Sexual Encounter Profile Diary Research Articles

The effect of combination treatment with low-intensity shockwave therapy and daily tadalafil on severe erectile dysfunction: a double-blind, randomized, sham-controlled clinical trial.

Patients with severe erectile dysfunction (ED) remain the most challenging group in terms of available noninvasive treatment modalities. The study sought to assess the role of combination therapy with low-intensity shockwave therapy (LiST) and daily tadalafil 5mg in a highly select group of patients with severe vasculogenic ED through a double-blind, randomized trial. Forty-eight sexually active men were randomly assigned to 12 sessions of LiST 3 times weekly and tadalafil 5mg once daily (n = 34) or sham therapy and tadalafil (n = 17) for 4 weeks. Patients were assessed at 1 and 3 months after completion of treatment. Improvement of erectile function was evaluated through the International Index of Erectile Function-Erectile Function domain (IIEF-EF) or 6-item IIEF and the Sexual Encounter Profile (SEP) diary. The primary outcome was the difference between the groups in the IIEF-EF at 3 months after completion of treatment. Secondary outcomes comprised (1) the difference between the groups in the IIEF-EF at 1 month after completion of treatment, (2) the difference between the groups in the "yes" responses to question 3 of the SEP diary at 1 and 3 months, and (3) the treatment-related adverse events. The number of patients attaining a minimal clinically important difference in the IIEF-EF (improvement of at least 7 points) was also assessed. After treatment, the absolute scores in the IIEF-EF were higher in patients receiving LiST and tadalafil vs sham therapy and tadalafil both at the 1-month (12.1 ± 2.4 vs 10.2 ± 1.7; P = .002) and at the 3-month (12.9 ± 2.1 vs 10.8 ± 1.8; P < .001) evaluation. Between the 2 groups, the proportion of "yes" responses to question 3 of the SEP diary was not statistically significant, whereas the number of patients attaining a minimal clinically important difference in the IIEF-EF was statistically significant only at the 3-month evaluation. No adverse events occurred. Application of LiST in patients with severe vasculogenic ED receiving daily dose tadalafil may further improve erectile function compared with tadalafil as a stand-alone treatment on the short term. Although we provided the first study in the field, severe vasculogenic ED was defined based on medical history and clinical examination and not based on penile ultrasound measures. The combination of 12 sessions LiST 3 times weekly and daily tadalafil for 4 weeks led to a 2-point difference in the IIEF-EF compared with sham therapy and daily tadalafil among patients with severe vasculogenic ED after 1 and 3 months from completion of treatment.

The impact of extracorporeal shock wave therapy for the treatment of young patients with vasculogenic mild erectile dysfunction: A prospective randomized single-blind, sham controlled study.

Low-intensity extracorporeal shock wave therapy (ESWT) for the treatment of vasculogenic erectile dysfunction (ED) has emerged as a promising method directly targeting the underlying pathophysiology of the disease. To compare outcomes in ED patients after ESWT and placebo treatment. Prospective randomized placebo-controlled single-blinded trial on 66 patients with mild ED. The study comprised a 4-week washout phase, a 4-week treatment phase, and a 48-week follow-up. Inclusion criteria included age between 18 and 75years and diagnosis of mild ED (IIEF-EF score=17-25) being made at least six months prior to study inclusion and being confirmed by Penile Doppler ultrasonography (US) at baseline examination. Efficacy endpoints were changes from baseline in patient-reported outcomes of erectile function (International Index of Erectile Function domain scores [IIEF-EF]), as well as erection hardness and duration (Sexual Encounter Profile diary [SEP] and Global Assessment Questions [GAQ]). Safety was assessed throughout the study. A total of 66 enrolled patients were allocated to ESWT (n=44) or placebo (n=22). Mean age of ESWT and placebo group was 42.32±9.88 and 39.86±11.64 (p=0.374), respectively. Mean baseline IIEF-EF scores of ESWT group and placebo were 20.32±2.32 and 19.68±1.55 respectively (p=0.34). At 3-months follow-up, mean IIEF-EF scores were significantly higher in ESWT patients than in placebo patients (23.10±2.82 vs. 20.95±2.19, p=0.003), and IIEF-EF scores of ESWT patients remained high during the 6months (22.67±3.35 vs. 19.82±1.56) follow-up. The percentage of patients reporting both successful penetration (SEP2) and intercourse (SEP3) in more than 50% of attempts was significantly higher in ESWT-treated patients than in placebo patients (p=0.001). A minimal clinically important difference between the IIEF=EF baseline and 3-months follow-up was found in 74% of ESWT and 36% of placebo. No serious adverse events were reported. ESWT significantly improved the erectile function of relatively young patients with vasculogenic mild ED when compared to placebo and the beneficial effect of this treatment up to 6months. These findings suggest that ESWT could be a useful treatment option in vasculogenic ED.

