Sexual Encounter Profile Questions Research Articles

(125) Efficacy of Hilti Gold vs. Epimedyumlu Macun in Duration of Erection and Its Correlation with Partners ´Sexual Quality of Life

Abstract Introduction In healthy men, the average duration of sexual intercourse ranges from nine to ten minutes. However, duration of erection has been shown to be shorter in men with Erectile Dysfunction (ED) and even shorter for men with ED plus associated underlying conditions. Furthermore, duration of Penis erection is most important for sexual couple. Objective The aim of this study was to assess two herbal supplements: HILTI gold (Hg) vs Epimedyumlu Macun (EM) efficacy in terms of duration of erection and (i) Its correlation with other efficacy end points and male and female sexual quality of life (QoL) and (ii) Its impact on intercourse duration. Methods A double-blind, controlled trial randomized men (18–65 years of age) with ED for more than six months, to receive fixed-dose either Hg, 1 capsule or EM, 1 tea spoon (60 minutes prior intercourse) for 12 weeks in 52 patients with ED, after four-week without medication. Primary efficacy end points were stopwatch-assessed duration of erection (min) at any attempt and when leading to successful intercourse, and the erectile function domain of the International Index of Erectile Function (EF-IIEF) score was assessed at week 12/ last observation carried forward (LOCF). Secondary end points were Sexual Encounter Profile question three (SEP3) response rate and male sexual QoL. End points in participating women were stopwatch-assessed duration of intercourse and sexual QoL. Results 52 men included. 42% had moderate ED. 58% had severe ED at baseline. At week 12 / LOCF, patients taking Hg had longer duration of erections vs EM group (least square mean ± standard error 10.3±0.8 minutes vs. 7.7±0.7 minutes, and 10.3±0.8 vs. 7.8 ±1.0 minutes, respectively), and significant increases in EF-IIEF scores, the SEP3 response, and all sexual QoL items. An increased duration of intercourse was also observed. Female sexual QoL improved significantly. Both duration end points strongly correlated with EF-IIEF scores, and the three end points correlated well with SEP3 response. Correlation was good with sexual QoL scores in men and women and with duration of intercourse, with difference between groups only for duration end points. Safety was better in Hg than in EM group. Conclusions The results indicate that duration of erection represents a novel efficacy measures for evaluating those herbal supplements (HS), and could be used as a predictor or efficacy measure of sexual performance in couples affected by ED. With regard to the method of measuring duration, stopwatch method was shown to be reliable and capable of complementing traditional self-assessment efficacy methods for evaluating the efficacy of HS. Hg is the best to significantly improve: Duration of erection in men with ED and Sexual QoL, in both members of a couple affected by ED than EM Absolutely, Hg and EM: Increase duration of erection; Improve sexual pleasure. And, thereby improving the sexual QoL of the COUPLE. And, most important is that sexual couples don’t risk to be unfaithfulness. Disclosure No.

(231) Low-Intensity Extracorporeal Shockwave Therapy Twice Per Week for Six Weeks May Result in Transient Subjective Improvements in Erectile Function

Abstract Introduction Low-intensity extracorporeal shockwave therapy (LiESWT) has been reported to result in subjective improvements in erectile function, but the ideal patient population and treatment protocol have not yet been established. Objective We aimed to assess improvements in International Index of Erectile Function – Erectile Function domain (IIEF-EF) scores following treatment with LiESWT of 1500 shocks of 0.2mJ/mm2 per treatment, twice a week for six weeks. We hypothesized that LiESWT results in subjective improvements of erectile function. Methods Patients were prospectively enrolled in a clinical trial examining changes in erectile function following LiESWT. The study was powered to detect a change in IIEF-EF scores of 5 points. Patients received 12 bi-weekly LiESWT treatments of 0.2mJ/mm2 at 5Hz, 1500 shocks delivered per treatment using the Storz Duolith T-Top Ultra shockwave device. Patients completed IIEF-EF, Sexual Encounter Profile (SEP) questions two and three, Global Assessment Questions (GAQ), and Erection Hardness Score (EHS) questionnaires prior to initiation of treatments and following completion of treatments at 1-2 weeks, 4-6 weeks, 3 months and 6 months post-treatment. Changes in questionnaire responses were compared to baseline responses. Data were analyzed using single variant one-tailed T-tests and one-tailed Fisher’s exact test. Values are reported as means ± standard error. Results Twenty-five patients completed all five study visits. Mean pre-treatment IIEF-EF score was 14.24 ± 1.21. Mean IIEF-EF scores increased to 15.80 ± 1.46 1-2 weeks following treatment (Study Time #2), 16.12 ± 1.46 4-6 weeks following treatment (Study Time #3), 18.12 ± 1.57 3 months following treatment (Study Time #4), and 16.36 ± 1.86 6 months following treatment (Study Time #5), though results only reached significance at Study Time #4 (p=0.016) and results were not sustained. Changes in IIEF-EF scores following treatment were evaluated by baseline ED severity (normal IIEF-EF 26-30, N=1; mild IIEF-EF 22-25, N=2; mild-moderate IIEF-EF 17-21, N=7; moderate IIEF-EF 11-16, N=10; severe IIEF-EF 6-10, N=5. Patients with IIEF-EF scores 11-21 reported significant improvements in IIEF-EF scores at all time points (Figure 1). Mean pre-treatment EHS score was 2.1±0.14. There was no significant improvement in EHS score following treatment at any time point, and no differences when analyzed based on pre-treatment ED severity. Similarly, no changes in SEP or GAQ positive response rates were noted following treatment. Conclusions Our results suggest that LiESWT using 1500 shocks per treatment with energy of 0.2mJ/mm2 twice per week for 6 weeks may transiently improve subjective erectile function as measured using IIEF-EF questionnaires, particularly for patients with mild-moderate to moderately severe ED, consistent with other studies. However, improvements may not be sustained 6 months following treatment. Disclosure No.

