External Catheter Collection Systems



Fig. 3.1
Disposable male external catheter with leg bag—Courtesy of Diane Newman



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Fig. 3.2
Reusable bodyworn pubic pressure external catheter containment system AFEX—Courtesy of Arcus Medical


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Fig. 3.3
External urinary pouch (a) Female (b) Male—Courtesy of Hollister Inc.


External catheter collection systems for men are also referred to as external catheters (EC) , condom catheters, “Texas” catheters, urisheaths, or penile or urinary sheaths. These external systems are connected to some type of drainage bag, small or large, or a collection receptacle that may be fastened either around the thigh or lower leg or held in a sleeve or brief. The most common disadvantage with ECCSs is the failure to stay in place due to an individual’s anatomy, incorrect sizing, or placement [4]. But not all ECCS perform the same, not one size fits all, and not all are suitable for all patients [5]. Knowledge about the various ECCS and their fitting can eliminate many of the difficulties attributed to them. Determining which ECCS is most appropriate for an individual patient requires careful user selection. Important performance characteristics include security (ability to keep a leak-proof seal and drain urine into a bag without leakage) and ease of application and removal of the catheter or pouch.



Indications


ECCSs are noninvasive devices that collect urine in men and women who experience moderate to severe urinary incontinence (UI) . Table 3.1 reviews appropriate and inappropriate uses of an ECCS. They may also be used for men with lower urinary tract symptoms of urinary urgency and frequency in circumstances in which it would be difficult to make frequent trips to restrooms [5, 6]. It is not uncommon for older adult men, who may or may not be incontinent, to use a toilet during the day but wear an ECCS during the night when asleep. In women, external pouches are most effectively used in those women with UI who are immobile. In men, an EP is indicated for men with UI who have a retracted and/or shorter length penile shaft or those who cannot use a disposable or reusable MEC.


Table 3.1
Appropriate and inappropriate uses of an ECCS













































Appropriate use

• Male or female patients who experience UI without retention

   – Long-term care residents in nursing homes

   – Urinary containment for men with neurogenic bladder dysfunction and UI who have perineal sensation

   – UI (no skin issues) and difficulty turning due to excess weight from obesity or edema

• Patient request for external catheter to manage UI

• Post-prostatectomy male patient with significant postoperative UI who is returning to work or wants to return to activities (e.g., golfing)

• Daily (not hourly) measurement of urine volume that is required to provide treatment and cannot be assessed by other volume and urine collection strategies (e.g., acute renal failure work-up, bolus diuretics, fluid management in respiratory failure)

• Single 24-h or random nonsterile urine sample for diagnostic test that cannot be obtained by other urine collection strategies

• Reduction in acute, severe pain with movement when other urinary management strategies are difficult (e.g., turning patient to remove an absorbent pad causes pain)

• Managing overactive bladder symptoms and improving comfort in palliative care patients

• External catheter placement to reduce risk for falls by minimizing the need to get up to urinate

Inappropriate use

• Any type of urinary retention (acute or chronic, with or without bladder outlet obstruction)

• Any use in an uncooperative patient expected to frequently manipulate the ECCS because of such behavior issues as delirium and dementia

• Hourly measurement of urine volume required to provide treatment

• UI in patients with intact skin when nurses can turn/provide skin care with available resources when the patient has not requested the external catheter

• Patient or family request in a patient who is continent when there are alternatives for urine containment (e.g., commode, urinal, or bedpan)

• A need for a sterile urine sample for diagnostic test

• In a patient who does not have perineal sensation


Adapted from [1, 56, 57]

The 2009 Centers for Disease Control and Prevention (CDC) Guidelines recommend that clinicians should “consider using external catheters as an alternative to an indwelling urinary catheter (IUC) in cooperative male patients without urine retention or bladder outlet obstruction” (p. 38) [7]. These recommendations are supported by other guidelines from medical and nursing professional organizations [811]. Cottenden et al. [12] recommended that external urisheaths, rather than an IUC , should be the urinary collection device of choice. When comparing an ECCS to an IUC , the advantages include no urethral instrumentation, no chance of urethral stricture, less incidence of bacteriuria, and less pain. Gray et al. [1] provide recommendations for improving use of ECCSs as part of a CAUTI reduction program.

