Studiourologicogallo.it

International Journal of Impotence Research (2005) 17, 484–493 & 2005 Nature Publishing Group All rights reserved Recovery of erection after pelvic urologic surgery: our experience L Gallo1*, S Perdona˜1, R Autorino1, E Celentano1, L Menna1, G Di Lorenzo1 and A Gallo1 1Division of Urology, National Cancer Institute, ‘Fondazione Pascale’, Naples, Italy The incidence of erectile dysfunction (ED) in patients undergoing pelvic urologic surgery, theefficacy and tolerability of vardenafil-based rehabilitative treatment as first option in these patients,the role of spontaneous erection (SE) as a possible positive predictive factor to erection recoveryafter such treatment, and the role of second-line therapies in those nonresponders are evaluated. Allthe patients undergoing pelvic urologic surgery at our Institution between November 2002 andDecember 2003 were considered. Preoperative erectile function (EF) was evaluated by using theabridged five-item version of the International Index of Erectile Function (IIEF5) questionnaire.
Study population was divided into separate groups considering grade of preoperative EF, nervesparing (NS) surgery and type of procedure (radical prostatectomy, radical cystectomy (RC) ornerve and seminal sparing cystectomy). In total, 86 patients were evaluated. After 6 months,an increase in mean IIEF5 score of 12.9 points was found in those who had undergone a bilateralNSRP after vardenafil therapy, of 8.0 points in those who had undergone unilateral NSRP, of 11.3in those who had undergone NSRC and of 11.5 in nerve and seminal sparing cistectomies. Abetter vardenafil response was found in patients with SE þ (Po0.001). Among those vardenafilnotresponders, 13 were treated by using intracavernous injections, one by vacuum device and threewith penile prosthesis implant. In conclusion, in our experience, vardenafil showed to be welltolerated and effective for recovery of EF in patients undergoing pelvic urologic surgery. This drugwas particularly effective for those with a normal preoperative EF undergoing an NS procedure. Ofcourse, it should be recognized that the absence of a control group in the study represents animportant limitation. However, based on the data from the literature, there is a strong belief thatsuch an approach will lead to an earlier recovery of EF than without rehabilitative treatment.
International Journal of Impotence Research (2005) 17, 484–493. doi:10.1038/sj.ijir.3901338;published online 12 May 2005 Keywords: pelvic cancer treatments and sexual dysfunction; oral vasoactive agents; pharmacologicstudies in sexual function; intracaversonal therapy (ED) ranging up to 80%, with a remarkable worsen-ing of quality of life especially in younger patients.2 Radical cystectomy (RC) represents the gold As a result of improved screening of men over the standard curative treatment for infiltrating bladder age of 50 y with digital rectal examination and PSA cancers, and it is increasingly advocated for high- testing, early diagnosis of prostate cancer (PCa) is risk aggressive superficial bladder cancer.3 During possible and makes it a curable disease. Radical this surgical procedure, the neurovascular bundles prostatectomy (RP) represents a potential definitive (NVBs) are usually removed or damaged, and it therapy in the management of organ confined results in a dramatic negative impact on many prostate cancer.1 On the other hand, this surgical act is burdened by high rates of erectile dysfunction Hence, the preservation of erectile function (EF) after pelvic urologic surgery still represents a majorchallenge for most urologists.