Covid 19 induced sildenafil lack efficacy is optimally improved by intra-urethral alprostadil

<h3>Objectives</h3> To find pharmacological options in post-COVID 19 Sildenafil therapy failure in men with before-COVID 19 onset and treated ED, starting from the fact that published studies proves COVID 19 as a risk factor for ED, as well as for Sildenafil loss efficacy in before COVID 19 started ED treatment. <h3>Methods</h3> From prior to 2020 Sildenafil treated ED's we selected 78 ED cases, recently claiming Sildenafil lack efficacy after a COVID 19 episode. According to optional recommendations, 42 cases (gr. A) have chose Avanafil instead to continue the ED therapy, whereas 36 cases (gr. B) preferred intra-urethral Alprostadil. The ED domain of International Index of Erectile Function (ED-IIEF), the erectile hardness score (EHS) and the Sexual Encounter Profile questions 2 (SEP2) and 3 (SEP3) were applied in 4 steps: V1=gr.A1/gr.B1 (first visit, presentation before COVID 19); V2=gr.A2/gr.B2 (second visit, before COVID 19 for Sildenafil benefit assessment); V3 gr.A3/grB3 (third visit, post-COVID 19, medical request for Sildenafil failure); V4=gr.A4/gr.B4 (forth visit, the assessment of the replacing Sildenafil new therapy). <h3>Results</h3> <i>ED-IIEF</i><b>:</b> gr.A1/gr.B1 = 17.32/18.07 (<i>P</i> = 0.22); gr.A2/gr.B2 = 25.33/24.54 (<i>P</i> = 0.15); gr.A3/grB3 = 14.67/14.22 (<i>P</i> = 0.1); gr.A4/gr.B4 = 20.78/26.33 (<i>P</i> = 0.065). <i>EHS:</i> gr.A1/gr.B1 = 1.12/1.7 (<i>P</i> = 0.35); gr.A2/gr.B2 = 3.33/3.54 (<i>P</i> = 0.15); gr.A3/grB3 = 1.67/1.22 (<i>P</i> = 0.5); gr.A4/gr.B4 = 2.4/3.67 (<i>P</i> < 0.05). <i>SEP 2:</i> gr.A1/gr.B1 = 2.2/1.7 (<i>P</i> = 0.3); gr.A2/gr.B2 = 4.53/4.54 (<i>P</i> = 0.9); gr.A3/grB3 = 1.67/1.33 (<i>P</i> = 0.2); gr.A4/gr.B4 = 3.12/4.33 (<i>P</i> < 0.05). <i>SEP 3:</i> gr.A1/gr.B1 = 1.8/2.3 (<i>P</i> = 0.35); gr.A2/gr.B2 = 4.33/4.87 (<i>P</i> = 0.75); gr.A3/grB3 = 1.45/1.54 (<i>P</i> = 0.15); gr.A4/gr.B4 = 3.22/4.66 (<i>P</i> < 0.001). <h3>Conclusions</h3> Sildenafil, as well as other PDE5I's, were already confirmed, as proper for treating ED. However, to correct COVID 19 induced Sildenafil failure, even Avanafil could represent another PDE5I option, the intra-urethral Alprostadil turned out to be a significantly better opportunity. <h3>Conflicts of Interest</h3> none

Covid 19 induced sildenafil lack efficacy is optimally improved by intra-urethral alprostadil

To find pharmacological options in post-COVID 19 Sildenafil therapy failure in men with before-COVID 19 onset and treated ED, starting from the fact that published studies proves COVID 19 as a risk factor for ED, as well as for Sildenafil loss efficacy in before COVID 19 started ED treatment. From prior to 2020 Sildenafil treated ED's we selected 78 ED cases, recently claiming Sildenafil lack efficacy after a COVID 19 episode. According to optional recommendations, 42 cases (gr. A) have chose Avanafil instead to continue the ED therapy, whereas 36 cases (gr. B) preferred intra-urethral Alprostadil. The ED domain of International Index of Erectile Function (ED-IIEF), the erectile hardness score (EHS) and the Sexual Encounter Profile questions 2 (SEP2) and 3 (SEP3) were applied in 4 steps: V1=gr.A1/gr.B1 (first visit, presentation before COVID 19); V2=gr.A2/gr.B2 (second visit, before COVID 19 for Sildenafil benefit assessment); V3 gr.A3/grB3 (third visit, post-COVID 19, medical request for Sildenafil failure); V4=gr.A4/gr.B4 (forth visit, the assessment of the replacing Sildenafil new therapy). ED-IIEF: gr.A1/gr.B1 = 17.32/18.07 (P = 0.22); gr.A2/gr.B2 = 25.33/24.54 (P = 0.15); gr.A3/grB3 = 14.67/14.22 (P = 0.1); gr.A4/gr.B4 = 20.78/26.33 (P = 0.065). EHS: gr.A1/gr.B1 = 1.12/1.7 (P = 0.35); gr.A2/gr.B2 = 3.33/3.54 (P = 0.15); gr.A3/grB3 = 1.67/1.22 (P = 0.5); gr.A4/gr.B4 = 2.4/3.67 (P < 0.05). SEP 2: gr.A1/gr.B1 = 2.2/1.7 (P = 0.3); gr.A2/gr.B2 = 4.53/4.54 (P = 0.9); gr.A3/grB3 = 1.67/1.33 (P = 0.2); gr.A4/gr.B4 = 3.12/4.33 (P < 0.05). SEP 3: gr.A1/gr.B1 = 1.8/2.3 (P = 0.35); gr.A2/gr.B2 = 4.33/4.87 (P = 0.75); gr.A3/grB3 = 1.45/1.54 (P = 0.15); gr.A4/gr.B4 = 3.22/4.66 (P < 0.001). Sildenafil, as well as other PDE5I's, were already confirmed, as proper for treating ED. However, to correct COVID 19 induced Sildenafil failure, even Avanafil could represent another PDE5I option, the intra-urethral Alprostadil turned out to be a significantly better opportunity. none

