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C Artificial Urinary Sphincter, O N Part I: Overview T I N Susanne A. Quallich U Dana A. Ohl I N rinary incontinence in has a tremendous impact on an individual’s G adults, regardless of its quality of life and self-esteem. A number of patients will fail both con- cause, presents a sig- servative medical as well as conservative surgical treatments in their E nificant quality of life pursuit to regain urinary control. The surgical implantation of an arti- D Uchallenge and contributes to a ficial urinary sphincter (AUS) is a definitive surgical option to re- socially uncomfortable situation U establish continence. However, there are many challenges that may for the individual. Incontinence arise as a patient progresses through the rigorous preparation, sur- C affects a range of behaviors, A including travel, social func- gical procedure, and recovery process. Understanding the history, tions, entertainment pursuits, various indications, and risks of AUS will aid in counseling T sexual activity, sleep, and simple patients considering AUS. I everyday activities around the O home. Patients may worry about the odor and embarrassment incontinence (a complete lack of History of the Artificial N associated with incontinence, control over urinary function). Urinary Sphincter suffer a loss of self-esteem, Incontinence is a significant The AUS was originally become socially isolated, and quality of life issue for patients, designed for patients with an may also become depressed. male and female alike. There exist incompetent or absent sphincter Types of incontinence include a variety of treatment options, who also had normal bladder mild incontinence (the loss of a medical and surgical, that attempt compliance and normal detrusor few drops of urine), stress incon- to correct the mechanisms that function (Roberts & Barrett, tinence (loss of urine with contribute to incontinence. Be- 2000). Different forms of an AUS changes in intra-abdominal pres- cause there are varied social and have been available since the sure, such as sneezing), urge cultural definitions that influence 1960s. These early devices not incontinence (loss of urine asso- a patient’s perception of conti- only had a variety of mechanical ciated with detrusor overactivi- nence, successful treatment must problems, but were of limited ty), overflow incontinence (a additionally account for the sub- usefulness. This was largely due bladder that does not empty jective experience of poor urinary to the fact that the pressure con- completely due to outlet obstruc- control. trol of the urethral cuff did not tion or neurogenic causes and Among the variety of treat- effectively occlude the urethra, spills urine when full), and total ment options, the artificial urinary and therefore did little to allevi- sphincter (AUS) is unique. The ate incontinence. Most of the AUS (see Figure 1) is a prosthetic devices consisted of some sort of Susanne A. Quallich, APRN,BC, NP- device that can substitute for a balloon pump that was used to C, CUNP, is a Nurse Practitioner, patient’s sphincteric mechanism fill a cuff surrounding the ure- Division of and Microsurgery, and prevent loss of urine. The thra, and all had continence University of Michigan Medical Center, AUS gives patients a definitive mechanisms that were volume Ann Arbor, MI. option for treating incontinence, dependent. These devices failed and does not require that their as a result of inherent design Dana A. Ohl, MD, is an Associate clothing or lifestyle be altered to Professor of and Head, Division flaws, including the lack of any of Andrology and Microsurgery, accommodate an incontinence mechanism to monitor pressure University of Michigan Medical Center, product. It consists of three parts: a in the cuff around the urethra Ann Arbor, MI. balloon pressure reservoir, a con- (Hajivassilou, 1998). Further- trol pump that is implanted in the more, the earliest of these Note: CE Objectives and Evaluation labia or scrotum, and a cuff that devices could not be used in Form appear on page 277. occludes the urethra. female patients.

UROLOGIC / August 2003 / Volume 23 Number 4 259 C Figure 1. The first reliable device, the TM O The AMS Sphincter 800 Urinary Control System AS 721, was manufactured by American Medical Systems N (AMS) and implanted in 1972 T (Fishman, Shabsigh, & Scott, I 1989; Hajivassilou, 1998; Siegel, 1989). It was made of Dacron- N reinforced silicone elastomer and U stainless steel. It could be I implanted in males or females, either the bladder neck or bul- N bous urethra. The device func- G tioned by sustaining pressure around the urethra and allowing E release of the pressure for void- ing or catheterization. Because D the AS 721 had a high incidence U of mechanical failure (Light & C Reynolds, 1992), few of these devices were actually implanted A despite the excellent return to T continence they facilitated. I Subsequent improvements to the AS 721 (see Table 1) involved O the addition of a pressure regula- N Courtesy of American Medical Systems, Minnetonka, MN. tion balloon, a variety of reser-

Table 1. Descriptions of Previous and Current Artificial Urinary Sphincters Manufactured by American Medical Systems

Description * Continence Mechanism Comments

AS 721 Four components: cuff surround- Fluid in cuff occluded urethra, System lost pressure over time; (1972) ing urethra, balloon fluid reser- providing continence; one pump high incidence of mechanical voir, two pumps (one to either to inflate, one pump to deflate. failure due to many components. side of reservoir).

AS 761 Three components: cuff sur- Pressure-regulating balloon Provided constant predictable (1974) rounding urethra, balloon fluid allowed for automatic cuff pressure. reservoir, pressure regulating closure. balloon.

AS 742 Three components: cuff sur- Delay-fill resistor between cuff Delay fill mechanism allowed rounding urethra, balloon fluid and reservoir. complete emptying of bladder. reservoir, deflating pump.

AS 791 Three components: cuff sur- Automatic cuff refill provided All silicone components; lack of AS 792 rounding urethra, balloon fluid pressure to bladder neck or deactivation button predisposed (1979) reservoir, valves and resistor in urethra. to urethral erosion; AS 791 supe- single pump unit. rior for bladder neck; AS 792 superior for bulbous urethra.

AS 800 Three components: cuff Fluid in cuff provides pressure to Inclusion of deactivation button (1982) surrounding urethra, balloon occlude urethra; delay fill mecha- decreased incidence of erosion; fluid reservoir, unidirectional nism. revision (1987) to narrow-backed valve and deactivation button in cuff further decreased incidence single pump. of erosion * All devices appropriate for use in males or females.

