Incontinence products and devices for fecal incontinence (FI) and urinary incontinence (UI) can be divided into two groups (Fader, 2003): (a) those that prevent incontinence (e.g., toilet substitutes such as commodes and urinals, urethral inserts or occlusive devices, anal plugs, intravaginal devices, and penile compression devices); and (b) those that collect or contain UI (e.g., absorbent pads, catheters, and urinary and anal pouches). Devices and products can be effective as primary management in UI and FI in those persons with advanced dementia who are unable to achieve any effects from behavioral, medical, or surgical interventions or who are cognitively unable to participate in or cooperate with treatment (Newman, 2003).

In the United Kingdom (UK), there is a systematic evaluation of a variety of incontinence devices and products to assist buyers in selecting those to underwrite in health plans; the evaluation is government-supported and independent of manufacturers (Fader, Cottenden, & Brooks, 2001). There is not a similar system for evaluation of incontinence devices and products to help guide clinicians and consumers in the United States.

In some areas, such as care for persons with chronic intractable UI, device and product selection is often based on personal opinion, manufacturers' claims, convenience of the caregiver, or cost of the product (Fantl et al., 1996). Many healthcare providers and device users assume that incontinence products and devices undergo US Federal Drug Administration (FDA) approval for safety and efficacy. However, approval depends on the product or device classification. All class I (penile compression devices, external catheters, external urethral occlusion devices, urinals, and commodes) and many class II (indwelling catheters, pessary, and intermittent or straight catheters) products and devices are exempt from undergoing FDA approval. Class III devices (urethral inserts and anal plugs) require Premarket Approval and for the most part require clinical studies that demonstrate a reasonable assurance of safety and effectiveness. Lacking in the FDA review of incontinence products or devices is their use in a clinical setting.

In certain areas, the technological advancement in the design of certain products and devices for UI has been significant. An example is the development of a category of devices called urethral occlusion devices (internal and external) for women with exercise-induced stress urinary incontinence (SUI) which have been developed in the past decade. But other devices (e.g., indwelling catheters or urinals) have remained largely unchanged for decades and there is much need for improvement. In the area of FI, there are few technological advances and associated research studies; the primary emphasis has been in the area of surgical techniques.

TABLE 1.

Devices and Products Used for Incontinence

Catheters

Indwelling Catheters

An indwelling catheter is an invasive device that collects urine and is associated with considerable complications. Indwelling catheters are either inserted into the bladder via the urethra or through a percutaneous puncture in the anterior abdominal wall done above the pubic bone (suprapubic). Although short-term (defined as 2-4 weeks) catheter use is indicated for management of acute urinary retention, postoperative bladder compression, and monitoring urinary output, catheters are used inappropriately for long-term (more than 30 days) management of UI. Despite recommendations that these catheters be used for the short-term the median length of time catheters are used in home care has been reported to be 3 to 4 years (Wilde, 1997). Long-term use of indwelling catheters is the most important risk factor for the development of bacteriuria.

The risk of acquiring a catheter-associated urinary tract infection (CAUTI) depends on the method and duration of catheterization, the quality of catheter care, and host susceptibility. Bacteria colonize the internal surface of the catheter, resulting in the formation of a biofilm that can lead to antibiotic-resistant urinary tract infections (Morris, Stickler, & McLean, 1999). Nurses are responsible for both inserting and managing indwelling catheters and once surgically inserted, manage suprapubic catheters. Therefore, nurses play a significant role in preventing CAUTIs. There are few to no clinical studies describing the use, indications, and complications of suprapubic catheterization.

In addition to CAUTIs, long-term use of an indwelling urethral catheter can lead to urinary tract complications such as periurethral abscess, urethral trauma, stricture and erosion, fistula formation, bladder stones, and cancer. In addition, catheter-related problems such as catheter bypassing, obstruction, inadvertent dislodgement, and balloon malfunction are commonly seen. Research is needed on the criteria for catheter use; selecting catheter type, catheter material, and balloon size; and managing urinary tract and catheter-related complications in long-term catheter use (Brosnahan, Jull, & Tracy, 2004).

