There are two basic barrier designs or shapes: flat or convex. Flat barriers (see Fig. 7.4) are used for standard stomas with good protrusion. Convex or curved barriers (see Fig. 7.5) apply gentle pressure on the skin around the stoma, helping the stoma protrude further. These barriers work very well for stomas that are flat or below skin level or protrude less than one inch, or where the abdomen is very soft or the skin is not flat around the stoma.

A regular/standard wear barrier, or the more commonly used extended wear barrier, is also available. Selecting the most appropriate barrier depends on the desired or required frequency of appliance changes, characteristics of the drainage (fecal versus urine; liquid versus formed), volume and cost. Ideal barriers should protect the peristomal skin from urine, provide a safe and secure seal, be gentle to the skin during flange removal, and provide cost-effective stoma management.

In general, regular wear barriers are less resistant to liquid stool and urine. Shorter wear times are expected with a regular wear barrier (usually no more than 1–2 days). These types of barriers tend to “melt” more readily with exposure to liquid, permitting unwanted peristomal skin exposure and the potential for skin irritation if left on for too long. Regular wear barriers work well for formed stool, which is typically found with colostomies. Because stool has less liquid content and the stoma tends to function less often, a regular wear barrier will not “melt” as easily and longer wear-times can be achieved.

Extended wear barriers, on the other hand, are formulated to provide greater resistance to liquid stool and urine (see Fig. 7.6a, b). Consequently, longer wear-times with these products are more realistic. Some of the extended wear barriers also contain substances that absorb the moisture from the stool or urine, causing the barrier to swell or “puff-up” around the stoma. This swelling allows for a better seal and resists undermining of the stool or urine under the flange. The barrier will move with the stoma and normal peristalsis, and will not occlude or block the opening of the stoma. There also tends to be greater tack and adhesion with extended wear products. While this adhesion assists with longer wear times, care must be taken with flange removal to avoid peristomal skin damage. Extended wear barriers are an appropriate choice for people who have urostomies or ileostomies, or those who have liquid stool with colostomies. In general, extended wear barriers tend to be more expensive. However, costs may be offset by the fact that the frequency of flange changes will likely be less with extended wear barriers. Additionally, if the peristomal skin is well protected, use of additional accessory products, such as powders, can be eliminated. Some product styles, such as convex flanges, may only be available as extended wear barriers.

Urostomies include one- or two-piece systems (see Fig. 7.7). In a one-piece system, the barrier and pouch consititute one unit. The advantages of one-piece system include their application in fewer steps and flat positioning against the skin. Patients with arthritis, who may have minimal hand strength and dexterity and limited eyesight, may find one-piece pouches easier to apply. A one-piece system adheres easier where the skin is uneven around the stoma and the pouch is less visible under clothing . A two-piece system has a separate barrier and pouch that connect together. It is less flexible than a one-piece pouch. The two-piece system allows the wearer to change the pouch for activities, such as swimming or intimacy.

In general, the pouch should be emptied when it is about 1/3–1/2 full to decrease the risk of leakage. This is typically every 2–3 hours (h) for most patients. The patient can sit or stand over the toilet. If sitting, the patient can place the spout of the pouch between their legs, open the spout and point it down into the toilet, and let urine drain out of the pouch. The patient should wipe the spout with toilet paper to dry and then close it.

A larger capacity drainage bag is available for nighttime drainage (see Chap. 5). It is attached to the spout of the urostomy pouch with a special connector that is included with the pouch (see Fig. 7.8). This larger urine bag stays connected to the pouch during sleep so there is no need to wake up and empty the pouch. The drainage system must be emptied and rinsed out with warm water every day [3]. Some health plans provide new bags each week. If bags are reused, the method for cleaning varies. Some advocate not using vinegar. The following are some tips for preventing or dealing with accidents during sleep:

Leg bags are medium-sized urinary bags that attach to the pouch at one end and can be secured to the leg (see Chap. 5). Leg bags have a larger capacity than a pouch, but less capacity than a night bag. They allow for storage of a larger amount of urine before emptying is necessary, which can be useful during travel or long meetings. The bag has two straps that hold it in place against the thigh or lower leg, depending on personal preference or type of clothing worn. The care is similar to the nighttime bag.

