Pii: s1569-9056(02)00112-4

European Urology Supplements 1 (2002) 4±11 What Do Patients Expect from Erectile DysfunctionTherapy?Geoffrey I. Hackett*Good Hope Hospital, Sutton Cold®eld, Elford Road, Fisherwick, Lich®eld, Straffordshire WS 149JR, UK Erectile insuf®ciency can precipitate emotional distress and a negative spiral of events and feelings. Excessive focus by the patient on the penis as the dysfunctional unit may be associated with physical and psychological problems in the female partner. With the advent of effective, well-tolerated treatments for erectile dysfunction, including the phosphodiesterase type 5 (PDE5) inhibitor sildena®l citrate, the needs and expectations of patients and their partners concerning their medications, their physicians and other factors have come into focus. In addition to the effectiveness or tolerability of a medication, a number of nonmedical outcomes may in¯uence patients and their partners when choosing between therapeutic modalities or pharmacotherapies. These include the spontaneity and naturalness of the sexual encounter, as well as the treatment's acceptability to the sexual partner, onset/duration of action and potential interactions with food or alcohol. Patients of different ages, marital statuses or cultures may assign distinct values to each of these criteria. Couples should therefore be involved in formulating treatment plans and afforded wide latitude when initially selecting therapy and/or deciding how, or whether, to take medications. For the physician, erectile dysfunction represents an opportunity to diagnose and treat other comorbid diseases, including hypertension, ischemic heart disease and diabetes.
# 2002 Published by Elsevier Science B.V.
Keywords: Apomorphine; Erectile dysfunction; Intracavernosal injection therapy; Male sexuality; Phosphodiesterase type 5 inhibitors; Treatment outcome marks to assess how expectations are being met .
The ideal tablet would be effective; safe; rapidly acting In the 1980s, the only available treatment option for and long-acting; unaffected by food, alcohol and other the sexually challenged man was sex therapy, a pros- drugs; and consistent with discreet, on-demand use and thetic implant, a vacuum device or testosterone ther- apy, which was often inappropriate. The advent of With the advent of effective and well-tolerated oral intracavernosal injection therapy (ICIT) enabled stoi- therapies, a number of ED patients can expect their sex cal couples to resume sexual relationships, but many lives to be restored to normal. For many, the concept of found such treatment painful and invasive. Despite a tablet with proven proerectile ef®cacy in response efforts to re®ne the procedures, more than half of to sexual stimulation in about 70% of intercourse the couples initiated on injection programs dropped attempts (or patients), usually within 1 hour, would out. According to certain literature reviews , about 15±22% of men in some clinical trials declined more Notwithstanding the widespread use and notoriety of than one trial injection of ICIT, and discontinuation sildena®l, large segments of ED patients either do not rates with treatment in clinical trials ranged from come forward for treatment or discontinue therapy approximately 40% after 3 months to as high as 70± prematurely. For instance, in an Australian study involving 62 general medical practices, 88% of men In 1998, Eardley described the ` ideal'' tablet for with ED failed to avail themselves of treatment, as did erectile dysfunction (ED; providing bench- about 75% in a European study Discontinuation rates range from 36% when ED is managed in a * Tel. ‡44-1-543-432-757; Fax: ‡44-1-543-433-303.
specialist clinic to 78% when care is initiated by E-mail address: [email protected] (G.I. Hackett).
a primary-care physician (Data on ®le, Abbott, UK).
1569-9056/02/$ ± see front matter # 2002 Published by Elsevier Science B.V.
PII: S 1 5 6 9 - 9 0 5 6 ( 0 2 ) 0 0 1 1 2 - 4 G.I. Hackett / European Urology Supplements 1 (2002) 4±11 changed the mindsets of many patients and their part- ners. The availability of effective and well-tolerated oral therapy taken as needed by men with ED enabled many patients and their partners to expect treatment to For many patients, the onset of erectile failure can be catastrophic, depending on such factors as culture, levels of physician and partner support, and age.
Reproduced from Eardley et al. with permission.