Since the anatomical studies by Walsh and Donker in the early 1980s, surgeons became aware *Correspondence: L Gallo, Division of Urology, National of the location of the NVBs carrying the cavernous Cancer Institute, ‘Fondazione Pascale’, Via Mariano nerves, which are responsible for erection.5 As a result of this improved understanding of the E-mail: [email protected] 24 December 2004; revised 7 March 2005; anatomy, nerve sparing (NS) techniques have be- come feasible in order to maintain EF without Recovery of erection after pelvic urologic surgeryL Gallo et al compromising cancer control.6,7 However, the risk For the patients with bladder cancer, we per- formed a NS cystoprostatectomy, as described by Treatment for postoperative ED historically has Brendler et al.17 A nerve and seminal sparing radical included the use of vacuum devices, intracavernosal cystectomy, as described by Colombo et al,18 was and intraurethral pharmacotherapy or placement of performed in selected cases (o65 y, strongly moti- a penile implant. The advent of a new class of drugs, vated patients, with multifocal T1 G3 or unifocal, phosphodiesterase type 5 (PDE5) inhibitors, has extratrigonal T2 cancer, with PSAr4 ng/dl and provided an oral treatment alternative to those patients suffering from this surgery related compli- The study was approved by Ethics Committee and Scientific Board of our Institution and all patients Sildenafil was the first agent to be approved in this class.10 In the last few years, two newmolecules, tadalafil and vardenafil, have beenintroduced and approved as a treatment for ED.11 The latter is rapidly absorbed, with the time formaximum plasma concentration as short as 0.5–0.6 h and an elimination half-life of 4.8–6.0 h. In At 1 month after catheter removal, the possibility of in vitro essays, it was shown to have a greater participating in an EF recovery protocol was offered selective affinity for receptorial site on PDE5 to all patients. For those interested in the protocol, enzyme than sildenafil.12 In clinical studies, varde- we administered again the IIEF5, considering the nafil significantly improved erections compared to scores, the questionnaire obtained at first visit as a placebo.13 At the dosage of 10 and 20 mg, it was baseline for evaluation of results. Moreover, we more effective than placebo in patients with ED investigated the presence of SEs during the period subsequent to surgery, defining ‘spontaneous erec- The objectives of our study were to evaluate the tion’ as the ability to achieve a partial or total penile incidence of ED in patients undergoing pelvic tumescence during the period immediately after the urologic surgery, the efficacy and tolerability of surgery without pharmacological aids (ie before the vardenafil-based rehabilitative treatment as first beginning of rehabilitative protocol). This aspect option in these patients, the role of spontaneous was investigated asking the patient: ‘Did you notice erection (SE) as a possible positive predictive factor in the period following catheter removal any to erection recovery after such treatment, the role of modification of your penis rigidity determined by second-line therapies in those nonresponders.
any type of sexual stimulation?’. Those answering‘yes’ were classified as SE þ .
Then, a rehabilitative therapy was started by using vardenafil 20 mg at least three times a week taken ondemand. Patients were encouraged to have sexualactivity.
The follow-up consisted in a visit every 3 months up to 12 months. During each visit, the tolerance tothe treatment and the EF was evaluated by using the All the patients undergoing pelvic urologic surgery IIEF5 questionnaire. We considered as ‘vardenafil at our Institution between November 2002 and responders’ patients totalizing a score Z3 to both questions 2 and 3 of the questionnaire. Practically, Preoperative EF was evaluated by using the these were the ones able to penetrate partners’ abridged five-item version of the International Index vagina and to keep erection in the most part of the of Erectile Function (IIEF5) questionnaire.15 Based on this questionnaire, study population was divided At second visit (6 months), we performed a into four groups: group a (normal EF: score 21–25), diagnostic test using intracavernous injection (ICI) group b (mild ED: score 15–20), group c (moderate with alprostadil 20 mg to all patients. We also gave a ED: score 9–14), group d (severe ED: score 1–8).
questionnaire asking grade of satisfaction for this Only patients in the groups a and b (ie normal EF or therapeutic option (see Appendix A). The vardenafil mild ED) were submitted to an NS surgery.