Despite these recommendations, ECCSs are under-utilized by clinicians. Nurses are not routinely taught about them during training, often believe that all urisheaths leak and/or fall off, and many find them difficult to fit. Many nurses and purchasers of MECs believe that “one size fits all.” For men, there are many different types of ECCSs to choose from and it is worth trying different types of urisheaths and fixation methods to find the most appropriate one.


Prevalence


Determining the prevalence of ECCS use is difficult, as it varies widely amongst countries, cultural differences and insurance reimbursement. Conflicting results from the few available studies have left the role of ECCSs in hospitalized patients or long-term care (LTC) residents unclear [13]. Hebel and Warren [14] reported on the use of urine collection devices in 4239 residents of 53 randomly selected nursing homes in Maryland. They found that 10% of women and 15% of men were using such devices. Among bedfast patients, 47% of women and 58% of men were using a collection device. Those with pressure injury, 37% of women and 33% of men were using a urine collection device. Not surprising, most women were only using an IUC, whereas men were using a urethral IUC (43%), external (39%) or suprapubic IUC (15%).

Rogers et al. [15] assessed the use of urinary collection devices (external, intermittent, and indwelling catheters; pads or briefs) and examined predictors of IUC usage in skilled nursing facilities (SNFs) . This retrospective cohort study was conducted in SNFs located in five states. Participants included residents who were admitted to SNFs in 2003 and who remained there for 1 year (N = 557,302). The predominant catheter type was an IUC with few residents (< 1%) using intermittent or external catheterization. Of the 57,302 residents, 7242 (12.6%) were using an IUC upon admission, which declined to 4.5% at 1 year (P < 0.001).

Most research available has been on men in Veterans Administration Medical Centers (VAMC) who report that an EC is more comfortable, less painful, and less restrictive on their activities than other devices (e.g., IUC) [16]. This study also indicated that nurses also preferred ECs to IUCs.


Description of Disposable Male External Catheters


Historically, MECs have been described as ineffective external urine collection devices. However, changes in the design, material, and type of MECs available have proven this description false. Edlich et al. [17] identified five desirable attributes for an MEC: (1) structural configuration that conforms to the anatomical configuration of the penis, (2) self-adhesive, integral to the inner surface for secure bonding, (3) transparency permitting a skin injury to be visible, (4) ability to elongate and retract during erectile function, and (5) avoidance of local or systemic allergic reactions.

The most popular ECCSs are those that are disposable (e.g., MECs) and changed every 24 hours (h) per manufacturer recommendations. The sheath is secured to the penile shaft by one of four methods : (1) a water-tight adhesive that is integral to the internal surface of the sheath, (2) a single- or double-sided adhesive strip that wraps around the penis with the sheath rolled over the strip, (3) a urisheath inflated with air once it is in place, or (4) a non-adhesive sheath that is kept in place with a Velcro™ strap [18, 19]. In all four methods, the sheath is applied by rolling it over the penis and urine drainage is accomplished by attaching the distal end (near the bag connector) of the sheath to a urinary drainage bag (leg bag or overnight bag) (see Fig. 3.4). Most MECs have a non-kinking and/or non-twisting junction between the catheter tip and drainage bag to reduce kinking/twisting at the distal end.

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Fig. 3.4
Silicone MEC attached to leg bag—Courtesy of Diane Newman

Penile sheaths are not suitable for all men; in particular, they are not suitable for men who have a penis which is permanently retracted or for those men whose penis retracts when they sit or bend down. The sheath will roil off the penis as it retracts into the body, resulting in the sheath coming off and allowing leakage to occur.