The outcomes of pics technique for the management of end-stage peyronie's disease

To present the surgical, the functional and patients’ reported outcomes (PROs) of PICS technique in multicentric series of patients affected by end-stage PD. Patients underwent an IPP implantation followed by PICS technique were recruited in two European tertiary referral center. The primary endpoint of the study was the achievement of a complete straightening of the penis. The secondary endpoints were surgical, functional and PROs. The International Index of Erectile Function (IIEF-5), the Sexual Encounter profile questions 2 and 3 (SEP 2 and SEP 3) and the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) were used to assess patients’ erectile function. The PICS technique was used in 37 patients. Median patient age was 62 years (IQR 57-70 years). Residual curvature after IPP was 60° (IQR 50–70°). Operative time was 100 minutes (IQR 90–120). Median follow-up resulted of 14 months (IQR 12–17). 27 of 37 patients (72.9%) achieved a totally straight penis. 6 patients (16.2 %) experienced a residual penile curvature: of 10° in 3 patients, 15° in 1 patient and 20° in 2 patients. The residual curvature did not interfere with sexual intercourse in any of the cases. No intraoperative complications were detected. 9 of 37 patients (24.3%) developed an early postoperative complications: 3 (8.1%) manifested a transient fever and 6 (16.2%) experienced a genital hematoma. We detected a single case (2.7%) of acute infection requiring a removal of the IPP. No cases of IPP mechanical failure were described. Median IIEF-5 score increased from 10 (8-12) in postoperative settings to 23.5 (22.2-25) at 12 months follow-up. SEP 2-3 increased from 5 (13.5%) and 0 (0%) to 34 (91.9) in both domains. EDITS scored 25 (21.2-29.5) at 12 months follow-up. The PICS technique represents a safe and effective approach to manage residual penile curvature during IPP placement in patients with end-stage PD. None

The Efficacy of Li-ESWT Combined With VED in Diabetic ED Patients Unresponsive to PDE5is: A Single-Center, Randomized Clinical Trial.

IntroductionPhosphodiesterase type 5-inhibitors (PDE5is) are the first-line treatment for patients with diabetes mellitus-induced erectile dysfunction (DMED), however, some patients are non-responser to PDE5is. We performed a perspective, randomized, comparative study to explore the efficacy of low intensity extracorporeal shock wave treatment (Li-ESWT) combined with vacuum erectile device (VED) in the treatment of DMED patients who were unresponsive to PDE5is.MethodsOne hundred and five eligible patients were randomly divided into three groups: group A (VED), group B (Li-ESWT) and group C (VED plus Li-ESWT). Follow-up was conducted at 4 weeks, 8 weeks and 12 weeks after the end of treatment. The erectile function was estimated by the international index of erectile function-erectile function domain (IIEF-EF), erection hardness score (EHS), sexual encounter profile questions 2 and 3 (SEP2 and SEP3) and global assessment question 1 and 2 (GAQ1 and GAQ2) before and after treatment. The changes of five points in IIEF-EF were calculated as the minimal clinical important difference (MCID), which was considered as the main index of efficacy.ResultsThe MCID was achieved in 14.7%, 14.7% and 17.6% patients in group A at the follow up on 4 weeks, 8 weeks and 12 weeks, respectively (36.4%, 39.4% and 36.4% in group B; 36.4%, 51.5%, and 66.7% in group C). There were significant differences in the percentage of MCID cases between group A and group C at the follow up on 12 weeks (P<0.001), as well as that between group B and group C (P=0.014). Additionally, comparison in MCID within group C showed that there were significant differences between 4 weeks and 12 weeks follow-up (P=0.014).ConclusionOur findings indicated the combined therapy Li-ESWT and VED was more beneficial to shift turn PDE5is non-responders to responders for moderate patients with DMED than VED or Li-ESWT monotherapy. Moreover, this study provided evidence that patients with DMED who failed after taking oral PDE5is could attempt to opt for an alternative physicotherapy (Li-ESWT or VED) prior to more invasive alternatives.

Erectile dysfunction in young patients and elderly patients by sexual encounter profile: A comparative study.