Table 7.1 outlines how to change the pouch system. Skin around the stoma and under a pouch/barrier should always be healthy and intact. The best way to keep skin healthy is by preventing leaks and keeping urine off the skin. Other ways to keep skin healthy include: (1) changing the pouch on a routine basis; (2) using only warm water to cleanse as soaps and lotions can leave a residue and the pouch/barrier will not adhere; (3) ensuring skin is clean and dry before applying pouch/barrier; (4) ensuring the barrier opening fits right around the stoma , not on leaving too much skin exposed; (5) carefully clipping or shaving hair where the barrier sits if it interferes with the pouch sticking, (6) always change a leaking pouch/barrier. Do not change the pouch/barrier too often, use harsh chemicals or roughly remove an old pouch/barrier.

There are many resources that patients can access for urostomy support. Several are listed in Table 7.4. There are several manufacturers of ostomy products (e.g., Coloplast, Convatec, Cymed, Hollister, Marlen, Nu-Hope) and supplies are usually sent to the patient’s home by mail after the patient is discharged from the hospital [4]. Table 7.1 lists a range of supplies needed when changing an ostomy pouch. Most insurance companies require a prescription from the prescribing provider for ostomy supplies. The orders are usually set up before the patient is discharged from the hospital or as adjustments are made during the months following the urostomy surgery. To re-order supplies, the patient should contact the supply company monthly. Insurance will cover 50–100% of the cost, but each plan is different. Most plans will cover at least ten barriers and ten pouches per month, along with necessary accessories. Different patients often have different needs in terms of the type of pouch, adhesive, and belt, and the quantity of supplies needed, depends on how well the appliances fit on the stoma. Much of this is determined by adjustments made by the ostomy and/or urology nurse with the patient if there are problems using the standard pouch or barrier. Patients should leave extra time in ordering, and be mindful when leaving on long trips to make sure they have enough supplies on hand. Other areas that should be reviewed include:

A penile compression (occlusive) device is a containment device for men designed to fit around the shaft of the penis and externally compress the urethra to reduce UI (see Fig. 7.11) The patient releases the device when he wishes to completely empty the bladder. These devices take the form of a clamp and are often referred to as a “penile clamp .” They are usually placed halfway down the shaft with the compression part of the device on the underside of the penis, compressing the urethra [5].

These devices can be used in men with mild to severe UI. Most commonly they are used for men with stress UI due to a weak urinary sphincter, which can occur after radical prostatectomy [6–9] or external beam radiation treatment for prostate cancer, or after transurethral resection of prostate “TURP” for benign enlargement of the prostate. In other cases, a weak urinary sphincter may be a result of congenital bladder anomaly or congenital spine malformation (spina bifida), or spinal cord injuries. Penile compression clamps should not be used in men who have an indwelling urinary catheter.

Penile clamps are typically composed of a plastic and/or metal frame with a foam or rubber internal cushion that compresses the urethra. While these clamps provide some advancement for controlling urinary dysfunction and protecting against bladder malfunction, improvements are needed [8]. A penile compression device does not completely eliminate urine leakage when applied at a comfortable position. A contoured designed clamp that “envelops” the penis without causing circumferential compression and adapts to allow for penis misalignment is needed [10]. There is need for a penile compression device that provides optimum comfort and that is easy to apply and remove, while sufficiently preventing urinary leakage. Another improvement would be a device that provides an absorbent mechanism conveniently, effectively and comfortably attached to the compression device.

