Maintenance Of Erection Research Articles

P02-36 - Effect of aripiprazole adjunctive to antidepressants on sexual functioning: A subgroup analysis of a 52-week open-label safety study (CN138–164)

IntroductionThis presentation addresses impacts of adjunctive aripiprazole (AA) in major depressive disorder (MDD).ObjectiveAssess impacts of long-term (≤52 weeks) open-label AA to ADT on efficacy, sexual function and weight change in MDD.MethodsData were analyzed post-hoc from de novo patients enrolled in an open-label safety study of AA after inadequate response to one or more ADT. Three ADT classes were included: SSRIs, SNRIs, and a noradrenaline-dopamine reuptake inhibitor, bupropion.Global well-being with AA was assessed (mean change in CGI-S score from baseline by ADT). Sexual functioning was assessed by Sexual Function Inventory (SFI) items: interest in sex, sexual arousal, achievement of orgasm, erection maintenance and sexual satisfaction. Item 6 captured change in the overall improvement score. Weight change at Week 52 (last observation carried forward) was assessed.ResultsOverall mean change in CGI-S (n = 285) by Week 52 was -1.5. Mean changes in CGI-S from baseline scores (4.2-4.4) were: escitalopram (n=64) -1.5, venlafaxine XL (n = 48) -1.4, sertraline (n = 39) -1.7, fluoxetine (n = 41) -1.3, paroxetine or CR (n = 37) -1.5 and bupropion XL or SR (n = 46) -1.4. Improvements on SFI items (n = 155) ranged from -0.2 (sexual satisfaction) to -0.6 (interest in sex and orgasm). Mean overall improvement score (3.8) indicated mild-to-moderate sexual dysfunction. All AA groups experienced a mean weight increase (range +1.8 kg [sertraline] to +3.3 kg [fluoxetine]).ConclusionsAA moderately improved CGI-S scores (to a similar degree) when added to three different classes of ADTs. Sexual functioning in patients on ADT modestly improved after adding aripiprazole to ADT.

Interrelationship of Sildenafil Treatment Effects on the Physiological and Psychosocial Aspects of Erectile Dysfunction of Mixed or Organic Etiology

In a previous paper using mediation modeling, the direct and indirect effects of sildenafil on erection maintenance were demonstrated. In an extension of this previous work, the historical psychosocial paradigm of ED, which focuses on performance anxiety, is tested by using mediation modeling to define the relationship of the physiological aspects (hardness and maintenance) and the associated psychosocial aspects (confidence, sexual relationship satisfaction, and performance anxiety) of ED. Statistical mediation analysis using the following outcomes from a double-blind placebo-controlled trial of fixed-dose sildenafil 100 mg or 50 mg: Erection Hardness Score; the 15-item International Index of Erectile Function (IIEF), including item 4 (frequency of erection maintenance after penetration) and item 5 (difficulty of erection maintenance to intercourse completion); the Self-Esteem And Relationship questionnaire; and the question, "Do you feel anxious about your next attempt at sexual intercourse?" Estimated percentages of direct and indirect effects of sildenafil on psychosocial aspects of ED (95% confidence intervals). The model estimated that erection hardness mediated 43.7% (29.3%, 62.4%) of the effect of treatment onto confidence and 45.9% (32.2%, 61.8%) of the effect of treatment onto sexual relationship satisfaction, and that erection maintenance (using IIEF item 4 as a proxy) mediated 23.0% (10.1%, 39.1%) and 22.4% (10.1%, 36.5%), respectively. Similar results were obtained when IIEF item 5 was used as the proxy for measurement of maintenance. Of all possible paths to performance anxiety, only that from treatment via confidence was statistically significant, mediating an estimated 88.6% (55.5%, 146.2%; item 4 model) or 74.9% (47.0%, 121.0%; item 5 model) of the effect of treatment onto anxiety. The direct path to anxiety from treatment was not statistically significant. In men treated with sildenafil for ED, performance anxiety might be ameliorated by improved confidence. Improved confidence might be mainly mediated via increased erection hardness.