Demand for erectile dysfunction treatments has increased not only in elderly patients but also in young patients. Reports indicate that frequent causes of erectile dysfunction in Japan are organic disorders in elderly patients and psychogenetic disorders in young patients. We defined patients under the age of 40 as young erectile dysfunction patients, and those over 65 as elderly erectile dysfunction patients. We divided these two groups and conducted a retrospective comparative study based on medical questionnaires. We selected 215 cases of patients under the age of 40, and 176 cases of patients over the age of 65, and created a group of young patients and a group of elderly patients. We implemented the erectile hardness score, Sexual Health Inventory for Men, and sexual encounter profile questions 2 and 3 as the patient's daily clinical journal. The median age of young patients was 36 years, and that of elderly patients was 70 years. With respect to Sexual Health Inventory for Men, the average score was a significantly higher score in the young patients (9.26 vs 7.10, P < 0.001). Concerning erectile hardness score, young patients showed significantly higher scores in erectile hardness score (3.15 vs 2.06, P < 0.001). In terms of sexual encounter profile question 2, 50.9% of young patients responded "yes," but 24.3% of elderly patients responded, thus indicating a significantly higher score in young patients. In terms of sexual encounter profile question 3, 6.1% of young patients responded "yes," and 0.7% of elderly patients responded "yes," indicating a significantly higher in young patients. The results showed that many young patients with erectile dysfunction were able to perform insertion, but were unable to maintain erection.

Efficacy of phosphodiesterase type 5 inhibitors in patients with erectile dysfunction after nerve-sparing radical prostatectomy: a systematic review and meta-analysis.

BackgroundNerve-sparing radical prostatectomy (NSRP) had to be performed because approximately 94% of patients are diagnosed with localized prostate cancer (PCa). Although NSRP is generally done to improve functional outcomes, erectile dysfunction (ED) is one of the most prevailing complications after radical prostatectomy (RP). Phosphodiesterase type 5 inhibitors (PDE5-Is) are the most well-known treatment agent for postoperative ED. This study aimed to assess the efficacy of PDE5-Is in patients with ED after NSRP.MethodsIn this systematic literature review, randomized controlled trials on the efficacy and safety of PDE5-Is in patients who underwent NSRP were searched in MEDLINE, EMBASE, and the Cochrane Controlled Trials Register using the OVID platform. This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses and Cochrane Review Methods. The quality of the evidence of the outcome data was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach.ResultsA total of 14 trials involving 2,822 patients were included. Significant improvements in the International Index of Erectile Function—Erectile Function (IIEF) domain score [mean difference (MD) =4.93; 95% confidence interval (CI): 4.14–5.71; P<0.00001] and erectile function recovery events [odds ratio (OR) =2.06; 95% CI: 1.45–2.94; P<0.0001] were observed after PDE5-I treatment. A higher positive response to Sexual Encounter Profile (SEP) question 2 (OR =2.27; 95% CI: 1.80–2.86; P<0.00001) and question 3 (OR =2.78; 95% CI: 1.97–3.91; P<0.00001) was also found after PDE5-I treatment. However, the incidence of treatment-emergent adverse events (TEAEs) was higher after PDE5-I treatment than after placebo treatment (OR =2.91; 95% CI: 1.84–4.61). Furthermore, the incidence of headache (OR =3.38; 95% CI: 2.40–4.75) and flushing (OR =9.44; 95% CI: 4.30–20.70) was also significantly higher after PDE5-I treatment (P<0.00001). In terms of the quality of the evidence of the outcome data, inconsistency problems were detected in all outcomes and imprecision problems in most outcomes.DiscussionPDE5-I treatment was more effective to placebo treatment in patients with ED after NSRP. No clinically serious complications were found in spite of the incidence of TEAEs being higher after PDE5-I treatment.

Efficacy and Safety of Mirodenafil Oro-Dispersible Film in Korean Patients with Erectile Dysfunction: A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter, Phase IV Study.

PurposeTo investigate the efficacy, safety, and tolerability of oro-dispersible film (ODF) formulation of mirodenafil 50 mg and 100 mg for the treatment of patients with erectile dysfunction (ED) in Korea.Materials and MethodsA multicenter, randomized, double-blind, placebo-controlled, parallel-group study of 129 subjects was performed. Subjects were randomized to either placebo or mirodenafil ODF 50 mg or 100 mg to be taken in an “on demand” manner for 8 weeks. The primary efficacy variable was the International Index of Erectile Dysfunction (IIEF)-5 questionnaire. The secondary efficacy variables comprised Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3), the Global Assessment Question (GAQ), and the Life Satisfaction Checklist (LSC).ResultsIIEF-5 was significantly increased in all groups after treatment. However, compared to the placebo group, only the mirodenafil ODF 100 mg group showed a significant difference. SEP2 and SEP3 were increased in both mirodenafil groups; however, the increase was not statistically significant for SEP2. In terms of GAQ and LSC, the mirodenafil ODF groups showed significant increases compared with the baseline. Most treatment-associated adverse events were mild and resolved spontaneously.ConclusionsMirodenafil ODF is an effective and well-tolerated agent for the treatment of patients with ED in Korea.

Sildenafil orodispersible film in the treatment of erectile dysfunction after radical prostatectomy: A single-centre open-label uncontrolled trial.

