes:
● “It helped me by the freedom it gave me.”
● “I would not have dreaded surgery as much if I had known about the valved catheter before the
surgery.”
● “I told [my friend] that the [valved] catheter would certainly be much better than using a Foley and a leg
bag.”
● “I would not have gone out to eat a few days after surgery if I had not had the [valved] catheter.”
● “I just finished doing a brick paver patio at my house. I was able to do it with [the valved] catheter in, I
would have never have done it with a leg bag attached to me and a long hose under my clothes.”
Patient management and practice benefits
Not all of the advantages of valved urinary management accrue to the patient. Physicians and
clinicians can realize substantial mutual benefit for the duration of the catheterization period through
promotion of greater efficiency and convenience in patient interaction leading to improved relationship
with the patient. An immediate benefit for the nursing staff is the elimination of patient training time to
teach intermittent self-catheterization or provide instruction about the periodic emptying, cleaning, and
replacement of urine drain bags. Valved-catheter patient training is, in essence, instructing the patient to
properly actuate the drainage valve when he feels the urge to void or at a prescribed interval. In some
instances, initial voiding trials can be eliminated by the routine placement of valved catheters following
procedures that often result in retention. Not only does this placement provide for efficient care, but it also
eliminates the 2:00 a.m. phone call because the patient has developed retention after having passed a
voiding trial before discharge, and the patient avoids a trip to the emergency room.
Early ambulation following surgery is well known for its association with both substantial clinical
benefits to patient outcome and practical patient management efficiencies for the facility and staff. As
compared to continuous urinary drainage systems, valved urinary catheters provide improved patient
mobility and elimination of potential physical hazards linked to the external urine bag and tube system.
Valved catheter patients tend to feel less encumbered and self-conscious, and thus can sooner achieve
the early ambulation benefits of improved bowel function, reduced post-op pain, and thrombus
prevention. A recent practice bulletin published by the American College of Obstetricians and
Gynecologists (ACOG) specifically identified “getting patients out of bed and walking as soon as possible
after surgery” as a simple and effective component of therapy in the prevention of deep vein thrombosis
(DVT) and pulmonary embolism (PE). ACOG also noted that “a significant number of lives can be saved
by providing relatively simple and safe preventive treatments” for the 2 million Americans diagnosed with
DVT, of whom approximately one third develop a PE, resulting in 60,000 deaths per year.9
Opportunity for broadened application
While valved catheters have achieved early adoption for male and female post-op care and acute
urinary retention, there remains great potential for application of their clinical advantages in selected other
management cases. The mobility benefits and urinary-bag hazard elimination has apparent application in
rehabilitation and nursing facilities to promote improved patient compliance with rehab protocols and
possible reduction in urinary-bag related accidents or trauma.10
Given the clear success demonstrated with post-surgical use, it would be logical to also investigate the
use of valved catheters for longer-term urinary management in properly qualified populations. To date,
valved urinary catheters have been used in isolated cases for extended-term urinary management and
have been highly successful in both urethral and suprapubic placements.
They have been shown anecdotally to reduce some commonly observed problems reported with longerterm indwelling catheter use, including rapid encrustation, balloon distension “memory” causing cuffing
and discomfort upon removal, latex associated sensitization including granulomatous stoma, and other
issues.2 In several European studies, chronic Foley-catheterized patients indicated strong preference for
the use of attachable valves attached to the ends of Foley catheters, despite having difficulties with valve
disconnections and requirements for frequent replacement of disposable valves or periodic boiling of
reusable valves. It would seem a valuable research objective to determine whether the observed clinical
benefits and strong preference for valved catheters remain consistent for long-term catheter use.
Summary
Use of valved catheters is preferred to other urinary management methods and brings important
benefits to a wide range of post-surgical and non-surgical patients who may have urinary retention. While
a large segment of patients are excellent candidates, specific factors indicate that valved catheters should
not be employed in those for whom continuous drainage is required or reliable emptying is not assured.
Concerns about heightened infection risk have not been substantiated in controlled studies; however,
patient satisfaction with valved catheters and benefits to quality of life, comfort, mobility, stress reduction,
and dignity have been clearly demonstrated through clinical validation and patient testimony.
An explanation of valved catheterization at the pre-surgical consult can alleviate patient anxiety about
urinary bag issues and reduce post-op patient training and voiding trial requirements. The recovery period
is then characterized by reduced patient stress, early ambulation, and the opportunity for earlier
discharge. Once patients with valved catheters are home, they and their physicians remain free from
anxiety and concerns about delayed-onset retention, collection-system maintenance, and bladder
performance. As substantiated by both a randomized study and patient testimony, patients with a valved
catheter will ambulate earlier and more often, which improves the overall post-op period and reduces risk
of complication.
Despite all of the noted advantages of the valved catheter, it is currently underutilized. This is largely a
result of lack of knowledge concerning the catheter’s availability and ease of use, and the requirement for
a change of routine (away from utilizing the traditional Foley catheter and bag) by the physician. I utilize
the valved catheter in virtually every surgical patient for whom there is a likelihood of short term urinary
retention. Patients routinely comment on their preference for the valved catheter over the traditional
catheter; many of these patients have been referred to me for recurrent prolapse and have experienced a
traditional catheter in the past. I routinely hear the relief expressed by patients when they realize that they
will not have a traditional catheter, and I know that
I have improved their overall experience.
As we have advanced in surgical procedures and moved toward more minimally invasive approaches,
we should also advance our management of post-op urinary retention and utilize a less-invasive (in the
sense of invasiveness emotionally perceived by our patients) approach. The valved catheter should be
routinely considered for application among patients who are good candidates for its use.
References
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3. Barron KI, Savageau JA, Young SB, Labin LC, Morse AN. Prediction of successful voiding immediately after outpatient midurethral sling. Int Urogynecol J Pelvic Floor Dysfunct. 2006;17(6):570-575. Epub 2006 Apr 1.
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