Understanding the Effects of Sildenafil Treatment on Erection Maintenance and Erection Hardness

Erectile dysfunction (ED) is defined as the inability to attain and/or maintain penile erection sufficient for satisfactory sexual performance. Although intuitively related, the link between erection hardness and erection maintenance has not been formally established and quantified. To understand the components of erection maintenance through statistical modeling. Data from a double-blind placebo-controlled trial of fixed-dose sildenafil (100 or 50 mg, 8 weeks) with open-label extension of flexible-dose sildenafil (100 and 50 mg, 4 weeks) were analyzed. Erection maintenance was assessed with item 4 (how often erection was maintained) or item 5 (difficulty in maintaining erection) of the International Index of Erectile Function (IIEF). Erection hardness was assessed with the Erection Hardness Score. Longitudinal modeling estimated mean treatment differences averaged over the double-blind phase for sildenafil 100 mg vs. placebo and 50 mg vs. placebo. Statistical mediation analysis was applied to partition the effect of sildenafil (pooled into one treatment group) on erection maintenance directly and indirectly through erection hardness. Longitudinal mean differences for sildenafil 100 and 50 mg vs. placebo were high (P < 0.0001 for each), with large standardized effect sizes (>0.8). Mediation modeling showed that sildenafil treatment affected maintenance directly as well as indirectly via erection hardness, when measured by IIEF item 4 (direct effect, 44.6%; indirect effect, 55.4%) or IIEF item 5 (direct effect, 56.9%; indirect effect, 43.1%). Sildenafil treatment significantly improved erection maintenance, a physiologic requirement for satisfactory sexual performance. According to our model, only approximately half of the effect of sildenafil on erection maintenance was estimated to be driven through direct effects. Rather, the effect of sildenafil on erection maintenance seems to be substantially driven by erection hardness. Therefore, achievement of optimal initial erection hardness appears to be an important treatment goal for enhancing erection maintenance and achieving successful ED treatment.

Efficacy of Udenafil for the Treatment of Erectile Dysfunction up to 12 Hours after Dosing: A Randomized Placebo-Controlled Trial

Udenafil is a newly developed selective phosphodiesterase type 5 inhibitor for the treatment of men with erectile dysfunction (ED). To evaluate the efficacy of udenafil in treating ED for up to 12 hours after dosing. This was a randomized, double-blind, placebo-controlled, parallel-group, fixed dose design, multicenter study. Following a 4-week nondrug baseline period, 104 men with ED of broad etiology and severity were randomized to one of two treatment groups: udenafil 100 mg or placebo. Participants were requested to attempt sexual intercourse at 12 hours after udenafil or placebo dosing during a 4-week treatment period. The primary efficacy variable was the response of patients to question 3 of the Sexual Encounter Profile (SEP Q3). The secondary efficacy measures were the response of patients to question 2 of the Sexual Encounter Profile (SEP Q2). Additional secondary efficacy measures included changes from baseline in the erectile function (EF) domain scores of the International Index of Erectile Function (IIEF) questionnaire. Of the 104 patients, 103 (50 in the udenafil group, 53 in the placebo group) completed the study. Udenafil significantly enhanced the rate of maintenance of erection (SEP Q3; placebo, 28.3% vs. udenafil, 54.7%; P < 0.0001). Significant change from baseline in the IIEF-EF domain was observed in the udenafil group (placebo, -0.58 ± 0.67; udenafil, 4.40 ± 0.84; P < 0.0001). For SEP Q2, there was no difference from baseline and no difference between the two groups. The overall adverse events rate was 11.3%. Most adverse events were mild or moderate in severity, and no serious adverse events were reported during the study and the follow-up period. Udenafil at 100 mg was effective for relieving ED for up to 12 hours after dosing. This duration of effectiveness could allow for flexibility and spontaneity in the sexual lives of patients.