260 UROLOGIC NURSING / August 2003 / Volume 23 Number 4 Figure 2. Figures 3a and 3b. C AUS Pump and Depression of the Pump to Move Fluid from the Cuff to the O Deactivation Button Reservoir Allows Urine to Pass from the Bladder. N A. T I N B. U I N G

E D U C A T I O Courtesy of American Medical N Systems, Minnetonka, MN. Courtesy of American Medical Systems, Minnetonka, MN. voir sizes, and a deflation pump. The Artificial Urinary activated, squeezing the pump The high incidence of erosion of Sphincter moves the fluid into the reser- the cuff into urethra, however, The only artificial urinary voir, allowing urination. The cuff still remained (Smith & Barrett, sphincter currently available, the gradually refills after 3 to 5 min- 2002). AS 800, is manufactured by utes, restoring continence (see More recent improvements AMS, and has existed in its pre- Figures 3a & 3b). include refinement of the surgi- sent form since 1982. The AS 800 The design of the AUS is lim- cal procedure itself. In the 1980s, is made of silicone elastomer and ited only because it cannot adjust the surgery was a two-step has a range of cuff sizes as well as to changes in intra-abdominal process: first the components an elastic pressure-controlling pressure. This can be apparent in were implanted, and 2 to 3 balloon reservoir that is preset to male patients who have the months later they were connect- a variety of pressures (51-60, 61- device implanted at the bulbous ed and activated. Today, the com- urethra, and may have some 70, 71-80, 81-90 cm H20). The plete device can be implanted in pump contains both a deactiva- degree of approximately 30 to 60 minutes. tion button and a unidirectional despite the presence of the The successful development of valve (see Figure 2). This deacti- device. the AUS is a result, in part, of the vation button allows for postop- involvement of the National erative healing without pressure Indications for the AUS Aeronautics and Space Ad- on the urethra by preventing the There are a variety of well- ministration with the medical flow of fluid from the device established reasons for patients device industry and the incorpo- reservoir to the cuff surrounding to be offered an AUS. These ration of reliable aerospace com- the urethra. It also allows for safe include post-prostatectomy uri- ponents in its development catheterization, , and nary leakage, congenital disor- (Hajivassilou, 1998). The most other genitourinary instrumenta- ders of the bladder, unsuccessful recent improvements to the AUS tion. Its addition to the device reconstructive surgery to the ure- include a revised cuff design and design eliminated the need for a thra, and genuine stress inconti- color-coded tubing which pro- second surgery to activate the nence in select women patients. motes ease of identification intra- device intraoperatively. Patients who have under- operatively. After the device has been gone a radical retropubic prosta-

UROLOGIC NURSING / August 2003 / Volume 23 Number 4 261 C tectomy (RRP) for prostate can- AUS, in which case the cuff 2001), although the degree of suc- O cer, and less commonly a radical would be placed at the bladder cess is directly dependent on the perineal prostatectomy or trans- neck (Smith & Barrett, 2002). number of previous continence N urethral resection of the prostate, Neurologic disease or injury, or a patient has undergone. T are often candidates for place- radiation to the spinal cord or I ment of an AUS. Urinary inconti- pelvis, can also result in sphinc- Contraindications to an AUS nence is a well-documented teric insufficiency (Roberts & Any patient considering N potential complication of RRP. Barrett, 2000) and in these surgery for an AUS should be U Although the degree of leakage instances the AUS would be evaluated for his or her level of I can continue to lessen for up to placed at the bladder neck. manual dexterity. Without the 18 months following surgery, less The AUS is implanted more ability to operate the pump N than 5% have persistent stress frequently in males than in mechanism, the patient will be at G incontinence (Peyromaure, Ravery, females, largely due to the numer- risk for (Elliott & Boccon-Gobod, 2002). Montague, ous indications for prostate surg- & Barrett, 1998a). Patients with E Angermeier, and Paolone (2001) eries. There are circumstances in poor cognitive function or a lack stated that the AUS is superior to which females are appropriate can- of motivation will also be poor D other incontinence treatment didates for the procedure, includ- candidates (Smith & Barrett, U options for patients with RRP. ing those who have previously 2002; Petrou, Elliot, & Barrett, C Discussion of an AUS as a failed anti-incontinence surgeries 2000). Patients who have a blad- treatment option should be as well as those with congenital der capacity less than 200 cc, a A delayed a minimum of 6 months abnormalities. The role of the AUS post-void residual greater than T after RRP surgery (Roberts & in women is to provide gentle pres- 100 cc, or who have been incon- I Barrett, 2000) to allow for the sure to the bladder neck to tinent less than 6 months are typ- possibility of spontaneous im- improve continence, while avoid- ically excluded from consid- O provement. Consideration of N surgery should be preceded by The AUS is implanted more frequently in conservative management, such as a trial of anticholinergics males than in females, largely due to the and/or α−agonists or pelvic floor numerous indications for prostate surgeries. exercises. In post-RRP patients, the AUS cuff is placed at the bul- bous urethra. Although the blad- ing distortion of the natural eration for an AUS. der neck is the preferred site for anatomic position of the bladder Individuals with a large post- placement of the AUS cuff due to neck. void residual are typically best its excellent blood supply, this Women who have genuine treated with intermittent self- area is scarred in these particular stress incontinence, defined as catheterization (ISC), which post-surgical patients, and so the involuntary urine loss when alone may resolve the problem. cuff is preferentially placed at the intravesical pressure exceeds ure- Patients with a small bladder bulbous urethra. thral closure pressure in the capacity and those with urge Several congenital disorders absence of detrusor activity, can incontinence are not candidates may lead to situations in which an benefit from an AUS. They must for AUS, since high bladder pres- AUS may be considered as a treat- demonstrate intrinsic sphincter sures may develop after urethral ment option. These involve deficiency, or a malfunction of the occlusion, placing the upper uri- absence of urinary sphincter func- urinary sphincter itself. This is nary tracts at risk. Intermittent tion due to neurologic conditions commonly referred to as Type III catheterization, if required after such as myelomeningocele. In stress incontinence. Female AUS implantation, has not been these cases, the cuff is typically patients who have failed more shown to increase the incidence placed at the bladder neck, conservative attempts at manage- of or cuff erosion although additional measures ment, such as periurethral colla- (Barrett & Furlow, 1984). such as intermittent catheteriza- gen injections, autologous fat Because the need for repeat- tion are nearly always required to placement, and/or sponge plugs ed surgical instrumentation of optimize bladder function. placed in the vulva or the urethra places the patient at Without intermittent catheteriza- (Costa et al., 2001), can be consid- risk for erosion of the cuff, the tion, these patients are at high risk ered for either an AUS or pubo- presence of active stone disease for urinary retention after AUS vaginal sling. In properly selected or a history of recurrent bladder implantation. patients, the rate of postoperative tumors or other progressive uro- A failed urethral reconstruc- continence with the AUS logic disease excludes patients tion may lead to the need for an approach is 88.7% (Costa et al, from consideration for an AUS.