Efficacy and safety of phosphodieterase-5 inhibitors for treatment of erectile dysfunction secondary to spinal cord injury: a systemic review and meta-analysis.

Systemic reviewObjective:We carried out a systematic review and meta-analysis to assess the efficacy and safety of phosphodieterase-5 (PDE5) inhibitors on erectile dysfunction (ED) secondary to spinal cord injury (SCI). A literature review was performed to identify all published randomized, double-blind, placebo-controlled trials of PDE5 inhibitors for treatment of ED secondary to SCI. The search included the following database: MEDLINE, EMBASE and the Cochrane Library. The outcomes and complications analyzed involved the Global Efficacy Question (GEQ), sexual encounter profile diary question 2 and 3 (SEP2 and SEP3) and adverse events. All statistical analysis was performed using Stata 12.0 software (Stata Corp., College Station, TX, USA). Six publications were used in analysis, including six randomized controlled trials that compared PDE5 inhibitors with placebo. Compared with placebo, PDE5 inhibitors were associated with significant improvements in GEQ (OR 11.997, 95% CI 8.073-17.830, P<0.0001), SEP2 (RR 1.847, 95% CI 1.561-2.185, P<0.0001) and SEP3 (RR 2.738, 95% CI 2.084-3.598, P<0.0001). Despite significant greater incidences of some adverse events observed (headache: RR 3.717, 95% CI 2.309-5.982, P<0.0001; flushing: RR 9.281, 95% CI 2.858-30.147, P<0.0001; gastrointestinal discomfort: RR 9.064, 95% CI 2.116-38.827, P=0.003), most adverse events were mild to moderate and transient. This systematic review and meta-analysis indicate that PDE5 inhibitors are effective and well tolerated to treat ED secondary to SCI compared with placebo, as measured by response to GEQ, SEP2, SEP3 and incidence of adverse events. PDE5 inhibitors could be considered as the first choice in the treatment of ED patients with SCI.

Comparison of the efficacy and safety of once-daily dosing and on-demand use of udenafil for type 2 diabetic patients with erectile dysfunction.

We compared the efficacy and safety between once-daily dosing and on-demand use of udenafil for type 2 diabetic patients with erectile dysfunction (ED). A multi-center, randomized, open-label, parallel-group, 12-week study was conducted. 161 patients who improved with on-demand 200 mg of udenafil according to Sexual Encounter Profile (SEP) diary Question 2 and 3 (Q2 and Q3) were randomized into 200 mg on-demand (n = 80) or 50 mg once-daily (n = 81) dosing groups for 8 weeks. The dosing period was followed by a 4-week treatment-free period. The primary efficacy endpoint was the change of the International Index of Erectile Function (IIEF) erectile function domain (EFD) score. The secondary efficacy endpoints included changes to the SEP diary Q2, Q3, IIEF Q3, Q4, other domains of IIEF, Global Assessment Question, and shift to the normal rate (EFD ≥ 26). Vascular endothelial markers were also assessed. The IIEF-EFD score of both groups improved after 8 weeks of treatment (P < 0.0001). There was no statistically significant difference between two groups. Improvement was not maintained after the treatment-free follow-up period. Similar results were observed in the secondary efficacy endpoints. There was also no significant difference in vascular endothelial markers. Daily udenafil was well-tolerated, and there was no significant difference in the adverse drug reactions and adverse events between the two groups. Flushing and headache were the most frequent adverse events. Both regimens improved ED in diabetic patients and were well-tolerated. Further studies are needed to assess the effect of daily udenafil treatment in diabetic patients.

Phosphodiesterase-5 Inhibitors Could Be Efficacious in the Treatment of Erectile Dysfunction after Radiotherapy for Prostate Cancer: A Systematic Review and Meta-Analysis