Guidelines recommended by the Centers for Disease Control were designed for short-term urinary catheter use only (Wong & Hooten, 1982) and there is a need to investigate appropriate management protocols for long-term use of urethral and suprapubic catheters. One prominent and often controversial topic in need of research concerns the frequency that indwelling catheters should be changed. Because of a lack of evidence-based recommendations, the interval of changing these catheters in practice has been driven by reimbursement and tradition. Finally, examining patients' perceptions of having a urinary catheter through qualitative research would inform nursing practice (Wilde, 2002).

External Catheters or Sheaths

There are many external catheters or devices designed for men to fit over the penis and attach to a drainage bag. Male collection devices (referred to as penile sheaths or condom catheters) offer an alternative to an indwelling catheter and absorbent incontinence product. The risk of CAUTIs is likely to be significantly less in men using condom catheters compared to men with long-term indwelling catheters because condom catheters are noninvasive devices. However, these devices are associated with side effects such as penile irritation and ischemia. There is debate as to the preferred sheath, but self-adhesive sheaths have been found to be more popular than two-part sheaths that include an adhesive strip or nonadhesive sheaths (Fader, 2003;Fader, Pettersson, et al., 2001; Thelwell, Syman, Gay, Cottenden, & Feneley, 1995). Disadvantages of these devices are that they can be bulky and difficult to apply. Their relatively low use especially in the long-term care environment indicates improvements are needed. Nurses could be instrumental in assisting manufacturers to improve the appearance of the catheters and to develop adhesives that adhere well but can be easily removed without causing skin irritation.

Intermittent Self-Catheterization

Nonsterile, clean, intermittent self-catheterization performed four to six times per day prevents overdistension of the bladder and UTIs secondary to urine stasis. This method is the standard of bladder drainage for patients with urinary retention secondary to neurologic disease or injury and in those patients with urethral obstruction and overflow UI. Research has shown that this procedure is effective and has a low risk of complications (Lapides, Diokno, Silber, & Lowe, 2002). Adverse side effects include UTIs, creation of a false urethral passage, urethral stricture, and urethritis. The coatings of these catheters may play an important role in their performance and merit further evaluation (Giannantoni et al., 2001). Fader, Moore, and colleagues (2001) showed significant differences between two catheters with different hydrophilic coatings for slipperiness on handling, comfort on insertion, smoothness, and sticking on removal.

Catheters have different tips, sizes, and, for indwelling catheters only, balloons. Research is lacking surrounding appropriate catheter selection, but published clinical literature recommends small catheter sizes (10-14FR) and small balloons (5 cc instilled with 10 cc sterile water preferred) to prevent damage to the urethra and bladder neck and to minimize unwanted bladder contractions or spasms (Fantl et al., 1996;Newman, 2002).

Absorbent Products

There is little published about the numbers of people using absorbent products (often referred to as "bodyworns") and their effectiveness in containing urine and fecal leakage, but experts in the field admit that most persons with incontinence easily find and purchase disposable products in retail stores and use them to contain urine and fecal leakage (Newman, 2002). Nondisposable (reusable) products are also available but there is little research on the indications for disposable versus nondisposable incontinence products. Nondisposable pants with integral pad have been found to be reasonably effective for low volume UI (Clarke-O'Neill, Pettersson, & Fader, 2003) but no direct correlation has been made with disposable products and low volume UI. Gallo & Staskin (1997) reported general satisfaction with reusable undergarments in ambulatory men and women, although 48% reported not feeling "very dry" or "dry" with the product. Nursing homes report high usage of disposable and nondisposable absorbent products. Absorbent products can be a practical way to manage incontinence, but few have undergone postmarketing evaluation by users or clinicians. Product selection is typically made by the consumer through trial and error and depends on their budgetary constraints and availability in stores (Baker & Norton, 1996). Similarly, the clinician has little information about product performance on which to base a recommendation (Fader, Cottenden, et al., 2001). In many cases, product selection is an administrative or corporate decision that is primarily influenced by cost as opposed to quality and effectiveness. In ambulatory office practices, clinicians routinely see women who report slight urine leakage and are using feminine hygiene products for protection instead of incontinence pads that have been specifically designed for this purpose (McClish, Wyman, Sale, Camp, & Earle, 1999), maybe because menstrual pads are lower-cost products. One study that examined use of perineal pads in women with SUI found that the most popular time for putting pads on was in the morning with mean wear time of 6.6 hours (Thornburn, Fader, Dean, Brooks, & Cottenden, 1997). The urine-holding capacity of all absorbent products varies and is not standardized. The quality and materials used in these products vary widely.