262 UROLOGIC NURSING / August 2003 / Volume 23 Number 4 Patients with recurrent urethral radiation urethritis, inflamma- plane of dissection for the pump C stricture disease, or who are at tion, or adhesions can be con- in the scrotum or labia. Small O risk for recurrent strictures, firmed preoperatively with office hematomas will spontaneously should also be excluded until cystoscopy. resolve, but larger hematomas N their disease is definitively treat- can displace the pump and may T ed (Carson, 1989; Petrou et al., Risks of AUS Surgery require drainage. I 2000) or controlled prior to AUS Because the AUS procedure Urinary retention after AUS implantation. involves implanting a foreign implantation is usually a result N Females with hypermobility- device into the body, the greatest of edema around the cuff site. It U related stress incontinence risk of the surgery is infection. should be confirmed that the cuff I (examples include women post- Most are thought to is in its open position; most childbirth, older women, or originate at time of surgery patients will be able to void N those who have had previous (Carson, 1989), and the incidence spontaneously after a short G pelvic surgery) are not candi- of infection requiring removal of course of ISC with a small diam- dates for an AUS, as they do not the device typically ranges from eter catheter. In the months fol- E have bladder neck hypermobili- 1.8% to 10% (Petrou et al., 2000) lowing activation of the cuff, ty. They should instead be con- but is commonly reported as retention can be a result of a new D sidered for bladder neck suspen- 4.5% (Venn et al., 2000). Patients or recurrent stricture in the ure- U sion procedures to increase out- at higher risk for infection after thra or indicate a change in blad- C let resistance and restore the this type of procedure include der function as in the patient bladder neck to its proper patients with spinal cord injury, with a neurogenic bladder. A anatomic position, as the prob- poorly controlled diabeties, a his- The AUS is also at risk for T lem in these cases is related to tory of recurrent UTIs, or replace- mechanical failure, which occurs I the inadequate pelvic support ment of a nonfunctional AUS. If in approximately 7.6% of cases rather than an intrinsic sphincter an infection occurs, it is usually (Petrou et al., 2000). Mechanical O deficiency. seen in the first 3 months postop- malfunction of the AUS is usually N Active urinary, genital, per- eratively, but can also present due to a fluid leak, kinked tubing, ineal, or lower abdominal infec- later. Pain, swelling, and indura- or a malfunction of the pump. The tions should be eradicated prior tion or erythema of the scrotum, overall risk of mechanical failure to surgery, as this can increase labia, or perineum are the com- has significantly decreased in the the risk of postoperative infec- mon signs of an early postopera- last 15 years since the introduc- tion of the AUS (Petrou et al., tive infection. Later signs include tion of the revised device with the 2000). Distant infections, such as fever, abscess and drainage, narrow-backed cuff (Elliott & diabetic foot disease and peri- pump erosion through scrotal Barrett, 1998b). odontal disease, must not be skin, and cuff erosion into the Erosion of the cuff into the overlooked as hematogenous urethra. urethra is most commonly seeding from these distant Treatment of an infected reported 3 to 4 months after sources may occur. AUS requires removing the implantation, and can also be Prior pelvic radiation is a rel- entire device with an indwelling seen after the patient has been ative contraindication to this catheter for 3 to 6 weeks to allow catheterized or otherwise instru- surgery (Venn, Greenwall, & for urethral healing. Surgeons mented without deactivation of Mundy, 2000), particularly in may consider implanting a sec- the device. The AUS relies on a female patients who have under- ond sphincter 3 to 6 months after balance of pressure to occlude gone radiation treatments for cer- documented eradication of the the urethra, but this same pres- vical cancers. Patients with infection, although risk of infec- sure can also lead to tissue prostate cancer who have been tion increases with the second ischemia and erosion of the ure- treated with external beam radia- prosthesis surgery (Smith & thra. This underscores the impor- tion are AUS candidates because Barrett, 2002). tance of careful selection of both the bulbous urethra is not within Postoperative hematoma is cuff size and reservoir pressure. the irradiated area. The presence another risk of AUS surgery. A There is a higher risk of erosion of an urethra that is free from hematoma can form along the when the cuff is placed at the bulbous urethra when compared with placement at the bladder Because the AUS procedure involves neck (Venn et al., 2000). An erod- ed cuff may cause pain, local implanting a foreign device into the body, swelling, , the greatest risk of the surgery is infection. recurrent incontinence, or a bloody urethral discharge.