Objective: This systematic review was performed to evaluate the efficacy and safety of phosphodiesterase-5 inhibitors (PDE5i) in the treatment of erectile dysfunction (ED) after radiotherapy for prostate cancer (PCa). Methods: A systematic search of PubMed, Embase and the Cochrane Library was performed to identify all randomized controlled trials (RCTs). All relevant studies on the outcomes and complications of PDE5i in the treatment of ED after radiotherapy for PCa were assessed. The outcomes and complications analyzed for this study included the International Index of Erectile Function (IIEF) questionnaire, Global Efficacy Questions (GEQs), Sexual Encounter Profile (SEP) diary and side effects. The Cochrane Collaboration Review Manager software (RevMan 5.1.4) was used for statistical analysis of the outcomes and complications. Results: A total of 4 RCTs were identified from the search strategy. Compared with placebo, the trials indicated that PDE5i significantly improved the IIEF scores, with the exception of two questions (questions 6 and 13), and statistically significantly more positive answers for the GEQs and SEP diary were acquired in intervention groups. Furthermore, almost all the side effects in both groups were mild or moderate, transient and well tolerated. Except for headache, flushing and dyspepsia, all other adverse events did not differ significantly between the two groups. Conclusions: The systematic review suggested significant advantages in the efficacy and safety of PDE5i in the treatment of ED after radiotherapy for PCa. PDE5i should be considered as the first choice for the treatment of PCa patients with ED after radiotherapy.

Sildenafil citrate for erectile dysfunction in patients with multiple sclerosis

Erectile dysfunction (ED) is a common sexual disease in male patients with multiple sclerosis (MS). Sildenafil citrate is considered as an effective drug in the treatment of male ED in the general population, but it has not been systematically reviewed in patients with MS. To assess the efficacy and safety of sildenafil citrate for ED in patients with MS. We searched the Cochrane (November 2011), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 4 of 4, 2011), MEDLINE (PubMed) (January 1966 to November 2011), EMBASE (January 1974 to November 2011) and the China Biological Medicine Database (CBM) (1979 to November 2011). We searched trials registers and conference proceedings and contacted pharmaceutical company and authors of included studies for additional data. There were no language restrictions. Randomised controlled trials comparing sildenafil citrate with placebo or no treatment for ED in patients with MS. Two review authors independently selected articles for inclusion, extracted data and assessed trial quality. Disagreements were resolved by discussion between review authors. Authors of included studies were contacted for additional information. Results were presented as relative risks (RR) or mean differences (MD) with 95% confidence intervals (CI). Two randomised controlled trials involving a total of 420 patients were identified. Both trials investigated the short-term efficacy and safety of sildenafil citrate for ED in patients with MS. Patients taking sildenafil citrate were more likely to improve their ability to achieve and maintain an erection measured by International Index of Erectile Function and achieve vaginal penetration ( (RR 1.28, 95%CI 0.92 to 1.78) and complete intercourse measured by Sexual Encounter Profile diary (RR RR 1.38, 95%CI 1.00 to 1.90). and receive A global well respond measured by Global Assessment Question (RR 2.72, 95%CI 1.40 to 5.28) was reported. One trial showed sildenafil citrate is effective in quality of life improvement, while the other trial did not find any significant difference between both groups. Both included trials were judged as high risk of attrition bias. Adverse events were also reported: the most common were headache, flushing, rhinitis, visual disturbances and dyspepsia. Two patients suffered serious adverse events: one with coronary artery disease requiring triple bypass surgery and one with a cerebrovascular accident. There is limited evidence to support sildenafil citrate as an effective treatment for ED in patients with MS. Future well designed randomised, double blinded, placebo-controlled trials with long-term duration are needed.

Efficacy and safety of avanafil for treating erectile dysfunction: results of a multicentre, randomized, double‐blind, placebo‐controlled trial

Study Type--Therapy (RCT) Level of Evidence 1b. What's known on the subject? and What does the study add? Avanafil is a potent selective phosphodiesterase type 5 (PDE5) inhibitor newly developed for treating erectile dysfunction (ED). Preclinical and clinical phase I studies showed that avanafil had enhanced selectivity, faster onset of action and a favourable side-effect profile relative to currently available PDE5 inhibitors. As the result of phase III clinical trial for the efficacy and safety of avanafil treatment (100 and 200 mg), taken as needed over a period of 12 weeks, in Korean patients with ED, avanafil is an effective and well-tolerated therapy for ED of broad-spectrum aetiology and severity. • To evaluate the efficacy and safety of avanafil, a new potent selective phosphodiesterase type 5 (PDE5) inhibitor, in patients with erectile dysfunction (ED). • The present study was a multicentre, randomized, double-blind, placebo-controlled, fix-dosed phase three clinical trial involving 200 patients with ED. • The subjects were treated with placebo or avanafil (100 or 200 mg) for 12 weeks and were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ). • The primary outcome variable was the change from baseline for IIEF erectile function domain (EFD) score. • The secondary outcome variables were SEP Q2 and Q3, the shift to normal rate (EFD ≥ 26), and response to the GAQ. • Compared with placebo, patients who took 100 or 200 mg of avanafil had significantly improved IIEF-EFD score. • There were similar results when comparing Q2 and Q3 in the SEP diary and the GAQ. • Flushing was the most common treatment-related adverse event. • Most adverse events were transient and mild or moderate in severity. • Avanafil is an effective and well-tolerated therapy for ED of broad-spectrum aetiology and severity.