Retracted: Physical therapy for premature ejaculation, erectile dysfunction and chronic pelvic pain syndrome

There is limited knowledge about the exact role of the pelvic floor in male sexual functioning. Pelvic floor muscle function might be involved in the enhancement of blood flow to the penis, and evidence suggests an active role for the ischio- and bulbocavernous muscles and other pelvic floor muscles in the initiation and maintenance of erection. Increased activity of pelvic floor muscles might also be preparatory to ejaculation. Studies have shown positive results after physical therapy for erectile dysfunction, premature ejaculation and chronic pelvic pain syndrome. However, the methodological quality of some of these studies is poor and further research validating specific physical therapies in the assessment and treatment of male sexual function is necessary. In this respect physical therapists have a potential role as integral members of healthcare teams involved in the improvement of male sexual health.

Dysfonction érectile et cellules endothéliales caverneuses

The physiopathology of erectile dysfunction (ED) is multifactorial. The recent discovery of the precise role of cavernosal endothelium in the functional regulation of the smooth muscle cells allowed to understand the physiological bases of erection. The purpose of this article is to make a synthesis of the current knowledge on the endothelial function and to allow a better understanding of the pathological responsible mechanisms of ED. Endothelium provides cavernosal smooth muscle cells relaxation by two main pathways: the NO/cGMP pathway induced by production of neural nitric oxide (NO) in cavernosal nerve terminals, and the AC/cAMP pathway which by-passes the NO route by using other mediators. This action allows the initiation and maintenance of erection. Risk factor-associated cavernosal endothelial alterations (diabetes mellitus, hypertension, hypercholesterolemia) are mostly induced by unifying mechanisms, including oxidative stress and accumulation of reactive oxygen species, alteration of NO production, or decrease of VEGF expression. The same cellular mechanisms can also be observed during aging. To a comprehensive appraisal of physiological bases of viable endothelium in erectile function, it is crucial to understand its biological activities. The hemodynamic evaluation of endothelial function and the current therapeutic implications will be later approached.

Characterization of nitrergic function in monkey penile erection in vivo and in vitro

The nitrergic nerve appears to have a major role in the neuronal regulation of penile erection. Cholinergic innervation has been shown histochemically in penile cavernous tissues, but its functional role is not well understood. This study was aimed at examining the functional properties of the nitrergic nerve and the possible involvement of cholinergic function in the regulation of monkey penile erection in vivo and in vitro. In anesthetized Japanese monkeys, electrical stimulation of the cavernous nerve caused a frequency-dependent increase in intracavernous pressure and penile erection, and atropine enhanced the pressure response. Intravenous injections of N(G)-nitro-L-arginine (L-NA) markedly inhibited the stimulation-induced pressure increase and the erectile response, and L-arginine partially restored the pressure response. In some monkeys, the intracavernous pressure increase caused by nerve stimulation was reversed by treatment with L-NA; however, L-arginine restored the pressor response. In addition, hexamethonium suppressed the pressure increase that resulted from the nerve stimulation. In corpus cavernosum isolated from monkeys, transmural electrical stimulation elicited frequency-dependent relaxation. The relaxation was attenuated by physostigmine, and was potentiated by atropine. Relaxation was markedly inhibited by treatment with L-NA. It appears that nitric oxide (NO) released from inhibitory nerves, even at low frequencies, has a pivotal role in the initiation and maintenance of intracavernous pressure increase and penile erection in monkeys. Prejunctional muscarinic receptors in nitrergic nerves are expected to participate in the impairment of NO release. Nitrergic nerves responsible for penile erection may originate from ganglia close to the corpus cavernosum.