responders were invited to choose between oral For those with PCa, a bilateral or unilateral NSRP therapy and ICI. In case of preference for vardenafil, was performed when lateral biopsy cores were based on the previous grade of response to the drug, negative at both sides or at one side only, respec- we considered modifying dosage to 10 or 5 mg (dose tively. On the other hand, bilateral excision of NVBs setting) or eventually abolishing therapy. Vacuum was chosen in any cases where older (465 y) constriction device (VCD) was offered as an alter- patients or when PSA Z20 ng/ml and/or Gleason native to ICI for vardenafil not-responders. As the score Z7 were involved. The NSRP technique was last option, we proposed surgical intervention of penile prosthesis implant to those not satisfied with International Journal of Impotence Research
Recovery of erection after pelvic urologic surgery One month after
catheter removal
• Presence of spontaneous erection
First visit
• IIEF 5
• Start therapy
Vardenafil 20 mg at least 3
times per week taken on
demand
• IIEF 5
• Tollerance to therapy
Second visit (3 months)
• Diagnostic ICI
RESPONDERS NOT
RESPONDERS
Vardenafil 20
mg at least 3
times per week
• IIEF 5
Third visit (6 months)
• Tollerance to therapy
Responders Not
Responders
RESPONDERS Not
Responders
Penile prsthesis
DOSE SETTING
any of the previous by mentioned therapeutic SE in the immediately postoperative period (SE þ ) from those who had not (SEÀ). In these two groups, In those patients who were not-responders, and we evaluated the different percentages of vardenafil previously submitted to NS surgery, initial therapy responders, oral therapy dose setting or abolish- was prolonged at least for 6 months, before defining a patient as a vardenafil responder or not. In thosenot-responders who were not submitted to NS, wedirectly offered an alternative treatment option (ieICI or VCD), after the initial three months.
In the evaluation of the data, study population was divided into separate groups considering thegrade of preoperative EF, the type of surgery (NS or Frequency distributions of IIEF5 scores were ana- not), the type of procedure (RP, RC or nerve and lysed at different times for each subgroup. Student’s t-test was used to compare distributions of scores Moreover, among the patients who underwent an at different times (1, 3, 6, 9, 12 months) in those NS surgery, we separated those who already had an International Journal of Impotence Research
Recovery of erection after pelvic urologic surgeryL Gallo et al subgroup could not be performed, because of the considering preoperative EF, type of procedure and To evaluate the efficacy of vardenafil therapy over 6 months, differences in IIEF5 scores at 6, 9, 12  Bilateral NSRP group (22 patients): 12 had a months on postoperative scores were calculated and normal preoperative EF, 10 a mild ED. The results transformed in categories of five points’ difference to perform analysis of concordance of these differ- therapy during the first month after surgery.
Pearson w2 test was used to compare, in the groups We found an increase of 12.9, 13, and 12.6 of patients with or without SE, proportions of those vardenafil-responders, those reducing the dose, to baseline after 6, 9 and 12 months, respec- those abolishing the therapy and those preferred tively. In seven of them, we could reduce dosage to 10 mg and in 2–5 mg. Only three patients All the tests were considered statistically signifi- were able to have sexual intercourse without cant when P-values were less than 0.01. All therapy. None required a second-line treatment.
statistical analyses were performed using SPSS for We did not find differences in IIEF 5 score after Windows statistical package (SPSS Inc., Chicago).
6, 9 and 12 months of therapy even after dosesetting.
Mild ED: 40% had SE during the first month.
The increase of mean IIEF5 scores after 6months was of 8.2. In none, was dose settingpossible. One patient preferred ICI.
 Unilateral NSRP group (18 patients): 10 had a normal EF, while eight presented a mild ED. Theresults were as follows (Figure 2): Overall, 95 patients underwent pelvic urologic surgery, 58 RPs and 37 RCs. Mean age was 59.4 Normal erection: two were SE þ . Mean IIEF5 (range 50–76 y, SD 9.6). In total, 40 patients had score increased by 8.0 at 6 months, 10.2 at 9 normal EF (42.1%), 31 mild ED (32.6%), 11 months and 10.5 at 12 months. In one patient moderate ED (11.5%) and 13 severe ED (13.6%).
We found the incidence of the following risk factors in moderate and severe ED: eight cases of hyperten- Mild ED: only one patient was SE þ . Increase of sion (30%), five cases of diabetes (20.8%), 12 cases IIEF5 mean score was of 4.8, 10.6 and 10.8 of chronic smoking (50%) and five cases of hyper- points at 6, 9 and 12 months, respectively. No diminution of dosage was required and fourpatients preferred ICI.
 NSRC group (20 patients): 12 presented a normal EF before surgery, eight had a mild ED.
* Normal erection: one-third of them was SE þ .
After 6 months of therapy, mean IIEF5 increased In total, 86 patients were included in the study, of 11.3 points. In four patients we could provide since nine patients refused to enter in the protocol.
dose setting and in two abolish therapy. No one As previously mentioned, the results were evaluated of these preferred other forms of treatment.