Efficacy and Safety of Vardenafil for the Treatment of Erectile Dysfunction in Men with Metabolic Syndrome: Results of a Randomized, Placebo‐Controlled Trial

The prevalence of erectile dysfunction (ED) is increased in men with metabolic syndrome compared with the general population. The aim of this study was to evaluate the efficacy and safety of vardenafil vs. placebo in men who had ED and metabolic syndrome. This was a 12-week, double-blind, randomized, multicenter, parallel-group, placebo-controlled prospective study in men with ED and metabolic syndrome (assessed by the International Diabetes Federation criteria). Vardenafil was administered at a starting dose of 10 mg, which could be titrated to 5 mg or 20 mg after 4 weeks, depending on efficacy and tolerability. Primary efficacy measures were the erectile function domain of the International Index of Erectile Function (IIEF-EF) and Sexual Encounter Profile (SEP) diary questions 2/3. Secondary efficacy measures included SEP1, a diary question assessing ejaculation, the percentage of men achieving "return-to-normal" erectile function, and the percentage of men who titrated to a different dose. Adverse events (AEs) were recorded throughout the study. The intent-to-treat population included 145 men (vardenafil, N = 75; placebo, N = 70). Baseline least squares IIEF-EF domain scores were low (vardenafil: 12.0; placebo: 12.7), indicative of moderate-to-severe ED. Vardenafil was statistically significantly superior to placebo for all primary efficacy measures (P < 0.0001) and showed nominally statistically significant superiority compared with placebo for SEP1/ejaculation success rates (P = 0.0003 and P < 0.0001, respectively) and the percentage of subjects reporting "return-to-normal" erectile function (P = 0.0004). Treatment-emergent AEs were mild-to-moderate in severity and consistent with the known AE profile of phosphodiesterase type 5 inhibitors. This is the first study to assess the efficacy and safety of vardenafil, taken alone, for ED therapy in a population of men who all had metabolic syndrome. Although baseline erectile function in these patients was low, vardenafil treatment was associated with significant improvements in erectile function and rates of successful intercourse, and was well tolerated.

A Therapeutic Confirmatory Study to Assess the Safety and Efficacy of Zydena® (Udenafil) for the Treatment of Erectile Dysfunction in Male Patients with Diabetes Mellitus

Patients with diabetes mellitus (DM) are reported to experience more severe erectile dysfunction (ED) symptoms and respond less to ED treatments compared with patients with ED of other etiologies. This study was undertaken to evaluate the safety and efficacy of udenafil for the treatment of ED in a larger number of patients with DM. A placebo-controlled, randomized, double-blind, double-dummy, parallel-group design multicenter study, fixed-dose trial was conducted. The trial involved seven study sites in Korea, with 174 ED patients with DM. The subjects, treated with placebo, 100 mg, or 200 mg of udenafil for 12 weeks, were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Question (GAQ) during the study period. The primary efficacy parameter was the change in the erectile function domain (EFD) score of IIEF from baseline. Secondary parameters were IIEF questions 3 (Q3) and Q4, SEP Q2 and Q3, rate of achieving normal erectile function (EFD ≥ 26), and the response to GAQ. Compared with the placebo, patients receiving both doses of udenafil showed statistically significant improvements in the IIEF-EFD score, respectively. However, statistically significant difference was not observed between the udenafil 100 mg and the udenafil 200 mg groups. Similar results were observed in the comparison of Q3 and Q4 of IIEF, SEP diary, and GAQ. The percentages of subjects experiencing at least one adverse event related to the study drugs were 3.6%, 15.8%, and 22.4% for the placebo, udenafil 100 mg, and udenafil 200 mg groups, respectively. However, these events were all mild in severity. Major adverse events were flushing, headache, nausea, and conjunctival hyperemia. Udenafil was significantly effective for the treatment of ED, demonstrating statistically significant improvement in erectile function in patients with DM. The incidence of adverse events was relatively low and well tolerated in patients with DM.