Phosphodiesterase-5 inhibitors are the first-line therapy for erectile dysfunction (ED) after radical prostatectomy (RP). This single-centre open-label uncontrolled study evaluated the efficacy and safety of the new sildenafil orodispersible film (ODF) in ED treatment after RP. Sildenafil 100mg ODF was administered twice a week for 3months to patients under 75years of age, with a Framingham cardiovascular risk score<20% and a pre-operative International Index of Erectile Function (IIEF)-5 score≥17, who had undergone open RP between 2016 and 2018. Erectile function was assessed pre-operatively, post-operatively and after treatment through the IIEF-5 score, the Sexual Encounter Profile Question (SEP-Q) 2 and SEP-Q3; adverse events (AE) were also investigated after 3months. A total of 65 patients with a median (25th-75th percentile) post-operative IIEF-5 score of 8 (7-9) were treated. Nine (13.8%) patients reported AE of mild/moderate grade and discontinued treatment. A significant IIEF-5 score median (25th-75th percentile) increase of 10 (0-12) was found after treatment in the other 56 patients (p<.001). Sildenafil 100mg ODF was effective in ED after RP in terms of improved IIEF-5 score and improved SEP-Q2 and SEP-Q3 in 67.9% of patients. It could represent a valid alternative for those patients with low compliance to tablet intake.

PS-5-2 The Daily Therapy With L-Arginine 2500 mg and Tadalafil 5 mg in Combination and in Monotherapy for the Treatment of Erectile Dysfunction: A Prospective, Randomized Multicentre Study

To evaluate the effectiveness and tolerability of tadalafil 5 mg and L-Arginine 2,5 grams in mono- and combination therapy in patients affected by erectile dysfunction (ED). Recruited patients completed at baseline and after treatment the International Index of Erectile Function erectile function domain (IIEF-EF) and Sexual Encounter Profile (SEP) diaries. The survey was randomized into three groups with an equal allocation ratio. Group A received daily L-Arginine 2500 mg; Group B received daily Tadalafil 5 mg and Group C received both daily L-Arginine 2500 mg plus daily Tadalafil 5 mg. The duration of therapy in all three groups was 12 weeks. The main outcome measures were the change from baseline to after treatment in IIEF-EF score and in per-patient percentage of “yes” responses to SEP Question 3. Safety was assessed by evaluating all reported treatment-emergent adverse events (AEs). 300 eligible patients were enrolled and 100 subjects for each group were allocated. Basing on the IIEF-EF score men were divided into three categories: Severe, Moderate and Mild ED. Overall IIEF-EF score increased after therapy in all groups: in Group A from 15 ± 7 to 18,1 ± 9,2; in Group B from 14,8 ± 6,9 to 20,8 ± 7,3 and in Group C from 14,9 ± 7,1 to 22 ± 7,5. In mild ED mean IIEF-EF score increased from 22,1 ± 2,2 to 27,5 ± 2,3 in group A; from 22,1 ± 2,2 to 27,8 ± 2 in group B and from 22,2 ± 2,2 to 29,3 ± 0,9 in group C. We report a total of 11, 53 and 67 cases of AEs in group A, B and C respectively.

Effects of chronic type 5 phosphodiesterase inhibition on penile microvascular reactivity in hypertensive patients with erectile dysfunction: a randomized crossover placebo-controlled trial.

This randomized crossover and placebo-controlled trial evaluated the effects of daily use of sildenafil citrate (SIL, 1-month 50 mg twice daily) on penile and systemic endothelial microvascular function in hypertensive patients presenting with erectile dysfunction. The effects of SIL on arterial pressure were evaluated using ambulatory blood pressure monitoring (ABPM). Fifty patients diagnosed with primary arterial hypertension and erectile dysfunction (aged 57.4 ± 5.6 years), recruited in a tertiary public hospital, were treated with SIL (50 mg twice daily) or placebo (PLA) for two 30-day periods with a 30-day washout between them. Laser speckle contrast imaging coupled with acetylcholine skin iontophoresis was used to evaluate penile and systemic (forearm) cutaneous microvascular reactivity. SIL treatment increased penile basal microvascular flow (P = 0.002) and maximal endothelial-dependent peak response to skin iontophoresis of acetylcholine (ACh, P = 0.006). The area under the curve of microvascular vasodilation induced by ACh was also significantly increased (P = 0.02). Lastly, SIL treatment did not modify systemic microvascular reactivity. Twenty-four-hour ABPM (P = 0.0002) and daytime (P = 0.002) and nighttime (P = 0.001) mean diastolic blood pressure values were significantly reduced after SIL treatment. The scores of the Simplified International Index of Erectile Function (P < 0.0001) and the number of patients with positive responses to Sexual Encounter Profile question 3 (P < 0.0001) also increased after SIL treatment. Penile endothelium-dependent microvascular reactivity improved after continuous use of sildenafil in hypertensive patients with erectile dysfunction; the treatment also reduced blood pressure, suggesting that, in addition to improving erectile function, daily use of sildenafil could improve blood pressure control.