The Efficacy and Safety of Udenafil, a New Selective Phosphodiesterase Type 5 Inhibitor, in Patients with Erectile Dysfunction

Udenafil is a potent selective phosphodiesterase type 5 (PDE5) inhibitor newly developed for the treatment of erectile dysfunction (ED). This study was performed to evaluate the efficacy and safety of udenafil therapy in patients with ED. In this multicenter, double-blind, placebo-controlled, fixed-dose, parallel-group phase III trial, 167 patients with ED of diverse origin and severity were randomized to take placebo or udenafil at fixed doses of 100 or 200 mg as needed for 12 weeks. Primary efficacy variable was change from baseline in erectile function (EF) domain scores of the International Index of Erectile Dysfunction (IIEF) questionnaire. Secondary efficacy variables include change from baseline in scores on the IIEF Questions 3 and 4 (IIEF Q3 and Q4), change from baseline in all domain scores of the IIEF, patients' responses to questions 2 and 3 of the Sexual Encounter Profile (SEP2 and SEP3), and patients' responses to the Global Assessment Question (GAQ). Any adverse events were also recorded during the trial. After 12 weeks of treatment, the patients treated with udenafil showed significantly greater change from baseline in the IIEF-EF domain score compared with placebo (placebo, 0.20; 100-mg udenafil, 7.52; and 200-mg udenafil, 9.93, respectively) (P < 0.0001). Compared with placebo, udenafil significantly enhanced the rates of successful penetration (SEP Q2) and maintenance of erection (SEP Q3) (P < 0.0001). Furthermore, significantly greater proportions of udenafil treatment groups responded positively to the GAQ compared with the placebo group (GAQ: placebo, 25.9%; 100-mg udenafil, 81.5%; and 200-mg udenafil, 88.5%, respectively) (P < 0.0001). Treatment-related adverse events were generally mild to moderate with facial flushing and headache being the most common. Udenafil is an effective and well-tolerated therapy for ED of broad-spectrum etiology and severity.

Treatment of erectile dysfunction: defyning the optimal response

Prevalence of erectile dysfunction (ED) has been estimated at 13% to 28% of men aged 40 to 80 years worldwide. The availability of oral treatments has enhanced awareness of the impact of ED on emotional well being and on sexual satisfaction (i.e., satisfaction with sexual intercourse, sex life, and sexual relationship). However, it is crucial for patients with ED non only to improve erectile symptoms but to optimize response to the treatment proposed. This allows to improve sexual function, patient satisfaction and overall couple relationship. In this context a novel patient assessment consisting of erection hardness evaluation has been proposed. Erection hardness is a physiologic response which can be easily graded subjectively with the Erection Hardness Grading Scale (EHGS). The importance of the ability to achieve a hard erection has been recently recognized by an International Consensus Advisory Panel of urology, psychology, and reproductive health specialists with experience in assessing and treating ED. This panel defined ED treatment efficacy as “…the ability of a pharmacologic agent to promote achievement and maintenance of firm or adequate erections” and described a complete response as “…consistent achievement and maintenance of full erection”. Several prospective double-blind trials have indeed demonstrated how erection hardness positively correlated with successful sexual intercourse rate, patient satisfaction, and satisfaction with overall couple relationship. Therefore, achievement of hard erections may be considered a unifying factor that defines response in ED treatment. Completely hard and fully rigid erections should be thus recognized as the optimal goal of an ED therapy.

T09-P-13 The importance of the Kegel exercises for the erection of the male and female erectile organs (male and female penis)

The erection of the male and female erectile organs (male and female penis) consists of three phases: a) latent, b) turgid, c) rigid or muscular. Ischiocavernosum muscles (muscles of erection) are much more developed in male than in female. These muscles are innervated by branches of the pudendal nerve, that originates from Onuf's nucleus located in the sacral spinal cord. The androgens are responsible of the sexual dimorphism of this nucleus. The tonic contraction of ischiocavernosum muscles during erection is necessary for the rigidity of penis. These muscles, as also the bulbocavernosum muscle (muscle of ejaculation and orgasm), though histologically striated, have a semiautomatic function: ischiocavernosum muscles, together with bulbocavernosum muscle, introduce a continuous involuntary reflected hypertonic contraction during erection. This is necessary not only for the rigidity of the penis, but also for the maintenance of erection. The Kegel exercises allow the contraction of the pubovaginalis (elevator of the prostate in male) and the puborectalis muscles, and of all the perineal muscles and especially of the superficial ones (the most important in sexology): only with these exercises it is possible to train the ischiocavernosum and bulbocavernosum muscles. This training could reduce the post-ejaculatory refractory period that increases in every man with age and could facilitate the erection after a first ejaculation. In elderly men the ejaculation takes place with less strength or without squirting. The Kegel exercises, training bulbocavernosum muscle, are important to prevent and postpose the physiologic reduction of the strength of ejection of the seminal liquid.