Efficacy and Safety of Once-Daily Dosing of Udenafil in the Treatment of Erectile Dysfunction: Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

BackgroundA once-daily dosing regimen with a phosphodiesterase type 5 inhibitor is needed for the treatment of erectile dysfunction (ED), in part because of the behavioral complexities associated with sexual intimacy. Many patients prefer spontaneous rather than scheduled sexual activities or they anticipate frequent sexual encounters. The pharmacokinetic profiles of udenafil with a time of maximal concentration of 1.0–1.5h and a terminal half-life of 11–13h make udenafil a good candidate for once-daily dosing. ObjectiveTo evaluate the efficacy and safety of once-daily dosing of udenafil in the treatment of ED. Design, setting, and participantsThis multicenter randomized double-blind, placebo-controlled, fix-dosed clinical trial involved 237 patients with ED. The subjects, who were treated with placebo or udenafil (25mg, 50mg, or 75mg) once daily for 12 wk, were asked to complete the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and the Global Assessment Questionnaire (GAQ) during the study. MeasurementsThe primary outcome parameter was the change from baseline for the IIEF erectile function domain (EFD) score. The secondary outcome parameters were SEP questions 2 and 3, the shift to normal rate (EFD ≥26), and the response to the GAQ. Results and limitationsCompared with placebo, patients who took 50mg or 75mg of udenafil had a significantly improved IIEF-EFD score. Similar results were observed in comparing questions 2 and 3 in the SEP diary and the GAQ. Flushing was the most common treatment-related adverse event, which was transient and mild to moderate in severity. ConclusionsUdenafil significantly improved erectile function among ED patients when administered in doses of 50mg or 75mg once daily for 12 wk. Daily administration of udenafil (50mg) may be another treatment option for ED.

Efficacy and Tolerability of Tadalafil for Treatment of Erectile Dysfunction in Men Taking Serotonin Reuptake Inhibitors

To evaluate the efficacy and safety of tadalafil in men with treatment-emergent sexual dysfunction due to serotonin reuptake inhibitors. The present prospective, double-blind, 12-week study, randomized in a 1:1 ratio to tadalafil 20 mg or placebo taken on demand, included 50 men. The efficacy measures were the changes in total and domain scores of the International Index of Erectile Function questionnaire, Sexual Encounter Profile diary questions 2-6, and the Global Assessment questions (GAQs) 1 and 2. The safety analyses included the evaluation of adverse events, vital signs, serum chemistry results, and electrocardiography findings. For the patients who took tadalafil 20 mg, the net median score change from baseline to the endpoint compared with placebo was 26 for the 15-item International Index of Erectile Function; 10, 4, 4, 3, and 3 for the erectile function, intercourse satisfaction, overall satisfaction, orgasmic function, and sexual desire domains; and 3 and 5 points for "yes" responses to the Sexual Encounter Profile 2 and Sexual Encounter Profile 3 questions, respectively. All comparisons between tadalafil and placebo were significant (P < .001). At the endpoint, 92% of the tadalafil group responded affirmatively to both GAQs 1 and 2 compared with 8% of the placebo group (P < .001, for each). In the safety measures, no clinically significant changes attributable to tadalafil use were found. Tadalafil 20-mg treatment significantly improved sexual function in patients who were taking serotonin reuptake inhibitors for depression, with mild to moderate, well-tolerable adverse events.

Onset of Efficacy of Tadalafil Once Daily in Men With Erectile Dysfunction: A Randomized, Double-Blind, Placebo Controlled Trial

We evaluated the efficacy onset and safety of tadalafil 2.5 and 5 mg once daily for 14 days compared with placebo in men with erectile dysfunction. In this randomized, double-blind, placebo controlled, parallel group study we randomized 372 men after a 4-week run-in period to receive placebo, or tadalafil 2.5 or 5 mg once daily for 14 days, followed by a 14-day open label extension period of tadalafil 5 mg once daily. Primary analysis focused on the cumulative percent of men with a successful intercourse attempt during the first 4 days of treatment. On secondary analysis we evaluated the percent of successful attempts during the study. The Sexual Encounter Profile diary question 3 was used to assess efficacy. Safety was assessed by monitoring adverse events and vital signs. Significantly more men in the tadalafil 5 mg group achieved successful intercourse, as indicated by a yes response to diary question 3, than those on placebo by day 2 (48.6% vs 36.6%, p < 0.025). The tadalafil 2.5 mg group did not separate from the placebo group on primary analysis. Secondary analysis showed that men on tadalafil 2.5 mg achieved a significantly higher percent of successful intercourse attempts than those on placebo by day 3 (35.5% vs 27.2%, p < 0.025). All groups further improved during the open label extension period. Tadalafil was well tolerated. This prospective trial shows the onset of efficacy of tadalafil 2.5 and 5 mg once daily within a few days of initiating therapy.