UROLOGIC NURSING / August 2003 / Volume 23 Number 4 267 C Erosion can also occur as a Candidates for AUS surgery must fit a O direct result of an infection. If no infection is identified, the eroded specific group of criteria to insure that N cuff alone can be removed, the they will benefit from the device. T remaining tubing occluded with I a stainless steel plug (manufac- tured by AMS), and a catheter N left in the bladder for at least 3 devices that had been implanted tional durability of the AMS 800 arti- ficial urinary sphincter: A review of U weeks to allow the urethra to many years previously. They reported an estimated AUS sur- 323 cases. The Journal of Urology, I heal. 159, 1206-1208. Recurrent or persistent in- vival of 66% at 10 years. Fishman, I.J., Shabsigh, R., & Scott, F.B. N continence after AUS implanta- (1989). Experience with the artificial G tion has a variety of etiologies. It Conclusions urinary sphincter model AS800 in Incontinence presents a sig- 148 patients. The Journal of Urology, can be attributed to mechanical 141, 307-310. nificant challenge to everyday E failure, such as a loss of fluid in Hajivassilou, C.A. (1998). The develop- the system. The leaking compo- activities for many patients. A ment and evolution of artificial ure- D nent can be replaced, if it can be variety of treatment options exist, thral sphincters. Journal of Medical Engineering & Technology, 22(4), U identified; the surgeon may also but some patients will find con- servative measures unsatisfacto- 154-159. C choose to replace the entire sys- Light, J.K., & Reynolds, J.C. (1992). Impact tem. If no site for fluid loss can be ry as they seek to regain urinary of the new cuff design on reliability A determined, however, then the control. The artificial urinary of the AS800 artificial urinary T entire system must be replaced. sphincter provides a unique, but sphincter. The Journal of Urology, invasive, method of restoring 147, 609-611. I Incontinence can also be the Montague, D.K., Angermeier, K.M., & result of tissue atrophy, and com- control over urinary function. Paolone, D.R. (2001). Long-term con- O monly presents approximately 4 Candidates for AUS surgery tinence and patient satisfaction after N months after device activation must fit a specific group of crite- artificial urinary sphincter for urinary ria to insure that they will bene- incontinence after prostatectomy. (Light & Reynolds, 1992). The Journal of Urology, 166, 547- 549. Typically the patient gives a his- fit from the device. With careful Petrou, S.P., Elliot, D.S., & Barrett, D.M. tory of decreased function and an patient selection and evaluation, (2000). Artificial urethral sphincter increased number of pumps to the AUS can improve a patient’s for incontinence. Urology, 56(3), 353- activate the device. In this case, a self-esteem and quality of life by 359. restoring a normal voiding pat- Peyromaure, M., Ravery, V., & Boccon- second surgery can be performed Gobod, L. (2002). The management of to decrease cuff size, increase tern. ¥ stress urinary incontinence after rad- reservoir pressure, or place a sec- ical prostatectomy. BJU International, ond cuff distal to the first. References 90(2), 155-161. Barrett, D.M., & Furlow, W.L. (1984). Roberts, S.G., & Barrett, D.M. (2000). Placing a second cuff has the Incontinence, intermittent self- Implantation of the artificial geni- added benefit of avoiding catheterization and the artificial uri- tourinary sphincter. In R.J. Krane, increased pressure on the ure- nary sphincter. The Journal of M.B. Siroky, & J.M. Fitzpatrick (Eds.), thra, but requires more involved Urology, 132, 268-269. Operative urology: Surgical skills (pp. urethral dissection. Incontinence Carson, C.C. (1989). Infections in geni- 323-332). Churchill Livingstone: New tourinary prostheses. Urologic York. that persists after AUS placement of North America, 16(1), 139-147. Smith, J.J., & Barrett, D.M, (2002). may also indicate cuff erosion Costa, P., Mottet, N., Rabut, B., Thuret, R., Implantation of the artificial geni- into the urethra, or in females, a Naoum, K.B., & Wagner, L. (2001). tourinary sphincter. In P.C. Walsh, . The use of an artificial urinary A.B. Retik, E.D. Vaughn, & A.J. Wein sphincter in women with type III (Eds.), Campbell’s urology (8th ed.) The expected 5-year survival incontinence and a negative Marshall (pp. 1187-1194). Philadelphia: Saun- of the device has been described test. The Journal of Urology, 165, ders. to be between 67% and 90% 1172- 1176. Siegel, S.W. (1989). History of the pros- (Smith & Barrett, 2002; Elliott & Elliott, D.S., & Barrett, D.M. (1998a). The thetic treatment of urinary inconti- Barrett, 1998a). Venn et al. (2000) artificial urinary sphincter in the nence. Urologic Clinics of North female: Indications for use, surgical America, 16(1), 99-104. demonstrated an overall revision approach and results. International Venn, S.N., Greenwall, T.J., & Mundy, A.R. rate of 33% for the AUS for rea- Urogynecology Journal, 9, 409-415. (2000). The long-term outcome of sons of mechanical failure, infec- Elliott, D.S., & Barrett, D.M. (1998b). Mayo artificial urinary sphincter. The tion/erosion, and revision of long-term analysis of the func- Journal of Urology, 164, 702-707.

268 UROLOGIC NURSING / August 2003 / Volume 23 Number 4 C Artificial Urinary Sphincter, O N Part II: Patient Teaching T I N And Perioperative Care U Susanne A. Quallich I Dana A. Ohl N G As discussed in Part I, effective management of urinary incontinence variety of patients are common candidates for is a tremendous quality of life intervention. The surgical implantation E of an artificial urinary sphincter (AUS) provides a definitive, although placement of an artifi- D cial urinary sphincter invasive, surgical option to re-establish continence. Understanding A(AUS). As discussed in Part I, the intraoperative surgical procedure, postoperative care, and teach- U these include patients with post- ing will aid in preparing patients undergoing AUS implantation for C prostatectomy urinary leakage, successful outcomes. A congenital disorders of the blad- der, unsuccessful reconstructive T surgery to the urethra, and gen- Preoperative Evaluation and pletely emptying the cuff prior to I uine stress incontinence in select Preoperative Patient urinating; the possibility that the O female patients. Counseling patient may continue to experi- N As the population continues Because AUS surgery is an ence some degree of stress incon- to age, the number of patients elective surgical procedure, the tinence despite the presence of presenting with questions about preoperative evaluation should the AUS; and the possible need the AUS is likely to rise. An confirm that the client is med- to replace the device or add an understanding of the preopera- ically optimized. Cardiovascular additional cuff after the initial tive process for the AUS as well disease, peripheral vascular implantation. Patients should as the surgical procedure itself occlusive disease, and diabetes also be counseled that their will aid in discussions with can increase a patient’s risk for incontinence will usually contin- these patients. Awareness of the surgery and can affect postopera- ue after surgery, because the cuff postoperative care will also help tive healing. Routine preopera- is not activated until they are prepare patients for a positive tive evaluation for patients cleared at subsequent postopera- outcome and realistic expecta- undergoing AUS includes base- tive visits. Only an occasional tions for the function of the line chemistries, complete blood patient will become continent device. count, coagulation studies, elec- after surgery but prior to activa- trocardiogram, and a chest film tion of the device. in patients over age 50. In addition to the general Glycosolated hemoglobin and medical evaluation, AUS candi- albumin may be added at the dates should undergo a special- provider’s discretion, but a clean ized urologic workup that can urinalysis and culture within 2 involve a variety of components Susanne A. Quallich, APRN,BC, NP- weeks of the anticipated surgery that often includes urodynamic C, CUNP, is a Nurse Practitioner, evaluation, cystoscopy, and radi- Division of Andrology and Microsurgery, date is mandatory (Carson, 1989). Appropriate patient educa- ologic studies. Despite the fact University of Michigan Medical Center, that the underlying cause of Ann Arbor, MI. tion must also occur prior to surgery, to ensure that the patient incontinence may seem obvious, Dana A. Ohl, MD, is an Associate understands what his/her role (for example, a radical prostatec- Professor of Urology and Head, Division will be in postoperative care as tomy) a patient must be evaluat- of Andrology and Microsurgery, well as to ensure that the ed for any conditions that could University of Michigan Medical Center, patient’s expectations are realis- lead to an unsuccessful outcome. Ann Arbor, MI. tic. Several points must be A urodynamic evaluation evaluates the patient for poor Note: CE Objectives and Evaluation emphasized to the patient preop- eratively: the importance of com- detrusor compliance, involun- Form appear on page 277. tary detrusor contractions, and

