The Management of Erectile Dysfunction in the Aging Male

Transcription

1 Urogenital Disorders The Management of Erectile Dysfunction in the Aging Male Peter J. Pommerville, BA, MD, FRCS(C), Consultant Urologist,Vancouver Island Health Authority,Victoria, BC; Principal Investigator, Can-Med Clinical Research Inc.,Victoria, BC. Introduction Erectile Dysfunction is a significant and common medical problem. The National Institutes of Health has defined erectile dysfunction as the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance. 1 The nature of sexual dysfunction is more precisely defined by the term erectile dysfunction (ED) than by the term impotence. 1 ED is a clearly defined problem that the medical practitioner must differentiate from premature ejaculation, orgasmic dysfunction and Peyronie s disease. Prevalence of Erectile Dysfunction According to the NIH Consensus Development Panel, ED may affect as many as 30 million males in the U.S. 1 Data collected by Statistics Canada indicate that as many as three million Canadian men may suffer from ED. However, it is estimated that fewer than 20% seek treatment. 2 Epidemiological studies conducted in the U.S. provide the most extensive information on the prevalence of ED. One such study that is often referred to is the Massachusetts Male Aging Study (MMAS). 3 This study demonstrated a combined prevalence of minimal, moderate and severe ED in 52% of non-institutionalized men aged 40 to 70 (Figure 1). Of these, 10% reported complete ED, 25% reported moderate ED and 17% minimal ED. Perhaps even more troubling is the finding that the prevalence of moderate ED doubled to 34% in 70 year olds from 17% in 40 year olds, while the incidence of complete ED tripled to 15% at 70 from 5% at 40 years. The prevalence of mild ED remained the same between the two age groups. Another disturbing finding was that nearly 40% of men in their 40s had some degree of ED. The variable most strongly associated with ED was, in fact, the age of the patient. After the adjustment for age in the MMAS, a higher probability of ED was directly correlated with heart disease, hypertension, diabetes mellitus, medication dependence (used to manage these conditions) and an index of anger and depression. Cigarette smoking was associated with a greater probability of complete ED in men with heart disease and hypertension. There was a higher incidence of ED among men who had undergone radiation or surgery for prostate cancer, or among those with spinal cord injuries. Psychosocial contributors to ED included depression, anger and stress from unemployment or other life changes. Despite its increasing prevalence among older men, ED is not considered a normal part of the aging process. However, ED does appear to be strongly linked to certain physiological (vascular, neurologic and endocrinologic) and psychological changes that the aging male experiences (Table 1, page 20). ED is rarely associated with age-related hypogonadism (less than 6% of cases), 4 and the possible correlation between ED and the decline of androgens in the aging male remains controversial. Diagnosis The diagnosis and treatment of ED are most effectively performed by the primary care physician (PCP). However, all physicians, including urologists, psychiatrists and internists as well as interested health care professionals, should be encouraged to assume an active role in Figure 1: Prevalence of Erectile Dysfunction 3 No ED 48% Massachusetts Male Aging Study Men aged 40 to 70 years ED (52%) Complete (10%) Moderate (25%) Mild (17%) 19

2 the management of ED. Physicians should initiate an open dialogue with male patients of all ages concerning sexual function. It is imperative to identify those patients with ED who would not otherwise discuss their sexual dysfunction openly. Although risk factors for ED are more commonly found in the aging male (i.e., hypertension, diabetes mellitus, coronary artery disease and depression), it is well known that older men require more physical stimulation and time to achieve an erection, become flaccid more rapidly and have a larger refractory period and less frequent nocturnal erections. Aging males tend to have some degree of ED, which they are, by nature, reluctant to discuss. However, once the topic is broached, they are often more than willing and relieved to accept a physician s advice on how to improve their sexual function. The Canadian Urological Association guidelines committee has recently completed the erectile dysfunction guidelines (Figure 2, page 22). Table 2 Inflammatory Urethritis Prostatitis Cystitis Urethral Stricture and unhurried atmosphere will help encourage the patient to discuss the severity of his problem and will give the physician some indication of whether the presenting complaint is ED versus loss of libido, orgasmic dysfunction, ejaculatory dysfunction or Peyronie s disease. Whenever possible, the patient s partner