BILATERAL
UNILATERAL
Normal Erection
Normal Erection
preoparative
1 month after catheter removal
preoparative
1 month after catheter removal
12 months
12 months
Figure 2 Mean IIEF5 score variations after vardenafil therapy in bilateral and unilateral nerve sparing radical prostatectomies.
International Journal of Impotence Research
Recovery of erection after pelvic urologic surgery NERVE AND SEMINAL
SPARING RADICAL
NS RADICAL CISTECTOMIES
CISTECTOMIES
Normal Erection
Normal Erection
preoparative
1 month after catheter removal
preoparative
1 month after catheter removal
12 months
12 months
Figure 3 Mean IIEF5 score variations after vardenafil therapy in NS radical cistectomies and in nerve and seminal sparing cistectomies.
Mild ED: two of eight were SE þ . Mean IIEF5 Vardenafil
increase was of 8.5 points after 6 months. In no Responders:
one did we considere lower dosage. Only one  Prostate and seminal sparing RC group (four patients): all had normal preoperative EF andwere SE þ . In all patients, rehabilitative treatmentwas not necessary. Mean IIEF 5 scores before andafter the surgery were not significantly different(Figure 3).
 Standard RP (12 patients): seven had normal EF or a mild ED. Five patients had a severe or moderateED before surgery. In this, group we tried oraltherapy just for 3 months. None showed aresponse to the treatment: four patients aban- doned the study, four responded to ICI, one Prosthesis: 3%
Drop out: 15%
accepted VCD and in three penile prosthesis wasimplanted.
VCD: 1.1%
 Standard RC (10 patients): none had a normal preoperative EF. We found no IIEF5 scores improvement. Nine abandoned the protocol andone pateint was successfully treated with ICI.
6, 9, and 12 months with respect to baseline oftherapy, statistical analysis showed that no further improvement of EF with vardenafil is obtained at9 and 12 months. The comparison between scoredistributions at different times in this group of In total, 13 out of 86 evaluable patients (13%) patients is represented in Figure 5. Student’s t-test abandoned the protocol, 13 preferred ICI (15%), one values, calculated in pairs of value at 6, 9, and 12 preferred VCD (1.1%) and three (3.4%) were months in respect of 1 month scores, were respec- submitted to penile prosthesis implantation. Over- tively 31.5, 30.8, and 32.8 (all with P-value o0.001).
all, independent of the type of surgery and pre- Analysis of concordance between calculated IIEF5 operative EF, 57 patients (66%) were vardenafil scores differences at 6 versus 1 month, at 9 versus 1 responders and none of them chose alternative month and at 12 versus 1 month resulted in Cohen K of 0.75 and 0.82, respectively (Po0.001).
After the first 6 months, in 12 of 57 patients (21%) In total, 25 out of 64 patients undergoing NS we could provide a dose setting and in nine (15.7%) surgery (39%) were SE þ after catheter removal. All no further treatment was required. Considering the these finally responded to vardenafil treatment. In modification of mean IIEF5 scores in the 57 this group, nine patients (36%) did not require vardenafil responder, patients over the time, after further therapy and eight (32%) could be treated International Journal of Impotence Research
Recovery of erection after pelvic urologic surgeryL Gallo et al Among the 20 patients who underwent RC, we had one case of incidental PC. Among the fourpatients who underwent nerve and seminal sparing RC, none had PSA values elevation at follow-up.
Adverse events related to vardenafil were: headache(8.8%), flushing (7.5%), dyspepsia (4.5%), nasal preoparative
1 month after catheter removal
congestion (3.2%), diarrhoea (2.6%), dizziness (2.2%), and arthralgia (2.0%). In the 13 patients 12 months
treated with ICI, adverse reactions were found in Figure 5 Mean IIEF5 variations in vardenafil responders group.
three cases: one with painful erections and two withpriapism, resolved with a-adrenergic agonist injec-tion. Nine patients agreed to try the VCD, but onlyone regularly used it.
