M

ore than four million men suffer from urinary incontinence.1 Surgery, medication, and behavioral therapy are successful in curing or significantly improving the condition for about 80 percent of these individuals. However, at least 20 percent of these men are left to deal with daily urinary leakage. These individuals have traditionally been treated with absorptive products, indwelling catheters, or external (condom) catheters. Each of these options is associated with significant disadvantages or limitations that must be considered.
       For example, absorptive products are associated with increased risk of skin breakdown as well as significant cost.2 Indwelling catheters are a major risk factor for serious urinary tract complications, especially when used on a long-term basis. Thus, they are typically considered to be “last resort.” External catheters provide containment of urine with lesser risk of skin breakdown than absorptive products and less risk of serious urinary tract complications than indwelling catheters. They are frequently considered the option of choice for men with intractable incontinence. However, condom catheters are associated with increased risk of urinary tract infection, so they are not complication free. In addition, some men are unable to use condom catheters due to penile skin lesions, penile retraction, or an uncircumcised state. For these individuals, there is now an external collection device that is designed to adhere to the glans itself. The BioDerm ECD® (BioDerm, Largo, Florida) is a new option for management of intractable incontinence.

Indwelling Catheter Complications
       Long-term use of indwelling catheters is a well-documented risk factor for serious urinary tract complications (see Tables 1–3).3–7 Urethral (Foley) catheters are the most widely used indwelling catheters. Many patients and clinicians consider them to be benign devices; however, studies have shown unacceptable incidence of the following complications: infectious complications including pyelonephritis and urosepsis; bladder and renal stones; stricture formation; penoscrotal fistula formation; and penile erosion. Suprapubic catheters are recommended by some clinicians as safer than urethral catheters, and suprapubic catheters are generally well tolerated by patients.8 However, placement of a suprapubic catheter involves a surgical procedure, and these catheters are not complication free. Clinicians must be alert to the potential for urinary tract infections, urosepsis, bladder and renal calculi, and gross hematuria. Due to the high incidence of complications with urethral and suprapubic catheters, current guidelines for use of indwelling catheters emphasize avoiding long-term use and employing meticulous care to minimize complications. External (condom) catheters are frequently recommended as an alternative to indwelling catheters for individuals who require long-term management.

Condom Catheters: Complications and Contraindications
       External catheters are a much safer alternative for long-term management of urinary incontinence. While there is increased risk for urinary tract infection, these devices are rarely associated with serious urinary tract complications. They are generally considered the best option for patients who require long-term management of urinary leakage. However, there are a number of men who are unable to use condom catheters effectively. This group includes those with penile retraction, those with penile skin lesions that preclude use of devices that adhere to the penile skin, and those who are uncircumcised. With an individual who is uncircumcised, it is difficult to obtain a secure seal without retracting the foreskin, and retraction of the foreskin places the patient at risk for circulatory compromise. Until recently, patients who could not utilize a standard condom catheter were forced to manage either with a pouch-type product or with absorptive products, both of which expose the skin to urine. The pouch-type product also requires shaving of the pubic hair, which introduces the potential for folliculitis.

Figure 1. The BioDerm ECD adheres only to the glans with hydrocolloid.

BioDerm ECD
       The BioDerm ECD represents a new concept in urinary collection devices. It combines hydrocolloid technology, borrowed from the wound care industry, with a simple but effective urinary drainage system. The key element in the BioDerm system is a thin hydrocolloid dressing that is designed to adhere securely to the glans of the penis. Connected to the hydrocolloid dressing is a drain tube that is attached to a leg or bedside bag. The dressing adheres to the glans, so a patient with a retracted penis or penile skin lesions can use it. The BioDerm ECD also allows the foreskin to be returned to its natural position once the device in place; it is equally suitable for men who are circumcised.

Guidelines and Considerations for Application of the BioDerm ECD
       Prior to application of the BioDerm ECD, the skin of the glans penis must be clean and dry. BioDerm recommends cleansing the skin with a mild, nonmoisturizing soap, such as Dial® or Ivory®; the skin should be rinsed thoroughly and patted dry before the device is applied.
       Wear time varies depending on skin type and skin hydration. Average wear time is reported to be one to two days, though some men are able to keep the device in place for as long as five days. Men whose skin is overhydrated from absorptive products or condom catheters will initially experience shorter wear times. Reports have shown that individuals who have been wearing condom catheters may get four hours wear time with the first application. However, the wear time rapidly improves; typically, the second device can be worn for eight hours, the third device can be worn for 12 hours, and the fourth device may remain in place for 24 hours.

Figure 2. The BioDerm ECD allows the foreskin to return to the natural position.

       The manufacturer suggests these three “rules” for obtaining the best seal: avoid use of soaps containing moisturizers, make sure the skin is dry, and avoid touching the hydrocolloid dressing.
       The BioDerm ECD is currently classified as A4324 under the Healthcare Common Procedure Coding System (HCPCS).

Conclusion
       Many men require long-term management of urinary leakage and are not candidates for external catheters due to penile anatomy or penile lesions. The BioDerm ECD offers these men a clinically proven alternative that provides urinary containment without requiring adhesion to the penile shaft.