Safety and efficacy of sildenafil citrate in the treatment of Parkinson-emergent erectile dysfunction: a double-blind, placebo-controlled, randomized study

Parkinson's disease (PD) is one of the most commonly occurring neurodegenerative disorders, with lifetime incidence between 1 and 2% among people older than 65 years. ED is one of the more disabling and poorly addressed aspects of PD. The purpose of this study was to assess the efficacy and safety of sildenafil citrate in Parkinson-emergent ED. Sexual function of participants was assessed using responses to the 15-question International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) diary questions 2 and 3, Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire and a Global Efficacy Question 'Has the treatment you have been taking over the study period improved your erections?' This randomized, double-blind, placebo-controlled study, comprised a screening period of at least 1 month, a placebo-lead in period of 1 week and treatment period. Two hundred thirty-six patients entered the trial. These patients had mild-to-moderate PD (stages I-III Hoehn-Yahr) and were experiencing Parkinson-emergent neurogenic ED. They were randomized to receive 100 mg sildenafil on demand 1 h before sexual activity (group 1, n=118), or similar regimen of placebo (group 2, n=118). Patients were instructed to use at least 24 doses/attempts at home. At the end of the trial, differences between sildenafil and placebo groups were significant for the IIEF erectile function (EF) score (22.6 ± 4.6 vs 14.8 ± 4.2, P=0.01), for percent Global Efficacy Question 'Yes' responses (68.1 ± 4.6 vs 12.2 ± 3.2, P=0.001), for SEP2 'Yes' responses (68.1 ± 4.2 vs 32.5 ± 2.2, P=0.003), for SEP3 'Yes' responses (75.9 ± 5.4 vs 33.5 ± 4.4, P=0.004) and for mean EDITS score (69.8 ± 4.2 vs 13.0 ± 2.7, P=0.004). A normal EF domain score (>or=26) at end point was achieved by 56.9 and 8.7% of the patients in the sildenafil and placebo groups, respectively (P=0.001). Sildenafil can be considered as an effective treatment in patients with Parkinson-emergent ED.

A Comparison of Outcomes for Interfascial and Intrafascial Nerve-sparing Radical Prostatectomy

To compare the outcome of intrafascial nerve-sparing endoscopic extraperitoneal radical prostatectomy (nsEERPE) with interfascial (standard) nsEERPE. Four-hundred patients underwent nsEERPE; 200 patients underwent bilateral intrafascial nsEERPE (group A) and 200 bilateral standard nsEERPE (group B). Tumor stages of T1 and T2a, prostate-specific antigen level <10 ng/mL, maximal Gleason score 3+4 (not 4+3) and preoperative potency were considered as candidates for nsEERPE. Patients were randomized to the aforementioned groups. Perioperative data, and functional and oncological outcome were reviewed. Patients not requiring any pads or requiring 1 pad for safety were defined as continent. Patients responding positively to sexual encounter profile diary question numbers 2, 3, and 5 were considered as potent. Perioperative data were similar between groups. At 3 months, 74% of group A and and 63% of group B were continent. At 6 months, the respective figures were 87.9% and 76.2%, respectively (A, B). At 12 months, 93.2% of group A and 90.7% of group B were continent. Potency rates of group A were 93.5% (<55 years), 83.3% (55-65 years), and 60% (>65 years) at 12 months. The respective figures for Group B were 77.1%, 50%, and 40%. Positive surgical margins were detected in 9% and 9.5% of groups A and B, respectively. Intrafascial nsEERPE provides significantly better potency in patients <55 years of age at 12 months and in patients 55-65 years of age at 6 and 12 months, with probably limited effect on the oncological outcome. Significantly improved continence was observed at 3 and 6 months in favor of intrafascial nsEEPRE.

An open label, randomized, fixed-dose, crossover study comparing efficacy and safety of sildenafil citrate and saffron (Crocus sativus Linn.) for treating erectile dysfunction in men naïve to treatment