The Russian experience of studying vardenafil efficacy and safety in men with erectile dysfunction of various aetiologies

Background Vardenafil is a first-line drug in the therapy for erectile dysfunction (ED) of various aetiologies. Methods An open, multi-centre study assessing the efficacy and safety of vardenafil prescribed in flexible doses for 12 weeks to men with ED from various aetiologies was performed in Moscow in 2003–2004. A total of 129 patients aged from 22 to 76 years (mean = 45.7 ± 12.9) were enrolled into the study. The efficacy of the drug was evaluated using the International Index of Erectile Function (IIEF) Questionnaire, individual patients’ diaries and the Global Assessment Questionnaire (GAQ). Results Scores for erectile function, maintenance of erection, satisfaction with sexual experience and satisfaction with overall sexual life all increased between the beginning and the end of this study, which has thus shown vardenafil's high efficacy and safety for patients. Conclusion Alongside its cardiovascular safety, one of the advantages of vardenafil is the opportunity for flexible dosing owing to the variety of dosages available.

The Effect of Physician and Patient Education When Combined with Vardenafil Treatment in Canadian Males with Erectile Dysfunction: An Open-Label, Factorial-Designed, Cluster-Randomized Clinical Trial

Studies evaluating the effect of education on treatment success with phosphodiesterase type 5 (PDE5) inhibitor therapy in men with erectile dysfunction (ED) are limited. Additional education of the primary care physician (PCP) and the patient are thought to optimize the treatment of ED. To assess the impact of education of the PCP or of the patient in the treatment of ED with vardenafil relative to usual care. In this 12-week, open-label, multicenter, factorial-designed, cluster-randomized Canadian study, 1,029 patients with ED were enrolled into four different education groups: usual care, patient education, PCP education, and both PCP and patient education. All groups started on vardenafil 10 mg, with the option to titrate at weeks 4 and 8. The primary efficacy measure was the difference at week 4 last observation carried forward (LOCF) in the overall improvement in erectile function (EF) as measured by the Global Assessment Question (GAQ), while on background vardenafil, between those receiving education vs. those who did not. Other secondary assessments included responses to diary questions regarding penetration (sexual encounter profile, SEP2) and erection maintenance (SEP3), and to questionnaires regarding treatment satisfaction (Erectile Dysfunction Inventory of Treatment Satisfaction [EDITS]). A total of 956 patients were included in the intent-to-treat population. Mean baseline International Index of Erectile Function-EF domain score was 13. GAQ response rates at week 4 LOCF were high (>80%) for all groups, regardless of the education given. Mean per patient SEP2 and SEP3 rates at week 12 LOCF were 86-89% and 79-83%, respectively. In an exploratory analysis, a positive relationship between GAQ responses and EDITS scores was observed (P < or = 0.0007). Vardenafil was generally well tolerated. In men with moderate ED, vardenafil led to high success rates and satisfaction regardless of the education given. The benefits of education for PCP and patients in Canada were possibly masked by a ceiling effect in this study population.