UROLOGIC NURSING / August 2003 / Volume 23 Number 4 269 C Table 1. gone a non-nerve sparing proce- O Preoperative Instructions Before Artificial dure. It is advised that during the Urinary Sphincter Surgery operative procedure the AUS be N implanted first so that in the T • Stop taking aspirin, ibuprofen, Motrin®, Advil®, Naprosyn®, and event of a surgical urethral I naproxen 7 days before your surgery date. These drugs can thin your injury, the entire procedure can blood. be aborted (Smith & Barrett, N • Stop taking all herbal supplements 2 weeks before surgery. 2002; Petrou, Elliot, & Barrett, U • If you take the blood thinners, such as Coumadin® (warfarin sodium), you 2000; Roberts & Barrett, 2000), will be given special instructions about when to stop this . and that the reservoirs are placed I • You will be given separate instructions about which you on opposite sides. Simultaneous N may take the morning of surgery. • Do not shave your groin or perineal area for the 2 weeks before your implantation does not increase G surgery date. This prevents any nicks to you skin that can provide an the patient’s risk for mechanical entrance for bacteria. problems with either device. If E • You will be given four Hibiclens® sponges, which have special antibi- one implant develops an infec- otic soap. Use two to bathe or shower the night before surgery: use tion, the uninfected device may D one to clean your entire body, and one to clean your groin. The morn- remain in place if it is clear that U ing of surgery, bathe or shower again, using one sponge to clean your it is not involved in the infec- entire body, and one to clean your groin. C tious process (Petrou et al., 2000). • Males and females: You will instructed to use one Fleet enema the Women of childbearing age A night before surgery. • Females: You will be instructed to use a vaginal douche while you are who are considering AUS implan- T waiting to go into the operating room. This will be provided to you. tation must also be informed that I vaginal delivery may put pressure on the urethral cuff and possibly O stretch the device’s tubing. Petro N et al. (2000) suggested that the detrusor hypocontractility, all of site of cuff placement contributes AUS should be deactivated dur- which would indicate a poorly to erosion and/or loss of cuff ing the last trimester as there is an functioning bladder that may not compression after implantation increased risk of the device erod- benefit from an AUS (Singh & (Fishman, Shabsigh, & Scott, ing through the urethra due to the Thomas, 1996). Cystometrogram, 1989). increasing pelvic pressure from pressure-flow studies, or video Patients may also require the developing infant. urodynamics may be used. It is evaluation of any existing upper- Patients should also be pro- essential to establish the absence tract abnormalities. Patients with vided with written instructions of involuntary detrusor contrac- a personal history of stone dis- specific to the artificial urinary tions that would result in a ease or previous reconstruction sphincter procedure (see Table 1). patient remaining incontinent of the upper genitourinary tracts This will not only provide a writ- despite the presence of an AUS. are at risk for additional invasive ten reminder to the patient regard- The overall goal of the preopera- procedures, and should be coun- ing the instructions for his/her tive urodynamic evaluation is to seled extensively as to the poten- surgery, but also serves to detail establish the presence of a low- tial risk this may pose to the the role of the patient in the pressure compliant bladder prior AUS. immediate preoperative process. to AUS implantation. Patients with both inconti- Endoscopic evaluation is nence and a poor response or Immediate Preoperative required preoperatively to look poor tolerance to primary and Patient Preparation for possible anatomic abnormali- secondary pharmacologic man- Patients scheduled to receive ties, such as stricture, bladder agement for erectile dysfunction an AUS should have a docu- neck contracture, false passage, may consider the simultaneous mented clean urinalysis within or diverticulum (Elliot & Barrett, implantation of a penile prosthe- the 2 weeks prior to the surgery 1998). Any patient who requires sis and an AUS. The benefits of a date (Carson, 1989). If a docu- surgical correction for any of combined procedure include a mented urinalysis is not avail- these conditions must wait a single episode of general anes- able, one may be ordered as part minimum of 3 additional months thesia, shorter inpatient of the routine preoperative before re-evaluation and consid- stay, and an overall decrease in orders for this procedure. The eration for an AUS. Endoscopic postoperative pain. This poten- patient should be made aware evaluation also helps to establish tial scenario is commonly seen that the surgeon may choose to urethral tissue viability, as a lack with patients undergoing radical cancel the surgery if the urinaly- of healthy tissue at the planned prostatectomy who have under- sis is suspicious for an infection.