Saffron (Crocus sativus Linn.) have been perceived by the public as a strong aphrodisiac herbal product. However, studies addressing the potential beneficial effects of saffron on erectile function (EF) in men with ED are lacking. Our aim was to evaluate the efficacy and safety of saffron administration on EF in men with ED. After a 4-week baseline assessment, 346 men with ED (mean age 46.6+/-8.4 years) were randomized to receive on-demand sildenafil for 12 weeks followed by 30 mg saffron twice daily for another 12 weeks or vice versa, separated by a 2-week washout period. To determine the type of ED, penile color duplex Doppler ultrasonography before and after intracavernosal injection with 20 microg prostaglandin E(1), pudendal nerve conduction tests and impaired sensory-evoked potential studies were performed. Subjects were assessed with an International Index of Erectile Function (IIEF) questionnaire, Sexual Encounter Profile (SEP) diary questions, patient and partner versions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire and the Global Efficacy Question (GEQ) 'Has the medication you have been taking improved your erections?' No significant improvements were observed with regard to the IIEF sexual function domains, SEP questions and EDITS scores with saffron administration. The mean changes from baseline values in IIEF-EF domain were +87.6% and +9.8% in sildenafil and placebo groups, respectively (P=0.08). We did not observe any improvement in 15 individual IIEF questions in patients while taking saffron. Treatment satisfaction as assessed by partner versions of EDITS was found to be very low in saffron patients (72.4 vs 25.4, P=0.001). Mean per patient 'yes' responses to GEQ was 91.2 and 4.2% for sildenafil and saffron, respectively (P=0.0001). These findings do not support a beneficial effect of saffron administration in men with ED.

Impact of Tadalafil Once Daily in Men With Erectile Dysfunction—Including a Report of the Partners' Evaluation

To evaluate the effect of tadalafil 5 mg taken once daily on efficacy (erection achievement and penetration) and overall sexual satisfaction in men with erectile dysfunction (ED) and their female partners. This retrospective analysis included data pooled from 2 multicenter, randomized, double-blind, placebo-controlled trials that included 505 couples (tadalafil, n=373; placebo, n=132) in which the men received tadalafil 5 mg once daily or placebo for 12 weeks. Individual Sexual Encounter Profile (SEP) diaries were completed independently by the male subject and his female partner after each sexual intercourse attempt. The mean per-subject/per-partner percentage of "yes" responses to SEP diary questions were assessed, as was agreement between subjects' and partners' responses. Subjects and partners in the tadalafil-treated group reported significantly greater improvements in the man's ability to achieve some erection, vaginal penetration, and overall sexual satisfaction compared with the placebo-treated group (P<.001). For all intercourse attempts, the mean per-couple percentage of agreement for those in the tadalafil and placebo groups, respectively, was high for erection achievement (99.0% and 96.6%), vaginal penetration (98.6% and 97.4%), and overall satisfaction (84.3% and 82.8%). Tadalafil 5 mg taken once daily as treatment for ED improved overall satisfaction for men and their female partners. This analysis demonstrates the high concordance among couples in their responses to the man's treatment for ED.

ORIGINAL RESEARCH—ED PHARMACOTHERAPY: The Efficacy and Safety of Udenafil [Zydena] for the Treatment of Erectile Dysfunction in Hypertensive Men Taking Concomitant Antihypertensive Agents

Erectile dysfunction (ED) and hypertension are frequent comorbid conditions. The vasodilating properties of type 5 phosphodiesterase inhibitor (PDE5I) are the major concerns for the treatment of ED patients on antihypertensive medications. To evaluate the efficacy and safety of Udenafil [Zydena] (Dong-A, Seoul, Korea), a newly developed PDE5I, for the treatment of ED patients on antihypertensive medication. It was a multicentered, randomized, double-blind, placebo-controlled, fix-dosed clinical trial among 165 ED patients receiving antihypertensive medications. The subjects treated with placebo, 100 mg or 200 mg of Udenafil for 12 weeks were asked to complete the Sexual Encounter Profile (SEP) diary, the International Index of Erectile Function (IIEF), and the Global Assessment Question (GAQ) during the study period. Primary parameter: the change from baseline for IIEF erectile function domain (EFD) score; Secondary parameters: the IIEF Question 3 and 4, SEP Question 2 and 3, the rate of achieving normal erectile function (EFD > or = 26) and the response to GAQ. Compared to placebo, patients receiving both doses of Udenafil showed significantly improved the IIEF-EFD score. The least squares means for the change from baseline in IIEF-EFD scores were 8.4 and 9.8 for 100 mg and 200 mg Udenafil groups, respectively; those values were significantly higher than that of placebo (2.4, P < 0.0001). Similar results were observed in the comparison of Q3 and Q4 of IIEF, SEP diary and GAQ. Headache and flushing were the most common treatment-emergent adverse events, which were transient and mild-to-moderate in nature. No parameters of efficacy and safety were affected among the subsets stratified according to either the number of antihypertensive medication received or the previous experience of PDE5Is treatment. Udenafil significantly improved erectile function among ED patients with hypertensive symptom treated with concomitant antihypertensive medication. The treatment did not increase the frequency or severity of adverse events.