should be encouraged to participate in this discussion. A general medical history should be taken to determine the presence of other factors that contribute to ED, such as the previously mentioned comorbid conditions, pelvic surgery, radiotherapy for pelvic cancer, psychiatric illness and medications to treat these conditions. Lifestyle factors such as alcohol and tobacco use can adversely affect penile blood flow and nerve function, both of which are critical in mediating the erectile response. Physical injury, trauma to the pelvis or spinal cord and previous prostate surgery have all been associated with ED (Table 2). Sexual History The sexual history should search out the specific characteristics related to ED, such as its onset, severity and significance, and whether the ED is situational. It is impor- The Organic Causes of Erectile Dysfunction Occlusive Vascular Disease Atherosclerosis Priapism Thromboembolism Medical History Due to the sensitive nature of the subject of ED, the physician must establish a trusting relationship with the patient as early as possible. A relaxed, comfortable Table 1 Risk Factors for Erectile Dysfunction Alcohol/Drug Abuse Coronary Artery/ Peripheral Vascular Disease Depression/Stress Diabetes Mellitus Hyperlipidemia Hypertension Hypogonadism Peyronie s Disease Smoking Pelvic/Spinal Trauma Prostate/Pelvic Surgery Mechanical Congenital Deformities Peyronie s Disease Morbid Obesity Hydrocele Phimosis Post-surgical Abdominal Perineal Resection Prostatectomy (TURP, Radical) Aortoiliac Surgery External Sphincterotomy Endurance Factors Post-myocardial Infarction Chronic Obstructive Pulmonary Disease Renal Failure Hepatic Failure Sleep Disorders Traumatic Ruptured Urethra (Pelvic Fracture) Neurogenic Parkinson s Disease Head Injury Spinal Cord Injury Multiple Sclerosis Amyotrophic Lateral Sclerosis Cerebral Vascular Accident Chemicals Hypnotics Sedatives Phenothiazines Antidepressants Antihypertensives Antiparkinsonian Agents Endocrine Diabetes Mellitus Klinefelter s Syndrome Hypogonadism Pituitary Disorders Thyroid Dysfunction 20 GERIATRICS & AGING September 2002 Vol 5, Num 7

3 Figure 2: Algorithm to Assess Treatment of Erectile Dysfunction 5 Assessment for Sexual Dysfunction History Physical and Labs (Glucose, Lipids*, Testosterone*, Prolactin*) Erectile Dysfunction (ED) Complete Exam Other Sexual Dysfunction Ejaculatory Problem Desire Disorder Anorgasmia Other Treatment, Possible Referral Penile Deformity (Peyronie s) Normal Exam Laboratory Abnormality Replace and Correct, Possible Endocrinology Referral No ED ED Medical Management Verapamil Vitamin E Consider Surgical Options No Treatment Trial First-line Oral Therapy Success Continue oral meds Success Continue oral meds Poor result Assess how drugs taken, optimize timing, situation Poor efficacy Not tolerated Trial Second-line Injection Therapy Urethral Therapy Vacuum Therapy Trial ICI Patient on NTG or unable to take PDE inhibitor 5 Trial VED If unsuccessful, specialized testing Consider surgical options Trial Intraurethral Therapy Success Continue with treatment Unsuccessful Consider Third-line Therapy * Optional Testing ICI=Intracorporal Injections VCD=Vacuum Erection Device NTG=Nitrates/Nitroglycerin Penile Implant Surgery Source: Canadian Urological Association 22 GERIATRICS & AGING September 2002 Vol 5, Num 7

4 tant to inquire about sexual desire, relationship issues, stress at home or at work and financial issues that may contribute to overall stress levels. The patient should also be questioned about genital pain, erection firmness and erection shape. The patient who has a complaint of sudden onset of ED often has a psychogenic cause, whereas ED of gradual onset usually indicates organic causation. The timing of the ejaculation should be discussed to determine if it is premature, delayed or absent. Partner support is important, as it is the general health of the partner and the presence of comorbid illnesses which may affect the couple s sexual relationship and, thus, success of treatment. The aging male may develop psychogenic ED after the death of his spouse, often occurring after a prolonged illness, and experience performance anxiety with a new partner. Even in cases when a physician has known a patient for a long time, it may be difficult to initiate the discussion of ED. The Sexual Health Inventory of Men (SHIM) is a five-question sexual function questionnaire that provides physicians with a non-threatening means of extracting vital information from a patient who is uncomfortable talking about his sexual health. 