Why to treat and prevent ED following pelvic RP is a potentially definitive therapy, but, at sametime, it is burdened by complications such as ED and urinary incontinence, with rates ranging up to Vardenafil
Dose setting (%)
Therapy switch to
80 and 25%, respectively.19 While an increasing response (% )
abolishment (%)
number of studies have reported very satisfactory SE þ and SEÀ groups: different percentages of oral postoperative rates of urinary continence, the pre- therapy response, therapy abolishment, dose setting and switched servation of EF after surgery remains the most important challenge for urologists.20 It has alreadybeen demonstrated that there is a significant andsustained effect of ED on quality of life after RP.21 On with a lower dosage of the drug; no patient had to the other hand, although surgical cure is always the switch to ICI. In those SEÀ, 31 patients (74.5%) priority in the patients undergoing RC, ED will responded to oral therapy, in only six cases (15.3%), become a more accountable end point in the future a lower dosage could be used, while eight patients management of bladder cancer. Similar to what switched to ICI (20.5%) (Figure 6). Statistical occurred in PCa, better screening and monitoring comparison between these two groups (SE þ versus protocols for bladder cancer will cause stage migra- SEÀ) showed that there was a significant difference tions and provide earlier indications for RC.4 in those requiring no further therapy after the initialperiod (w2 value 16.337 with Po0.001), in thoseallowing a reduced dosage (w2 value 2.461 with P not significant) and in those switching to ICI (w2 value5.861 with Po0.001).
We used the abridged five-item version of IIEFquestionnaire to define and validate the degree of ED in our surgical population. This diagnostic toolwas found to be very useful. It consists of a fivequestion schedule exploring all the aspects of sexual In 38/40 patients (95%), who had undergone an activity including erection quality, penetrating abil- NSRP, cancer was pT2. In the two cases (5%) with a ity, difficult to keep erection and sexual intercourse pT3 tumor, gleason score was o5. Both patients are pleasure.15 Moreover, we consider the question 2 under hormonal therapy with bicalutamide 150 mg, and 3 (penetrating and maintenance ability) to be without libido problems and no PSA relapse at the more appropriate to evaluate the response to the International Journal of Impotence Research
Recovery of erection after pelvic urologic surgery We think that for this category of patients IIEF5 is Commonly after an NSRP with the slow return of preferable to more expensive and invasive studies SEs, a dysfunctional sexual dynamic may develop in such as eco-colour-doppler or Rigiscan. Moreover, couples, the patient withdraws sexually as he is the aetiology of this kind of ED is well understood increasingly discouraged with his lack of EF, which (Surgical damage or complete excision of NVBs22) is a constant reminder of cancer. The female partner, and for this reason further diagnostic assessment is relieved that the patient has survived the surgery, may be satisfied with his companionship and is notanxious to upset him by making sexual overturesthat may frustrate him. Successful rehabilitative Positive predicting factors to erection recovery therapy early after surgery may contribute to breakthis negative cycle.26 It is preferable to start the therapy always with It has been suggested that positive predicting factors maximal dosage and providing dose setting at for recovery of EF after RP are young patient age, follow-up in cases of good response. Previously preoperative EF, preservation of NVBs and early published data with sildenafil suggest that the highest available dose of a PDE5 inhibitor is usually In our experience, the two main predicting factors necessary to treat ED following surgery.27 were preoperative EF and NVBs preservation: when We could not provide a control group for ethical these two elements were concomitant, we observed reasons: the same drug already showed to be more the maximum positive response to vardenafil ther- active than placebo for this same indication in a apy, evaluated as an increase of mean IIEF5 scores.