PD26-07 EFFICACY OF RESTOREX PENILE TRACTION THERAPY IN IMPROVING PENILE LENGTH AND ERECTILE FUNCTION POST PROSTATECTOMY

INTRODUCTION AND OBJECTIVE: Penile length loss and erectile dysfunction (ED) are common post-prostatectomy, with 100% of men experiencing some degree of impairment. Prior publications of RestoreX penile traction therapy (RxPTT) have demonstrated statistically significant improvements in length and erectile function among men with Peyronie’s Disease. The objective of this study is to evaluate the efficacy of PTT in preventing penile length loss and ED in men post-prostatectomy. METHODS: A randomized, controlled trial (NCT03500419) is ongoing to evaluate RxPTT in 70 men post prostatectomy. Men are randomized 1-month post-prostatectomy to no therapy (control) or RxPTT for 30 minutes 5x/week or 60 minutes 7x/week for 5 months. Participants then enter an open label phase for 3 months. Assessments include stretched penile length, standardized (International Index of Erectile Function [IIEF]), and non-standardized questionnaires. RESULTS: A total of 70 men (mean age 58.4) have been enrolled, with 6-month data available on 36 men (controls=17, RxPTT combined 19). Median baseline penile length (corona) and erectile function domain scores (IIEF-EFD) were 12.5 cm and 27, respectively. After 5 months, results demonstrated significant improvements in penile length among the combined RxPTT group compared to controls (median +2.0 vs 0 cm, p<0.001). RxPTT men also had preserved erectile function, with smaller reductions in IIEF-EFD (median -1 vs -8, p=0.04) and intercourse satisfaction (+0 vs -3.5, p=0.01) compared to controls. RxPTT men had non-statistically significant, higher rates of answering “yes” to sexual encounter profile questions 2 (penetration) and 3 (rigidity) compared to controls (72 vs 54%, p=0.29 and 65 vs 58%, p=0.73, respectively). Mean satisfaction with RxPTT was 8.1/10, while 84% found it meaningful, 90% would recommend it to a friend, and 80% would use RxPTT again if they could start anew. CONCLUSIONS: Based on a limited series, use of RxPTT results in significant improvements in penile length and preserves erectile function and intercourse satisfaction post-prostatectomy compared to controls. If validated with external series, these findings would represent a significant advancement in the prevention of sexual dysfunction post-prostatectomy. Source of Funding: PathRight Medical provided device to patients free of charge & Internal funding from Mayo Clinic

The Daily Therapy With L-Arginine 2,500 mg and Tadalafil 5 mg in Combination and in Monotherapy for the Treatment of Erectile Dysfunction: A Prospective, Randomized Multicentre Study

IntroductionA synergistic effect of the combination therapy tadalafil plus L-Arginine is conceivable in patients affected by erectile dysfunction (ED).AimTo evaluate the effectiveness and tolerability of tadalafil 5 mg and L-Arginine 2.5 grams in monotherapy and combination therapy.MethodsRecruited patients completed the International Index of Erectile Function – Erectile Function domain (IIEF-EF) and Sexual Encounter Profile diaries completed at baseline and after treatment. The survey was randomized into 3 groups with an equal allocation ratio. Group A received daily L-Arginine 2,500 mg, group B received daily tadalafil 5 mg, and group C received both daily L-Arginine 2,500 mg plus daily tadalafil 5 mg. The duration of therapy in all 3 groups was 12 weeks. Safety was assessed by evaluating all reported treatment-emergent adverse events.Main Outcome MeasureThe main outcome measure was the change in IIEF-EF score and in per-patient percentage of “yes” responses to Sexual Encounter Profile Question 3 from baseline to after treatment.Results300 eligible patients were enrolled, and 100 subjects for each group were allocated. Based on the IIEF-EF score, the participants were divided into 3 categories: severe, moderate, and mild ED. IIEF-EF score increased in group A from 15 ± 7 to 18.1 ± 9.2, in group B from 14.8 ± 6.9 to 20.8 ± 7.3, and in group C from 14.9 ± 7.1 to 22 ± 7.5. In mild ED group, the mean IIEF-EF score increased from 22.1 ± 2.2 to 27.5 ± 2.3 in group A; from 22.1 ± 2.2 to 27.8 ± 2 in group B, and from 22.2 ± 2.2 to 29.3 ± 0.9 in group C. We report a total of 11, 53, and 67 cases of adverse events in group A, B, and C respectively.ConclusionsCombination therapy was superior to monotherapies.Gallo L, Pecoraro S, Sarnacchiaro P, et al. The Daily Therapy With L-Arginine 2,500 mg and Tadalafil 5 mg in Combination and in Monotherapy for the Treatment of Erectile Dysfunction: A Prospective, Randomized Multicentre Study. Sex Med 2020;8:178–185.

Chinese herbal medicine combined with tadalafil for erectile dysfunction: a systematic review and meta-analysis.

Erectile dysfunction (ED) is a tough problem in medicine. This article aims to provide the latest evidence for the efficacy and safety of traditional Chinese medicine (TCM) combined with tadalafil in treatment of erectile dysfunction. All randomized controlled trials that Chinese herbal medicine combined with tadalafil for erectile dysfunction were included in databases of China National Knowledge Infrastructure (CNKI), Wanfang, Weip Database, ChinaBiology Medicine disc (CBM), MEDLINE, EMBASE, and Cochrane Library. The quality of the included articles was evaluated using Cochrane Reviewer's Handbook 5.3, and meta-analysis was performed using Stata 13.1. A total of 11 studies including 451 cases in the treatment group and 452 cases in the control group were obtained. Compared with tadalafil alone, meta-analysis suggests there were statistically significant differences in International Index of Erectile Function-5 (IIEF-5), effective rate, Sexual Encounter Profile questions 2 and 3 (SEP-Q2, SEP-Q3) between traditional Chinese medicine combined with tadalafil, and no statistically significant differences in side effects between the two groups. All included studies were tested for publication bias, and the results indicated that there was no significant bias. Two of the articles mentioned the scheme that traditional Chinese medicine combined withlow-dose tadalafil for erectile dysfunctionby down stairs. Traditional Chinese medicine combined with tadalafil has significant efficacy in the treatment of ED with no increase in side effects. The specific implementing regulations and effect of de-escalation therapy still need more long-term, multicenter, randomized, and double-blind clinical trials.