Material


Both disposable and reusable types of ECCSs are made from a variety of material including latex rubber, polyvinyl (PVC), silicone, or synthetic polymers. Latex is used in many urologic products, including all types of ECCSs, because it is a soft and flexible material. But the presence of latex material in many catheters, devices, and products creates a greater risk of an allergic reaction in urologic patients. In general, the use of latex in the healthcare setting is being phased out. Silicone sheaths have the advantage that they are latex-free and transparent, allowing visualization of the penile skin. Silicone MECs are also skin-friendly because of their biocompatibility, as they allow the skin to breathe by permitting the transfer of water vapor and oxygen and reducing the amount of moisture build-up under the sheath. PVC is a synthetic and resistant material that contains plasticizers. Placticizers can be a problem in long-term users [2]. MECs also often use polyurethane (PU), a thinner material which may be more comfortable for the wearer.


Types


Self-adhesive or one-piece MECs are the most popular as they have an internal fixation of integral adhesive (adherent to the inside of the sheath) that sticks to the penile shaft [20]. They are rolled over the shaft of the penis (see Fig. 3.5) and pressed to ensure adherence. A section between the adhesive and distal end prevents kinking and the tip attaches to a drainage tube with a bag. Variations exist in the different types of adhesives, the placement of the adhesive on the MEC, and the size of adhesive area [2] (see Fig. 3.6). Self-adhesives MECs are preferred because they are easy to self-apply, are more secure, and are covered by most insurers. All-silicone MECs cause less irritation and fewer adverse reactions and thus are recommended for men with a latex allergy [17] (see Fig. 3.7). Some adhesive MECs have an applicator or a strip (see Fig. 3.8) that may assist the individual or caregiver in unrolling the sheath. These catheters may also be useful for patients with reduced manual dexterity. To ensure adequate drainage, most have an “anti-kinking” outlet and/or “anti-twisting” internal flap feature that reduces kinking and twisting at the distal end of the MEC, near the connection to the drainage tube [12] (see Fig. 3.9).

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Fig. 3.5
MEC application (2 pics)—Courtesy of Diane Newman


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Fig. 3.6
Self-adhesive MEC (one-piece system) consists of three parts: the connecting tube, buffer zone, and adhesive zone. The size of the three parts differs between products and manufacturers


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Fig. 3.7
Thin silicone soft breathable conforming MEC (Spirit) with 3 sizes: Style 1: sheath length 3 in., adhesive length 1.75 in. Style 2: sheath length 1.5 in., adhesive length 1.75 in. Style 3: sheath length 3 in., adhesive length 3 in.—Courtesy of C.R. Bard, Inc.


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Fig. 3.8
(a) Conveen® Compact Optima MEC . (b) Compact Optima silicone MEC with applicator/pull-tab for easy application. (c) The loop of the double-grip strip can be pulled which may make MEC application MEC easier. MEC has a push ring at distal end (tip) of the MEC for secure connection to a leg bag and an anti-kink bellow to prevent backflow of urine—Courtesy of Coloplast Corp.


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Fig. 3.9
Latex MEC with an anti-reflux valve and double convolutions that resist kinking and twisting and prevents urine backflow and leakage. Extended Wear Male External Catheter—Courtesy of Hollister Inc.

Two-piece sheaths have either an internal or external fixation method. External fixation methods are less effective than internal methods, as no adhesive is physically attaching the sheath to the penis, making the fixation less secure. Adhesive tapes are not recommended as they are inflexible and not designed for sheath fixation. They can result in constriction of the penis, interfere with voiding and cause trauma.

An internal fixation MEC has a double-sided hydrocolloid adhesive strip, separate from the sheath that has adhesive on both sides, and can be applied internally in a spiral fashion around the penile circumference (see Fig. 3.10). The thickness and size of adhesive strips can vary.