study by Brock et al.14 It remains unclear whether When only one NVB was spared or when preopera- patients who did not receive oral therapy, especially tive EF was not complete, we did not find the same in the most favourable groups, would not have positive results. Hence, we believe therapy must otherwise recovered function over time with ob- be conducted only in men without ED or affected servation alone. The question as to whether varde- by mild ED before operation. Oral therapy is useless nafil or related oral drugs truly rehabilitate erection for patient with preoperative ED and/or for ones that remains open. However, there is a strong belief that did not undergo NS surgery. For this reason, such treatment will lead to earlier recovery of providing different therapeutic options is suitable erections than without treatment.28 As yet data on in these cases. Anyway we chose to start with oral the efficacy of early postoperative erectile treatment treatment as recommended by the EAU guidelines, rely on very few randomized trials.29 As the natural which consider PDE5 inhibitors as the first-line recovery of EF has been reported to take as long as 2 years,26 it is possible that the erectile rehabilitation About NS surgery, it is not always possible to may simply bring forward the natural healing time preserve both NVBs for oncological reasons and, of potency rather than saving patients from perma- above all, it is not always possible to be sure to have nent erectile failure. Larger randomized trials with preserved them. Devices such as Cavermaps could at least 2 y of follow-up are required before a definite help surgeons for this purpose.25 Unfortunately, this conclusion can be drawn on the true efficacy of device is not yet widespread and its definitive results are not yet available. Therefore, only the Among the PDE5 inhibitors, we chose to use clinical evidence of EF after surgery could confirm vardenafil because it has been introduced recently into the Italian market and for its pharmacologicalprofile. We thought it was the most suitablemolecule for this difficult category of patients.
However, comparative studies are necessary, sinceall the three available molecules showed to be moreeffective than placebo to treat DE after pelvic The introduction of PDE5 inhibitors revolutionized urologic surgery.31 In particular, vardenafil has been tested in patients treated with ED following a uni- Their role is much more important in patients or bilateral NSRP in a multicentre, prospective, undergoing unilateral NS surgery or presenting mild placebo controlled, randomized study. This was preoperative ED, in which it is necessary to max- a 12-week parallel arm study comparing placebo to imize all residual neurovascular function to ensure vardenafil 10 and 20 mg. In total, 71 and 60% of the best cavernous tissue response. In our experi- patients treated with a bilateral NS procedure ence, no patient with these characteristics was able reported an improvement of EF following the to have sexual activity without vardenafil and few of administration of vardenafil 20 and 10 mg, respec- tively. A positive answer to SEP2 question (were you For patients who underwent bilateral NS surgery, able to insert your penis into your partner’s vagina) PDE5 inhibitors accelerate erection recovery work- was seen in 47 and 48% of patients using vardenafil ing as an incentive to maintain sexual interest.
10 and 20 mg, respectively. A positive answer to the International Journal of Impotence Research
Recovery of erection after pelvic urologic surgeryL Gallo et al more challenging question SEP3 question (did your after pelvic urologic surgery: MUSE (Medicated erections last enough to have successful inter- Urethral System for Erection), combination of MUSE course?) was seen in 37 and 34% of patients, and sildenafil,36 VCD and penile prosthesis im- plant.37 Among these options, MUSE is an interest-ing unfortunately it is not yet available in Italy at themoment.
When to start oral therapy and how long to waitbefore providing alternative options? Could spontaneous postoperative erections be It has been suggested that rate of success strongly considered as a positive predicting factors to oral depends on early beginning of therapy and used dosage.9 Starting the therapy as early as possible is avery important issue since several reports showedhow ‘penis is not a muscle, but behaves like a We found the presence of SE after catheter removal muscle’: the better understanding of pathophysiol- in our study as a positive predictive factor to ogy of post prostatectomy ED including the concept vardenafil therapy response and final erection of tissue damage induced by poor corporeal oxyge- recovery. Indeed, there were statistically significant nation paved the way to the application of pharma- differences in SE þ and SEÀ groups regarding the percentages of those in which we could abolish therapy (36 versus 0%, respectively) and of those We chose to begin treatment 1 month after who had to use ICI to have sexual intercourse (0 catheter removal to verify the presence of SE and versus 20.5%, respectively). SE had the same role to reduce the influence of urinary incontinence that also in patients treated with tadalafil, as reported by could alter the results of rehabilitative therapy.