270 UROLOGIC NURSING / August 2003 / Volume 23 Number 4 The patient must be instruct- and 160 mg of gentamicin in dissection of the bladder neck. C ed to shower the night before and 1,000 mL of normal saline. This The cuff is then placed around O the morning of surgery with mixture will be surgeon and/or the bladder neck, and the reser- chlorhexidine soap that is pro- facility dependent. These strin- voir is placed in the perivesical N vided. Both males and females gent recommendations for oper- space. A pocket for the device T will also have a limited bowel ating room procedure were pump is created in the labia I prep (one Fleet® enema) the night inspired by Carson’s work in majora on the side of the patient’s before surgery, and females will 1989 that evaluated causes for dominant hand for the device N be instructed to perform a vagi- infection in genitourinary pros- pump. The device is cycled and U nal douche the morning of theses. left deactivated with the cuff in I surgery. Male patients are placed in the open position. Placement of Antibiotics, such as van- the dorsal lithotomy position if the device is also possible via a N comycin and gentamicin, are the AUS cuff is to be implanted transvaginal approach. G given in the holding area in the at the bulbous urethra. The pro- Postoperative Management hour before surgery to provide cedure for AUS implantation in E broad-spectrum coverage against the male begins with the place- The inpatient stay after AUS common skin flora and gram- ment of a urethral catheter. An placement is approximately 1 to D negative bacteria, most common- incision is made over the bul- 2 days. Oral pain medication is U ly Staphylococcus epidermidis bous urethra, and the urethra is prescribed, and ambulation is C and Escherichia coli. The specif- then dissected away from the not restricted. Intravenous antibi- ic antibiotics will be surgeon tunica albuginea and corporal otics are continued until dis- A and/or facility dependent. The bodies. This allows cuff place- charge; oral antibiotics (typically T patient’s genital and perineal ment around the urethra. A trans- a cephalosporin) are given for 7 I area should be carefully inspect- verse incision is then made to the to 10 days postoperatively. ed in the holding area to confirm lower abdomen, over the rectus Patients are advised to use ice O that there are no lesions present muscle, allowing the creation of packs on the scrotal/labial and N that could be a source for infec- a pocket for the reservoir by perineal areas for 24 to 48 hours tion. bluntly dissecting beneath the after the surgery as a local com- belly of the rectus muscle. The fort measure to prevent swelling Surgical Procedure reservoir is then placed and and for a degree of pain control, The surgical field is shaved filled. A pouch is then created in both while they are inpatient and in the operating room itself, to the hemiscrotum, and the pump after discharge. Patients and care- prevent bacterial contamination is usually placed on the side of giving staff alike must be remind- by exposure to skin pathogens. the patient’s dominant hand. The ed to avoid any traction on the For females, the labia, perineal AUS system is tested and left urethral catheter, as this will lead area, and lower abdomen are deactivated with the cuff in the to increased pressure on the cuff shaved; for males, the scrotum, open position. If the cuff is being of the sphincter. perineum, and lower abdomen placed at the bladder neck, the On the first postoperative are shaved. After a 10-minute operative procedure in the male day, the surgical dressings, any betadine scrub of the surgi- drains, and catheter are cal field, the patient is removed. The patient draped with paper The inpatient stay after is asked to void. If he or drapes (paper drapes AUS placement is she is unable to void, are used because wet he/she will be instruct- cloth is permeable to bac- approximately 1 to 2 days. ed in intermittent self- teria). The surgical team catheterization and scrubs for 10 minutes and will begin with an abdominal advised to continue to self- dons paper gowns. It is also rec- incision, and the reservoir is catheterize with a small caliber ommended that the scrub techni- placed in the perivesical space. catheter until he/she is able to cian or nurse remain in the oper- The female patient is also void spontaneously. ating room for the duration of the placed in the dorsal lithotomy A stool softener may be rec- case. Traffic in the surgical suite position, and iodoform-impreg- ommended, along with a recom- itself should be limited to pre- nated gauze is placed into the mendation to increase fluid vent contamination. The AUS is vagina followed by the place- intake to prevent straining with assembled on a separate Mayo ment of a urethral catheter. The bowel movements. Patients with stand and soaked in a solution procedure for AUS implantation AUS implants should be advised consisting of two antibiotics, in the female begins with a lower to avoid heavy lifting (greater such as 50,000 U of bacitracin abdominal midline incision and than five pounds) or strenuous

UROLOGIC NURSING / August 2003 / Volume 23 Number 4 271 C Table 2. O Postoperative Instructions for Artificial Urinary Sphincter Surgery N Activity: Avoid heavy lifting (greater than 5 pounds) SPECIAL CONSIDERATIONS T or strenuous activity prior your postoperative appoint- ment. This causes increased abdominal pressure and • Follow any special instructions your doctor has I puts stress on the incision. If you need to brace your- given you. N self to pick up an object, it is too heavy. • Men: If your scrotum is swollen, wear a scrotal sup- port. When resting, elevate your scrotum on a towel U Sexual Activity: It is recommended that sexual activi- roll. I ty should be avoided for 6 weeks after surgery. Use of • Avoid constipation to prevent straining. Increase the AUS prior to proper healing of the incision roughage in your diet, drink prune juice or orange N could cause damage to the incision and result in juice, or take milk of magnesia or another over-the- G potential infection. Your doctor will discuss resum- counter laxative if necessary. You will be prescribed ing sexual activity at a postoperative visit. a stool softener when you are discharged. It is rec- ommended that you drink 6-8 glasses of water a E Clothing: Wear loose-fitting undergarments and avoid day to enhance the effectiveness of the stool soften- D wearing clothing that is too tight. er. Should constipation become a problem that is not relieved, call the urology care provider. U Bathing: You may shower if you wish. Gently wash C the incision with soap and water, rinse thoroughly, and Reasons to Call Your Doctor pat dry. This will keep your incision clean, dry, and free • Men: Increased scrotal swelling. A of bacteria. Beginning 5 days after your surgery, you • Women: Increased swelling of the labia. T may also take a bath. • Drainage from your incision. I • Incision becomes red or swollen. Incision Care: It is extremely important that you care- • Skin around your incision is warmer than else- O fully monitor your incision for signs of redness, where. N swelling, or drainage. It is also important to keep the • Difficulty passing your urine or starting a stream. incision clean. • Blood in your urine. • Nausea and vomiting. Driving: Long car trips can put pressure on the per- • Severe pain that is not relieved by your pain med- ineal area, where the device cuff is located. Avoid long ication. drives, or make frequent stops, such as after every 30- • Chills or fever of 101 F or more degrees. 45 minutes in the car. You will be scheduled for an appointment to return approximately 6 weeks after your surgery. At this time Carry your AUS identification card in your wallet the doctor will check your AUS, and will discuss at all times. activating the device and resuming sexual activity.