Safety and efficacy of sildenafil citrate in treating erectile dysfunction in patients with combat‐related post‐traumatic stress disorder: a double‐blind, randomized and placebo‐controlled study

To evaluate the safety and efficacy of sildenafil citrate for treating erectile dysfunction (ED) in patients with combat-related post-traumatic stress disorder (PTSD). In all, 266 combat-exposed war veterans with ED (aged 37-59 years) were recruited. They met the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for PTSD according to the Structured Clinical Interview for Patients, Investigator Version. The patients were also evaluated with the Clinician-Administered PTSD Scale, both to establish the diagnosis of PTSD and to measure symptom severity. Only patients with psychogenic ED were included in the study. Patients with comorbid conditions (diabetes mellitus, hypercholesterolaemia, hypertension, Peyronie's disease) and smokers of more than five cigarettes daily were excluded. The patients were randomly divided into a group of 133 who received 100 mg of on-demand sildenafil 0.75-2 h before sexual stimulation, and 133 who received placebo. Patients were asked to use > or =16 doses or attempts at home. The efficacy of the treatments was assessed every four attempts during treatment, and at the end of the study, using responses to the 15-question International Index of Erectile Function (IIEF), Sexual Encounter Profile diary questions 2 and 3, Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire, patients' event logs of sexual activity, and a Global Assessment Question about erections. Sildenafil did not produce significantly and substantially greater improvement than placebo in each of the primary and secondary outcome measures (P = 0.08). A normal EF domain score (> or =26) at endpoint was reported by 13 (9.8%), and 11 (8.3%) of patients on the sildenafil and placebo regimens, respectively (P = 0.09). Patients treated with sildenafil had no statistically significantly greater improvement in the five sexual function domains of the IIEF questionnaire than those treated with placebo (P = 0.08). The incidences of treatment-emergent adverse events were significantly greater in the sildenafil arm than in the placebo group (P = 0.01). Sildenafil is no better than placebo in treating PTSD-emergent ED. Further randomized clinical trials are warranted in combat veterans and other populations with PTSD to better elucidate the role of phosphodiesterase type 5 inhibitors in treating PTSD-emergent ED.

Daily patterns of sexual intercourse attempts by men with erectile dysfunction treated with tadalafil: influence of age and marital status

This retrospective analysis examined the daily/weekly patterns of sexual activity, by age and marital status, of men with erectile dysfunction (ED) participating in a 12-week, multicenter, open-label study of tadalafil (20 mg) as needed. The timing of intercourse attempts post dose and satisfaction were assessed using the Sexual Encounter Profile diary. Patients' behaviors regarding sexual self-confidence, spontaneity and time concerns were assessed with the Psychological and Interpersonal Relationship Scale. Overall, the timing of sexual intercourse attempts varied among patients, regardless of age or marital status; at least 46% of intercourse attempts occurred within the 4-36-h post-dose time interval. Across age groups and marital status, men treated with tadalafil reported greater satisfaction compared with baseline; they also reported fewer time concerns, improved self-confidence and improved spontaneity. Information regarding sexual behavioral patterns of men with ED is important to consider when discussing patient expectations.

Efficacy and safety of tadalafil taken as needed for the treatment of erectile dysfunction in Asian men: results of an integrated analysis

We evaluated the efficacy and safety of as-needed tadalafil in a diverse clinical population (with varying patient demographics, disease severity, and comorbid medical conditions) of Asian men with erectile dysfunction (ED). An integrated analysis of five double-blind, placebo-controlled trials (N = 1 046) was performed. Patients were randomly assigned to receive 10 mg tadalafil (N = 185), 20 mg tadalafil (N = 510), or placebo (N = 351). Efficacy assessments included the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) diary and Global Assessment Question (GAQ). Patients receiving 10 mg or 20 mg tadalafil showed significant improvement from baseline-to-end point on the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) domain score in all clinical sub-populations analyzed, compared with patients receiving placebo (P < 0.001). The 10-mg and 20-mg tadalafil groups showed a mean success rate of 64.1% and 70.5% for sexual intercourse attempts (SEP3, successful intercourse), respectively, compared with 33.4% in the placebo group (P < 0.001), and 85.5% and 85.4% reported improved erections at end point GAQ, respectively, versus 43.5% in the placebo group (P < 0.001). Tadalafil was well tolerated across all groups studied. Headache and back pain were the most frequently reported adverse events. Overall, tadalafil was effective and well tolerated across a diverse clinical spectrum of Asian men with ED.