Plexiforme Neurofibroma with Compromising of the Penile Function

The objective of this article was to describe a case of Von Recklinghausen's disease with plexiform neurofibroma of the penis. The patient was 26 years old and reported difficulty with sexual intercourse owing to a penile mass, despite experiencing normal sensation and erection. Physical examination demonstrated this penile mass with café au lait spots, subcutaneous neurofibromas, and lisch nodules. The treatment consisted of subcoronal incision and resection of the lesion. Pathologic examination revealed a plexiform neurofibroma. The patient recovered well with subsequent maintenance of penile sensation and erection. In cases of plexiform neurofibroma compromising penile function, total resection of penile mass offers a good therapeutic option.

Fiberoptic Imaging of Cavernous Nerves In Vivo

A critical intraoperative variable for the return of tumescence following radical prostatectomy is preservation of the cavernous nerves. We developed a nontoxic technique that would allow high resolution, in vivo real-time imaging specifically of the cavernous nerves. The cavernous nerves were labeled by injecting a fluorescent retrograde nerve tracer into the corpus cavernosum of male rats. Nerves were subsequently imaged in vivo using fiberoptic confocal fluorescent microscopy. Initial screening trials were performed to decide on a nerve tracer capable of axonal labeling, optimize injection concentration and characterize retrograde transport time. Toxicity studies included intracavernous pressure monitoring following electrical nerve stimulation, apoptotic staining of injected cavernous tissue and measurement of lipid peroxidation in nerves exposed to laser emissions during imaging. In vivo real-time video sequences of fluorescently labeled cavernous nerves were recorded. The screening trial indicated that the B subunit of cholera toxin conjugated to AlexaFluor 488 (Invitrogen) provided optimal imaging after 9 days of retrograde transport. Toxicity studies showed that maximal intracavernous pressure responses did not differ between labeled and unlabeled nerves (p = 0.9671). Tracer injection did not increase apoptosis in cavernous tissue and laser exposure did not increase lipid peroxidation in nerves. In vivo real-time imaging of the cavernous nerves is possible with no measurable toxicity, allowing the maintenance of erection. This novel imaging modality may allow urologists to identify cavernous nerves during pelvic surgery.

The erectile–endothelial dysfunction nexus: new opportunities for cardiovascular risk prevention

Erectile and endothelial dysfunction are common in individuals with multiple cardiovascular risk factors and are longitudinal predictors of cardiovascular events. The pathogenesis of both endothelial and erectile dysfunction is intimately linked through increased expression and activation of endothelial nitric oxide synthase, and the subsequent physiological actions of nitric oxide. Endothelial production of nitric oxide by endothelial nitric oxide synthase in the corpus cavernosum is involved in the maintenance of penile erection. Erectile dysfunction can be detected clinically using systematic questioning and could potentially be employed as an independent predictor of cardiovascular risk to target treatment of cardiovascular risk factors. Both erectile and endothelial dysfunction respond to lifestyle modifications, particularly in individuals with the metabolic syndrome. Drugs that improve endothelial dysfunction can also improve erectile dysfunction, but responses are not always concordant. Phosphodiesterase type 5 inhibitors, however, are powerful agents that commonly improve erectile and endothelial dysfunction, with potential cardiac applications. The recent Princeton consensus requires more extensive implementation and evaluation in clinical practice. The judicious diagnosis of erectile dysfunction, nevertheless, provides a unique opportunity for the prevention of cardiovascular disease.

Differential brain processing of audiovisual sexual stimuli in men: Comparative positron emission tomography study of the initiation and maintenance of penile erection during sexual arousal