The patient's self-con®dence can also be eroded by ED. Up to 51% of European men reported that erectile dif®culties made them feel generally less con®dent in In addition, discontinuation rates for ED treatment life, according to a recent survey of 26,000 European with sildena®l range from 29% at 5 months in sildena®l and American men aged 40±60 years (Data on ®le, responders to as high as 72% after 1 year These data suggest that currently available therapies do not In this survey, the impact of ED on self-con®dence meet all patient and partner expectations, that insuf®- was less marked in UK men than their counterparts in cient advice and follow-up are being furnished by other European countries. Moreover, only 41% of physicians or that some combination of these British men considered sex important to their relation- factors serves to compromise patient compliance and ships compared with 71% of respondents in Turkey.
Sixteen percent of UK respondents admitted concerns over sexual problems, but only 4% remembered ever being asked about sex by their family doctors, a ®nding that ranked the United Kingdom as the lowest of the seven countries studied. Only 36% of Britons felt that Advances in the clinical management of erectile their general practitioners should routinely ask about insuf®ciency have been accompanied by a marked sex compared with 70% of respondents in Turkey.
evolution of ED treatment objectives and patients' expectations over the past ®ve decades (Before 2.1. What do patients expect of their physicians? 1960, when only surgery and natural remedies were When presenting with a health problem, most available, to the introduction of vacuum devices in the patients would expect their primary-care physicians 1960s and penile implantation in the 1960s through to be interested and initiate investigations of the 1970s, the modest aim of treatment was any improve- problem and/or specialist referrals. When the problem is ED, however, a number of patients are reluctant to With the availability of ICIT in the 1980s and 1990s, come forward, often for fear of embarrassing them- an erection suf®cient for successful sexual intercourse selves and/or their physicians. In a US survey became a rational treatment goal. Finally, the introduc- approximately 70% of respondents believed that their tion of oral therapy with the phosphodiesterase type 5 physicians would either dismiss, or be uncomfortable (PDE5) inhibitor sildena®l citrate has completely discussing, their concerns about sexual dysfunction.
In the United Kingdom, men infrequently attend their family physicians, and many patients may be surprised when the physician discusses the associations between ED and important medical conditions. A British survey of 789 men and 979 women demonstrated that sexual problems were associated with a range of social, psychological and physical problems, particularly pros- Erectile insuf®ciency represents an excellent oppor- tunity for health interventions that may result in long- term improvements in cardiovascular and overall health, because ED may be a risk marker for, or the ®rst sign of, occult coronary artery disease (CAD) or cardiovascular Fig. 1. Changing treatment, changing mindset.
G.I. Hackett / European Urology Supplements 1 (2002) 4±11 2.2. What do patients expect from their medications? Several studies have looked at patient expectations Reasons for sildena®l treatment discontinuation in 53 (30.9%) of 171 from ED therapy, and the results obtained have varied according to what questions were asked and how they were phrased. When devising a treatment plan, it is important to leave the patient and partner wide latitude for personal choice. Couples will assess the success of any ED therapy largely on the basis of its ef®cacy and tolerability, but a range of social, cultural, religious and potentially incomprehensible reasons will help to determine how a particular couple will take treatment (e.g. frequency) or whether they will continue with the Many patients are hoping for a cure, and most expect that treatment will involve a tablet. Among 52 US men of varying demographic and socioeconomic a lifetime of medication taking. One recent UK study pro®les, including ages ranging from 18 to 70 years involving 260 consecutive patients addressed the outcome variables valued by participants when reasons for discontinuation of oral therapy with sil- de®ning the success of ED treatment, in descending dena®l 12 months after hospital clinic attendance order of importance, were (1) cure, which was de®ned by some patients as ``bringing back normal sexual study population, or 11% of sildena®l patients who intercourse''; (2) pleasure (e.g. ``sensation,'' ``orgasm discontinued therapy, stopped treatment because their is achieved''); (3) partner satisfaction with inter- erections had returned to normal. This study was more course; (4) reproduction (e.g. ``ability to ejaculate''); likely to re¯ect the true reasons for discontinuation of and (5) naturalness with reference to the temperature, therapy than clinical trials, in which patients with size, color and overall appearance of the penis during high motivation may in effect be preselected and administered greater quantities of medications for This study also demonstrated that patients with different demographic and socioeconomic character- A total of 19% of 791 patients seen in an Argentinean istics may attach distinct values to health outcome clinic discontinued sildena®l therapy because of variables when either deciding whether to use surgery, recovery of erectile function. Finally, a majority of men pharmacotherapy or vacuum devices as a treatment for in a recent open-label study reported the return of ED, or choosing between competing pharmacothera- spontaneous erections over 12 months of treatment pies. For instance, whereas men younger than 40 years with self-injected prostaglandin E1 (PGE1).
were more concerned about the long-term conse- quences of therapy, those over the age of 60 were more concerned with immediate results .
