Incontinence is the loss of control of urination resulting in involuntary loss of urine. It affects people of all ages and both sexes. It is a condition that affects an estimated 10 million Americans. This educational program will be focusing on male urinary incontinence. We will describe an innovative approach to the management of incontinence in men.

This educational program has been developed to introduce you to a revolutionary advance in the management of male urinary incontinence, the wide band silicone external condom catheter. The design and superior performance of this silicone catheter is so unique that it should replace all latex external condom catheters.

There are seven objectives of this educational program (Table 1). First, we will be reviewing the indications for the use of external condom catheters. Second, we will be describing the desirable attributes of an ideal external condom catheter. Third, we will be reviewing the unique design configuration of the wide band silicone external condom catheter that accounts for its successful performance. Fourth, we will be comparing the biomechanical performance of silicone external condom catheter to that of latex external condom catheters. Next, we will recommend innovative techniques for the application and removal of this silicone external condom catheter in the healthcare setting. This management system for silicone external condom catheters will then be compared to that of latex external condom catheters. Finally, we will discuss a new adjunct to the silicone external condom catheter.

External condom catheters are valuable in managing selected male patients with incontinence. The decision to use external condom catheters must be made with your primary care physician and urologist. Incontinent male patients using external condom catheters must have complete emptying of their bladders with no residual urine collecting in the bladder after voiding. Bladder emptying must not be associated with retrograde passage of urine through the ureter to the kidney.

Desirable Attributes of the Ideal External Condom Catheter

The design configuration of the ideal external condom catheter must have the following five desirable attributes. First, it must have a structural configuration that conforms to the anatomical configuration of the penis. Second, it must have an adhesive attached to its inner surface that bonds to the skin of the penis. Third, the catheter must be transparent so that one can visualize skin injury. Fourth, the catheter must be able to elongate and retract during penile erection. Fifth, the external condom catheter should cause no local or systemic allergic reactions.

Unique Design Configurations of the Silicone External Condom Catheter

This new external condom catheter is made of silicone, an industrial polymer used during the last 80 years. Physicians have safely used tubes, catheters and drains made of silicone in billions of patients without adverse effects. The silicone catheter with its self-adhesive

is transparent allowing visualization of the underlying penile skin. Note the location of the glans of the penis and the skin convolutions covered the by silicone catheter. The load elongation properties of the silicone catheter resemble that of skin. It remains attached to the penis when its shaft is short. As the penile shaft elongate during erection, the silicone external condom catheter remains attached to penile skin. The adhesive of this silicone external condom catheter has been positioned in two unique locations in the catheter. This positioning of the adhesive considerably influences its performance. When the silicone external condom catheter is removed from its package, you will note that its adhesive is adherent to the rim of the external catheter. This strategic location considerably facilitates positioning of the product on the glans of the penis. This adhesive on the rim of the external condom catheter is protected by a plastic cone fitted into the silicone external condom catheter.

It is important to emphasize that the adhesive coats the entire length of the shaft of the silicone external condom catheter, approximately 10 cm. This long length of adhesive along the shaft of the silicone external condom catheter accounts for its secure adherence to the skin of the shaft of the penis. Note that the adhesive extends the entire length of the shaft of the external condom catheter, maintaining apposition of the catheter end to the penile skin. If the adhesive did not extend to the catheter end, the end of the catheter will curl up causing potential injury to the scrotum.

Biomechanical Performance of the Silicone and Latex External Condom Catheters

The performance of the latex and silicone external condom catheters have been compared by standardized biomechanical studies as well as a clinical outcome study. The biomechanical performance of silicone and latex external condom catheters has been determined by two standardized measurements of strips of these catheters. These measurements include peel adhesion, and water vapor transmission.

The results of these studies provide a valuable scientific basis for selecting an external condom catheter.

The silicone and latex external condom catheters have been described as self-adhesive because an adhesive lines portions of the internal surface of these catheters. The bond between the adhesive and the skin has been determined by measurements of the peel adhesion of measured catheter strips to human skin. Peel adhesion measurements provide insight into how aggressively the external condom catheter adhesive binds with human skin. In this study, we also examined if warming the external surface of the catheter with a warm cloth could reduce adhesion. Before this measurement, a strip of each external condom catheter was uniformly pressed against the skin and allowed to remain in place for one hour.