Montorsi et al.31 We think it is always necessary to In a previous experience, sildenafil appeared to be consider this aspect for its clinical utility.
ineffective in the first 9 months following surgery;therefore, it was suggested to wait this time afterevaluating treatment.33 We think this period to be NS surgery is not always possible: correct case excessive: in our experience, we found concordance selection and respect of oncological criteria in vardenafil responders considering mean IIEF5scores at 6, 9 and 12 months. Practically, vardenafilachieves its maximum effect already at 6 months of Recovery of EF is certainly an important goal for treatment. After this time it is possible to provide a urologists. Anyway we do not have to forget that the dose setting to vardenafil responders and to counsel main purpose of uro-oncological surgery remains to try a second-line of treatment to those not the cancer control. In a previous study, patients interviewed about their expectations were interestedmore to quality of life and absence of complicationsthan to overall survival.38 We think both goals can be achieved if correct Efficacy and compliance of second-line treatments oncological criteria on cases selection are respected:NS prostatectomy determines an excision of the In patients who did not undergo NS surgery, gland very close to its lateral aspect and for this independently on their preoperative EF, it is reason there is the risk to leave tumoral tissue in the necessary to start immediately with alternative field. In our experience, this complication occurred options. In particular, we agree with the fact that only in 5% of the cases and in all of them we could ICI is the best treatment.34 Delaying treatment with manage the problem by using antiandrogen mono- ICI could determine cavernous tissue fibrosis. To therapy with bicalutamide without consequences on avoid this dangerous complication we provided to all our study population ICI diagnostic test inde-pendently from response to therapy. Furthermore,early ICI could help patients psychologically, mak- ing them understand that oral therapy is not the onlyoption and even when it fails other forms oftreatment are available. Our experience confirmed In our experience, vardenafil showed to be well that patients preferred ICI to VCD as reported in tolerated and effective for recovery of EF in patients undergoing pelvic urologic surgery. This drug was Other studies reported different types of therapies particularly effective for those with a normal showing to be successful in recovery of erection preoperative EF undergoing an NS procedure.
International Journal of Impotence Research
Recovery of erection after pelvic urologic surgery A 6-month period can be considered sufficient for a 12 Keating GM, Scott LJ. Vardenafil: a review of its use in erectile correct evaluation of oral therapy. After this time, dysfunction. Drugs 2003; 63: 2673–2703.
not-responder patients should be counselled to try 13 Porst H et al. The efficacy and tolerability of vardenafil, a new, oral, selective phosphodiesterase type 5 inhibitor, in patients with erectile dysfunction: the first at-home clinical trial. Int J Of course, it should be recognized that the absence of a control group in the study represents 14 Brock G et al. Safety and efficacy of vardenafil for the an important limitation to the proof of our rehabi- treatment of men with erectile dysfunction after radical litative therapy on EF recovery after surgery. How- retropubic prostatectomy. J Urol 2003; 170(4 Part 1):1278–1283.
ever, based on the data form the literature, there is a 15 Rhoden EL, Teloken C, Sogari PR, Vargas Souto CA. The use of strong belief that such approach will lead to an the simplified International Index of Erectile Function (IIEF-5) earlier recovery of EF than without rehabilitative as a diagnostic tool to study the prevalence of erectile dysfunction. Int J Impot Res 2002; 14: 245–250.
16 Walsh PC. Anatomic radical retropubic prostatectomy. In: The presence of SE after catheter removal is a Walsh, Retik, Vaughan, Wein (eds) Campbell’s Urology, 8 edn, useful clinical instrument to predict response to oral therapy and final EF recovery. Among the second- 17 Brendler CB et al. Local recurrence and survival following line therapies, ICI showed to be more effective and nerve-sparing radical cystoprostatectomy. J Urol 1990; 144: 1137–1140, discussion 1140–1141.
18 Colombo R et al. Nerve and seminal sparing radical cystect- omy with orthotopic urinary diversion for select patients withsuperficial bladder cancer: an innovative surgical approach.
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19 Stanford JL et al. Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer: theProstate The questionnaire for evaluation of ICI was invented and created by Dr Ana Puigvert and Dr JoseMaria 20 Siegel T et al. The development of erectile dysfunction in men Pommerol of Andrology Service ‘Fondacion Puig- treated for prostate cancer. J Urol 2001; 165: 430–435.
vert’ Barcelona Spain. The same questionnaire was 21 Meyer JP, Gillatt DA, Lockyer R, Macdonagh R. The effect of erectile dysfunction on the quality of life of men after radical translated and adapted to Italian and English by prostatectomy. BJU Int 2003; 92: 929–931.