The human male psychosexual cycle consists of four phases: excitation, plateau, orgasm, and resolution. Identification of the specific neural substrates of each phase may provide information regarding the brain’s pathophysiology of sexual dysfunction. We previously analyzed regional cerebral blood flow (rCBF) with H215O-positron emission tomography (PET) during the excitation phase (initiation of penile erection) induced by audiovisual sexual stimuli (AVSS) and identified activation of the cerebellar vermis, the bilateral extrastriate cortex, and right orbitofrontal cortex, suggesting a role of cognition/emotion in the excitement phase. In the present study, we analyzed rCBF of the same six healthy volunteers during the plateau phase (maintenance of penile erection) induced by AVSS and compared the results with those of the excitation phase. Penile rigidity was monitored in real time with RigiScan Plus® during PET scanning. Images were analyzed by statistical parametric mapping (SPM) software, and rCBF in the amygdala, hypothalamus, anterior cingulate, and insula was measured. During the plateau phase, primary subcortical activation was noted in the right ventral putamen, indicating motivational factors in the sexual response via the limbic reward circuit. A significant increase in rCBF in the left hypothalamus was also observed during the plateau phase. The right anterior cingulate and left insula were specifically activated during the excitation phase but not during the plateau phase. These results indicate a significant role of the ventral putamen and the hypothalamus in the plateau phase and confirm that paralimbic and limbic components of the human brain differentially coordinate the sexual response in a psychosexual phase-dependent manner.

Real-Life Safety and Efficacy of Vardenafil in the Treatment of Erectile Dysfunction—Results from 30,010 U.S. Patients

Clinical trials show that vardenafil produces effective and satisfactory first-dose success rates and reliability for erection and intercourse in men with erectile dysfunction (ED). This study was conducted to evaluate real-life efficacy, safety, and acceptance of vardenafil in men with ED. This open-label, prospective study, conducted in 6,740 U.S. centers, included an initial visit and one or two follow-up visits within a 2-month period of the first vardenafil dose. Vardenafil was administered in 5-20 mg doses. Efficacy variables included first-dose success rates for vaginal penetration, maintenance of erection, and satisfaction based on physician and patient assessments. Safety was assessed by adverse events (AEs). A total of 30,010 men were included in the safety/intent-to-treat (S/ITT) analysis, with 26,043 men in the adjusted S/ITT population. Vardenafil improved erectile function in 78% of men, with 75% rating overall efficacy as "satisfying" or "very satisfying." The overall rates of successful penetration and maintenance with vardenafil following the first dose were 78% and 68%, respectively. For men with mild and moderate ED, first-dose success rates for penetration were 89% and 82%, respectively, and for maintenance, 82% and 71%, respectively. First-dose penetration and maintenance of erection rates were 76% and 66%, respectively, for men with self-reported hypertension, and 70% and 60%, respectively, for men with diabetes mellitus. At study end, 67% of patients preferred to continue using vardenafil. The most frequently reported AEs were headache (4%) and flushing (2%). Vardenafil was well tolerated, with a "satisfied/very satisfied" tolerability rating in 75% of cases as assessed by the physician. This observational study demonstrated the tolerability and efficacy of vardenafil in men with ED and comorbidities. Vardenafil provided a high rate of first-dose intercourse success and a favorable safety profile in patients with and without comorbid disease.

Radical Prostatectomy: Which Quality of Life?

The aim of the present study was to evaluate quality of life in patients submitted to radical prostatectomy, by correlating the results of the post-operative condition with follow-up data at 6 and 12 months. Materials and Methods. Between october 2004 and december 2005, 68 patients - mean age 68 (range 49–76) - treated with radical retropubic prostatectomy for localized prostate cancer (T2a, T2b, No, Mo) were consecutively enrolled onto the study. All patients underwent sexual as well as urinary incontinence rehabilitation, showing good compliance. We evaluated quality of life before prostatectomy (T0), 6 (T1) and 12 (T2) months after surgery through the Short Form 36 questionnaire, for which an analysis of variance for repeated measures was carried out. Patients were interviewed by our department psychologist regarding urinary incontinence and erectile dysfunction. All patients were disease-free at the time of evaluation. Results. No significant differences were observed between physical and mental health indices. Conversely, a significant improvement (p&lt;0.001) was seen in all SF-36-questionnaire 8 scales, comparing preoperative T0 values with T1 and T2 values. Of the 68 patients, 53 (78%) no longer needed pads at the T2 follow-up, while 15 (22%) reported using 3–4 pads/day A significant worsening of the sexual function (maintenance of erection) was observed in 51 (75%) patients, who had reported having normal sexual activity preoperatively (T0). On the other hand, 17 (25%) patients reported having an adequate erection to engage in sexual intercourse. Conclusions. Despite the differences observed in physical and mental health scores during the three periods evaluated (T0, T1 and T2), overall quality of life does not appear to have been greatly compromised by surgery. At T2 follow-up, in fact, all 68 patients reported to be satisfied with having undergone radical prostatectomy because of its benefits in terms of survival and its limited effects on their quality of life. (Urologia 2007; 74: 22–9)

Radical prostatectomy: which quality of life?