6 The SHIM is both sensitive and specific for Table 3 Sexual Health Inventory For Men (SHIM) IIEF-5 Based on the International Index of Erectile Function Patient Instructions Sexual health is an important part of an individual s overall physical and emotional well-being. Erectile dysfunction, also known as impotence, is one type of very common medical condition affecting sexual health. Fortunately, there are many different treatment options for erectile dysfunction. This questionnaire is designed to help you and your doctor identify if you may be experiencing erectile dysfunction. If you are, you may choose to discuss treatment options with your doctor. Each question has several possible responses. Circle the number of the response that best describes your own situation. Please be sure that you select one and only one response for each question. OVER THE PAST SIX MONTHS: 1. How do you rate your Very low Low Moderate High Very high confidence that you could get and keep an erection? 2. When you had erections with No sexual Almost A few times Sometimes Most times Almost sexual stimulation, how often were activity never/never (much less (about half (much more always/always your erections hard enough for than half the the time) than half penetration? time) the time) During sexual intercourse, Did not Almost A few times Sometimes Most times Almost how often were you able to attempt never/never (much less (about half (much more always/always maintain your erection after you intercourse than half the the time) than half had penetrated (entered) time) the time) your partner? During sexual intercourse, Did not Extremely Very difficult Difficult Slightly Not how difficult was it to maintain attempt difficult difficult difficult your erection to completion intercourse of intercourse? When you attempted sexual Did not Almost A few times Sometimes Most times Almost intercourse, how often was it attempt never/never (much less (about half (much more always/always satisfactory for you? intercourse than half the the time) than half time) the time) SCORE 23

5 identifying men who may have ED. When the total SHIM score is 21 or less, the patient may have ED and should be further investigated (Table 3). Physical Examination Afocused physical examination should be performed on every patient with suspected ED. This examination does not differ substantially from routine primary care practice, except that much greater emphasis should be placed on the genitourinary, vascular and neurologic systems. Even though the yield is low, the physical examination in patients with ED should not be overlooked. 7 Without a proper exam, the patient may feel that he has not been taken seriously and may be reluctant to accept a psychogenic diagnosis if it is present. The signs of endocrine disease which may be found include: testicular atrophy, gynecomastia, sparse body hair, skin hyperpigmentation and visual field disturbance. The signs of vascular disease include decreased peripheral pulses, presence of a prominent abdominal pulsation (with abdominal aortic aneurysms) or Dupytren s contracture (seen with Peyronie s disease). The presence of neurologic disease may be indicated by absent genital reflexes (cremasteric, bulbocavernosus or anal reflex), decreased sensation over the S2 S4 sacral nerve root distribution or decreased sensation to light touch on the penis. The physical exam of the aging male should always include a digital rectal exam to rule out prostate and rectal carcinoma. The findings on the physical exam may be used to indicate the need for specialist referral. Investigations Assessment for occult diabetes mellitus should be performed with a fasting blood glucose or HbgA1c (glycosylated hemoglobin). In addition to HbgA1c, the WHO consensus panel recommends a lipid profile if one is not available within the last 12 months. 8 If the patient complains of low sexual desire and is, on physical examination, found to have testes of diminished size, an assessment of the hypothalamic-pituitary-gonadal axis should be performed with a testosterone assay. Although the relative value of the various testosterone assays (total, free or bioavailable) remains controversial, there is strong consensus that at least one of these assays should be performed. 8 Testosterone testing is often associated with a low positive yield in the group of men with ED secondary to hypogonadism, which is a potentially reversible form of ED. Optional tests such as thyroid stimulating hormone, luteinizing hormone, prolactin, complete blood count and urinalysis are considered complimentary and are not felt to be essential in the evaluation of ED in most cases (Table 4, page 26). At this point in the ED evaluation, the majority of older patients can be treat- Figure 3: Mechanism of Action of Sildenafil 24 GERIATRICS & AGING September 2002 Vol 5, Num 7

