Baseline International Index Of Erectile Function Research Articles

Assessment of changes in sexual function in patients undergoing endoscopic surgery for upper urinary tract lithiasis

ObjectiveTo evaluate the effect of endoscopic surgery on sexual function in patients with upper urinary tract (UUT) lithiasis. Material and methodsWe conducted an observational, prospective, longitudinal study with a single cohort of cases undergoing ureteroscopy (URS), retrograde intrarenal surgery (RIRS), or endoscopic combined intrarenal surgery (ECIRS). Patients' sexual response was assessed with questionnaires in the 30 days prior to surgery, and at one and three months after surgery. The International Index of Erectile Function (IIEF-t) was used in male patients, and the Female Sexual Function Index (FSFI) was used in female patients. ResultsSeventy patients – 34 men and 36 women – completed the study. Among men, the IIEF-t did not show significant difference between baseline scores (64.1 ± 7.50) and those obtained at 3 months (63.8 ± 9.51), with a non-significant decrease (p = 0.054) at the first month (61.4 ± 10.4). Subdomains did not worsen at 3 months, and desire (IIEF-SD) improved from 7.3 ± 1.9 to 8.0 ± 1.8. Among women, the FSFI-t did not change significantly after surgery: baseline score (27.3 ± 4.1), 1-month score (26.8 ± 3.7) and 3-month score (27.5 ± 4.2). No subdomain worsened at the third month. ConclusionEndoscopic surgery for UUT is a safe technique in both sexes with no negative effect on sexual function. There are no differences between the baseline IIEF-t and FSFI-t scores and those obtained at 3 months.

Evaluación de los cambios en la función sexual en pacientes sometidos a cirugía endoscópica de la litiasis del tracto urinario superior

ObjectiveTo evaluate the effect of endoscopic surgery on sexual function in patients with upper urinary tract (UUT) lithiasis. Material and methodsWe conducted an observational, prospective, longitudinal study with a single cohort of cases undergoing ureteroscopy (URS), retrograde intrarenal surgery (RIRS), or endoscopic combined intrarenal surgery (ECIRS). Patients’ sexual response was assessed with questionnaires in the 30 days prior to surgery, and at one and three months after surgery. The International Index of Erectile Function (IIEF-t) was used in male patients, and the Female Sexual Function Index (FSFI) was used in female patients. ResultsSeventy patients -34 men and 36 women- completed the study. Among men, the IIEF-t did not show significant difference between baseline scores (64.1±7.50) and those obtained at 3 months (63.8±9.51), with a non-significant decrease (p=0.054) at the first month (61.4±10.4). Subdomains did not worsen at 3 months, and desire (IIEF-SD) improved from 7.3±1.9 to 8.0±1.8. Among women, the FSFI-t did not change significantly after surgery: baseline score (27.3±4.1), 1-month score (26.8±3.7) and 3-month score (27.5±4.2). No subdomain worsened at the third month. ConclusionEndoscopic surgery for UUT is a safe technique in both sexes with no negative effect on sexual function. There are no differences between the baseline IIEF-t and FSFI-t scores and those obtained at 3 months.

Spontaneous erectile function recovery among young men with erectile dysfunction taking tadalafil 5mg once a day.