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Fig. 3.10
Double-sided adhesive strip
The strip is wrapped around the circumference of the penis and the catheter sheath is then rolled up and over the penis and strip. Pressure should be applied to ensure adherence. A strip can be too tight around the shaft so men who use this type of MEC should have penile sensation and understand correct application. These double-sided strips are more elastic, do not tend to absorb urine, and are better able to accommodate changes in penile size. Such strips may be more appropriate for men who have erectile function.

A second type of two-piece sheath has an external fixation that is foam or a Velcro™ reusable strap (see Fig. 3.11) which is secured around the shaft of the penis once the nonadhesive sheath is applied. External fixatives are sometimes placed on the end of the MEC for extra security (especially when using a one-piece system). But foam straps are not elastic, so they will not stretch and should be used with caution [21].

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Fig. 3.11
Silicone MEC with Velcro™ or Foam external band—Courtesy of C.R. Bard, Inc.

A third type is an inflatable retention ring that secures the catheter (see Fig. 3.12) with air inflation, and is deflated for removal. The inflatable MEC is nonsterile and can be reused.

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Fig. 3.12
Non-adhesive balloon-inflating MEC . The inflatable retention ring secures the catheter and can be easily deflated for removal. The retention ring must be positioned behind the head of the penis. It is non-sterile, reusable, and intended for single patient use only. (X-Large 33 m, Large 33 mm, Medium, 28 mm, Small 23 mm)—Courtesy of Cook Medical

Some men prefer external fixation, especially in cases where the catheter is removed and replaced frequently. Catheters with a circumferential band may be too restrictive for the shaft of the penis and should be used only by men who are cognitively intact and have penile sensation because they are associated with an increased risk of penile strangulation. In addition, external, two-piece MCEs can be difficult to apply and may not be as effective as one-piece MECs.

Non-penile sheath, glans-adherent external device , a more recent device in the MEC category, is gaining in popularity. This device is a small, soft adhesive faceplate or wafer in the shape of a daisy flower that adheres to a small area of the glans penis around the meatus. A hydrocolloid seal (hypoallergenic, latex-free) is placed over the faceplate (see Fig. 3.13). Hydrocolloid polymer is the material often used to produce wound dressings. It has a central urine outlet opening to make a complete parameatal seal and directs all urine into a leg (see Fig. 3.14) or bedside collection bag [22]. This device functions like an ostomy device for normal male anatomy, directing all urine immediately away from the meatus to establish an environment where the skin (including penile shaft and glans) is consistently protected from moisture or exposure to urine. By keeping the skin dry, the device prevents skin maceration, breakdown, and wounds. It is highly effective for all normal male anatomy. It allows the foreskin to return to a natural, forward position making it equally suitable for both circumcised and uncircumcised anatomy. If present, the foreskin must be pulled back to place this device and then returned to the natural forward position over the seal (see Fig. 3.15). The device is also a good urine containment product for men with a retracted penile shaft, who are obese with large girths, who experience frequent erections. Because this device is applied exclusively to the glans penis, it is recommended for patients with penile shaft ulceration, inflammation, irritation or for men who have developed an penile shaft allergic reaction to a more occlusive urisheath [23].

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Fig. 3.13
Parts of the Reliafit or Mens Liberty External Male Catheter


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Fig. 3.14
Non-penile sheath, glans-adherent external device attached to drainage bag, the Reliafit or Mens Liberty External Male Catheter —Courtesy of BioDerm


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Fig. 3.15
Foreskin returned in place. When the foreskin is brought forwards, prepuce covers the faceplate and seal and only the outlet channel is visible. Reliafit or Mens Liberty External Male Catheter—Courtesy of BioDerm

Preliminary data indicates that the occlusive nature of the parameatal seal and application site cleansing may reduce the incidence of infection to less than 4%, more than a 10-fold improvement over any other modality [24]. Parameatal glans hygiene is required prior to application, thereby reducing ambient bacteria. The parameatal hydrocolloid seal establishes an occlusive dressing that can prevent bacteria from accessing the urinary meatus. The hydrocolloid seal will adhere to clean, dry skin for an average of 24–72 h. Although initial applications may have a shorter wear time, the device may be worn up to 3 days. The seal turns a milky-white color when the device is ready to be changed. Soaking the seal with warm water will allow the device to slide off easily.