The aim of the present study was to evaluate quality of life in patients submitted to radical prostatectomy, by correlating the results of the postoperative condition with follow- up data at 6 and 12 months. MATERIALS AND METHODS. Between october 2004 and december 2005, 68 patients - mean age 68 (range 49-76) - treated with radical retro-pubic prostatectomy for localized prostate cancer (T2a, T2b, No, Mo) were consecutively enrolled onto the study. All patients underwent sexual as well as urinary incontinence rehabilitation, showing good compliance. We evaluated quality of life before prostatectomy (T0), 6 (T1) and 12 (T2) months after surgery through the Short Form 36 questionnaire, for which an analysis of variance for repeated measures was carried out. Patients were interviewed by our department psychologist regarding urinary incontinence and erectile dysfunction. All patients were disease-free at the time of evaluation. RESULTS. No significant differences were observed between physical and mental health indices. Conversely, a significant improvement (p<0.001) was seen in all SF-36-questionnaire 8 scales, comparing preoperative T0 values with T1 and T2 values. Of the 68 patients, 53 (78%) no longer needed pads at the T2 follow-up, while 15 (22%) reported using 3-4 pads/day. A significant worsening of the sexual function (maintenance of erection) was observed in 51 (75%) patients, who had reported having normal sexual activity preoperatively (T0). On the other hand, 17 (25%) patients reported having an adequate erection to engage in sexual intercourse. CONCLUSIONS. Despite the differences observed in physical and mental health scores during the three periods evaluated (T0, T1 and T2), overall quality of life does not appear to have been greatly compromised by surgery. At T2 follow-up, in fact, all 68 patients reported to be satisfied with having undergone radical prostatectomy because of its benefits in terms of survival and its limited effects on their quality of life.

First-dose success with vardenafil in men with erectile dysfunction and associated comorbidities: RELY-I

First-dose success of phosphodiesterase type 5 (PDE5) inhibitors may be adversely affected in patients with comorbidities. This article reports first-dose success rates for vardenafil 10 mg in men with erectile dysfunction (ED) and associated comorbidities who participated in the challenge phase of the Reliability--Vardenafil for Erectile Dysfunction I study. This study involved an open-label, single-dose, 1-week challenge period where patients who achieved SEP-2 (penetration) success were randomised to vardenafil 10 mg or placebo for 12 weeks in a double-blind manner. The first-dose success rates for SEP-2 and SEP-3 (maintenance of erection to completion of intercourse) were stratified according to comorbidities. Safety was assessed using adverse events (AEs). Of 600 men who received a single 10 mg dose of vardenafil, 32% had hypertension, 16% had diabetes and 19% had dyslipidaemia. Vardenafil demonstrated overall effectiveness, including first-dose SEP-2 and SEP-3 success rates in patients with and without specific comorbidities. Initial overall success rates for SEP-2 and SEP-3 during the challenge phase were 87% and 74% respectively. First-dose SEP-2 and SEP-3 success rates were 84% and 66% in men with hypertension (n = 191); 84% and 72% in men with dyslipidaemia (n = 116); and 75% and 58% in men with diabetes (n = 95). Vardenafil was well tolerated and most AEs, including the most frequently reported flushing (3.5%), were mild to moderate in intensity. Vardenafil 10 mg is generally well tolerated and efficacious, providing first-dose success with a consistently high rate of reliability of penetration and maintenance of erection in men with ED and associated comorbidities.