There are many designs and manufacturers of penile compression devices. Table 7.5 provides a comprehensive list and description of currently available clamps. Many are made by small companies and samples may not be readily available in the office for patients to try before ordering. However, companies are usually happy to send samples, if requested.

Applying an occlusive penile device can be a problem for men with decreased manual dexterity, poor vision and/or a retracted penis. Have the man apply the clamp while observing and coaching him. Most penile compression devices operate on these similar principles:

Penile clamps can cause reduction in systolic penile blood flow and thus carry the risk of penile edema, urethral erosion, pain, and skin breakdown unless the penis is inspected properly on a daily basis [7, 8]. Penile clamps should only be used in men who are “cognitively intact, aware of bladder filling, have normal genital sensation, intact penile skin and sufficient manual dexterity to open and close the device” [7]. Another trial found that although clamps are more secure, associated with less UI, and less restrictive than other containment devices (external catheter, body-worn urinal), they can be more painful than other devices [9]. Pain has been reported when penile compression is sufficient to prevent urine leakage [7].

Levy et al. [10] developed a set of computational three-dimensional models of the penis and applied compression from five generic penile compression device designs. They found that the stiffness of the device’s internal material affected its ability to cushion the soft tissues of the penis during external compression. The opposite was found with penile compression devices that had soft internal materials (e.g. foam). Those devices that were angled or contoured had increased contact area with the skin of the penis allowing for increased area for load transfer and more uniform distribution of internal tissue loads.

There are methods to prevent complications, including: (1) release the clamp every 1–2 hours, or sooner if there is urinary urge, and empty the bladder of urine; (2) check for skin breakdown daily when the clamp is removed, prior to bed or in the morning before the clamp is applied; (3) check the device for any breakdown or defect daily; (4) stop using the clamp immediately if there is any visible torn skin or discoloration or pain of the penis; (5) alternate the location of the clamp on the penis to avoid always compressing the same area, but do not place the clamp on the glans penis; and (6) do not wear the clamp to bed while asleep. Some patients choose to only use the device when they leave the home, or when engaging in more strenuous exercise or activity (e.g., while playing golf). This will allow more penile rest and can further prevent complications.

Moore et al. [7] conducted a randomized block assignment with crossover design comparing 3 different penile clamps (Cunningham clamp, U-Tex Male Adjustable Tension Band, C3 Penile Compression Device) to no device in 12 men after radical prostatectomy. They found that all 3 devices significantly reduced the amount of UI compared to no device (p < 0.05), but that the Cunningham clamp was preferred by men for ease of use, comfort, and least amount of urine leaked. The reduction in urine volume lost was directly correlated to the pressure of the device and limited by patient discomfort [7].

Macaulay et al. [9] conducted a randomized controlled trial comparing a sheath drainage system (external male catheter), body-worn urinal (rubber cone + flange), and penile clamp (Cunningham) in 56 men after radical prostatectomy with 1-year follow-up. Each device was tested for 3 weeks. Device and pad performance were assessed and quality of life (QoL) was measured using the King’s Health Questionnaire . Intended and actual use preference for the products were also assessed. The sheath was rated as “good” for extended use (e.g., golfing, when traveling) when pad changing is difficult. The body-worn urinal was generally rated worse than the sheath and was used for similar activities, but by men who could not use a sheath due to retracted penis or because the device was not good for seated activities. The Cunningham penile clamp was found to be best for short duration vigorous activity (i.e., exercise) as it was the most secure, least likely to leak, and most discreet, but also the most painful. Pads and devices have different strengths. Most men prefer to use pads at night, but would choose a mixture of pads and devices during the day.