An increasing amount of research is being conducted in the UK on the characteristics and properties of disposable absorbent products used for UI and their relationship to leakage and patient satisfaction (Brazzelli, Shirran, & Vale, 2004; Clarke O'Neill et al., 2003). These factors include the shape or contour of the pad, their capacity and speed of absorbency, amount of core fluff, fit, and comfort when dry or wet (Clancy & Malone-Lee, 1991;Cottenden & Ledger, 1993). Evaluation of the performance of existing incontinent products for FI and possible redesign is needed. In the long-term setting, early identification of leaked stool by caregivers is imperative to reduce the likelihood of skin damage. Checking the need to change a saturated pad or brief can be physically challenging and time-intensive for the caregiver. A mechanism that alerts a caregiver of an incontinent stool and maintains the dignity of the resident may be beneficial.

Toilet Substitutes

Products that are used as toilet substitutes to prevent incontinence include commodes and urinals. The basic design of commodes has changed little over the last 20 years. Caregivers and users are mostly dissatisfied with these products because of poor stability, comfort, pressure relieving properties, and unattractive appearance (Fader, 2003).

Although there have been some advances in the characteristics of newer models of commodes there is a need for design improvements to tackle difficulties associated with noise, odor, and cleaning. Commodes cannot be easily used by all persons. Women who use a wheelchair but have difficulty transferring have problems maintaining continence simply because they cannot easily access a toilet.

Many female urinals are available in the UK and incorporate a very diverse set of designs. Researchers' evaluations of these products have shown the difficulty of designing a urinal that can be used effectively by women who use a wheelchair, although some functioned well for those who could stand or move to the edge of a chair (Fader, Pettersson, Dean, Brooks, & Cottenden, 1999). Women had difficulty positioning the urinal so that drainage flowed toward the front of the wheelchair. Unfortunately, urinals described in the UK evaluation are not currently available in the US. The basic design of the male urinal has remained unchanged for years although the spill-proof rehabilitation urinal has become available more recently and can be adapted for use by women (Fader, 2003;Newman, 2000).

Occlusive Devices

External occlusive devices for men consist of penile compression devices (clamps). These devices are most often used by men with postprostatectomy SUI. They have been available for decades, yet there are few published studies that have evaluated their safety, comfort, or effectiveness in preventing UI. Moore and colleagues (2004) assessed the safety, efficacy, comfort, and patient satisfaction with three commonly used penile compression devices in cognitively intact men who experienced UI following prostatectomy. Because of the risk of significant circulation complications, they recommended that a penile compression device be used with caution.

Support of the bladder neck to prevent UI has been achieved with the use of intravaginal support devices which are used by women who primarily lose urine during physical exertion (i.e., with SUI). If support tissues are weak, the urethra fails to close with physical exertion, causing incontinence. Small studies in women have found that a tampon (Nygaard, 1995), pessary (Nygaard & Zinsmeister, 1993), vaginal sponge (Glavind, 1997), and bladder neck support prostheses (Davila & Ostermann, 1994;Morris & Moore, 2003) can alleviate SUI symptoms. The most recent research has focused on a disposable vaginal device called a continence guard made of polyurethane (Thyssen & Lose, 1997). This vaginal guard is made in three sizes and placed in the vagina by means of an applicator. When saturated with water the device enlarges approximately 30% expanding in the vagina to add support to pelvic structures. Recent design changes have been made to a ring-support pessary (a device that has been used for pelvic organ prolapse for centuries) that provides additional support at the bladder neck. Robert and Mainprize (2002) found that use of an incontinence ring pessary was an effective long-term means of managing SUI for 6 (16%) of 38 women diagnosed with SUI.