activity for at least 6 weeks, or Patients must be advised that should be counseled that their until their postoperative appoint- abstinence from sexual activity is incontinence will most likely ment. This avoids the increased essential until complete healing continue after surgery. Some abdominal pressure caused by has occurred, typically a period patients actually report immedi- straining and avoids stress on the of 6 weeks. This helps prevent ate correction of their inconti- incision. any unnecessary tension on the nence. This is largely a result of Patients may also be instruct- incision and also helps decrease postoperative edema at the site of ed to gently pull down on the the risk of opening the suture cuff placement, which narrows pump as it heals to prevent its line(s) and exposing the device to the diameter of the urethra. upward migration in the scrotum the risk of infection. Patients Any patient who did not or labia. Beginning 5 days after must also be advised not to acti- experience nighttime inconti- AUS implantation, patients may vate the device until they are nence should be advised to leave shower daily or take a bath. cleared to do so at a postopera- the AUS cuff deactivated when Patients with AUS implants tive visit. Table 2 is a summary of sleeping. This will have the are placed on a driving restric- discharge instructions for patients added benefit of decreasing any tion and should avoid long peri- with AUS implants. potential tissue ischemia that ods of time sitting in the car, for 6 may lead to urethral atrophy. weeks postoperatively, in part to Followup Regardless of the site of cuff prevent increased pressure on Because the cuff is not acti- placement, most patients will the perineal area. vated postoperatively, patients have the device activated 6 to 8

272 UROLOGIC NURSING / August 2003 / Volume 23 Number 4 weeks postoperatively. In the dures (Smith & Barrett, 2002). or as a result of a chronic medical C clinic, they will be shown how to The AUS has also been stud- condition. As the population O cycle the device and will be ied to verify its safety in magnet- continues to age, less-invasive instructed that recompression ic resonance scanners because of treatments for urinary inconti- N takes from 3 to 5 minutes. its small metallic components. nence will continue to improve. T Patients should be able to There is no risk to the patient or The artificial urinary sphincter I demonstrate that they can open the device with an MRI scan will remain a definitive and the cuff and void prior to leaving (Shellock, Morisoli, & Kanal, unique surgical option to restore N the clinic to avoid the risk of uri- 1993) and its presence should continence in a well-chosen per- U nary retention. Cuff reactivation not cause the images from the centage of patients. ¥ I takes from 3 to 5 minutes and scan to be distorted. The device continence occurs only when the will not cause airport metal References N device cuff is inflated. Patients detectors to alarm. Carson, C.C. (1989). Infections in geni- G tourinary prostheses. Urologic Clinics of North America, 16(1), 139- 147. E The AUS enjoys a high patient satisfaction rating Elliott, D.S., & Barrett, D.M. (1998). The artificial urinary sphincter in the D due to the significant improvement in quality female: Indications for use, surgical approach and results. International U of life afforded by the recovery of continence. Urogynecology Journal, 9, 409-415. C Fishman, I.J., Shabsigh, R., & Scott, F.B. (1989). Experience with the artificial A must also be reminded to deflate Conclusion urinary sphincter model AS800 in T 148 patients. The Journal of Urology, the cuff prior to self-catheteriza- In both male and female 141, 307-310. I tion, even if using a small-caliber patients who have been carefully Petrou, S.P., Elliot, D.S., & Barrett, D.M. catheter. screened, the artificial urinary (2000). Artificial urethral sphincter O Patients with AUS implants sphincter remains an excellent for incontinence. Urology, 56(3), N have restrictions that will last as option for treating urinary incon- 353-359. Roberts, S.G., & Barrett, D.M. (2000). long as the device remains in tinence. The AUS offers many Implantation of the artificial geni- place. Patients who had the cuff benefits to patients by restoring a tourinary sphincter. In R.J. Krane, placed at the bulbous urethra natural voiding pattern, making M.B. Siroky, & J.M. Fitzpatrick should be advised not to sit for possible a normal pattern of social (Eds.), Operative urology: Surgical skills (pp. 323-332). Churchill prolonged periods of time, as behavior without worry about uri- Livingstone: New York. well as to avoid chairs with hard nary leakage. The AUS enjoys a Shellock, F.G., Morisoli, S., & Kanal, E. seats. This will prevent unneces- high patient satisfaction rating (1993). MR procedures and biomed- sary pressure on the perineal due to the significant improve- ical implants, materials, and area. Patients with AUS implants ment in quality of life afforded by devices: 1993 update. , 189, 587-599. are permanently restricted from the recovery of continence. Singh, G., & Thomas, D.G. (1996). horseback riding and from bicy- Patient satisfaction ratings have Artificial urinary sphincter for post- cling of any kind with a tradi- been variously documented, with prostatectomy incontinence. The tional saddle seat (Smith & some reports as high as 84.5%. British Journal of Urology, 77, 248- 251. Barrett, 2002), as this will pre- Successful treatment of uri- Smith, J.J., & Barrett, D.M, (2002). vent increased pressure in the nary incontinence in any patient Implantation of the artificial geni- perineal area and decrease the provides increased self-esteem tourinary sphincter. In P.C. Walsh, risk of cuff erosion. Newer bicy- and independence, particularly A.B. Retik, E.D. Vaughn, & A.J. Wein cle seat designs with open areas as incontinence can be the conse- (Eds.), Campbell’s urology (8th ed.) (pp. 1187-1194). Philadelphia: Saun- in the center to decrease perineal quence of treating a malignancy ders. compression may be acceptable. Patients should carry identi- fication for the AUS, such as a wallet card or MedicAlert bracelet, so that the device can be Earn 3.7 deactivated prior to catheteriza- tion and prevent erosion of the urethra that would necessitate Contact Hours replacing the AUS. Patients with AUS implants should routinely See page 277 receive antibiotic prophylaxis prior to dental or surgical proce-

UROLOGIC NURSING / August 2003 / Volume 23 Number 4 273 C O Artificial Urinary Sphincter N T Case Study I N U I Susanne A. Quallich N Dana A. Ohl G