Proper application is essential for successful utilization of the device (see Fig. 3.16) and it requires more dexterity than in applying a one-piece sheath. If application is not performed correctly, the device may be more likely to come off early or leak. Patients who experience a sudden, large diuresis have reported a feeling of suction on the tip of the penis, which tends to be more noticeable than in patients who experience this sensation when wearing a more traditional form of MEC.

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Fig. 3.16
Application of the Reliafit/Liberty Pouch . (a) A flexible “faceplate” is positioned by aligning the central hole over the external urethral meatus, pressed down over the glans penis avoiding wrinkles, and held firmly for 20 s. The end of the faceplate directs the flow of urine into a tube for collection in a bag. (b) Hydrocolloid seal is wrapped around the faceplate to ensure adherence. (c) Apply pressure for 20 s. A new Reliafit/Liberty Pouch, when applied to the glans penis, is translucent. As it absorbs water and other discharge from the skin, it gradually becomes opaque—Courtesy of BioDerm

This device has two sizes: standard size is indicated in patients who have normal anatomy of the external urethral meatus. Men who have a hypospadiac or enlarged urinary meatus (e.g., spinal cord injury patients as a result of long-term use of IUCs), may need to use the XLS model which has a larger outlet channel. Patients should use the tube holder recommended by the manufacturer or a conventional thigh strap to secure the urinary drainage tubing to the leg to avoid undue traction. An extension tube may be necessary.


Descriptions of Disposable External Pouches


External pouches that resemble ostomy pouches are available for both men and women. These are one-time use devices and usually only stay in place for 24 h as the weight of the urine will pull the product off.


Material


There are currently only two available EPs and they are made from flexible vinyl.


Types


External pouches are modeled on ostomy appliances. One type is a bodyworn pubic pressure type flange, which fits over the penis and sits against the abdomen using straps (see Fig. 3.17). A second type is a pouch with a pectin-based adhesive skin barrier that secures the device to the pubis [25]. The pouch holds about 90 mL but is more effective if connected to a drainage bag (see Chap. 4) using an extension tube. The pouch can be left in place for up to 3 days.

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Fig. 3.17
Bodyworn pubic pouch with waist strap or belt

In men, the opening of an EP may be widened to allow for application over the penis and the integral adhesive barrier is attached to the pubis (see Fig. 3.18). In women, the opening can also be widened, and the adhesive is placed over the mons pubis (see Fig. 3.19).

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Fig. 3.18
Male adhesive external urinary pouch —Courtesy of Hollister Inc.


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Fig. 3.19
Female adhesive external urinary pouch —Courtesy of Hollister Inc.

Pouches are available for men with a retracted penis or with a shorter length penis or who cannot use a regular MEC [26]. They are also available for nonambulatory incontinent women [27].

Prior to application, the skin should be cleansed and pubic hair removed at the base of the penis in men and the perineum in women. The hair should be trimmed, not shaved, because shaving causes more irritation. Pouches can be attached to dependent drainage.

In men, the base of the penile shaft is assessed. The opening in the adhesive surface of the hydrocolloid wafer barrier should be cut to the circumference of the widest point of the penis. The wafer opening should be large enough that the penis is able to pass through the pouch and be able to move freely within the pouch [10]. The pouch is then applied over the penis and the adhesive is adhered to the pubis (base of the penis).

The female urinary pouch is a one-piece system that encompasses the labia and features an integral adhesive barrier. Training in device application is necessary and actual application can be time intensive, requiring removal of the mons pubis hair and the use of adhesive paste to increase adherence to the perineum. The vulvar opening is measured; the barrier is cut to fit the woman and then adhered to the labia. Problems with leakage persist with these pouches as poor adherence is common, especially in women.