Mehta et al. [11] enrolled 124 post-prostatectomy patients who had climacturia during >25% of orgasms. With use of a variable tension loop (ACTIS^® band, Vivus, Mountain view, CA), there was significant improvement in the degree of climacturia and QoL. At baseline, the degree of climacturia was small, moderate, and large in 16%, 72% and 12% of patients, respectively. Climacturia occurred rarely, occasionally, most of the time, or always in 15%, 48%, 16%, and 21% of cases, respectively, at baseline with use of the variable tension loop, 48% of patients experienced no climacturia. Distress was experienced by 14% and 61% of patients and partners at baseline, and 2% and 11% of patients and partners at follow-up (P < 0.01). This band is not considered a device for preventing urine leakage, but is used for men with erectile dysfunction who have a venous leak. A similar device, the UroStop, is discussed in Table 7.5.

External urethral occlusive devices (may be referred to as a meatal barrier) have been developed to block urinary leakage by creating a seal or barrier over the urethral meatus. There have been several models developed to adhere to the meatus through the use of adhesive or mild suction. The current one available is the Finess™ (previously known as the Miniguard). The Finess™ urethral barrier device (see Fig. 7.12) is a small, single-use disposable foam shield or patch that is worn externally over the urethral meatus. This barrier is held in place over the meatus by an adhesive hydrogel and is easily removed for voiding. Voiding may also dislodge the device.

The currently available urethral external device is recommended for daytime use during vigorous physical exercise in adult women with stress UI. In women with urgency UI, an external device may provide some reduction in leakage, but use in this population of women is discouraged as the external device does not have sufficient adhesive power to prevent urine leakage associated with urgency UI. If used in these women, the device will probably become dislodged during an urgency UI episode.

The Finess™ is made from a material used in a number of medical applications in contact with sensitive tissue, including wound dressings. The principal component of the hydrogel adhesive is also used in other devices such as contact lenses and in permanent medical implants. The device is designed to provide a barrier at the urethral opening to prevent, not absorb, urine leakage.

The current external meatal barrier is the Finess™ which can be purchased without a prescription from a health care provider (https://​havefiness.​com/​). Applying the device should not be difficult for most women. The Patient Education Tool found at the end of this chapter provides information on applying on the Finess™ Barrier device. It may be helpful to have a woman apply and remove the device while observing and coaching her. In one study, the majority (62%) placed it correctly on the first attempt, 25% required a second attempt , and 13% required three attempts [12].

As with any device placed on mucosal tissue, adverse events can occur. Some women may feel the Finess™, but most women, are unaware of it because the soft, flexible foam material makes it very comfortable to wear. Irritative voiding symptoms and physical signs of inflammation have been reported [12]. The device is felt to be comparable to other external adhesive products that adhere to mucosal tissue (e.g. patches).

Brubaker et al. [12] conducted a 20-site study to assess the efficacy and safety of the external urethral barrier Miniguard (earlier version of the Finess) in adult women (n = 346 completed study) with slight to moderate stress UI. The 21-week study period consisted of a 1-week qualifying period, 4-week baseline assessment period, 12 weeks of device use, and 4 weeks of follow-up after discontinuation of use. All subjects kept a daily journal throughout the study, recording menses and the number of devices used. The urinary leakage severity questionnaire , completed at every visit, rated the severity of leakage experienced during various activities. Thirteen activities commonly associated with stress urine loss were rated on a scale of 0–3, yielding a maximum score of 39. Subjects used an average of 4.3 ± 2.3 barriers each day at week 9, 4.1 ± 2.1 barriers at week 13, and 4.0 ± 2.4 barriers at week 17. The device was worn an average of 9.2 ± 5.1 hours per day at week 9, 9.2 ± 5.0 hours at week 13, and 9.0 ± 5.3 hours at week 17, with no statistically significant difference at the 0.01 level (P = 0.037). The Miniguard barrier device was found to be efficacious as subjective reports of urinary leakage severity fell during device use, from a baseline mean of 10.1 ± 5.1 (median 9.0) to 3.3 ± 4.0 (median 2.0) during week 9, to 3.5 ± 4.3 (median 2.0) during week 13, and to 3.5 ± 4.3 (median 2.0) during week 17 (P < 0.001 for all three comparisons). After discontinuing use of the device, leakage severity scores increased 7.0 ± 4.6 (median 6.0), however, control of incontinence was not complete in the majority of patients.