Technological advances have been made in external and internal (urethral) occlusive devices for women with exercise-induced SUI. In terms of preventing or reducing urinary leakage, external devices have good efficacy (>50% of subjects dry;Brubaker, Harris, Gleason, Newman, & North, 1999;Eckford, Jackson, Lewis, & Abrams, 1996) or result in poor reduction in urine leakage and high subject dropout rates (Tincello, Adams, Bolderson, & Richmond, 2000). Internal urethral devices have higher efficacy (Dunn, Brandt, & Nygaard, 2002;Sand et al. 1999) than external devices but are associated with a higher incidence of complications such as urethral irritation and hematuria (Gallo et al., 1997;Miller & Bavendam, 1996).

External urethral barrier devices or urinary control pads have been developed and tested. A small, triangular foam pad with a layer of hydrophilic coated adhesive on one side permits application to the intralabial epithelium (over the urinary meatus), just anterior to the vaginal introitus (Eckford et al., 1996). This device was free of irritation or discomfort during use or removal. In a multisite clinical trial in the US, 356 women with symptoms of mild to moderate SUI using this same device reduced urine loss on 12-hour pad test from 15.8 +/- 26.5 mL (median = 6.9) before device use to 6.9 +/- 11.5 mL (median = 3.7) during device use (p > .001). Subjects reported less fear of odor and embarrassment and an enhanced quality of life (Brubaker et al., 1999). However, total control of incontinence was not complete in the majority of subjects. Another product was a soft reusable suction cup made of silicone (Bellin et al., 1998; Shinopulos, Dana, & Smith, 1999). This device was designed so that the suction created negative pressure, which enabled coaptation of the urethral walls, thereby increasing urethral pressure. The negative pressure within the device was optimized to counteract the pressure created by activities that would usually cause SUI in women, thereby maintaining continence. The device was not intended as a reservoir that collects the urine during leakage. This product was removed from the market because of the belief that the constant suction on the urinary meatus may cause urethral prolapse.

There have been several intraurethral inserts or internal urethral occlusive devices introduced as one-time use, disposable devices for use in women with SUI. An initial device was catheter-like in design and generated several studies in preparation for FDA approval (Miller & Bavendam, 1996;Sand et al., 1999;Staskin et al., 1996). Nurse researchers reported that women felt that the device kept them drier, controlled odor better than other products, and gave them increased confidence during physical activities (Gallo et al., 1997). However, this device is no longer available; it was poorly accepted by clinicians who felt that adverse events of hematuria and UTI were unacceptable. A device that is commercially available consists of a narrow, silicone tube entirely enclosed in a soft, thin, mineral oil-filled silicone sleeve (Dunn et al., 2002). As the insert is advanced into the urethra, fluid in the balloon is transferred toward the external retainer to facilitate passage through the urethra. Once the tip of the insert has entered the bladder, the fluid returns to fill the balloon forming a mechanical barrier to retain urine within the bladder. Dunn and colleagues (2002) reported that median urine loss decreased from 20 g without the device to 2.6 g with the device in six women with SUI who used this insert during exercise sessions.