Designs


Designs have not been significantly changed since this device was first introduced [28, 29, 30]. Pieper and Cleland [31] provided a review of external female devices noting that early designs involved a vaginal insert or locator to anchor the device and prevent urine from flowing into the vagina. A urine collection receptacle, which may have resembled a cup-shaped device, was either placed between the labia or suctioned against the meatus. They [31] designed and tested a “female urine collection device ” that consisted of a latex periurethral adapter that fit laterally between the labia minora and vertically between the clitoris and vaginal orifice. The drainage part of the adapter surrounded the urethra, adhering with the use of adhesive. However, none of the early designs proved to be effective in collecting urine in women. The ideal device for women would be one that is easy to place and works well for women who are bedridden, who transfer from beds to chairs, or who use wheelchairs. Also, if correctly fitted, urine should not contaminate the skin.

Unfortunately, no device has proven to be very useful for women.


Description of External Catheter Containment Systems


In the US, there is growing use of ECCSs that can be washed and reused for weeks to months. These reusable and washable devices are available, primarily for men, and many find them on the internet. These systems are referred to as “bodyworn” products (see Fig. 3.20) or pubic-pressure urinals or devices [12]. They consist of some type of receptacle or cone-shaped device that is fitted over the penis and held firmly in place against the pubis with close-fitting straps, belts or cloth underwear. This pressure allows the penis to protrude into the MEC. The device is attached to a drainage bag. This system is not suitable for overnight use because of urine leakage. They are used by men with slight to moderate incontinence and are designed for men who find other MECs unsuitable.

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Fig. 3.20
Reusable external bodyworn containment system (Mc Guire)—Courtesy of Coloplast Corp.

Reusable ECCS can be easily removed and are popular for episodic wearing (e.g., while traveling, golfing, etc.) (see Figs. 3.20, 3.21, and 3.22). There is also a growing need for ECCSs for men and women in the military who encounter difficulties with voiding while in active war zones [32] or in fighter planes [33]. Newer products are latex-free.

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Fig. 3.21
Reusable latex ECCS that consists of a tubular sleeve, which encompasses the penis at one end, has an external fixation Velcro™ strap, and an outlet at the other end. The outlet can be drained by means of a tap. These are also referred to as “drip urinals”—Courtesy of AlphaDry


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Fig. 3.22
Parts of the AFEX Male bodyworn ECCS —Courtesy of Arcus Medical. Receptacle high style shape is best suited for patients who may be more active or stand for longer periods of time. The high style is also recommended for bedtime use and better suited for men who may be at the threshold for required penis length. The design offers a double wall for back-flow protection and is designed for skin rash prevention. The receptacle is latex free, pressure free, and adhesive free


Types


Technological advances are making these products more available and more user-friendly. The main driver for these technological advances has been the military and, in particular, Air Force pilots. Agarwal and Subramaniam [33] developed a set of 56 questions addressing nine areas of pilot concern associated with long duration flying of which in-flight urine disposal was one of the areas. A total of 30 male pilots with a mean age of 30 years were questioned about their preferred method of in-flight urine disposal. Most pilots (80%) agreed that the adult diaper was not an appropriate method for urine disposal and 95% reported never using a diaper for in-flight urination . In aircraft used for long missions, pilots use the negative-G strap, a thick flat strap that presses on the crotch. Urination requires a loosening of the strap, which in the absence of an autopilot, is difficult if not impossible for these pilots. Sixty-six percent reported preferring condom drainage and 100% of these pilots felt that better research is needed for urine disposal.

Von Thesling et al. [37] reported on a male in-flight urine collection device, a reusable latex sheath-style catheter worn throughout flight and affixed during donning of a pressure suit. This device has evolved into sensor-driven technology that actively pulls urine away from the body (see Fig. 3.23).
Jan 26, 2018 | Posted by in UROLOGY | Comments Off on External Catheter Collection Systems

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