Initially, men often focus on penile rigidity as their main treatment objective. However, recent work by A reliable and consistent erection for sexual activity Riley in the United Kingdom demonstrated that was rated as the highest priority in younger patients and ED may be associated with sexual problems (e.g.
the second-most important among older men urogenital atrophy) and relationship con¯ict in the (Data on ®le, Lilly ICOS LLC). Among patients with female partner (see below). Treatment outcomes are severe ED, a PDE5 inhibitor is more likely to be likely to be enhanced if the objectives of treatment are oriented toward the restoration of a satisfying sexual Where proerectile ef®cacy is high, other features relationship rather than enhancing penile tumescence of a given medication may be less important for the majority of patients. For patients seeking a therapy that confers reliable, consistent improvements in erectile function, the physician should recommend the drug that will, in his or her opinion, be most effective, because repetitive treatment failures may Finding a cure for ED was the central hope of compromise the patient's outlook and compliance with many younger men, as it would deliver them from G.I. Hackett / European Urology Supplements 1 (2002) 4±11 have advantages for couples who desire more sponta- Clinicians often forget that ED therapy is prescribed neous or more frequent sexual activity. As discussed by to facilitate a pleasurable experience for a patient and Prof. Porst elsewhere in this supplement, treatment his partner. In younger men, pleasure is more likely to with tadala®l enabled a majority of ED patients to revolve around sexual performance and the rigidity of experience successful intercourse at any time up to penile erections, whereas, for older couples, vaginal penetration may not be the main goal.
Safety concerns may in¯uence partner satisfaction, The concept of pleasure is in¯uenced by not only age and these concerns may be greater if a drug remains in but also by ethnic, cultural, religious and even ®nancial the bloodstream for several days. However, the pro- factors. The search for a better sexual experience longed plasma residence of tadala®l, which has a half- frequently leads patients to try new therapies, even life of 17.5 hours has not been associated with an if the existing one seems to be effective. Such an increase in the frequency or severity of adverse events approach is virtually unique to therapies for sexual reported with other (shorter-lived) PDE5 inhibitors, dysfunction and may also be in¯uenced by the require- according to large, multicenter, randomized, double- ment of the patient to pay for treatment.
blind, placebo-controlled clinical trials .
The assessment of satisfaction with ED therapy is Invasive therapies, such as ICIT and medicated largely based on traditional methods such as the Inter- urethral system for erection (MUSE1), are often less national Index of Erectile Function (IIEF) Global satisfying options for patients' partners. For instance, Assessment Question (GAQ), Sexual Encounter Pro- partners of MUSE patients may experience vaginal ®le (SEP) and Erectile Dysfunction Inventory of Treat- burning or itching, although these symptoms may be ment Satisfaction (EDITS) . However, more manifestations of resuming sexual intercourse rather sensitive measures of ejaculation and desire may be than a direct consequence of transurethral PGE1 per se required to establish a reliable index or de®nition of The female partner may also resent or feel unin- volved with the ``pharmacologically induced'' erection associated with ICIT . Vacuum constriction is also generally less satisfying to the female partner, although Erectile dysfunction can adversely affect patients' occasionally, her desire for the ED patient to avoid sexual partners. In one study approximately 60% medication use can result in selection of the vacuum of women whose partners experienced ED reported a device as the preferred treatment option. Apart from diminished interest in sex compared with 29% of those psychosexual counseling, vacuum devices represent the least-invasive ED treatment alternative.