6 ed by the PCP. However, the PCP may decide the patient needs referral for specialized testing or treatment. Indications for referral might include: (1) Patient request for further testing; (2) Need for vascular, neurological or cardiological assessment; (3) A history of Peyronie s disease; (4) Previous pelvic trauma, perineal, pelvic or penile surgery; (5) Refractory depression, psychosis or bipolar disorder; (6) Hypogonadism, diabetes or complicated endocrinopathy; (7) Patient with treatment failures who may be candidates for penile implants or intracavernosal injection therapy. Treatment Options If modifiable risk factors have been identified in the workup of the aging male with ED, there may be great value in risk factor alteration where possible. Good clinical practice mandates attention to these issues either prior to or along with direct therapies as a key to the treatment of ED. Potentially modifiable risk factors may include: (1) Lifestyle factors such as smoking, alcohol, substance abuse and obesity; (2) Psychosocial factors including partner conflict, sexual misinformation, Table 4 Diagnostic Testing in Erectile Dysfunction 8 A. Recommended Tests If not done in the last 12 months: Fasting blood glucose (of HbgA1c) Lipid profile If low desire or small testes: Testosterone assay (total or bioavailable) B. Optional Tests Luteinizing hormone, prolactin, thyrotropin hormone, urinalysis If not done in the last six months: Complete blood count depression and limited sexual experience; (3) Information on sexual technique can be helpful, especially in the areas of need for partner foreplay and lubrication, as well as normal agingrelated changes in sexual function; (4) Prescription and non-prescription drug use can impact the quality and sustainability of the patient s erection. Alteration in drug type and dosage may improve erectile function and sexual function; (5) Hormone replacement therapy may be appropriate where there is a documented deficiency of testosterone in androgen deficiency and hypogonadism. Unfortunately, adequate replacement of testosterone often does not improve ED. Testosterone replacement therapy is contraindicated in any male with breast cancer or prostate cancer, but may be necessary to improve erectile function in select cases. ED is not a life-threatening disease but does have a tremendous impact on a patient s quality of life. The treating physician must discuss with the patient and, preferably, his partner, the risks, benefits and costs associated with the various treatment modalities currently available. It is also important whenever possible to assess the sexual functioning of the aging male s partner. ED is a couple s problem and the treatment should be a shared decision-making process. The issue of cardiovascular disease also emerges in the treatment of the aging male with ED, and whether the patient should be or is capable of being sexually active should be considered. In other words, are the patient s expectations realistic? Treatment choices may be influenced by the cultural, religious and economic background of the patient as well as by the efficacy and relative safety of the therapeutic options. Other factors such as ease of use, invasiveness, reversibility and ongoing costs will also affect choice of therapy. Many of the patients in the older group who seek treatment for ED are on limited retirement incomes. Affordability of the chosen treatment is a prime factor in patient acceptance and utilization of a specific therapy long term. The treatment options that are currently available to the PCP for the treatment of ED in the older patient can be classified as first-line (oral agents), second-line (intracavernosal injection therapy, intraurethral therapy or vacuum erection devices) or third-line (inflatable and rigid penile prostheses) (Table 5, page 28). First-line Therapy Sildenafil (Viagra), a selective inhibitor of PDE 5, is currently the only oral agent available in Canada for the treatment of ED. Relaxation of penile smooth muscle is an essential aspect in the development of an erection. This relaxation is mediated by nitric oxide (NO) via cyclic guanosine monophosphate (cgmp). 9 Cyclic PDE isozymes hydrolyse cgmp. Sildenafil is an efficient inhibitor of PDE, which enhances the action of nitric oxide/cgmp on penile smooth muscle (Figure 3, page 24). Sildenafil is the first representative of a new class of agents known as PDE 5 inhibitors for the safe and effective treatment of ED. Plasma concentration levels of sildenafil reach a maximum within one hour after oral administration. Sildenafil should be taken on an empty stomach, one hour before or two hours after a meal, to ensure complete absorption from the GI tract. The serum half-life of sildenafil is three to five hours. The drug may be taken on an as-needed basis about one hour prior to anticipated sexual activity, 10 but it is recommended that it be taken only once in a 24-hour time period. The recommended starting dose is 50mg, but dosage adjustment to 25mg or 100mg can be initiated based on response during a trial of therapy. In clinical trials, sildenafil has demonstrated clinical efficacy in the majority of patients regardless of the underlying etiology of ED, the baseline severity of ED or the age of the patient. 10 Recent studies in patients with diabetes mellitus, hypertension, spinal cord injury, multiple sclerosis and depression 26 GERIATRICS & AGING September 2002 Vol 5, Num 7