22 Podlasek CA et al. Analysis of NOS isoform changes in a post radical prostatectomy model of erectile dysfunction. Int JImpot Res 2001; 13(Suppl 5): S1–S15.
23 Rabbani F et al. Factors predicting recovery of erections after radical prostatectomy. J Urol 2000; 164: 1929–1934.
24 Wespes E et al. EAU Guidelines on Erectile Dysfunction.
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7 Spitz A, Stein JP, Lieskovsky G, Skinner DG. Orthotopic 31 Montorsi F et al. Tadalafil in the treatment of erectile urinary diversion with preservation of erectile and ejaculatory dysfunction following bilateral nerve sparing radical retro- function in men requiring radical cystectomy for nonuro- pubic prostatectomy: a randomized, double-blind, placebo thelial malignancy: a new technique. J Urol 1999; 161: controlled trial. J Urol 2004; 172: 1036–1041.
32 Montorsi F et al. Recovery of spontaneous erectile function 8 Siegel T et al. The development of erectile dysfunction in men after nerve-sparing radical retropubic prostatectomy with treated for prostate cancer. J Urol 2001; 165: 430–435.
and without early intracavernous injections of alprostadil: 9 Briganti A et al. Emerging oral drugs for erectile dysfunction.
results of a prospective, randomized trial. J Urol 1997; 158: Expert Opin Emerg Drugs 2004; 9: 179–189.
10 Raina R et al. Efficacy and factors associated with successful 33 Raina R et al. Long-term effect of sildenafil citrate on erectile outcome of sildenafil citrate use for erectile dysfunction after dysfunction after radical prostatectomy: 3-year follow-up.
radical prostatectomy. Urology 2004; 63: 960–966.
11 Meuleman EJH, Mulders PFA. Erectile function after radical 34 Raina R et al. Long-term efficacy and compliance of prostatectomy: a review. Eur Urol 2003; 43: 95–102.
intracorporeal (IC) injection for erectile dysfunction following International Journal of Impotence Research
Recovery of erection after pelvic urologic surgeryL Gallo et al radical prostatectomy: SHIM (IIEF-5) analysis. Int J Impot Res desiring noninvasive therapy. Int J Impot Res 2002; 14(Suppl 35 Soderdahl DW, Thrasher JB, Hansberry KL. Intracavernosal 37 Carson CC, Mulcahy JJ, Govier FE. Efficacy, safety and patient drug-induced erection therapy versus external vacuum de- satisfaction outcomes of the AMS 700CX inflatable penile vices in the treatment of erectile dysfunction. Br J Urol 1997; prosthesis: results of a long-term multicenter study. AMS 700CX Study Group. J Urol 2000; 164: 376–380.
36 Nehra A, Blute ML, Barrett DM, Moreland RB. Rationale for 38 Hatzichristou D. Come trattare la disfunzione erettile post- combination therapy of intraurethral prostaglandin E(1) and prostatectomia radicale. 76th Congress of Societa` Italiana di sildenafil in the salvage of erectile dysfunction patients Intracavernous injection diagnostic test (ICIDT) In order to evaluate your problem properly and assess the best therapy for you, it is very important that youbring back this questionnaire filled on your next visit. In case of persistent erection for more than 4 h, pleaseavoid any erotic stimulation and soak your penis in cold water. If erection persists do not hesitate to contactus.
INJECTION——————————————— DATE——————————————— TIME——————————————— Did you have any erection after the injection? How much time elapsed between injection and erection?———————————————————————— How long did it last?—————————————————————————————————————————————— How was it compared with your spontaneous penile tumescence? Did you attempt any sexual activity with your Did sexual stimulation increase your erection? if yes, what did you do? ——————————————————————————————————————————— Did any other complications occur ?NO & Specify——————————————————————————————— In conclusion, do you think you will use this kind of injection regularly for 10. Comments ——————————————————————————————————————————————————— —————————————————————————————————————————————————————————— —————————————————————————————————————————————————————————— —————————————————————————————————————————————————————————— —————————————————————————————————————————————————————————— (Please do not forget to take this questionnaire on the day of your next visit.) International Journal of Impotence Research

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