Many men who are resuming sexual activityÐespe- Sexual satisfaction may be in¯uenced by a disparity cially those in new relationships after bereavement or in sexual desire between the man and his partner, and divorceÐput themselves under extreme pressure to health authorities have stressed the importance satisfy a new partner. It may be necessary for these of assessing potential sexual problems in the partner.
men not to inform their new partner that they are taking The sexual history should evaluate the patient's and therapy, at least until the relationship is established. In partner's expectations and motivations concerning ED such cases, a rapidly acting therapy, such as sublingual therapy, and the effectiveness of therapy may be opti- apomorphine, may be more appropriate than a drug such mized by including both parties in formulating treat- as sildena®l, as these men are more likely to complain ment plans Vaginal dryness is the most common about the need for premeditation associated with taking partner problem unmasked when ED therapy is the therapy 1 hour before planned sexual intercourse.
initiated. Fortunately, unlike a disparity in sexual However, a recent study suggested that, among desire, vaginal dryness is readily treatable.
the majority of men in stable relationships, such plan- ning is a minor issue. Further, a randomized, double- blind, placebo-controlled trial involving 247 ED Among younger patients, reproduction is considered outpatients showed that men who were treated with an important issue in the treatment of ED erecti le sildena®l, as well as their partners, exhibited signi®- dif®culties, as well as premature ante portas and retro- cantly higher levels of treatment satisfaction (accord- grade ejaculation, are not uncommon causes of inferti- ing to the EDITS) compared with their counterparts in lity. Many patients for whom fertility is an issue expect their physicians to show a high level of interest and offer Agents with the potential for a longer duration of clinical support, such as prescribing oral therapies for action, such as tadala®l (a PDE5 inhibitor), may also frequent use or medications for ejaculatory disorders G.I. Hackett / European Urology Supplements 1 (2002) 4±11 when indicated, as well as providing other, supportive Among men under 40 years of age in the study by Hanson-Divers et al. ``naturalness,'' or the degree to which a treatment had a physiologic effect on the body, was rated as moderately important when choos- ing between pharmacotherapies for ED, but not more important than the success associated with each drug Oral therapy with a rapidly acting agent that potenti- ates the physiologic erectile response to sexual stimu- lation is more likely to ful®ll the requirement for naturalness than MUSE1 or ICIT. The planning asso- Fig. 2. Patient expectations. About half of the patients surveyed preferred ciated with the use of an agent such as sildena®l, which, not to plan their sexual activities. Data on ®le, Lilly ICOS LLC.
for optimal effectiveness, must be administered on an empty stomach approximately 1 hour before sexual intercourse, may not satisfy the patient's concept of a ED and the likelihood that a newly presenting ED natural erection and sexual encounter.
patient has undiagnosed IHD has been estimated at In addition, a rapidly acting agent such as sublingual apomorphine, whose pharmacokinetics are not affected Case reports of myocardial infarction (MI) in silde- by food intake, may also provide a more natural na®l users together with avid coverage in popular erection and be easier to use, but it must also be media, have prompted concerns among many patients effective and reliable. Of note, tadala®l has been and their partners that resumption of sexual activity administered in clinical trials without any instructions while using oral ED therapy may be dangerous. Such concerning timing of intercourse relative to dosing or concerns need to be discussed openly with the ED any restrictions regarding food or alcohol intake.
patient and his partner so that they understand that the risk usually results from the underlying IHD and not Younger men value spontaneity as a more important Many patients will select sublingual apomorphine or issue than men over 40 years of age, for whom sex is ICIT because of concerns about MI with sildena®l.