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8 Table 5 Erectile Dysfunction Treatment Options First-line Therapy: Oral Agents (a) Type 5 Phosphodiesterase inhibitors (PDE 5 ) i. Sildenafil (Viagra) ii. Agents currently under investigation: Vardenafil and Tadalafil (b) Central acting dopaminergic agonist (available in Europe) i. Apomorphine (Uprima) Second-line Therapy (a) Intracorporal injection therapy (ICI) i. Alprostadil (Caverject) ii. Combination therapy phentolamine, papaverine, prostaglandin E1 (b) Intraurethral therapy i. Alprostadil (MUSE) (c) Vacuum erection device (VED) Third-line Therapy: Penile Implants (a) Rigid (b) Inflatable have shown sildenafil to be safe and effective in the treatment of ED. 11 Sexual stimulation in a relaxed and comfortable atmosphere is necessary to establish a firm erection with sildenafil. Sufficiently firm erections for intercourse will be achieved in 70 80% of men with ED taking 50mg sildenafil. 10 The side effects seen with sildenafil at dosages of 50mg are minor in nature but increase with higher dosages. The most common side effects are: headache (21%); flushing (27%); dyspepsia (11%); rhinitis (3%); and visual disturbance (6%). 10 There have been no reported cases of priapism with sildenafil. The concomitant use of nitrates and sildenafil is strictly contraindicated because severe hypotension can occur with this combination. However, as long as this combination is avoided, sildenafil has been shown to be safe and highly effective for most cardiac patients (Table 6). 11 Two other PDE 5 inhibitors are currently under clinical investigation. The action mechanism of vardenafil is similar to that of sildenafil, but does not lead to the blue vision/visual disturbances that sildenafil can produce. 12 Vardenafil has the same duration of action (five to six hours), but a more rapid onset (at 30 minutes) and can be taken with food. Tadalafil, like vardenafil, can also be taken with food and has a reported rapid onset of action of 15 to 30 minutes. Tadalafil has no reported visual side effects and has a prolonged duration of action (up to 36 hours). 13 Both of these PDE 5 inhibitors interact with nitrates to cause severe hypotension, so must not be used in combination. 12,13 Both vardenafil and tadalafil are expected to be released in North America within the next year. Apomorphine (Uprima ) is a dopaminergic agent that acts centrally at the paraventricular nucleus in the hypothalamus. Apomorphine, which is not currently available in Canada but may be released in early 2003, is a sublingual pill that is rapidly absorbed and reportedly enhances erectile activity within 20 minutes. 14 Unlike the PDE 5 inhibitors, apomorphine does not cross-react with nitrates, and so may be used in combination safely. Its main adverse effect is nausea, which has been reported to be mild at 2.0mg and 3.0mg doses, and which tends to disappear with repeated dosing. The other reported side effects are dizziness, sweating, somnolence, yawning and syncope. There is no interaction with food. 14 Second-line Therapy Intracorporal Injection Therapy For those patients who don t achieve a sufficient erection for vaginal intercourse with sildenafil, intracorporal injections (ICI) are an acceptable next step in treatment. The delivery of agents that relax penile smooth muscle by direct penile injection has been popular since The popularity of ICI has since been displaced by the ease of use of a safe and efficacious oral medication. The acceptance of ICI by older patients is variable and requires manual dexterity and, in most cases, a willingness to learn the technique of injection. Three substances were initially used for ICI: papaverine, phentolamine and prostaglandin E1 (PGE1). They have all been used as single agents or in combination. The most popular combination is that of all three, which is commonly referred to as Trimix. The technique and recommended dosage of ICI treatment is reviewed extensively elsewhere. 15 Alprostadil (Caverject ) is a single agent form of prostaglandin E that has been used for the treatment of ED with success. However, alprostadil tends to be more expensive than Trimix, making Trimix the agent of choice for most patients. It should be noted, however, that the triple combination is made up by local pharmacies and the quality of the mixture can be variable. The patient is usually taught the injection technique by a physician or a nurse educator, and then begins selfinjection at home. The dosage is adjusted 28 GERIATRICS & AGING September 2002 Vol 5, Num 7