An intra-anal device referred to as an anal plug, available in the UK, is one of the only devices that can prevent involuntary leakage of stool. Even so, its effectiveness in eliminating leakage completely has been reported to be approximately 50% (Norton & Kamm, 2001). It has been tested for safety but one of its major disadvantages is discomfort. Only 5 of 20 patients who tested the plug tolerated wearing it, and an additional 8 patients refused to conduct the evaluation after trying one on (Norton & Kamm, 2001). A mechanical barrier to preventing stool leakage is an option for FI management, but additional development on the comfort and effectiveness of the anal plug is needed before it will be acceptable to most patients.

Collection Devices

An external urinary collection device is a flexible plastic form-fitting ostomy-style pouch which is placed over the urinary meatus (for men or women) or anus to funnel urine or feces away from the perineum into a drainage bag. One such device has been tested in nonambulatory urinary incontinent women (Johnson, Muncie, O'Reilly, & Warren, 1990). Although the urinary device is still available, training in device application is necessary and actual application can be time-intensive, requiring shaving of the mons pubis and the use of adhesive paste to increase adherence to the perineum. An external penile pouch is available for older men with a retracted penis that is placed over the penis and adhered to the pubis with adhesive. For FI, nurses use devices such as a rectal tube, rectal trumpet (Grogan & Kramer, 2002), or fecal collection pouch (Ross, 1993) to divert feces from coming in contact with skin. Questions remain about the safe duration of insertion of rectal tubes and risk of damage to the rectal mucosa from tubes with or without balloons in critically ill patients, in whom they are often used. It is unknown whether a rectal pouch prevents FI-associated dermatitis better than an absorbent brief. Rectal pouches would benefit from faster adherence.

Skin Care Products

The use of skin care products is integral in the care of persons who have severe or intractable incontinence since perineal skin problems can be a consequence of incontinence (Fantl, 1996). Fecal incontinence and double incontinence (FI and UI combined) are major risk factors for the development of perineal dermatitis in aging adults, especially those who are immobile (Bliss, Savik, Fan, & Harms, 2003). Incontinence exposes the skin to moisture, digestive enzymes, and microorganisms and alkalinizes skin pH (Gray, Ratcliff, & Donovan, 2002;Newman, Wallace, & Wallace, 2001) which alters skin integrity and precipitates dermatitis. No one would dispute the importance of good skin care in preventing skin breakdown, yet no randomized controlled clinical trials have examined the methods or products most likely to achieve this goal. Recommendations about skin care are generally based on experience or made through marketing materials provided by product manufacturers.

New Approaches to Research

Research on technology for incontinence invites new models of collaboration among corporate, clinical, and academic investigators. Currently, investigators in all three settings independently develop and test technologies. Collaboration between corporate and noncorporate researchers most often takes the form of hiring expert consultants or sponsorship of clinicians with access to the appropriate sample of patients who can implement a protocol designed by the corporation. Often, the products and devices needed, the capability of producing them, and the evidence supporting their benefit are not synchronized. Confusion, lack of confidence, or frustration on the part of the patient-consumer or clinician hampers appropriate continence care (Newman & Palmer, 2003).

We support a more integrated collaboration in which corporate, clinical, and academic investigators are equal partners in all phases of the research process. Collaborators in this model would jointly determine and prioritize questions to be investigated; have input into the design, procedures, and outcome measures; allow joint ownership of findings in a transparent and traceable manner; interpret the results with the benefit of multiple perspectives; and be assured results would be disseminated. Potential advantages of the model are greater likelihood of high quality clinical research that has sufficient power and integrity, efficient utilization of resources special to each setting, and expedited application of technologies for patient use. It may be possible to address the scientific merit along with the utility of a technology in this model.

Given the state of the science and practice of incontinence care technology, development of new products and processes are needed which might be fostered by an innovative and expeditious strategy. The proposed model extends the successful principles of interdisciplinary research to corporate collaborators, while reducing problems or suggestions of bias that have been associated with corporate underwriting of research in the past. Mechanisms exist to fund new technology through the Small Business Innovations Research and/or Scientific Technology Transfer. This model may require a reevaluation of criteria for funding from private and public sources and development of mechanisms within academic and federal institutions to accept and manage the funds.

References