more likely to be organized and scheduled into a busy However, a number of men with severe IHD may be work and family life, particularly when both partners disappointed in the outcomes of therapy with sublin- have careers. In some countries in the Middle and Far gual apomorphine. In a recent randomized, double- East, spontaneity and facility for multiple sexual blind, placebo-controlled crossover study of 296 attempts may be important; among 460 Saudi Arabian men with ED of various severities and etiologies, 42% men with ED seen from 1991 to 1995, a lack of sexual of attempts resulted in erections ®rm enough for sexual spontaneity and naturalism accounted for 24% of pre- intercourse among men with CAD who were treated with sublingual apomorphine 3 mg for 4 weeks com- A recent study of 30,000 men in six countries pared to 28% with placebo; this difference was not showed that approximately 50% of European and statistically signi®cant, although the number of CAD American men did not want to plan their sexual patients was small (n ˆ 14). Consensus recommenda- activities ((Data on ®le, Lilly ICOS LLC). If tions can assist clinicians in risk-stratifying and coun- approved by regulatory agencies, a longer-acting oral seling ED patients with cardiovascular disease who are drug such as tadala®l might have practical advantages interested in resuming sexual activity and/or treatment Administration of PDE5 inhibitors can amplify the hypotensive effects of nitrates or nitric oxide donors, with deleterious outcomes, and sildena®l is hence abso- lutely contraindicated for concomitant use with these A number of studies have clearly demonstrated an association between ischemic heart disease (IHD) and therapy is being considered, the prescribing physician G.I. Hackett / European Urology Supplements 1 (2002) 4±11 may stop nitrate therapy and/or change therapy to a drug of nitrates that should not be overlooked in the medical that in¯uences the prognosis of IHD rather than merely treating its symptoms with nitrates. Analyses of large clinical databases suggested that the overall incidences of MI with either sildena®l or tadala®l were Compared with men seeking treatment for largely asymptomatic conditions (e.g. hypertension, hypercho- lesterolemia), some ED patients might be expected to assign a higher priority to therapies that enhance sexual Compared with the reporting of adverse events in function; such men might even be more willing to pay randomized, controlled, clinical trials, side effects out of pocket for ED treatment. For other patients who tend to be reported less frequently in daily clinical expect their ED therapies to be covered in the same practice. Patients often tolerate side effects, including way as interventions for other medical conditions, headache, dyspepsia and ¯ushing with sildena®l, issues such as private cost and medication rationing because these effects are far outweighed by the gains may have adverse effects on treatment compliance and in erectile function obtained from effective treatment.
outcomes. The common practice of tablet splitting is In general, ED therapies are well tolerated, with few evidence that cost is a signi®cant issue.
Few population studies have surveyed patients about Some patients will wish to try other medications to the issue of cost. In a transitional Latin American econ- avoid side effects. For instance, the centrally acting omy, nearly one of every four sildena®l responders who dopamine agonist apomorphine has a different discontinued did so because of medication costs mechanism of action and side-effect pro®le than those whereas, in the United Kingdom, ®nancial reasons of PDE5 inhibitors. Nausea, headache and dizziness accounted for about 9% of sildena®l discontinuations were among the predominant side effects seen in . Whether the availability of treatment is regulated or clinical trials with sublingual apomorphine In a restricted by what the patient can or is willing to afford, large, long-term European study involving ICIT, costs can ultimately in¯uence patient expectations.
penile pain (occurring in 29% of patients), hematoma Results with oral therapy are improved if the patient is (33%), ®brotic changes (12%) and prolonged erection exposed to multiple doses early in the course of ther- apeutic regimens, but such regimens often prove to be unsuccessful because patients cannot or will not pay for them. Depending on post-registration costs, potentially longer-acting drugs may represent improved values.
Much public concern has been expressed about patients' ordering sildena®l over the Internet or through newspaper advertisements. The common view of such patients is that they are seeking performance There are fundamental differences between treat- enhancement, but it is likely that most of them have ments for ED and other chronic diseases. The aim mild ED and, like other men, resort to alternative drug- of treating sexual problems in couples is to enable them seeking behaviors to avoid consultations with their to enjoy a satisfactory sexual experience. For these reasons, simple or conventional considerations as to Obtaining therapy through the Internet or other whether one medication is more effective than another alternative sources is probably a feature of modern may be of little relevance to couples when selecting consumerism and may, to some extent, be reinforced by treatment. Many couples will experiment with different the ED patient's knowledge that he will have to pay therapies to see if the sexual experience is enhanced.
privately for his ED treatment irrespective of how it is They may also decide that they want a variety of obtained. Because many of these patients also have experiences and may wish to alternate therapies. The undiagnosed CAD, hypertension and/or diabetes, couple will also decide, based on a number of social, accessing them represents an important challenge.
cultural, religious and often incomprehensible reasons, Clinicians should also be vigilant for occult, recrea- how often they take therapy and when to discontinue tional nitrate use in their patients who are taking PDE5 treatment. Consequently, physicians need a range of inhibitors. Amyl nitrate ` poppers'' represent one source therapies to satisfy these diverse patient needs.
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GERMAN ECONOMIC TEAM IN BELARUS 76 Zakharova Str., 220088 Minsk, Belarus. Tel./fax: +375 (17) 210 0105 E-mail: [email protected]. Internet: http://research.by/ Public Private Partnership Summary In recent decades governments in most industrial and developing countries promote co-operation between the public and private sectors in providing public goods. This cooperation takes the


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