.L. is a 57-year-old was very uncomfortable by the M.L. decided to proceed with E gentleman with a end of the day. the urologic evaluation for an D history of Gleason M.L. found his current situa- AUS. His office cystoscopy U 3+4=7 prostate can- tion extremely unsatisfactory showed him to be free from any Mcer, with a preoperative prostate and that he was both unable and postoperative scarring at the C specific antigen (PSA) of 5.1. He hesitant to pursue his active pre- bladder neck, the site of the radi- A underwent a unilateral nerve- operative lifestyle. He presented cal prostatectomy anastomosis. His T sparing radical prostatectomy to the urology clinic for discus- urodynamic evaluation showed a approximately 1 year ago. In the sion of an artificial urinary normal capacity bladder of 450 I immediate period after the sphincter (AUS). mL, good compliance, an exter- O surgery, despite the nerve-spar- M.L. has a history of well- nal sphincter pressure of 35 cm N ing procedure, he suffered from controlled hypertension and a of water, and a stress leak point almost complete incontinence. vasectomy 20 years ago, in addi- pressure of 40 cm of water. These He had some slow improvement tion to the prostate cancer. He findings were consistent with of his urinary symptoms, but currently takes a baby aspirin sphincteric incontinence. An currently uses an average of six and lisinopril 10 mg daily. He intravenous pyelogram to evalu- medium-sized pads in 24 hours has a 15 pack-year history of ate his upper urinary tracts to control his leakage. Initially smoking and consumes three showed him to be free of M.L. underwent training in mixed drinks in a week. hydronephrosis, filling defects, Kegel exercises, which helped to or stones. improve his symptoms some- Preoperative Assessment M.L.’s preoperative physical what. He tried oxybutynin chlo- Initial discussion with M.L. showed him to be free of any evi- ride to aid in the management of included a review of the risks dence of open areas or lesions to his urinary leakage, but found and benefits of the AUS. the penis, scrotum, or inguinal that the medication’s Discussion of the operative pro- area. He is uncircumcised, with were bothersome and that the cedure included counseling on evidence to the glans of the penis drug was ineffective. He also the following points: there is a of mild irritation due to urine used a penile clamp, but this slightly higher risk of infection entrapment under the foreskin. with AUS surgery when com- The preoperative laboratory val- pared with other surgical proce- ues were all within normal lim- dures because a foreign body is its, with a PSA that was unde- being implanted; should the tectable. His urinalysis was also Susanne A. Quallich, APRN,BC, NP- device have to be removed for within normal limits and showed C, CUNP, is a Nurse Practitioner, mechanical failure or infection no evidence of infection. Chest x- Division of Andrology and Microsurgery, he would have to wait several University of Michigan Medical Center, ray showed no active disease, Ann Arbor, MI. months before another could be and his preoperative ECG implanted; and the expected showed normal sinus rhythm, Dana A. Ohl, MD, is an Associate lifespan of the device is approxi- with some increased R wave pro- Professor of Urology and Head, Division mately 5 years. He was instructed gression, consistent with left ven- of Andrology and Microsurgery, that his incontinence would tricular hypertrophy. M.L. also University of Michigan Medical Center, improve initially due to postop- demonstrated adequate manual Ann Arbor, MI. erative swelling of the urethra, dexterity to operate the pump on even before the device is activat- the AUS model in the clinic. Note: CE Objectives and Evaluation ed 6 weeks postoperatively. Form appear on page 277. continued on page 276

274 UROLOGIC NURSING / August 2003 / Volume 23 Number 4 C Case Study use over-the-counter pain med- from the patient. Proper cycling O continued from page 274 ications as needed, and to contact of the device was demonstrated the urology clinic for any changes to the patient, and M.L. left the N M.L. underwent an unevent- in his condition, such as a fever clinic able to correctly cycle the T ful placement of an AS 800 artifi- greater than 100 F, drainage from AUS. He was also reminded that I cial urinary sphincter, with reser- the incision, or an increase in he should carry identification voir placement through the right pain. He was also reminded that that indicates he has an implant- N external inguinal canal. He was his degree of incontinence may ed AUS, and to avoid horseback U discharged home after 24 hours of actually worsen as the postopera- riding and cycling with a tradi- I intravenous antibiotics, with tive swelling continues to tional saddle seat. written postoperative instruc- improve. M.L. returned to the urology N tions and the manufacturer’s At his second postoperative clinic several months later for G patient education brochure. visit 6 weeks after his surgery, routine followup of both his Two weeks later at his initial M.L. had no complaints, with the prostate cancer and urinary sta- postoperative visit, M.L. had no exception that his preoperative tus. He reported that while it ini- E complaints. He reported that the incontinence had returned. His tially took some time to become D initial postoperative bruising had incisions were well-healed, and familiar with the use of the AUS, U resolved, and that he was using he had no tenderness to palpation he is very pleased with the out- fewer pads in 24 hours to protect of his scrotum, perineum, or right come of his surgery. He has C against urine loss. On physical inguinal region. He was cleared returned to his active lifestyle, A exam, his sutures were intact, to begin to use his AUS; the ini- including 18 holes of golf and his T and there was no evidence of tial activation was accomplished program of lap swimming for I infection. He was encouraged to without any complaints of pain exercise. ¥ O N

EnDOUROLOGY CLINICAL COORDINATOR

UCI Medical Center has an immediate career opportunity We require a current California RN license and BLS with for an enthusiastic, self-motivated RN to participate in 3-5 years medical/surgical experience. ACLS, BSN and previous Urology and/or Research experience preferred. advanced clinical practice in the Department of Urology. UCI Medical Center offers a competitive salary and You will provide and coordinate the care of urology patients excellent benefits package, including up to 3 weeks in ambulatory and inpatient settings. As an integral part of vacation, up to 2 weeks sick time, and 13 holidays. Please the clinical research team you will act as a role model to forward resume, indicating Job Number MN08903B to: UCI Medical Center, Human Resources, 101 The City Drive, nursing students and clinical nurses, and as a clinical Route 114, Orange, CA 92868; or fax: (714) 456-6590. resource to staff. AA/EOE.

276 UROLOGIC NURSING / August 2003 / Volume 23 Number 4