9 Table 6 Sildenafil Mode of Action: Peripheral PDE 5 inhibitor Onset of Action: Within 60 min of oral administration Duration of Action: < five hours Dosing: 25mg, 50mg and 100mg Start at 50mg and assess efficacy Efficacy: 80% report firm erections for intercourse Side Effects: Headache, facial flushing, blue vision, dyspepsia, rhinitis Contraindication: Nitrates in any form will cause severe hypotension when used with sildenafil to avoid the worrisome side effect of priapism, which needs to be treated within four to six hours of its development. Surprisingly, the incidence of priapism with ICI is reported to be 0.3% with the home injections. 15 Priapism is treated with injection of epinephrine into the corporal bodies at a dose of 15mg every five minutes until detumescense occurs. Other side effects reported with ICI include fibrotic plaques (Peyronie s deformities), pain (especially with PGE1 alone), infection, bruising, vasovagal episodes and liver function abnormalities (with papaverine). Although ICI is safe and reliable, many patients stop using it either because it does not feel natural, they have concerns about side effects, or there was a lack of partner cooperation and involvement in the initial discussion about ICI as an ED treatment. 15 Intraurethral Therapy: Alprostadil The intraurethral application of alprostadil is an alternative to injection therapy. Alprostadil is a synthetic compound identical to PGE1. With Medicated Urethral System for Erection (MUSE), the medication is put into a tiny pellet and deposited into the end of the urethra with a special applicator. The patient is instructed to urinate prior to insertion of the applicator to lubricate his urethra. MUSE is significantly less efficacious than ICI, although in some cases the efficacy can be enhanced by application of a rubber band at the base of the penis. MUSE is distributed in doses of 250mg, 500mg and 1,000mg. The best responses, with firm erections satisfactory for vaginal intercourse, are seen with the 1,000mg dose. 16 The most common side effects encountered with MUSE are penile pain (33%), urethral trauma (5%), dizziness (2%) and testicular ache (10%). 16 MUSE is advantageous to the PCP because of its simplicity compared to ICI: it is easier for the patient to learn the technique and can be used at home without fear of priapism or penile fibrosis. Vacuum Erection Devices Vacuum erection devices (VED) appeal mainly to men who are on nitrates, and who do not wish to pursue ICI or MUSE. Although the use of the VED, like ICI, has diminished since the introduction of sildenafil, it should not be dismissed as an effective alternative treatment for ED in properly selected and motivated patients. A more comprehensive look at the VED as a treatment for ED has been reviewed elsewhere. 17 VED is likely to remain the first choice of PCP s for the treatment of ED because it is low tech, safe and efficacious. The technique for VED use is virtually the same for all devices. A cylinder is placed over the flaccid penis and pressed firmly to the body to create an airtight seal. Air is pumped out of the cylinder, creating a vacuum. During this process, blood is effectively drawn into the penis and a rubber band is then placed over the base of the penis from the cylinder base. The vacuum release valve is then opened and the cylinder is removed. The erection is maintained until the rubber band is removed. The common side effects reported with VEDs include hematoma and bruising, pain, penile numbness, blocked and painful ejaculation, and trapping of the scrotum and contents into the cylinder. Table 7 Comparison of Intracorporal Injection Therapy (ICI) and Vacuum Erection Devices (VED) FACTOR ICI VED Efficacy Neurogenic Good Response Good Response Vasculogenic Poor >> Good Good Idiopathic Good Good Psychogenic Adequate Adequate >> Good Psychological Benefit Positive Positive Patient Acceptance 40 50% 80 95% Cost $75/month $200 to $400 total outlay Side Effects Priapism Hematoma/Bruising Penile fibrosis Numbness Hepatotoxicity Ejaculatory dysfunction Bruising Scrotal/Testicle entrapment Pain Fainting Infection Prolonged Intercourse Possible Less than 30 minutes Frequency of Intercourse 2x/week unlimited 30 GERIATRICS & AGING September 2002 Vol 5, Num 7

10 Patients who discontinue treatment with the VED often complain of failure to produce an adequate erection, mechanical difficulties and the sense that the erection is too artificial. A comparison between ICI and VEDs is illustrated in Table 7. Patients may choose one therapy over the other for various reasons, but often cost, side effects, partner acceptance, manual dexterity and obesity factor into the final choice of treatment. Third-line Therapy The final treatment option for ED is the implantation of a malleable (rigid) or inflatable penile prosthesis. This option is highly invasive and irreversible, and so it should be reserved for select cases that have failed all other treatment modalities. When properly selected, the penile prosthesis is associated with a very high level of patient satisfaction. The subject of the penile prosthesis has been thoroughly reviewed elsewhere. 