Meta-Analysis of the Long-Term Efficacy and Tolerance of Tadalafil Daily Compared With Tadalafil On-Demand in Treating Men With Erectile Dysfunction.

BackgroundErectile dysfunction (ED) is highly prevalent in aging men. Tadalafil daily and on-demand are widely used for the treatment of ED.AimWe performed a meta-analysis to evaluate the efficacy and safety of tadalafil daily compared with tadalafil on-demand in treating men with ED after at least 24 weeks of long-term treatment.MethodsRandomized controlled trials of tadalafil daily vs on-demand in treating men with ED were searched using MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. Systematic review was carried out using the Preferred Reporting Items for Systematic Reviews and Meta-analyses. The data was calculated by RevMan version 5.3.0. The references of related articles were also searched.OutcomesInternational Index of Erectile Function-Erectile Function domain, sexual encounter profile question 2 (SEP2), SEP question 3 (SEP3), any treatment-emergent adverse event (AE), discontinuation due to AEs, myalgia, back pain, headache, dyspepsia, and nasopharyngitis.Results4 articles, including 1,035 participants were studied. The analysis found that tadalafil daily had a greater improvement than tadalafil on-demand in terms of International Index of Erectile Function-Erectile Function (mean difference (MD) 1.24; 95% CI 0.03−2.44; P = .04), SEP2 (MD 10.08; 95% CI 9.15−11.01; P < .00001) and SEP3 (MD 8.19; 95% CI 2.09−14.29; P = .009) in treating ED after at least 24 weeks treatment cycle. For safety, tadalafil on-demand had a higher incidence of any treatment-emergent AE (odds ratio 0.73; 95% CI 0.56−0.96; P = .02) compared with tadalafil daily, but for other aspects, including discontinuation due to AEs, myalgia, back pain, headache, dyspepsia, and nasopharyngitis, there were no significant difference between the 2 treatments.Clinical ImplicationsTadalafil daily may offer a better effect for ED than on-demand for long-term treatment.Strengths and LimitationsFrom the perspective of evidence-based medicine, we evaluated the efficacy and safety of tadalafil daily compared with tadalafil on-demand in treating men with ED after a long-term treatment. The quality of these studies included is flawed, primarily in difference in tadalafil doses and severity of the ED.ConclusionTadalafil daily provides a preferable therapeutic effect for ED with a lower incidence of treatment-emergent side effects relative to tadalafil on-demand after at least 24 weeks of long-term treatment.Zhou Z, Chen H, Wu J, et al. Meta-Analysis of the Long-Term Efficacy and Tolerance of Tadalafil Daily Compared With Tadalafil On-Demand in Treating Men With Erectile Dysfunction. J Sex Med 2019;7:282–291.

079 Low-intensity shockwave therapy for erectile dysfunction: the effect of energy flux density level and frequency of sessions per week

Low-intensity shockwave therapy (LiST) is safe and efficacious in men with vasculogenic erectile dysfunction(ED). There is lack of data however, on the safety and efficacy of different energy levels and session frequency per week. This study compares the safety and efficacy of different LiST protocols for vasculogenic ED. Two different energy flux density (EFD) and two different session frequencies are investigated. 96 patients were randomized into 4 groups. All patients received a total of 12 LiST sessions: Group A received LiST twice a week with EFD of 0.05mJ/mm2; Group B received LiST three times a week with EFD of 0.05mJ/mm2; Group C received LiST twice a week with EFD of 0.10mJ/mm2; Group D received LiST three times a week with EFD of 0.10mJ/mm2. Sessions were delivered within a 4 week (Groups B, D) or 6 week (Groups A, C) period, without any break in treatment. IIEF-EF domain score, Minimally Clinical Important Differences (MCID), and Sexual Encounter Profile question 3 (SEP3) assessed subjective erectile function; objective assessment of penile hemodynamics was based on Peak Systolic Velocity (PSV).

A Comparative Study Between 2 Different Grafts Used as Patches After Plaque Incision and Inflatable Penile Prosthesis Implantation for End-Stage Peyronie's Disease

BackgroundAlthough many grafts have been used for plaque incision with grafting (PIG) and penile prosthesis (PP) implantation, there is no evidence that favors 1 specific graft over another. AimTo compare fibrin-coated collagen fleece (TachoSil; Baxter International, Deerfield, IL, USA) with porcine small intestinal submucosa (SIS; Cook Biotech, West Lafayette, IN, USA) as grafts. MethodsFrom January 2007 to January 2015, 60 non-randomized consecutive patients affected by end-stage Peyronie disease underwent PIG and PP implantation (AMS 700CX; Boston Scientific, Marlborough, MA, USA). All patients underwent preoperative penile dynamic duplex ultrasound. All procedures were performed by the same surgeon. Patients were divided in 2 different groups according to the graft used to cover the albuginea defect. SIS was used for grafting in 34 patients (group A) and TachoSil was used in 26 patients (group B). OutcomesOverall hospital stay, operative time, 5-point Likert hematoma scale, visual analog scale, incidence of postoperative complications, and PP mechanical failure were selected as outcome measures. Functional outcomes were assessed through validated questionnaires (International Index of Erectile Function, Erectile Dysfunction Inventory of Treatment Satisfaction, and Sexual Encounter Profile questions 2 and 3) preoperatively and 3, 6, and 12 months postoperatively. ResultsThe patients' median age was 63 years. No statistically significant differences were detected between groups for age and type and degree of curvature (median = 65°). Average follow-up was 35 months. No major intraoperative complications were reported. The average operative time was 145 minutes for group A and 120 minutes for group B. No statistically significant differences between groups were detected for postoperative complications. Only 3 patients developed a major postoperative complication requiring a 2nd surgical intervention: 1 patient in group A for mechanic failure and 1 patient in group A and 1 in group B for inflatable PP infection. Multivariate statistical analysis showed no significant difference for all variables analyzed between the 2 groups, except for operative time, which was significantly shorter for group B. Clinical ImplicationsTachoSil could represent a valuable option for grafting, considering its advantages in operative time and cost compared with SIS. Strengths and LimitationsLong-term follow-up represents a strength factor. Main limitations are the non-randomized nature of the study and the small number of patients. ConclusionsTachoSil seems to represent an effective solution for grafting after PIG and PP implantation. However, additional studies are warranted to confirm our results.Falcone M, Preto M, Ceruti C, et al. A Comparative Study Between 2 Different Grafts Used as Patches After Plaque Incision and Inflatable Penile Prosthesis Implantation for End-Stage Peyronie's Disease. J Sex Med 2018;15:848–852.

Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment

BackgroundThere is lack of evidence-based optimization of the protocol for low-intensity shockwave therapy for erectile dysfunction. Furthermore, the safety and efficacy of repeating shockwave therapy have not been explored. AimTo compare the efficacy and safety of 6 and 12 treatment sessions within a 6-week treatment period and investigate the effect of repeat treatment after a 6-month period in a 2-phase study. MethodsPatients with vasculogenic erectile dysfunction that responded to phosphodiesterase type 5 inhibitors were randomized into 2 groups: low-intensity shockwave therapy sessions once (group A, n = 21) or twice (group B, n = 21) per week for 6 consecutive weeks (phase 1). Patients who completed 6-month follow-up were offered 6 additional sessions (phase 2); group A received 2 sessions per week and group B received 1 session per week. Patients were followed for 6 months. OutcomesInternational Index for Erectile Function erectile function domain (IIEF-EF) score, minimally clinical important differences (MCIDs), Sexual Encounter Profile question 3 (SEP3) score, and triplex ultrasonographic parameters. ResultsIn phase 1, groups A and B showed improvement in IIEF-EF score, MCID, SEP3 score, and mean peak systolic velocity compared with baseline. MCIDs were achieved in 62% of group A and 71% of group B, and the percentage of yes responses to SEP3 was 47% in group A and 65% in group B (P = .02). Mean peak systolic velocity at baseline and at 3-month follow-up were 29.5 and 33.4 cm/s for group A and 29.6 and 35.4 cm/s for group B (P = .06). In phase 2, group A showed a greater increase in the percentage of yes responses to SEP3 (group A = +14.9; group B = +0.3). When the impact of the total number of sessions received was examined, MCIDs in IIEF-EF score from baseline were achieved in 62%, 74%, and 83% of patients after 6, 12, and 18 sessions, respectively. No treatment-related side effects were reported. Clinical ImplicationsThe total number of low-intensity shockwave therapy sessions affects the efficacy of erectile dysfunction treatment. Retreating patients after 6 months could further improve erectile function without side effects. 12 sessions can be delivered within 6 weeks without a 3-week break period. Strengths and LimitationsThis study lacked a sham-controlled arm. However, all patients were randomized to different groups, and baseline characteristics were similar between groups. Also, all patients were confirmed by triplex ultrasonography to have arterial insufficiency. ConclusionPatients can benefit more in sexual performance from 12 sessions twice per week compared with 6 sessions once a week. Shockwave therapy can be repeated up to a total of 18 sessions.Kalyvianakis D, Memmos E, Mykoniatis I, et al. Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment. J Sex Med 2018;15:334–345.

Topical alprostadil (Vitaros©) in the treatment of erectile dysfunction after non-nerve-sparing robot-assisted radical prostatectomy.

The aim of the study is the evaluation of the efficacy and safety of the treatment with topical alprostadil (Vitaros©) in post-robot assisted radical prostatectomy (RARP) rehabilitation therapy of patients with erectile dysfunction (ED). Seventy-four patients were enrolled and underwent non-nerve-sparing RARP. age <75, preoperatively International Index of Erectile Function (IIEF-5) >16, erection hardness score (EHS) ⩾2, weekly sexual intercourse ⩾1, affirmative answers to Sexual Encounter Profile Question (SEP-Q) 2 and SEP-Q3, Charlson Comorbidity Index (CCI) ⩽5, Eastern Cooperative Oncology Group (ECOG) performance status ⩽1, no moderate/severe cardiovascular disease. Vitaros was administered ⩾2 twice a week. At month 6, the IIEF-5 decreased from 20.5 preoperative to 18.1 post-treatment. EHS score decreased from a mean of 3.3 to a mean of 3.0. The quality of life score decreased from an average of 5.1 to 2.3. Weekly sexual intercourse decreased from an average of 2.1 to 1.7. Six patients dropped out; 89.7% patients showed a positive SEP-Q2 and 77.8% a positive SEP-Q3. All patients responded positively to Global Assessment Questions (GAQ)-1 and 97% to GAQ-2. Of all 68 analyzed patients, 13 (17.6%) switched to intracavernous injection therapy. In conclusion, Vitaros may become a viable alternative to common injective therapies in well-selected patients after RARP.