A urethral insert is a device that is temporarily inserted into the urethra to prevent urine leakage. Usually these devices have a means to prevent intravesical migration (a tab at the meatus), a mechanism to maintain the device in its proper place at the bladder neck (e.g., balloon, fins), and a device or mechanism to permit removal for voiding (e.g., string, pump) [5]. Currently, only the inFlow™ urethral insert is available. The inFlow™ is a single-use device that requires a prescription from a health care provider. The FemSoft^® [12] is no longer manufactured.

The inFlow™ is an intraurethral valve-pump and activator. It is a non-surgical urinary prosthesis that pumps urine out of the bladder for women with incomplete bladder emptying due to impaired detrusor contractility.

The inFlow™ is indicated for adult women with incomplete bladder emptying due to impaired detrusor contractility of neurologic origin, who are seeking an alternative to intermittent catheterization (IC), and who are capable of operating the device in accordance with instructions or who have trained caregivers or significant others who can operate the device.

The inFlow™ is a catheter-like device with four components: a sterilized, single-use urethral insert component with silicone shaft, fins, and flange; an introducer; an activator; and a sizing component (see Fig. 7.13). Under patient control, the internal activator draws urine out of the bladder when voiding is desired and blocks urine flow when continence is desired. The internal activator is opened by operating an external remote control unit [13].

The inFlow™ device has nine sizes and ranges in length from 3 centimetre (cm) to 7 cm (in 0.5 cm increments) and in diameter from 24 Fr and 28 Fr diameter. An inFlow™ sizing device is used to measure the patient’s urethral length. The device is in a silicone housing and the inner valve pump consists of a neodymium-ion-boron magnet shaped like a turbine. An internal valve and pump mechanism inserted into the urethra is opened by operating an external remote control unit (see Fig. 7.14a). The device is fixed in position at the base of the bladder by a flexible flange at the external urethral meatus. Device sizing and initial insertion is performed by a health care provider.

The appropriate length for the inFlow™ device is determined by measuring the urethral length using a graduated indwelling urinary catheter. It may take several fittings to find a size that is comfortable and well-fitted. Insertion is similar to that for a urinary catheter. A disposable inserter is used to introduce the device into the urethra. The inserted device resides almost entirely in the urethra. The flexible silicone fins open like flower petals at the level of the bladder neck to keep the device in position. Once in place, the external flange will sit at the urethral meatus. If the patient has discomfort once the inFlow™ is inserted, rotating the device may remove possible pressure and improve comfort.

Inside the internal valve and pump mechanism is a small magnet, which is remotely energized by the inFlow™ activator. To void and empty the bladder, the patient must operate the mechanism. The user should sit on the toilet, hold the remote control activator against the lower pelvic area (symphysis pubis), and push the “on” button (see Fig. 7.14b). The valve then opens and the miniature rotor spins at 10,000 revolution per minute (rpm), generating a urine flow of 10–12 milliliter per second (mL/s). When the “on” button is released, the activator beeps and its magnet automatically counter-spins in order to close the valve and restore continence. The activator is powered by two 3 volts (V) lithium batteries that need to be replaced every 4–6 weeks.

Each inserted component must be replaced at least once every 29 days, typically by a caregiver, the patient or a spouse. The device is easily removed by manipulating the external flange that collapses the fixation system .

Chen et al. [14] recommended that patients receive support from medical teams during the initial device-fitting phase and for the few first weeks of use.

Adverse events include incontinence, urethral discomfort, frequency and urgency, UTI, expulsion, and hematuria. Table 7.6 lists these in detail. Once the patient has become accustomed to the device, discomfort and episodes of unexpected urine leakage tend to subside with continued use [14]. The position of the fins may also influence patient tolerability.