19 Most surgeons implant the inflatable device because it is easier for the patient to conceal the prosthesis and affords the patient a more natural erection compared to the rigid device. The rigid device may be preferred for some patients who lack the manual dexterity required to inflate a prosthesis. Another consideration is that the inflatable device is more expensive. Patient and partner satisfaction with a penile implant are reported to be high, with 80% of the men willing to have the surgery again and 60% of their partners pleased with the decision to have undergone the procedure. 19 Penile implant surgery is infrequently associated with infection that requires removal of the device (making it impossible to reimplant a device at a later date), mechanical failure of the inflatable device, or erosion of the prosthesis. Conclusion A great deal of progress in the diagnosis and treatment of ED has been made in the last 20 years. The most effective treatment available was ICI until sildenafil revolutionized the treatment of ED. With the development of oral pharmacological agents, sexual dysfunction has been reconsidered as a disease entity and not simply a lifestyle issue. The newer oral agents under clinical evaluation offer fewer side effects and greater duration of action than sildenafil. The possibility of combination therapy through pharmacologic synergism awaits clinical investigation and may offer more hope for difficult to treat elderly patients with multiple comorbid conditions. The ideal oral agent for ED treatment which should include good efficacy, ease of use, few side effects, rapid onset and long duration of action may not be that far away in the making. The future of ED management looks promising for the older male with difficult to treat ED. Acknowledgements: Dr. Pommerville is involved in clinical research trials with Abbott, Eli Lilly ICOS LLC, Pfizer and Bayer. Dr. Pommerville sits on advisory boards for Eli Lilly ICOS, Bayer, Pharmacia, Pfizer, Solvay Pharma and Abbott. References 1. NIH Consensus Development Panel on Impotence. JAMA 1993;270: Canadian Male Sexual Health Council, National Sex Survey; April In press. 3. Feldman HA, Goldstein I, McKinley JB, et al. Impotence and its medical and psychosocial correlates in men aged 40-70: results of the Massachusetts Male Aging Study. J Urol 1994;151: Morales A, Johnston B, Heaton JPW, et al. Oral androgens in the treatment of hypogonodal impotent men. J Urol 1994;152: Canadian Urological Association: Guidelines Committee: Erectile Dysfunction Guidelines, Spring 2002 newsletter. 6. Rosen RC, Riley A, Wagner G, et al. The International Index of Erectile Dysfunction (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997;49: Buvat J, Buvat-Herbaut M, Lemaire A, et al. Recent developments in the clinical assessment and diagnosis of erectile dysfunction. Annual Rev Sex Research 1990;1: Jardin A, Wagner G, Khoury S, et al. Recommendations of the international scientific committee on the evaluation and treatment of erectile dysfunction. 1st International Consultation of E.D., Paris: 1999, July Boolell M, Allen MJ, Ballard SA, et al. Sildenafil: an orally active type 5 cyclic GMP-specific phosphodiesterase inhibitor for the treatment of penile erectile dysfunction. Int J Impotence Res 1996;8: Goldstein I, Lue TF, Padma-Nathan H, et al. Oral sildenafil in the treatment of erectile dysfunction. N Engl J Med 1998;338: Shabsigh R, editor. Sildenafil citrate: Three years later: A worldwide review of clinical articles from the scientific literature. New York: Columbia University, Stark S, Sachse R, Liedl T, et al. Vardenafil increases penile rigidity and tumescence in men with erectile dysfunction after a single dose. Eur Urol 2001;40: Porst H, Rosen RC, Padma-Nathan H, et al. Tadalafil allows men with erectile dysfunction to have successful intercourse up to 36 hours postdose. Proceedings of the American Urological Association s 97th Annual Meeting; 2002, May 25-30; Orlando. 14. Heaton JP, Morales A, Adams MA, et al. Recovery of erectile function by oral administration of apomorphine. Urology 1995;45: Fallon B. Intracaverous injection therapy for male erectile dysfunction. Urol Clin North Am 1995;22: Padma-Nathan H. Treatment of men with erectile dysfunction with transurethral alprostadil. N Eng J Med 1997;336: Althof SE, Turner LA. Self injection therapy and external vacuum devices in the treatment of erectile dysfunction. In Rosen RC, Leiblum SR (editors). Erectile dysfunction: assessment and treatment, New York: The Guildford Press, 1992; pp Melman A, Tiefer L. Surgery for erectile disorders: operative procedures and psychological issues. In Rosen RC, Leiblum SR (editors). Erectile Dysfunction: assessment and treatment, New York: The Guildford Press, 1992; pp Pederson B, Tiefer L, Ruiz M, et al. Evaluation of patients and partners 1 to 4 years after penile prosthesis surgery. J Urol 1988;139: