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How Urologists Manage Erectile Dysfunction after Radical Prostatectomy: A National Survey (REPAIR) by the French Urological Association
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How Urologists Manage Erectile Dysfunction after Radical Prostatectomy: A National Survey (REPAIR) by the French Urological Association François Giuliano, MD, PhD,* Edouard Amar, MD,† Daniel Chevallier, MD, PhD,‡ Olivier Montaigne, MD,§ Jean-Michel Joubert, MD,¶ and Emmanuel Chartier-Kastler, MD, PhD** *AP-HP, Raymond Poincaré Hospital, Garches, France; †Department of Urology, Bichat Hospital, Paris, France; ‡ Department of Urology, Pasteur Hospital, Nice, France; §Department of Andrology, Lille University Hospital, France; ¶ Schwarz-Pharma, Boulogne-Billancourt, Franc; **AP-HP, Department of Urology, La Pitié Salpétrière Hospital, Paris, France DOI: 10.1111/j.1743-6109.2007.00670.x
ABSTRACT
Introduction. There is little sound information on how urologists manage erectile dysfunction (ED) arising after radical prostatectomy (RP) in a real-world situation. Aim. To perform a national survey of how French urologists manage ED after RP in routine practice. Main Outcome Measures. Choice of first-line treatment, type of treatment (rehabilitation of erectile function vs. treatment on demand for intercourse), and timing and duration of treatment. Methods. All French urologists were invited to take part in a survey; 59.7% accepted provisionally (760/1,272). They received the survey questionnaire and 10 patient data forms to be completed during the visits of the first 10 patients with fewer than 12 months follow-up post-RP. These were returned to an independent third party for analysis. Results. The final response rate was 535/1,272 (42%). Before performing RP, 80% of the urologists assessed sexual activity and 76% erectile function; 9% did neither. Thirty-eight percent reported that they systematically proposed ED treatment to their patients post-RP (“routine prescribers”). The remainder was treated on occasion, either at the patients’ request (49%) or at their own discretion (13%). Routine prescribers tended to be younger and had performed more RPs in the preceding year. Most urologists (88%) always used the same first-line treatment: regular intracavernosal injections (ICIs) for rehabilitation, 39%; ICI on demand for intercourse, 30%; phosphodiesterase type 5 (PDE5) inhibitors on demand, 16%, or regular PDE5 inhibitors for rehabilitation, 8%; alternating ICI and PDE5 inhibitors, 7%; vacuum device, <1%. ED treatment was initiated within 3 months of RP by 72% of the urologists (92% of routine prescribers). The percentage of urologists recommending ED treatment for 6 months was 20%, 38% for 1 year, and 33% for 2 years. Conclusion. ED was commonplace after RP. French urologists reported a proactive attitude to ED treatment, many favoring pharmacologic rehabilitation therapy. ICI was their first-line treatment of choice. Giuliano F, Amar E, Chevallier D, Montaigne O, Joubert J-M, and Chartier-Kastler E. How urologists manage erectile dysfunction after radical prostatectomy: A national survey (REPAIR) by the French Urological Association. J Sex Med 2008;5:448–457. Key Words. First-Line Treatment; On Demand; Intracavernous Injections; PGE1; Rehabilitation; Practice; Sexual Activity
Introduction
R
adical prostatectomy (RP) is associated with a high degree of disease control in patients with organ-confined prostate cancer. RP reduces
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specific mortality, overall mortality, and the risks of metastasis and local progression. In a randomized controlled trial comparing RP to watchful waiting, the absolute reduction in the risk of death after 10 years was small, but the reductions in the © 2007 International Society for Sexual Medicine
Managing Erectile Dysfunction after Radical Prostatectomy risks of metastasis and local tumor progression were substantial [1]. Patients are therefore increasingly likely to choose active treatment, provided that morbidity is acceptable. A number of studies have addressed functional outcomes after RP, whether urinary incontinence or erectile dysfunction (ED). ED is considered to be of particular concern and has been the subject of several topical reviews [2–6]. Large patient cohorts have been monitored for long follow-up periods [7–11]. However, there is little sound information on urologists’ routine daily practice, i.e., how they manage ED arising post-RP in a real-world situation. A notable exception is a recent national survey of urologists in Germany, which has provided valuable insight into longterm ED management of RP patients [12]. However, this survey did not address questions such as choice of first-line treatment, type of treatment (rehabilitation of erectile function vs. treatment on demand for intercourse), and timing and duration of treatment. Along with critical appraisals of the literature, practice surveys are key steps in the development of clinical practice guidelines if these are to impact on physician behavior. Although the clinical management of ED has been the subject of recent guidelines [13–15], no guideline has yet considered the specific case of RP patients. The aim of the present article was to describe how French urologists manage ED arising post-RP as given by the results of a national survey conducted under the auspices of the French Urological Association (AFU). In a companion article based on the same survey, we shall analyze to what extent urologists’ declared practice meets patients’ needs. Materials and Methods
This was a cross-sectional survey of urological practice in France conducted between June 1 and July 31, 2005, for the AFU and analyzed by TNS Healthcare (SOFRES). The survey targeted all urologists in France and overseas French counties (N = 1,272; source: Cegedim, France). They were sent a joint letter (AFU–TNS Healthcare) explaining the rationale of the survey, which was followed by an explanatory telephone call inviting them to participate. A moderate fee was offered to compensate for their time. Five experts (the authors) chosen to represent AFU on the basis of their experience in performing RPs and/or of diagnosing and treating functional outcomes designed the survey instruments. These
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were (i) a physician survey instrument relating to urologic practice which comprised of 23 questions, of which 17 were on ED management (see Appendix); (ii) a 12-question anonymous patient data form, which included questions on surgery, and on ED diagnosis and management; this form was completed by the urologist for each of the first 10 patients who came to their office and who had undergone RP less than 12 months previously; and (iii) a questionnaire given by the urologist to these 10 patients for completion at home. The urologist returned the competed physician instrument and patient forms directly to TNS healthcare for data analysis; the patient returned the completed patient questionnaire to TNS healthcare. This article described only the results derived from the physician instrument and from a single question extracted from the patient questionnaire (“Are you currently being treated for ED? yes/no; if yes, are you using tablets, penile injections, or a vacuum constriction device”). Answers to other questions from the patient questionnaire will be analyzed in the companion article. Data were analyzed by the one-sample z-test for surveys.
Results
Survey Population: Demographics Overall, 760/1,272 (59.7%) urologists accepted to take part in the survey and received a complete dossier (the physician survey instrument, 10 patient data forms, 10 patient questionnaires). A total of 535/1,272 urologists (42% of all French urologists) returned the completed physician questionnaire. Their mean age was 45.6 ⫾ 8.7 years (range 28–67). They came from across France: 16.3% (Paris and surroundings), 20.6% (north/ northeast), 15.5% (west), 22.1% (center/east of center), 15.3% (southeast), 9.2% (southwest); 1% (6) worked overseas. Their place of work was a private hospital or clinic (61.1%), a general public hospital (26%), a teaching hospital (21.9%), and/or a cancer clinic (1.3%) (urologists could have more than one affiliation). Over the previous 12 months, they had performed an average of 29.4 ⫾ 20.3 RPs (median 25; range 2–150). This average was calculated from the answers of 505 urologists who replied to the question and who had performed at least one RP. Eight urologists (1.5 %) reported that they had performed no RPs but managed patients post-RP. Of their last 10 patients, 78% had undergone open surgery and 22% laparoscopy. J Sex Med 2008;5:448–457
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Giuliano et al.
A
B
Percent patients
80
90
70 60 50
67AB
60a 52
68AB
70
47bCD
60
39CD
40
31
50
31
40
30
10
67a
60 40bCD
30
20
32CD 21
20
1
1
2
1
0
1 to 2 3 to 4 5 to 7 mos mos mos (n=416) (n=527) (n=582)
8 or more mos (n=699)
10 0
79AB
78AB
80
1
0 1 to 2 mos (n=225)
3 to 4 mos (n=278)
1
20 1
5 to 7 8 or more mos mos (n=311) (n=410)
Time elapsed since RP Figure 1 (A) Percent patients who were prescribed treatment for erectile dysfunction (ED) after radical prostatectomy (RP) (baseline: all patients); (B) percent patients who were prescribed treatment for ED (baseline: patients with normal erections before RP) (white bars: ED treatment; gray bars: no ED treatment; black bars: unknown). Statistically significant differences between columns (A/a: 1–3 months; B/b: 3–4 months; C/c: 5–7 months; D/d: (8 months) are given by the paired z-test (A, B, C, D: 99% confidence interval [CI]; a, b, c, d: 95% CI).
Routine Management of ED Of the 535 participating urologists, 65% regularly managed patients referred to them by their colleagues. Overall, 80% replied that, before performing an RP, they enquired about sexual activity, and 76% reported that they assessed erectile function; 9% replied that they did neither. Only 38% reported that, after the RP, they systematically prescribed ED therapy to their patients (hereafter denoted “routine prescribers”). The other 62% (“occasional prescribers”) provided treatment either at the patient’s request (49%) or at their own discretion (13%). The routine prescribers were slightly younger than occasional prescribers (mean age 44 vs. 46 years, P < 0.05; 35% vs. 24% under 40 years of age, P < 0.01); they were more likely to assess whether the patient had ED prior to surgery (81% vs. 72%, P < 0.05); they had performed more RPs in the previous year (mean 32 ⫾ 23 vs. 28 ⫾ 19, P < 0.05) and more of them reported that their patients accepted post-RP ED management (73% vs. 60%, P < 0.05). Urologists who initiated ED management at their own discretion (N = 69; 13%) took the following into account in their decision: pre-RP sexual activity (88%), patient profile (age, marital status) (81%), the partner’s expectations (71%), nerve-sparing J Sex Med 2008;5:448–457
technique (36%), and factors such as treatment on demand (16%).
Analysis of the Patient Data Overall, 92% of the patients were diagnosed with ED after RP. The percentage of patients who were prescribed treatment for ED was significantly higher (P < 0.01) after 5 months than before 5 months of follow-up, for the entire population of patients with ED (Figure 1A) or only the subpopulation with erections with normal rigidity before RP (Figure 1B). Choice of First-Line ED Treatment Among the 535 urologists, 518 (96.8%) managed their patients’ ED themselves and did not refer the patient to another physician. Of these 518 urologists, 457 (88%) always used the same first-line treatment and, of these 457 urologists, 54% prescribed treatment for rehabilitation of erectile function, i.e., pharmacologic treatment not on demand before sexual intercourse but for regular use independently of intercourse. The percentage of urologists prescribing rehabilitation treatment was even higher among routine prescribers (67%). Intracavernosal injections (ICIs) were the firstline treatment, whether for rehabilitation or on
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Managing Erectile Dysfunction after Radical Prostatectomy Table 1
Choice of first-line erectile dysfunction treatment as a function of practice Percent urologists Treatment practice All who treat (N = 457)
Rehabilitation ICIs 39 PDE5 inhibitors 8 ICIs + PDE5 inhibitors 7 On demand before intercourse ICIs 30 PDE5 inhibitors 16 Other/not specified <1
Number of RPs over the last 12 months
Routine prescribers A (N = 178)
Occasional prescribers B (N = 279)
<20 A (N = 143)
20–29 B (N = 109)
30–39 C (N = 62)
ⱖ40 D (N = 118)
51B 8 8
32 8 5
32 9 4
44a 10 6
50A 3 2
38 7 14abC
25 6 2
33a 22A 0
30 24cD 1
24 15 1
32 13 0
33 8 0
Statistically significant differences are given by the paired z-test (A, B, C, D 99% confidence interval [CI]; a, b, c, d 95% CI). RPs = radical prostatectomies; ICIs = intracavernosal injections; PDE5 = phosphodiesterase type 5.
demand for intercourse, and whether among routine or occasional prescribers (Table 1). Overall, 84% of routine prescribers compared to 70% of occasional prescribers prescribed ICI. Urologists who had performed between 30 and 39 RPs during the previous year were most likely to prescribe ICI for rehabilitation (Table 1) but this result should be viewed with caution in view of the smaller sample size. The percentage of patients who reported that they were taking treatment for ED is given in Table 2. A third of the patients were already under treatment at 1–2 months and a half as from 3–4 months (P < 0.01). Of the patients under treatment, two-thirds were self-injecting. At 8 months or more, 46% of patients were not being treated.
Recommended Timing and Duration of ED Treatment Overall, 79% of all urologists (92% of routine prescribers) recommended that ED treatment be initiated in 3 months following RP; 9% recom-
Table 2
mended initiation within the first few days (Table 3). Urologists who recommended treatment initiation after 3–6 months were significantly older (mean age 48 years) than urologists who recommended initiation either a few days (mean age 43 years, P < 0.01) or 1–3 months post-RP (mean age 46 years, P < 0.05). Early prescribers (1–3 months post-RP) tended to work in private clinics (65% vs. 51%, P < 0.05) and had performed a greater mean number of RPs during the preceding year (31 ⫾ 21 vs. 26 ⫾ 16) than the urologists who recommended prescribing treatment 3–6 months post-RP. Few urologists (5%) considered that treatment should be pursued beyond 2 years (Table 4). There was no significant difference in the percentage of urologists recommending ED treatment for 6 months, 1 year, or 2 years. Nor was there any significant difference in the recommended duration of ED treatment between routine and occasional prescribers.
Ongoing erectile dysfunction treatment according to the patients’ responses Percent patients
Treated for ED ICIs Tablets VCD Not treated Not specified
1–2 months post-RP A (N = 524)
3–4 months post-RP B (N = 608)
5–7 months post-RP C (N = 676)
ⱖ8 months post-RP D (N = 797)
30 20 11 <1 67BCD 4
48A 34A 15a <1 50C 2
55AB 41AB 16A 1a 43 3
51A 37A 16A 1 46 3
Statistically significant differences are given by the paired z-test (A, B, C, D 99% confidence interval [CI]; a, b, c, d 95% CI). RP = radical prostatectomy; ICIs = intracavernosal injections; VCD = vacuum constriction device.
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452 Table 3
Giuliano et al. Recommended timing of erectile dysfunction management post-radical prostatectomy Percent urologists All participating urologists
Treatment initiation
(N = 535)
Routine prescribers A (N = 203; 38%)
A few days 1–3 months 6–12 months When UI resolved When patient complains
9 70 1 3 2
12 80B 1 1 1
Occasional prescribers B (N = 332; 62%) 7 63 2 4 3
Statistically significant differences between routine and occasional prescribers are given by the paired z-test (A, B 99% confidence interval). UI = urinary incontinence.
The relationships between choice of first linetreatment, timing, and duration of treatment are given in Table 5. The number of urologists who prescribed phosphodiesterase type 5 (PDE5) inhibitors for rehabilitation was too low
Table 4
(N = 36) for the data to be broken down. ICI was the preferred overall treatment option, and also for very early rehabilitation (within a few days of RP). There was no significant difference between the percentage of urologists
Recommended duration of erectile dysfunction treatment Percent urologists
6 months 1 year 2 years 3 years 5 years Unspecified
Total population (N = 518)
Routine prescribers (N = 199)
Occasional prescribers (N = 319)
20 38 33 2 3 4
17 41 33 2 3 4
22 36 34 2 2 4
No significant differences between routine and occasional prescribers for the recommended duration of treatment.
Table 5 Cross-table between choice of first-line erectile dysfunction (ED) treatment and recommended start and duration of ED treatment Percent urologists Choice of first-line treatment
Treatment initiation A few days 1–3 months 3–6 months 6–12 months When UI resolved When patient complains Treatment duration 6 months 1 year 2 years 3 years 5 years Unspecified
ICI rehabilitation (N = 179)
ICI on demand (N = 136)
PDE5 inhibitors on demand (N = 72)
17 73 7 0 2 0
3 71 19 2 2 3
1 57 25 5 6 6
18 42 34 2 1 3
16 34 35 3 4 8
36 32 23 3 3 3
No significant differences between columns 2 and 3 (ICI and PDE5 inhibitors on demand). ICI = intracavernosal injection; PDE5 = phosphodiesterase type 5; UI = urinary incontinence.
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Managing Erectile Dysfunction after Radical Prostatectomy prescribing ICI or PDE5 inhibitors for ondemand treatment. Discussion
The present survey has provided support for several prevailing views of the urologists’ practice but also challenges accepted notions. Practice does not always follow the tenets of the mainstream literature. Only 76% of the French urologists assessed erectile function before performing RP, and yet the most important predictor of post-surgery ED is preexisting erectile function [2–11]. ED may preexist in a substantial number of cases, even in younger patients. Preoperative ED assessment is becoming all the more important as an increasingly young population of men is being diagnosed with prostate cancer. Pharmacologic rehabilitation of erectile function after RP is not widely accepted. It is a tertiary prevention activity, i.e., an attempt to restore to highest function, minimize the negative effects of disease, and prevent disease-related complications. Despite the high prevalence of ED post-RP (92% in this survey), only 38% of the urologists were routine prescribers of ED treatment and, in the subgroup who always prescribed the same firstline treatment, only 54% were proactive and prescribed rehabilitation treatment. Overall, 49% of the urologists treated at the patient’s request and 13% at their own discretion. Other authors have already remarked on the failure to spontaneously offer ED therapy to RP patients [8]. Although current practice guidelines recommend PDE5 inhibitors as first-line therapy for ED regardless of whether the patient is an RP patient or not [13–15], most French urologists prefer to prescribe ICI after RP, probably because of its well-established efficacy [16,17]. It must also be mentioned that ICIs are reimbursed by the French National Health Insurance in this indication. RP patients tend to be poor responders to PDE5 inhibitors; the probability of response in seven combined studies was 35% (95% confidence interval [CI], 24–48%) [18]. About 50% of the patients in our survey were undergoing ED therapy as from 3–4 months post-RP. When questioned on their ongoing treatment, they confirmed that they were self-injecting rather than taking oral treatment. These data may be compared with those of the national German study in which 73.9% of the German urologists were prescribing the following ED treatments 18 months or more after RP [12]:
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PDE5 inhibitors, 38.4%; ICI, 37.4%; vacuum constriction device (VCD), 20.4%; medicated urethral system for erection (MUSE), 3.6%; penile prosthesis, 0.3%. However, according to the patients, 26.7% were self-injecting, 19.8% were taking oral medication, 1.7% were using MUSE, 0.9% had undergone implantation of a penile prosthesis, and a surprising 50.9% were using a VCD. The higher rate of self-injection over oral medication supports our survey observations, but the use of VCDs in France only reached 1%. According to a study in 50 men, ICI provides a higher quality of erections and significantly better satisfaction than VCD [19]. Several reasons were given for widespread use of VCDs in Germany: a once-only expenditure, easy availability, no need for a prescription, no contraindications or side effects described. Clearly, besides efficacy and tolerance, cultural factors need to be taken into account when prescribing ED therapy in RP patients. Although most French urologists (70%) recommended starting treatment 1–3 months postRP, patient data showed that, despite these recommendations, treatment was actually initiated in significantly more patients 5 or more months post-RP rather than earlier. This discrepancy may be because of work organization problems. Of the urologists who favored pharmacologic rehabilitation of erectile function with ICI, 90% thought that this should be initiated within the first 3 months, and even within the first few days after RP according to 17%. This view is in line with Montorsi et al.’s recommendations based on the results of a small uncontrolled randomized trial in which the recovery of spontaneous erection occurred at 6 months in 67% of patients who selfinjected regularly vs. 20% who did not [20]. It is supported by investigative studies and clinical trials: (i) according to a Doppler ultrasound study, satisfactory erectile responses for intercourse were obtained in a significantly higher proportion of patients when ICI was started within 3 months after RP rather than at 4–12 months [21]; (ii) a recent nonrandomized trial showed that, at 18 months post-RP, a significantly higher proportion of patients who underwent rehabilitation were capable of having nonmedication-assisted intercourse (52% in the rehabilitation group vs. 19% in the no rehabilitation group) or medicationassisted intercourse (64% with sildenafil and 95% with ICI in the rehabilitation group vs. 24% and 76%, respectively, in the no rehabilitation group) [22]. J Sex Med 2008;5:448–457
454 Recommending early treatment post-RP was closely correlated with the choice of ICI as firstline treatment. The post-RP ED observed even after nerve-sparing surgery has been attributed to hypoxia-induced fibrosis of the cavernosal tissue. It is thought that repeated ICI promotes cavernosal oxygenation, increases the production of prostanoids, and thus protects erectile smooth muscle. On the other hand, PDE5 inhibitors may be less effective in the early phase of nerve healing or neuropraxia as its action would be more dependent on nerve supply to the corpora than on blood flow. Response rates with PDE5 inhibitors depend upon whether nerve-sparing surgery has been used, whereas ICI has the unique advantage of producing high erectile responses in non-nerve-sparing patients [22]. Overall, mild to moderate efficacy has been reported in RP patients with the three PDE5 inhibitors available on demand. An as yet unpublished randomized controlled trial comparing daily nightly sildenafil (50 or 100 mg) with placebo for 8 months post-RP has suggested improved recovery of preoperative erectile function in carefully selected patients after bilateral nerve sparing (27% vs. 4%) [23]. The recommended duration of treatment for post-RP ED was 2 years or less, maybe because the natural recovery of erectile function has been reported to be as long as this [24]. Our study design had several major strengths. It was a national survey of practice and not restricted to academic centers of excellence. All urologists in France were contacted. The 42% response rate was highly satisfactory by current standards. It was considerably higher than the 26.7% rate reported in the German study and even higher than the 36.2% rate for American and Canadian urologists in a survey of bladder cancer [12,25]. Even though the respondents were probably mostly urologists performing RPs and not a true representative sample, they covered all regions of France, different types of practice (public/private, teaching, and general hospitals), and a wide age distribution. They may have had a special interest in post-RP functional outcomes as 65% saw patients referred by another urologist but few referred their patients to colleagues. All data were collected and analyzed by an independent third party, thus minimizing bias. The potential limitations of this national survey were the restrictions imposed on the number of items to ensure a satisfactory response rate and valid data analysis, and the bias in physician selfreporting that has been reported previously. This is why we have compared physicians’ claims with J Sex Med 2008;5:448–457
Giuliano et al. patients’ satisfaction in a second article. Several questions remain outstanding, e.g., the definition of ED, acute complications of post-RP, treatment dropouts, information provision to the patient and their partner, and attitudes to patient risk factors. We also had to restrict the time span to 12 months to minimize problems of recall (although data on patients were entered prospectively). Symptoms may, however, evolve for up to 2 years post-RP if not longer. In conclusion, the prevalence of ED after RP was high. A significant proportion of French urologists reported that they had a proactive attitude to managing post-RP ED. Their preferred ED treatment was undoubtedly ICI, which is readily available in France. About two-thirds of those who treated post-RP ED as a matter of routine were in favor of penile rehabilitation with ICI [26,27]. We thus note that, even in the absence of evidence-based guidelines, current everyday practice not only in specialist centers but also in the field is to favor early management of post-RP ED, with pharmacologic rehabilitation in a proportion of cases. Corresponding Author: François Giuliano, MD, PhD, AP-HP, Neuro-Uro-Andrology, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, 104 bd Raymond Poincaré, 92380 Garches, France. Tel: +33147107832; Fax: +33147104443; E-mail: [email protected] Conflict of Interest: The REPAIR study and all authors are sponsored by Schwarz Pharma, France. References
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Appendix: The Physician Survey Instrument
You 1. 2. 3.
and Your Practice Your sex (male, female) Your age (in years) Do you practice in a teaching hospital, a public general hospital, a private clinic/ hospital, a cancer center? (more than one answer possible) J Sex Med 2008;5:448–457
456 4. Have you performed any radical prostatectomies over the last 12 months? (if yes, go to question 5; if no, go to question 6) 5. How many prostatectomies did you perform during these last 12 months? Which surgical technique did you use in your last 10 patients? (number of patients undergoing open surgery, number of patients undergoing laparoscopy) 6. Do you regularly manage post-RP functional outcomes in patients you did not operate? Urinary incontinence (yes, no); sexual dysfunction (yes, no)
The Pre-Op Visit 7. In general, when you deliver information to your patients before surgery, which post-RP functional disorder concerns them most? (urinary incontinence, erectile dysfunction, both to the same extent) (only one answer) 8. Before performing an RP, do you ask your patient about their sexual activity (frequency of intercourse, stable partner . . .)? (yes, no) 9. Before performing an RP, do you assess your patient’s erectile function? (yes, no) Post-Op Visits 10. In general, who manages any post-RP urinary incontinence? (yourself, you prescribe rehabilitation sessions with a physiotherapist) (only one answer) 11. What is your practice with regard to post-RP erectile dysfunction? (only one answer) a. I prescribe treatment as a matter of routine. (go to question 13) b. I prescribe treatment on occasion at the patient’s request. (go to question 13) c. I prescribe treatment on occasion at my own discretion. (go to question 12) d. I do not prescribe treatment. (go to question 20) 12. Which factors do you take into account when deciding on treatment for post-RP erectile dysfunction? (the patient’s age and marital status, a request or an expectation voiced by the partner, whether surgery was nerve sparing or not, pre-op sexual activity, other factors (which ones)) (more than one answer possible) 13. Approximately what percentage of your patients accept the post-RP treatment for erectile dysfunction that you offer? J Sex Med 2008;5:448–457
Giuliano et al.
Your Practice with Regard to Post-RP Management of Erectile Dysfunction 14. In general, when do you offer your patients treatment for post-RP erectile dysfunction? (a few days post-op, 1–3 months post-op, 3–6 months post-op, 6–12 months post-op, more than 12 months post–op, after resolution of problems due to urinary incontinence, when the patient complains) (only one answer) 15. Do you treat erectile dysfunction yourself (go to question 16), do you refer your patient to another urologist (question 27), do you refer your patient to a health professional other than a urologist (go to question 27)? (only one answer) 16. Most of the time, do you use the same treatment protocol for managing erectile dysfunction in all of your patients (yes (go to question 17), no (go to question 19)) 17. If you do use the same protocol, does this increase the number of post-op visits? (yes, no) 18. Which is your first-line treatment? (one answer only) a. Oral PDE5 I (Cialis, Levitra, Viagra) on demand for sexual intercourse b. ICI (Edex, caverject) on demand for sexual intercourse c. Oral PDE5 I (Cialis, Levitra, Viagra) taken regularly and continuously over several weeks for rehabilitation of sexual function regardless of whether sexual intercourse takes place after ingestion d. ICI (Edex, caverject) injected on a regular and continuous basis over several weeks for rehabilitation of sexual function regardless of whether sexual intercourse takes place after injection e. A combined treatment with alternating ICI (Edex, caverject) and oral PDE5 I (Cialis, Levitra, Viagra), administered on a regular and continuous basis over several weeks for rehabilitation of sexual function regardless of whether sexual intercourse takes place after administration f. Vacuum constriction device 19. Should you not use one of the above first-line treatments, what do you do? 20. For how long after RP do you think that rehabilitation of erectile function should continue? (6 months, 1 year, 2 years, 3 years, 5 years) (one answer only)
Managing Erectile Dysfunction after Radical Prostatectomy
Your Patients 21. In general, when do your patients most often request post-RP management of erectile dysfunction? (immediately post-op, 1–3 months post-op, 3–6 months post-op, 6–12 months post-op, more than 12 months post-op, after resolution of problems due to urinary incontinence) (only one answer) 22. On average, how important do you think erectile dysfunction is to your patients at the (a)
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1-monthly, (b) 6-monthly, and (c) 1-year post-RP visit? (very important, fairly important, not very important, not at all important)? (only one answer per visit) 23. In your opinion, on a 0–10 point scale, what is the impact of persisting erectile dysfunction on the quality of life of your patients? (0 = no impact, 10 = very high impact)
J Sex Med 2008;5:448–457
How Urologists Manage Erectile Dysfunction after Radical Prostatectomy: A National Survey (REPAIR) by the French Urological Association François Giuliano, MD, PhD,* Edouard Amar, MD,† Daniel Chevallier, MD, PhD,‡ Olivier Montaigne, MD,§ Jean-Michel Joubert, MD,¶ and Emmanuel Chartier-Kastler, MD, PhD** *AP-HP, Raymond Poincaré Hospital, Garches, France; †Department of Urology, Bichat Hospital, Paris, France; ‡ Department of Urology, Pasteur Hospital, Nice, France; §Department of Andrology, Lille University Hospital, France; ¶ Schwarz-Pharma, Boulogne-Billancourt, Franc; **AP-HP, Department of Urology, La Pitié Salpétrière Hospital, Paris, France DOI: 10.1111/j.1743-6109.2007.00670.x
ABSTRACT
Introduction. There is little sound information on how urologists manage erectile dysfunction (ED) arising after radical prostatectomy (RP) in a real-world situation. Aim. To perform a national survey of how French urologists manage ED after RP in routine practice. Main Outcome Measures. Choice of first-line treatment, type of treatment (rehabilitation of erectile function vs. treatment on demand for intercourse), and timing and duration of treatment. Methods. All French urologists were invited to take part in a survey; 59.7% accepted provisionally (760/1,272). They received the survey questionnaire and 10 patient data forms to be completed during the visits of the first 10 patients with fewer than 12 months follow-up post-RP. These were returned to an independent third party for analysis. Results. The final response rate was 535/1,272 (42%). Before performing RP, 80% of the urologists assessed sexual activity and 76% erectile function; 9% did neither. Thirty-eight percent reported that they systematically proposed ED treatment to their patients post-RP (“routine prescribers”). The remainder was treated on occasion, either at the patients’ request (49%) or at their own discretion (13%). Routine prescribers tended to be younger and had performed more RPs in the preceding year. Most urologists (88%) always used the same first-line treatment: regular intracavernosal injections (ICIs) for rehabilitation, 39%; ICI on demand for intercourse, 30%; phosphodiesterase type 5 (PDE5) inhibitors on demand, 16%, or regular PDE5 inhibitors for rehabilitation, 8%; alternating ICI and PDE5 inhibitors, 7%; vacuum device, <1%. ED treatment was initiated within 3 months of RP by 72% of the urologists (92% of routine prescribers). The percentage of urologists recommending ED treatment for 6 months was 20%, 38% for 1 year, and 33% for 2 years. Conclusion. ED was commonplace after RP. French urologists reported a proactive attitude to ED treatment, many favoring pharmacologic rehabilitation therapy. ICI was their first-line treatment of choice. Giuliano F, Amar E, Chevallier D, Montaigne O, Joubert J-M, and Chartier-Kastler E. How urologists manage erectile dysfunction after radical prostatectomy: A national survey (REPAIR) by the French Urological Association. J Sex Med 2008;5:448–457. Key Words. First-Line Treatment; On Demand; Intracavernous Injections; PGE1; Rehabilitation; Practice; Sexual Activity
Introduction
R
adical prostatectomy (RP) is associated with a high degree of disease control in patients with organ-confined prostate cancer. RP reduces
J Sex Med 2008;5:448–457
specific mortality, overall mortality, and the risks of metastasis and local progression. In a randomized controlled trial comparing RP to watchful waiting, the absolute reduction in the risk of death after 10 years was small, but the reductions in the © 2007 International Society for Sexual Medicine
Managing Erectile Dysfunction after Radical Prostatectomy risks of metastasis and local tumor progression were substantial [1]. Patients are therefore increasingly likely to choose active treatment, provided that morbidity is acceptable. A number of studies have addressed functional outcomes after RP, whether urinary incontinence or erectile dysfunction (ED). ED is considered to be of particular concern and has been the subject of several topical reviews [2–6]. Large patient cohorts have been monitored for long follow-up periods [7–11]. However, there is little sound information on urologists’ routine daily practice, i.e., how they manage ED arising post-RP in a real-world situation. A notable exception is a recent national survey of urologists in Germany, which has provided valuable insight into longterm ED management of RP patients [12]. However, this survey did not address questions such as choice of first-line treatment, type of treatment (rehabilitation of erectile function vs. treatment on demand for intercourse), and timing and duration of treatment. Along with critical appraisals of the literature, practice surveys are key steps in the development of clinical practice guidelines if these are to impact on physician behavior. Although the clinical management of ED has been the subject of recent guidelines [13–15], no guideline has yet considered the specific case of RP patients. The aim of the present article was to describe how French urologists manage ED arising post-RP as given by the results of a national survey conducted under the auspices of the French Urological Association (AFU). In a companion article based on the same survey, we shall analyze to what extent urologists’ declared practice meets patients’ needs. Materials and Methods
This was a cross-sectional survey of urological practice in France conducted between June 1 and July 31, 2005, for the AFU and analyzed by TNS Healthcare (SOFRES). The survey targeted all urologists in France and overseas French counties (N = 1,272; source: Cegedim, France). They were sent a joint letter (AFU–TNS Healthcare) explaining the rationale of the survey, which was followed by an explanatory telephone call inviting them to participate. A moderate fee was offered to compensate for their time. Five experts (the authors) chosen to represent AFU on the basis of their experience in performing RPs and/or of diagnosing and treating functional outcomes designed the survey instruments. These
449
were (i) a physician survey instrument relating to urologic practice which comprised of 23 questions, of which 17 were on ED management (see Appendix); (ii) a 12-question anonymous patient data form, which included questions on surgery, and on ED diagnosis and management; this form was completed by the urologist for each of the first 10 patients who came to their office and who had undergone RP less than 12 months previously; and (iii) a questionnaire given by the urologist to these 10 patients for completion at home. The urologist returned the competed physician instrument and patient forms directly to TNS healthcare for data analysis; the patient returned the completed patient questionnaire to TNS healthcare. This article described only the results derived from the physician instrument and from a single question extracted from the patient questionnaire (“Are you currently being treated for ED? yes/no; if yes, are you using tablets, penile injections, or a vacuum constriction device”). Answers to other questions from the patient questionnaire will be analyzed in the companion article. Data were analyzed by the one-sample z-test for surveys.
Results
Survey Population: Demographics Overall, 760/1,272 (59.7%) urologists accepted to take part in the survey and received a complete dossier (the physician survey instrument, 10 patient data forms, 10 patient questionnaires). A total of 535/1,272 urologists (42% of all French urologists) returned the completed physician questionnaire. Their mean age was 45.6 ⫾ 8.7 years (range 28–67). They came from across France: 16.3% (Paris and surroundings), 20.6% (north/ northeast), 15.5% (west), 22.1% (center/east of center), 15.3% (southeast), 9.2% (southwest); 1% (6) worked overseas. Their place of work was a private hospital or clinic (61.1%), a general public hospital (26%), a teaching hospital (21.9%), and/or a cancer clinic (1.3%) (urologists could have more than one affiliation). Over the previous 12 months, they had performed an average of 29.4 ⫾ 20.3 RPs (median 25; range 2–150). This average was calculated from the answers of 505 urologists who replied to the question and who had performed at least one RP. Eight urologists (1.5 %) reported that they had performed no RPs but managed patients post-RP. Of their last 10 patients, 78% had undergone open surgery and 22% laparoscopy. J Sex Med 2008;5:448–457
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Giuliano et al.
A
B
Percent patients
80
90
70 60 50
67AB
60a 52
68AB
70
47bCD
60
39CD
40
31
50
31
40
30
10
67a
60 40bCD
30
20
32CD 21
20
1
1
2
1
0
1 to 2 3 to 4 5 to 7 mos mos mos (n=416) (n=527) (n=582)
8 or more mos (n=699)
10 0
79AB
78AB
80
1
0 1 to 2 mos (n=225)
3 to 4 mos (n=278)
1
20 1
5 to 7 8 or more mos mos (n=311) (n=410)
Time elapsed since RP Figure 1 (A) Percent patients who were prescribed treatment for erectile dysfunction (ED) after radical prostatectomy (RP) (baseline: all patients); (B) percent patients who were prescribed treatment for ED (baseline: patients with normal erections before RP) (white bars: ED treatment; gray bars: no ED treatment; black bars: unknown). Statistically significant differences between columns (A/a: 1–3 months; B/b: 3–4 months; C/c: 5–7 months; D/d: (8 months) are given by the paired z-test (A, B, C, D: 99% confidence interval [CI]; a, b, c, d: 95% CI).
Routine Management of ED Of the 535 participating urologists, 65% regularly managed patients referred to them by their colleagues. Overall, 80% replied that, before performing an RP, they enquired about sexual activity, and 76% reported that they assessed erectile function; 9% replied that they did neither. Only 38% reported that, after the RP, they systematically prescribed ED therapy to their patients (hereafter denoted “routine prescribers”). The other 62% (“occasional prescribers”) provided treatment either at the patient’s request (49%) or at their own discretion (13%). The routine prescribers were slightly younger than occasional prescribers (mean age 44 vs. 46 years, P < 0.05; 35% vs. 24% under 40 years of age, P < 0.01); they were more likely to assess whether the patient had ED prior to surgery (81% vs. 72%, P < 0.05); they had performed more RPs in the previous year (mean 32 ⫾ 23 vs. 28 ⫾ 19, P < 0.05) and more of them reported that their patients accepted post-RP ED management (73% vs. 60%, P < 0.05). Urologists who initiated ED management at their own discretion (N = 69; 13%) took the following into account in their decision: pre-RP sexual activity (88%), patient profile (age, marital status) (81%), the partner’s expectations (71%), nerve-sparing J Sex Med 2008;5:448–457
technique (36%), and factors such as treatment on demand (16%).
Analysis of the Patient Data Overall, 92% of the patients were diagnosed with ED after RP. The percentage of patients who were prescribed treatment for ED was significantly higher (P < 0.01) after 5 months than before 5 months of follow-up, for the entire population of patients with ED (Figure 1A) or only the subpopulation with erections with normal rigidity before RP (Figure 1B). Choice of First-Line ED Treatment Among the 535 urologists, 518 (96.8%) managed their patients’ ED themselves and did not refer the patient to another physician. Of these 518 urologists, 457 (88%) always used the same first-line treatment and, of these 457 urologists, 54% prescribed treatment for rehabilitation of erectile function, i.e., pharmacologic treatment not on demand before sexual intercourse but for regular use independently of intercourse. The percentage of urologists prescribing rehabilitation treatment was even higher among routine prescribers (67%). Intracavernosal injections (ICIs) were the firstline treatment, whether for rehabilitation or on
451
Managing Erectile Dysfunction after Radical Prostatectomy Table 1
Choice of first-line erectile dysfunction treatment as a function of practice Percent urologists Treatment practice All who treat (N = 457)
Rehabilitation ICIs 39 PDE5 inhibitors 8 ICIs + PDE5 inhibitors 7 On demand before intercourse ICIs 30 PDE5 inhibitors 16 Other/not specified <1
Number of RPs over the last 12 months
Routine prescribers A (N = 178)
Occasional prescribers B (N = 279)
<20 A (N = 143)
20–29 B (N = 109)
30–39 C (N = 62)
ⱖ40 D (N = 118)
51B 8 8
32 8 5
32 9 4
44a 10 6
50A 3 2
38 7 14abC
25 6 2
33a 22A 0
30 24cD 1
24 15 1
32 13 0
33 8 0
Statistically significant differences are given by the paired z-test (A, B, C, D 99% confidence interval [CI]; a, b, c, d 95% CI). RPs = radical prostatectomies; ICIs = intracavernosal injections; PDE5 = phosphodiesterase type 5.
demand for intercourse, and whether among routine or occasional prescribers (Table 1). Overall, 84% of routine prescribers compared to 70% of occasional prescribers prescribed ICI. Urologists who had performed between 30 and 39 RPs during the previous year were most likely to prescribe ICI for rehabilitation (Table 1) but this result should be viewed with caution in view of the smaller sample size. The percentage of patients who reported that they were taking treatment for ED is given in Table 2. A third of the patients were already under treatment at 1–2 months and a half as from 3–4 months (P < 0.01). Of the patients under treatment, two-thirds were self-injecting. At 8 months or more, 46% of patients were not being treated.
Recommended Timing and Duration of ED Treatment Overall, 79% of all urologists (92% of routine prescribers) recommended that ED treatment be initiated in 3 months following RP; 9% recom-
Table 2
mended initiation within the first few days (Table 3). Urologists who recommended treatment initiation after 3–6 months were significantly older (mean age 48 years) than urologists who recommended initiation either a few days (mean age 43 years, P < 0.01) or 1–3 months post-RP (mean age 46 years, P < 0.05). Early prescribers (1–3 months post-RP) tended to work in private clinics (65% vs. 51%, P < 0.05) and had performed a greater mean number of RPs during the preceding year (31 ⫾ 21 vs. 26 ⫾ 16) than the urologists who recommended prescribing treatment 3–6 months post-RP. Few urologists (5%) considered that treatment should be pursued beyond 2 years (Table 4). There was no significant difference in the percentage of urologists recommending ED treatment for 6 months, 1 year, or 2 years. Nor was there any significant difference in the recommended duration of ED treatment between routine and occasional prescribers.
Ongoing erectile dysfunction treatment according to the patients’ responses Percent patients
Treated for ED ICIs Tablets VCD Not treated Not specified
1–2 months post-RP A (N = 524)
3–4 months post-RP B (N = 608)
5–7 months post-RP C (N = 676)
ⱖ8 months post-RP D (N = 797)
30 20 11 <1 67BCD 4
48A 34A 15a <1 50C 2
55AB 41AB 16A 1a 43 3
51A 37A 16A 1 46 3
Statistically significant differences are given by the paired z-test (A, B, C, D 99% confidence interval [CI]; a, b, c, d 95% CI). RP = radical prostatectomy; ICIs = intracavernosal injections; VCD = vacuum constriction device.
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452 Table 3
Giuliano et al. Recommended timing of erectile dysfunction management post-radical prostatectomy Percent urologists All participating urologists
Treatment initiation
(N = 535)
Routine prescribers A (N = 203; 38%)
A few days 1–3 months 6–12 months When UI resolved When patient complains
9 70 1 3 2
12 80B 1 1 1
Occasional prescribers B (N = 332; 62%) 7 63 2 4 3
Statistically significant differences between routine and occasional prescribers are given by the paired z-test (A, B 99% confidence interval). UI = urinary incontinence.
The relationships between choice of first linetreatment, timing, and duration of treatment are given in Table 5. The number of urologists who prescribed phosphodiesterase type 5 (PDE5) inhibitors for rehabilitation was too low
Table 4
(N = 36) for the data to be broken down. ICI was the preferred overall treatment option, and also for very early rehabilitation (within a few days of RP). There was no significant difference between the percentage of urologists
Recommended duration of erectile dysfunction treatment Percent urologists
6 months 1 year 2 years 3 years 5 years Unspecified
Total population (N = 518)
Routine prescribers (N = 199)
Occasional prescribers (N = 319)
20 38 33 2 3 4
17 41 33 2 3 4
22 36 34 2 2 4
No significant differences between routine and occasional prescribers for the recommended duration of treatment.
Table 5 Cross-table between choice of first-line erectile dysfunction (ED) treatment and recommended start and duration of ED treatment Percent urologists Choice of first-line treatment
Treatment initiation A few days 1–3 months 3–6 months 6–12 months When UI resolved When patient complains Treatment duration 6 months 1 year 2 years 3 years 5 years Unspecified
ICI rehabilitation (N = 179)
ICI on demand (N = 136)
PDE5 inhibitors on demand (N = 72)
17 73 7 0 2 0
3 71 19 2 2 3
1 57 25 5 6 6
18 42 34 2 1 3
16 34 35 3 4 8
36 32 23 3 3 3
No significant differences between columns 2 and 3 (ICI and PDE5 inhibitors on demand). ICI = intracavernosal injection; PDE5 = phosphodiesterase type 5; UI = urinary incontinence.
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Managing Erectile Dysfunction after Radical Prostatectomy prescribing ICI or PDE5 inhibitors for ondemand treatment. Discussion
The present survey has provided support for several prevailing views of the urologists’ practice but also challenges accepted notions. Practice does not always follow the tenets of the mainstream literature. Only 76% of the French urologists assessed erectile function before performing RP, and yet the most important predictor of post-surgery ED is preexisting erectile function [2–11]. ED may preexist in a substantial number of cases, even in younger patients. Preoperative ED assessment is becoming all the more important as an increasingly young population of men is being diagnosed with prostate cancer. Pharmacologic rehabilitation of erectile function after RP is not widely accepted. It is a tertiary prevention activity, i.e., an attempt to restore to highest function, minimize the negative effects of disease, and prevent disease-related complications. Despite the high prevalence of ED post-RP (92% in this survey), only 38% of the urologists were routine prescribers of ED treatment and, in the subgroup who always prescribed the same firstline treatment, only 54% were proactive and prescribed rehabilitation treatment. Overall, 49% of the urologists treated at the patient’s request and 13% at their own discretion. Other authors have already remarked on the failure to spontaneously offer ED therapy to RP patients [8]. Although current practice guidelines recommend PDE5 inhibitors as first-line therapy for ED regardless of whether the patient is an RP patient or not [13–15], most French urologists prefer to prescribe ICI after RP, probably because of its well-established efficacy [16,17]. It must also be mentioned that ICIs are reimbursed by the French National Health Insurance in this indication. RP patients tend to be poor responders to PDE5 inhibitors; the probability of response in seven combined studies was 35% (95% confidence interval [CI], 24–48%) [18]. About 50% of the patients in our survey were undergoing ED therapy as from 3–4 months post-RP. When questioned on their ongoing treatment, they confirmed that they were self-injecting rather than taking oral treatment. These data may be compared with those of the national German study in which 73.9% of the German urologists were prescribing the following ED treatments 18 months or more after RP [12]:
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PDE5 inhibitors, 38.4%; ICI, 37.4%; vacuum constriction device (VCD), 20.4%; medicated urethral system for erection (MUSE), 3.6%; penile prosthesis, 0.3%. However, according to the patients, 26.7% were self-injecting, 19.8% were taking oral medication, 1.7% were using MUSE, 0.9% had undergone implantation of a penile prosthesis, and a surprising 50.9% were using a VCD. The higher rate of self-injection over oral medication supports our survey observations, but the use of VCDs in France only reached 1%. According to a study in 50 men, ICI provides a higher quality of erections and significantly better satisfaction than VCD [19]. Several reasons were given for widespread use of VCDs in Germany: a once-only expenditure, easy availability, no need for a prescription, no contraindications or side effects described. Clearly, besides efficacy and tolerance, cultural factors need to be taken into account when prescribing ED therapy in RP patients. Although most French urologists (70%) recommended starting treatment 1–3 months postRP, patient data showed that, despite these recommendations, treatment was actually initiated in significantly more patients 5 or more months post-RP rather than earlier. This discrepancy may be because of work organization problems. Of the urologists who favored pharmacologic rehabilitation of erectile function with ICI, 90% thought that this should be initiated within the first 3 months, and even within the first few days after RP according to 17%. This view is in line with Montorsi et al.’s recommendations based on the results of a small uncontrolled randomized trial in which the recovery of spontaneous erection occurred at 6 months in 67% of patients who selfinjected regularly vs. 20% who did not [20]. It is supported by investigative studies and clinical trials: (i) according to a Doppler ultrasound study, satisfactory erectile responses for intercourse were obtained in a significantly higher proportion of patients when ICI was started within 3 months after RP rather than at 4–12 months [21]; (ii) a recent nonrandomized trial showed that, at 18 months post-RP, a significantly higher proportion of patients who underwent rehabilitation were capable of having nonmedication-assisted intercourse (52% in the rehabilitation group vs. 19% in the no rehabilitation group) or medicationassisted intercourse (64% with sildenafil and 95% with ICI in the rehabilitation group vs. 24% and 76%, respectively, in the no rehabilitation group) [22]. J Sex Med 2008;5:448–457
454 Recommending early treatment post-RP was closely correlated with the choice of ICI as firstline treatment. The post-RP ED observed even after nerve-sparing surgery has been attributed to hypoxia-induced fibrosis of the cavernosal tissue. It is thought that repeated ICI promotes cavernosal oxygenation, increases the production of prostanoids, and thus protects erectile smooth muscle. On the other hand, PDE5 inhibitors may be less effective in the early phase of nerve healing or neuropraxia as its action would be more dependent on nerve supply to the corpora than on blood flow. Response rates with PDE5 inhibitors depend upon whether nerve-sparing surgery has been used, whereas ICI has the unique advantage of producing high erectile responses in non-nerve-sparing patients [22]. Overall, mild to moderate efficacy has been reported in RP patients with the three PDE5 inhibitors available on demand. An as yet unpublished randomized controlled trial comparing daily nightly sildenafil (50 or 100 mg) with placebo for 8 months post-RP has suggested improved recovery of preoperative erectile function in carefully selected patients after bilateral nerve sparing (27% vs. 4%) [23]. The recommended duration of treatment for post-RP ED was 2 years or less, maybe because the natural recovery of erectile function has been reported to be as long as this [24]. Our study design had several major strengths. It was a national survey of practice and not restricted to academic centers of excellence. All urologists in France were contacted. The 42% response rate was highly satisfactory by current standards. It was considerably higher than the 26.7% rate reported in the German study and even higher than the 36.2% rate for American and Canadian urologists in a survey of bladder cancer [12,25]. Even though the respondents were probably mostly urologists performing RPs and not a true representative sample, they covered all regions of France, different types of practice (public/private, teaching, and general hospitals), and a wide age distribution. They may have had a special interest in post-RP functional outcomes as 65% saw patients referred by another urologist but few referred their patients to colleagues. All data were collected and analyzed by an independent third party, thus minimizing bias. The potential limitations of this national survey were the restrictions imposed on the number of items to ensure a satisfactory response rate and valid data analysis, and the bias in physician selfreporting that has been reported previously. This is why we have compared physicians’ claims with J Sex Med 2008;5:448–457
Giuliano et al. patients’ satisfaction in a second article. Several questions remain outstanding, e.g., the definition of ED, acute complications of post-RP, treatment dropouts, information provision to the patient and their partner, and attitudes to patient risk factors. We also had to restrict the time span to 12 months to minimize problems of recall (although data on patients were entered prospectively). Symptoms may, however, evolve for up to 2 years post-RP if not longer. In conclusion, the prevalence of ED after RP was high. A significant proportion of French urologists reported that they had a proactive attitude to managing post-RP ED. Their preferred ED treatment was undoubtedly ICI, which is readily available in France. About two-thirds of those who treated post-RP ED as a matter of routine were in favor of penile rehabilitation with ICI [26,27]. We thus note that, even in the absence of evidence-based guidelines, current everyday practice not only in specialist centers but also in the field is to favor early management of post-RP ED, with pharmacologic rehabilitation in a proportion of cases. Corresponding Author: François Giuliano, MD, PhD, AP-HP, Neuro-Uro-Andrology, Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, 104 bd Raymond Poincaré, 92380 Garches, France. Tel: +33147107832; Fax: +33147104443; E-mail: [email protected] Conflict of Interest: The REPAIR study and all authors are sponsored by Schwarz Pharma, France. References
1 Bill-Axelson A, Holmberg L, Ruutu M, Haggman M, Anderson SO, Bratell S, Spangberg A, Busch C, Nordling S, Garmo H, Palmgren J, Adami HO, Norlen BJ, Johansson JE, Scandinavian Prostate Group. Radical prostatectomy versus watchful waiting in early prostate cancer. N Engl J Med 2005;352:1977–84. 2 Meuleman EJH, Mulders PFA. Erectile function after radical prostatectomy. Eur Urol 2003;43:95– 102. 3 Carson CC, Slade Hubbard J, Wallen E. Erectile dysfunction and treatment of carcinoma of the prostate. Curr Urol Rep 2005;6:461–9. 4 Briganti A, Salonia A, Gallina A, Suardi N, Deho F, Fabbri F, Zanni G, Scattoni V, Rigatti P, Montorsi F. Potency after radical prostatectomy: From new techniques to better results. EAU-EBU Update Ser 2006;4:33–45. 5 Viola D, Comerci F, Martorana G. Rehabilitation therapy and urinary incontinence after radical retropubic prostatectomy. A critical review of the literature. Urol Int 2006;76:193–8.
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Appendix: The Physician Survey Instrument
You 1. 2. 3.
and Your Practice Your sex (male, female) Your age (in years) Do you practice in a teaching hospital, a public general hospital, a private clinic/ hospital, a cancer center? (more than one answer possible) J Sex Med 2008;5:448–457
456 4. Have you performed any radical prostatectomies over the last 12 months? (if yes, go to question 5; if no, go to question 6) 5. How many prostatectomies did you perform during these last 12 months? Which surgical technique did you use in your last 10 patients? (number of patients undergoing open surgery, number of patients undergoing laparoscopy) 6. Do you regularly manage post-RP functional outcomes in patients you did not operate? Urinary incontinence (yes, no); sexual dysfunction (yes, no)
The Pre-Op Visit 7. In general, when you deliver information to your patients before surgery, which post-RP functional disorder concerns them most? (urinary incontinence, erectile dysfunction, both to the same extent) (only one answer) 8. Before performing an RP, do you ask your patient about their sexual activity (frequency of intercourse, stable partner . . .)? (yes, no) 9. Before performing an RP, do you assess your patient’s erectile function? (yes, no) Post-Op Visits 10. In general, who manages any post-RP urinary incontinence? (yourself, you prescribe rehabilitation sessions with a physiotherapist) (only one answer) 11. What is your practice with regard to post-RP erectile dysfunction? (only one answer) a. I prescribe treatment as a matter of routine. (go to question 13) b. I prescribe treatment on occasion at the patient’s request. (go to question 13) c. I prescribe treatment on occasion at my own discretion. (go to question 12) d. I do not prescribe treatment. (go to question 20) 12. Which factors do you take into account when deciding on treatment for post-RP erectile dysfunction? (the patient’s age and marital status, a request or an expectation voiced by the partner, whether surgery was nerve sparing or not, pre-op sexual activity, other factors (which ones)) (more than one answer possible) 13. Approximately what percentage of your patients accept the post-RP treatment for erectile dysfunction that you offer? J Sex Med 2008;5:448–457
Giuliano et al.
Your Practice with Regard to Post-RP Management of Erectile Dysfunction 14. In general, when do you offer your patients treatment for post-RP erectile dysfunction? (a few days post-op, 1–3 months post-op, 3–6 months post-op, 6–12 months post-op, more than 12 months post–op, after resolution of problems due to urinary incontinence, when the patient complains) (only one answer) 15. Do you treat erectile dysfunction yourself (go to question 16), do you refer your patient to another urologist (question 27), do you refer your patient to a health professional other than a urologist (go to question 27)? (only one answer) 16. Most of the time, do you use the same treatment protocol for managing erectile dysfunction in all of your patients (yes (go to question 17), no (go to question 19)) 17. If you do use the same protocol, does this increase the number of post-op visits? (yes, no) 18. Which is your first-line treatment? (one answer only) a. Oral PDE5 I (Cialis, Levitra, Viagra) on demand for sexual intercourse b. ICI (Edex, caverject) on demand for sexual intercourse c. Oral PDE5 I (Cialis, Levitra, Viagra) taken regularly and continuously over several weeks for rehabilitation of sexual function regardless of whether sexual intercourse takes place after ingestion d. ICI (Edex, caverject) injected on a regular and continuous basis over several weeks for rehabilitation of sexual function regardless of whether sexual intercourse takes place after injection e. A combined treatment with alternating ICI (Edex, caverject) and oral PDE5 I (Cialis, Levitra, Viagra), administered on a regular and continuous basis over several weeks for rehabilitation of sexual function regardless of whether sexual intercourse takes place after administration f. Vacuum constriction device 19. Should you not use one of the above first-line treatments, what do you do? 20. For how long after RP do you think that rehabilitation of erectile function should continue? (6 months, 1 year, 2 years, 3 years, 5 years) (one answer only)
Managing Erectile Dysfunction after Radical Prostatectomy
Your Patients 21. In general, when do your patients most often request post-RP management of erectile dysfunction? (immediately post-op, 1–3 months post-op, 3–6 months post-op, 6–12 months post-op, more than 12 months post-op, after resolution of problems due to urinary incontinence) (only one answer) 22. On average, how important do you think erectile dysfunction is to your patients at the (a)
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1-monthly, (b) 6-monthly, and (c) 1-year post-RP visit? (very important, fairly important, not very important, not at all important)? (only one answer per visit) 23. In your opinion, on a 0–10 point scale, what is the impact of persisting erectile dysfunction on the quality of life of your patients? (0 = no impact, 10 = very high impact)
J Sex Med 2008;5:448–457