One half of the latex and silicone external condom (Fig. 1- Peel Measurements Adhesion) catheter strips were warmed for five minutes with a wet towel. One hour later, the forces required to peel the strips off of the skin were recorded (Fig.1). The order of performing peel adhesion measurements was randomly assigned. The results of these measurements have been graphically displayed for you. The peel adhesion of the dry silicone strips was significantly greater than that of the latex strips. In addition, warming the surface of the silicone strip with a wet cloth markedly reduced its peel adhesion. Warming the surface of the latex strip with a wet cloth had no demonstrable effect on it adhesion. These measurements indicate that the adhesive bond of the silicone catheter is more secure than that of the latex catheter. However, the strong adhesive bond of the silicone catheter to skin may be reduced by applying a warm, wet cloth to its surface. Later, we will show you how warming the external surface of silicone external condom catheters with a warm wet cloth can facilitate its removal in a patient.

Water evaporates from all skin surfaces of our body. Coverage of skin by an occlusive impermeable membrane prevents this evaporative water loss allowing condensation of water vapor on the skin surface with subsequent skin maceration. Collection of fluid on the skin surface is an invitation for bacterial growth and skin infection (Fig.2, see right). Consequently, water vapor transmission was measured after application of either latex or silicone external condom catheter strips. The silicone external condom catheter strip encouraged water vapor transmission. Water vapor transmission through silicone was nearly two fold more than through latex.

Table 2: Pilot Clinical Study (100 trials of either the silicone or latex external condom catheter)
	Latex	Silicone
Catheter Pop-off	12%	1%
Adverse Reaction	1%	--

The clinical performance of the silicone external condom catheter and the latex external condom catheter was tested in a pilot clinical study involving five volunteers (Table 2). The performance of each catheter was judged by two clinical measurements: security and adverse reactions. These external condom catheters were subjected to one hundred clinical trials. Pop-off or dislodgement of the latex external condom catheter was encountered in 12 instances. Silicone catheter pop-off was only encountered in one instance. Moreover, one volunteer experienced scrotal irritation at the site of the curled end of a latex external condom catheter conversion. When the volunteer developed this scrotal irritation, it disappeared after using the silicone external condom catheter.

Technique of Application and Removal of Silicone External Condom Catheter

We will now describe the use of the silicone external condom catheter in a healthcare setting. Our approach to the application and removal of the silicone external condom catheter involved the careful selection of a variety of important healthcare products that will considerably facilitate the use of the silicone external condom catheter. Application of the silicone external condom catheter in a healthcare setting involves two important steps:

1. Institution of universal precautions
2. Skin preparation

Institution of universal precautions

Universal precautions are instituted to prevent transmission of pathogens to the healthcare worker and other patients. Transmission of pathogens usually occurs by spillage and splashing of urine that occurs during application and removal of external condom catheters. Consequently, healthcare workers must wear protective eyewear and examination gloves.

Anti-fog spectacles or goggles protect the healthcare worker from any droplet contamination during application and removal of the external condom catheter. The healthcare worker first positions the protective spectacle or goggle over the eyes. Note that each spectacle has a transparent splash-guard. The lightweight spectacles are secured to the head by an adjustable tightening strap attached to both arms of the glasses.

Powder-free, latex-free gloves are used to protect healthcare workers hands from the transmissible pathogens. Powder-free nitrile gloves are ideally suited for the application and removal of external condom catheters. Select a nitrile glove that is certified

by the National Fire Protection Association. Gloves approved by the National Fire Protection Association must pass a battery of tests that include tests of viral penetration through gloves. The boxes of examination gloves approved by the National Fire

Protection Association are appropriately labeled. Powder-free, nitrile gloves are examination gloves designed for single use only. The gloves are manufactured to be ambidextrous and can fit comfortably on either hand. Even though examination gloves are not form fitted like sterile surgical gloves, they conform to the configuration of the healthcare worker’s hands. They are available in four different sizes: small, medium, large and extra-large.

Biomechanical tests have demonstrated the superior performance of nitrile examination gloves as compared to latex examination gloves. The thickness of the nitrile gloves is half that of latex gloves. Healthcare workers wearing the thin nitrile gloves have better tactile discrimination than with latex gloves. In addition, the puncture resistance of the thin nitrile gloves is two fold greater than the thicker latex gloves. Finally, the force required for the healthcare worker to don the latex and nitrile examination gloves are remarkably similar.

Skin preparation

Preparation of skin around the genitalia is accomplishedfirst with atraumatic hair removal. Hair removal must be accomplished by a surgical clipper with a single use blade assembly that eliminates the need for cleaning and reduces he risk of cross-contamination (Fig.3). An additional advantage of hair removal is that it considerably facilitates skin cleansing. A skin cleansing agent must be selected that removes hair, dirt and debris without interfering

A surgical clipper with its clipper blade assembly is used to remove body hair from the skin around the genitalia in preparation for application of the external condom catheter.

The rechargeable, cordless models of electric clippers are lightweight and convenient for use. After removing the surgical clipper from its charging cradle, the clipper blade

assembly is attached to the surgical clipper. Note that the clipper blade assembly can be rotated to achieve the precise angle for clipping hair. The surgical clipper clips hair without knicks or cuts.

The skin should be cleansed with a sterile surfactant, poloxamer 188, that is marketed as Shur-Clens ™. This surfactant is so safe that it can be poured into an individual’s eyes without irritation. It has washed the wounds of millions of patients without an adverse effect. The skin should then be thoroughly washed with water to remove the surfactant from the skin’s surface. The skin surface must now be dried with a clean dry towel. Do not use lotion, powders or emollients on the penis or in the water because they will impair adhesion.

Application

Application of the silicone external condom catheter is achieved in seven steps. We will now review each of these steps with you during the application of the silicone external condom catheter to an individual with incontinence. We encourage you to explain the application procedure to your patient if your patient will be involved in his own care. It will be important that he knows how to apply the catheter so that he can assume responsibility for self-care as early as possible. This catheter is appropriate for situations in which catheter changes are required everyday. The catheter is cost effective and offers unique features which ensure ease of use and patient comfort.

Because the silicone external condom catheter is available in five sizes, it is important that the proper size be selected. To help you determine the appropriate catheter size, use the catheter sizing guide. The soft cardboard catheter sizing guide consists of five cut-out sections that illustrate the circumference measurements of the penis. Each circumference measurement is color-codedcorresponding to the appropriate sized silicone external condom catheter. Position the different sections of the sizing guide snugly around the shaft of the penis behind the glans. Note that the green sizing guide section fits most comfortably around the penis shaft. Discard the used sizing guide immediately. The size should be noted in the medical record.

The silicone external condom catheters are packaged in clean plastic packages. The manufacturers have produced the external condom catheter in five different sizes listed on the packages (Table 3). The size is color-coded and corresponds to the color identified on the measuring device.

Because the color code on the sizing guide corresponds to the colored bar on the clean plastic package, the healthcare worker can easily identify the appropriate size silicone external condom catheter.

Each clean package, containing a silicone external condom catheter, has a perforated edge that allows the healthcare worker to tear open the bag easily along these perforations. After removing the silicone external condom catheter from the package you will note that each silicone catheter is positioned on a plastic cone that protects the adhesive on the rim of the unrolled catheter.

Squeeze the silicone catheter between your right thumb and index finger at the tip of the plastic cone causing the silicone catheter to separate from the cone. After the catheter separates from the cone, remove the plastic cone with your left hand and discard.

The application technique of wide band silicone external condom catheter to the penis can be viewed in the following three photographs: positioning of catheter (Fig.4), unrolling of catheter (Fig.5), and bonding catheter adhesive to skin (Fig.6).

Fig. 4 - Positioning the Catheter

Fig.5-Unrolling the Catheter

Fig. 6- Bonding catheter to the skin

Holding the silicone external condom catheter in your right hand, position it on the skin of the glans of the penis (Fig.4). The adhesive on the rim of the silicone external condom catheter bonds to this skin allowing the catheter to be positioned accurately. The transparent catheter allows you to see the meatus of the urethra in the center of the glans.

By applying gentle pressure between your right thumb and index finger, you can grasp the glans of the penis and apply gentle counter traction to the penile shaft. With your left thumb and index finger, unroll the silicone external condom catheter along the penile shaft (Fig.5). Catheter unrolling ends when the soft end of the catheter is secured to skin. After application of the catheter, you may note that the length of the penile shaft may shorten. As the skin of the penile shaft shortens, the silicone catheter will assume gentle convolutions that correspond to the skin undulations. The transparent catheter allows you to visualize the urethral meatus, glans and penile shaft.

After unrolling the catheter, grasp the penile shaft between the palm of the hand and your index, middle, ring and small fingers (Fig.6). This compression of the catheter seals the catheter adhesive to the skin. Maintain this gentle compression of the external condom catheter for approximately 30 seconds.

Connect the end of the silicone catheter to the Christmas tree plastic adapter of the plastic tubing that connects to the leg bag. Gentle force must be applied to the silicone tubing to allow it to slip over the adapter.

Removal

On the basis of our studies of the biomechanical performance of silicone external condom catheters, we have devised a simple four-step approach to external condom catheter removal. In our experience, our removal technique is safe and comfortable to the patient.

Fig.7-Disconnect the Plastic Connector of the Leg Bag Tubing

Fig.8-Apply Warm Wet Cloth to Silicone External Condom Catheter

Fig.9-Apply Gentle Constant Traction to the Outlet of the External Condom Catheter

Fig.10-Cleans Surface of Genitalia Skin

You must first disconnect the end of the silicone external condom catheter from the plastic Christmas tree adapter of the leg bag tubing (Fig.7). Gentle forces applied in opposite directions will disconnect the outlet of the catheter from the adapter of the leg bag tubing.

Previous biomechanical performance studies demonstrated that the adhesion of the silicone catheter to skin was markedly reduced by applying a warm wet cloth to the outside of the silicone external condom catheter (Fig.8). In our clinical experience, this reduction in adhesion of the silicone external condom catheter to skin can be achieved in three to six minutes.

Gentle constant traction is applied to the outlet of the external condom catheter(Fig.9). Within 15 to 30 seconds, this traction begins to separate the silicone catheter from the underlying skin. As the adhesive bond begins to fail, the silicone external condom catheter will begin to advance off the penile shaft. At this point, regrasp the external condom catheter close to the urethral meatus and reapply traction. This continued repositioning of your hands prevents rapid recoil of the catheter toward the healthcare worker, an invitation for unnecessary spillage and splashing of urine. Discard the external condom catheter.

Wash the skin surface with a clean wet cloth to remove any residual adhesive (Fig.10).

Heretofore, most healthcare workers removed the external condom catheter by peeling it back off the skin. The fingernail can abrade or cut the skin as the catheter is separated from the skin surface. Even the gloved fingertip can inadvertently roll the skin edge up against the catheter causing skin abrasion. In addition, these events may be exquisitely painful to the patient causing some individuals to keep their catheters in place for a prolonged period of time, an invitation to skin maceration and urinary tract infection.

Disadvantages of the Latex External Condom Catheters

There are notable disadvantages of the latex external condom catheters that caused us to discontinue their use. We now use only the silicone external condom catheter.Unlike the silicone external condom catheter, the latex external condom catheter has no adhesive on the rim of unrolled catheter. Consequently, it takes considerable dexterity to position the catheter.

A previous pilot clinical study demonstrated that the frequency of catheter pop-off was considerably greater with latex external condom catheters than with silicone external condom catheters. This failure of latex external condom catheters can be attributed to two factors. First, the adhesive used in latex external condom catheters does not bind as aggressively to skin as the adhesive used in the silicone external condom catheters. In addition, the portion of the silicone external condom catheter coated with an adhesive is approximately 5 cm longer than that of the latex external condom catheter.

The latex external condom catheters are opaque and do not allow visualization of the underlying skin. Consequently, the presence of skin abrasions or cuts cannot be detected though the opaque latex condom catheters.

Contact dermatitis has been reported in patients following the use of latex external condom catheters. In addition, frequent exposure to this natural rubber product is an invitation to the development of latex allergy. Patients with contact dermatitis and latex allergy have been successfully managed with silicone external condom catheters.

New Adjunct to External Condom Catheter Management

Male incontinent patients using external condom catheters are frequently being referred to us with a challenging new clinical problem, skin abrasions and cuts. While we now understand the cause of this injury - the peel removal technique - we have discovered an innovative technique to manage this injury:

Small pieces of thin silicone are cut from large sheets of silicone. These non-adherent segments of silicone are positioned on the injured tissue before application of the silicone external condom catheter (Fig.11). This silicone sheet protects the injured skin from the adhesive. Healing is usually encountered in four to seven days.

Fig.11.-Segments of Silicone are positioned on injured penile skin

Discussion

This online manual has been provided to inform the patient, physician and healthcare worker about the most innovative products in incontinence management and the most effective methods in using these products. This hospital approach to the use of silicone external condom catheters must be modified appropriately for home use. The strategies for using external condom catheters will obviously have to be individualized to respond to your unique patient's abilities, like personal dexterity. We provide this manual to make managing incontinence as easy as possible. It is also our goal to reduce discomfort and to eliminate allergic reactions caused by products that are made of latex. This information should be shared with everyone involved in the care of a male incontinent patient. As you practice the application and use of the Wide Band silicone condom catheter in your hospital or home, you will be learning many important lessons that we hope you will share with us on our website's chatrooms.