Daily (once a day [OaD]) tadalafil intake is a valuable option for men favoring spontaneous over scheduled sexual intercourse. The study sought to assess the rate of and the clinical factors associated with spontaneous, medication-free erectile function (EF) recovery after discontinuation of tadalafil 5mg OaD in a cohort of young men seeking first medical help for psychogenic erectile dysfunction (ED) as their primary complaint. Data from 96 consecutive patients <50years of age seeking first medical help for ED and prescribed tadalafil 5mg OaD were analyzed. Patients completed the International Index of Erectile Function (IIEF) and underwent baseline penile color Doppler ultrasound. Follow-up involved clinical assessments or phone interviews. Spontaneous medication-free EF recovery was defined as IIEF EF domain score >22 after tadalafil discontinuation, prompting cessation of follow-up. Descriptive statistics compared tadalafil OaD responders and nonresponders. Cox regression hazard models explored the association between baseline characteristics and EF recovery risk post-drug discontinuation. Kaplan-Meier analyses estimated EF recovery probability over time. The primary outcome was EF recovery after discontinuation of tadalafil 5mg OaD. Overall, median age was 39 (interquartile range [IQR], 32-45) years. Of all, 82 (85.4%) patients achieved EF recovery after tadalafil OaD discontinuation, while 14 (14.6%) patients were identified as nonresponders. Median tadalafil usage time (from beginning to discontinuation) was 3 (IQR, 2-11) months. The most common treatment-emergent adverse event was headache in 9 (9.4%) patients. Nonresponders were older (43 [IQR, 42-45] years vs 38 [IQR, 31-44] years; P = .03), had higher body mass index (25.5 [IQR, 23.4-29.9] kg/m2 vs 23.6 [IQR, 21.8-25.9] kg/m2; P = .04), and reported lower baseline IIEF EF domain scores (12 [IQR, 7-15] vs 15 [IQR, 10-22]; P = .02) than responders. Nonresponders and responders did not differ in terms of baseline ED severity, Charlson comorbidity index, smoking, alcohol consumption, regular physical exercise, and color Doppler ultrasound parameters. Upon Cox regression analysis, younger age (hazard ratio, 0.95; 95% confidence interval, 0.92-0.99; P = .01) was associated to EF recovery, after adjusting for baseline ED severity, body mass index, smoking, and Charlson comorbidity index ≥1. The Kaplan-Meier analysis displays the probability of EF recovery over time, indicating rates of 43%, 60%, and 72% at 3-, 6-, and 12-month follow-up intervals, respectively. Tadalafil 5mg OaD is an effective short-term treatment for psychogenic ED, allowing its discontinuation after achieving a normal medication-free EF. The main limitations are the limited number of participants and the potential neglect of confounding factors. Almost 1 out of 2 young men with primary psychogenic ED who were prescribed with tadalafil 5mg OaD recovered spontaneous medication-free EF after 3months of treatment. Overall, the younger the patient was, the higher the chance there was of spontaneous EF recovery after drug discontinuation.

Effect of aerobic exercise on erectile function: systematic review and meta-analysis of randomized controlled trials.

The health benefits of regular aerobic exercise are well established, although there is limited high-quality evidence regarding its impact on erectile function. To determine the effect of aerobic exercise on erectile function in men and to identify factors that may influence this effect. This systematic review and meta-analysis included randomized controlled trials that evaluated the effects of aerobic exercise on erectile function via the Erectile Function domain of the International Index of Erectile Function (IIEF-EF). The mean difference in IIEF-EF scores between the aerobic exercise and nonexercising control groups was estimated by a random-effects meta-analysis. Meta-regression was used to evaluate the association of moderator variables on meta-analysis results. The IIEF-EF score is reported on a 6-30 scale, with higher values indicating better erectile function. Among 11 randomized controlled trials included in the analysis, aerobic exercise resulted in statistically significant improvements in IIEF-EF scores as compared with controls, with a mean difference of 2.8 points (95% CI, 1.7-3.9; P < .001) and moderate heterogeneity among studies (I2= 53%). The effect of aerobic exercise on erectile function was greater in men with lower baseline IIEF-EF scores, with improvements of 2.3, 3.3, and 4.9 points for mild, moderate, and severe erectile dysfunction, respectively (P = .02). The meta-analysis results were not influenced by publication bias or individual study effects. Health care providers should consider recommending regular aerobic exercise as a low-risk nonpharmacologic therapy for men experiencing erectile difficulties. The primary strength of this review was the generation of level 1 evidence on a topic of general interest regarding sexual health in men. However, the included studies evaluated diverse groups, which may complicate data interpretation for specific segments of the population. Regular aerobic exercise can improve the erectile function of men, particularly those with lower baseline IIEF-EF scores.

(330) Trends of Reporting Premature Ejaculation Among Men with Erectile Dysfunction – Findings From a Real-life Cross-sectional Study

Abstract Introduction Patients with erectile dysfunction (ED) may have an increased risk to report concomitant premature ejaculation (PE) Objective We aimed to explore the trend of reporting PE across three different age groups of a homogenous cohort of men seeking first medical help for ED (&amp;lt; 40 yr, 40-60 yr, &amp;gt; 70yr) over a 16-year period at a single tertiary academic centre. Methods Complete data of 1258 men consecutively assessed for ED as primary complaint by a single Sexual Medicine expert between 2005 and 2021 were analysed. Patients were divided into three age categories: i) &amp;lt;40 years, ii) 40-69 years, and iii) ≥ 70 years. All patients were assessed with a comprehensive medical and sexual history. Comorbidities were scored with the Charlson Comorbidity Index (CCI). All patients completed the International Index of Erectile Function (IIEF) at baseline. Between the three groups i) descriptive statistics tested the sociodemographic and clinical differences; ii) regression models tested the probability of reporting concomitant PE over time; and, iii) local polynomial regression models graphically explored the probability of reporting PE (primary/secondary) together with ED over the analysed time frame. Results Overall, median (IQR) age was 51 (40-61) years. Of all, 326 (25.9%) reported either life-long or acquired PE at time of first clinical assessment. Among the three age groups (70) there were no significant differences in terms of baseline IIEF domains. Younger patients reported higher rates of PE in respect to older ones (0.5% vs. 0.4% vs. 0.3%, p=0.001). Logistic regression analysis showed a statistically significant trend of reporting PE over the years among the &amp;lt; 40yr (OR: 1.4; 95%CI: 1.3-1.5) and 40-69yr (OR: 1.3; 95%CI: 1.2-1.4) groups respectively (all p&amp;lt;0.0001). A not significant trend was found in the ≥ 70yr group. Figure 1 graphically displays the probability of reporting PE in the whole cohort and among the three age-matched groups between 2005 and 2021. Conclusions Almost one out of four patients seeking first medical help for ED also reports to suffer from PE. The probability of reporting PE (either primary or secondary) has been exceptionally increasing over the last 15 years among young (&amp;lt;40) and middle-age (40-69) men with ED. This finding is of major clinical relevance in order to a better tailored therapeutic work-up in the real life setting. Disclosure No

MP45-13 CAN DELAYED EJACULATION HAVE AN IMPACT ON PSYCHOLOGICAL HEALTH? FINDINGS FROM A CROSS SECTIONAL STUDY

You have accessJournal of UrologyCME1 Apr 2023MP45-13 CAN DELAYED EJACULATION HAVE AN IMPACT ON PSYCHOLOGICAL HEALTH? FINDINGS FROM A CROSS SECTIONAL STUDY Christian Corsini, Federico Belladelli, Edoardo Pozzi, Giuseppe Fallara, Simone Cilio, Massimiliano Raffo, Alessandro Bertini, Francesco Lanzaro, Donato Cannoletta, Fausto Negri, Ludovica Cella, Margherita Fantin, Luigi Candela, Paolo Capogrosso, Luca Boeri, Alessia D'Arma, Francesco Montorsi, and Andrea Salonia Christian CorsiniChristian Corsini More articles by this author , Federico BelladelliFederico Belladelli More articles by this author , Edoardo PozziEdoardo Pozzi More articles by this author , Giuseppe FallaraGiuseppe Fallara More articles by this author , Simone CilioSimone Cilio More articles by this author , Massimiliano RaffoMassimiliano Raffo More articles by this author , Alessandro BertiniAlessandro Bertini More articles by this author , Francesco LanzaroFrancesco Lanzaro More articles by this author , Donato CannolettaDonato Cannoletta More articles by this author , Fausto NegriFausto Negri More articles by this author , Ludovica CellaLudovica Cella More articles by this author , Margherita FantinMargherita Fantin More articles by this author , Luigi CandelaLuigi Candela More articles by this author , Paolo CapogrossoPaolo Capogrosso More articles by this author , Luca BoeriLuca Boeri More articles by this author , Alessia D'ArmaAlessia D'Arma More articles by this author , Francesco MontorsiFrancesco Montorsi More articles by this author , and Andrea SaloniaAndrea Salonia More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003291.13AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Delayed Ejaculation (DE) is among the most challenging male sexual dysfunctions. We aimed to explore and compare the sociodemographic and clinical characteristics of men with DE with those complaining of primary premature ejaculation (PE) METHODS: Data from 555 consecutive men seeking first medical help for DE and/or primary PE between 2005 and 2022 at a single tertiary-referral center were retrospectively analyzed. Complete socio-demographic, clinical and laboratory data were collected for all patients. All patients completed the International Index of Erectile Function (IIEF) and the Beck Depression Inventory (BDI) at baseline. We excluded men with known or potential causes responsible for ejaculatory disorders (n= 52). Descriptive statistics was used to detail and compare clinical and sociodemographic characteristics between the two groups (DE vs. PE). Linear regression models tested the association between depressive symptoms (BDI) and baseline IIEF domains scores among men with DE. RESULTS: Of 555 patients, 479 (86.3%) and 76 (13.7%) primary PE and DE, respectively. Men with DE were significantly older (44 vs. 47, p=0.01) than patients with PE. Conversely, the two groups did not differ in terms of educational/relational status, BMI, comorbidities, and hormonal milieu. At psychosexual interview, men with DE report more frequently symptoms referable to anxiety and depression (9.4% and 12,7%) along with higher median baseline BDI scores (8 vs. 6), all p<0.01. DE patients reported lower median IIEF-OF, -SD domains (6 vs. 9) and (7 vs. 8) than patients with PE only, all p<0.05. At linear regression analysis, among DE patients, a higher BDI score was associated with lower IIEF-OS (coeff. -1.57 p=0.004), and IIEF-IS (coeff. -0.72 p=0.01) domains (Figure 1). No association between BDI and IIEF-OF, -EF, -SD domains was found. CONCLUSIONS: Among men complaining of ejaculatory disorders, one out of ten reports DE. These patients have higher chances to report clinically significant depression significantly impacting on their overall satisfactory sexual life. Source of Funding: None © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e626 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Christian Corsini More articles by this author Federico Belladelli More articles by this author Edoardo Pozzi More articles by this author Giuseppe Fallara More articles by this author Simone Cilio More articles by this author Massimiliano Raffo More articles by this author Alessandro Bertini More articles by this author Francesco Lanzaro More articles by this author Donato Cannoletta More articles by this author Fausto Negri More articles by this author Ludovica Cella More articles by this author Margherita Fantin More articles by this author Luigi Candela More articles by this author Paolo Capogrosso More articles by this author Luca Boeri More articles by this author Alessia D'Arma More articles by this author Francesco Montorsi More articles by this author Andrea Salonia More articles by this author Expand All Advertisement PDF downloadLoading ...

PD10-04 CHARACTERIZING MALE ERECTILE FUNCTION AFTER RADICAL CYSTECTOMY

You have accessJournal of UrologyCME1 May 2022PD10-04 CHARACTERIZING MALE ERECTILE FUNCTION AFTER RADICAL CYSTECTOMY Benjamin Beech, Matthew Clements, Thomas Atkinson, Yuelin Li, Guido Dalbagni, Andrew Vickers, Harry Herr, S. Machele Donat, Daniel Sjoberg, Amy Tin, John Mulhall, Bruce Rapkin, and Bernard Bochner Benjamin BeechBenjamin Beech More articles by this author , Matthew ClementsMatthew Clements More articles by this author , Thomas AtkinsonThomas Atkinson More articles by this author , Yuelin LiYuelin Li More articles by this author , Guido DalbagniGuido Dalbagni More articles by this author , Andrew VickersAndrew Vickers More articles by this author , Harry HerrHarry Herr More articles by this author , S. Machele DonatS. Machele Donat More articles by this author , Daniel SjobergDaniel Sjoberg More articles by this author , Amy TinAmy Tin More articles by this author , John MulhallJohn Mulhall More articles by this author , Bruce RapkinBruce Rapkin More articles by this author , and Bernard BochnerBernard Bochner More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002536.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Radical cystectomy (RC) is understood to have a large impact on sexual function, but long-term outcomes and the impact of preoperative function have been poorly characterized. Our objective was to examine the natural history of male erectile function (EF) before and following RC. METHODS: Male patients participating in a single-center, prospective, non-randomized study of patient reported quality of life that accrued between 2008-2014 were analyzed. Patients completed the International Index of Erectile Function (IIEF) at their presurgical visit and 3, 6, 12, 18, and 24 months post-RC. Baseline differences between orthotopic neobladder (NB) and ileal conduit (IC) patients were separately analyzed based on significant surgical selection bias. Using established erectile dysfunction (ED) severity definitions for the IIEF, patients were categorized into “severe ED”, “mild-moderate ED”, or “no ED” at baseline and post-RC. We were interested in recovery of EF in patients with no preop ED and examined EF in this cohort over time. RESULTS: A total of 323 men were eligible, of which 210 completed baseline IIEF surveys. NB was performed in 115 (55%) men and IC in 95 (45%). Any attempt at bilateral or unilateral nerve sparing was performed in 50% of NB and 11% of IC patients. IC patients were older (73 vs 63 years, p <0.001), and had higher rates of severe ED (65% vs 44%, p=0.002) and lower rates of no ED (17% vs 30%, p=0.02) prior to RC. Post-RC, 84% of men reported having severe ED at 12 months and 79% at 24 months. However, among 35 men with no ED preop and NB diversion, 16.7% reported no ED at 3 months. In this group, the largest recovery occurred from 12-24 months, where rates of no ED improved from 14% to 35%. Notably, in these patients, 67% had bilateral nerve sparing and 22% underwent partial nerve sparing. Thus, in men that are potent preop, with nerve sparing, >60% report some EF, while >30% report no ED within two years. CONCLUSIONS: Men who are candidates for NB (younger, less comorbid compared to IC patients) have considerably higher baseline EF. Most recovery appeared to occur after 12 months. In highly selected patients with good baseline EF, EF recovery is possible for the majority following RC with nerve preservation surgery. Source of Funding: This work was supported by the Sidney Kimmel Center for Prostate and Urological Cancers and the NIH/NCI Cancer Center Support Grant P30 CA008748 © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e184 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Benjamin Beech More articles by this author Matthew Clements More articles by this author Thomas Atkinson More articles by this author Yuelin Li More articles by this author Guido Dalbagni More articles by this author Andrew Vickers More articles by this author Harry Herr More articles by this author S. Machele Donat More articles by this author Daniel Sjoberg More articles by this author Amy Tin More articles by this author John Mulhall More articles by this author Bruce Rapkin More articles by this author Bernard Bochner More articles by this author Expand All Advertisement PDF DownloadLoading ...

2 Year Quality of Life Follow up Following Palladium-103 Line Source for Prostate Brachytherapy Implants

To assess the quality of life (QOL) following the implant of a polymer encapsulated Pd-103 source with a unique linear radioactive distribution intended to provide a useful refinement on prostate brachytherapy. Prostate brachytherapy is known to successfully treat prostate cancer with minimal side effects to patients. Urinary, rectal and sexual function toxicities are reported with standard questionnaires to assess QOL in this registry study. Thirty-seven subjects with prostate cancer were implanted with the Pd-103 line source. Prostate specific antigen (PSA) was recorded before implant and in 6 month intervals following implant. Patients were asked to respond to International Prostate Symptom Score (IPSS), Rectal Function Assessment Score (RFAS), and International Index of Erectile Function (IIEF) questionnaires. Questionnaires were administered before implant, one month after implant, and at 6 month intervals following implant. PSA and responses to questionnaires have been collected for up to 24 months for some patients. Patients were not excluded based on pre-implant QOL function. The average PSA prior to implant and at 6 months following implant were 7.7 and 1.2, respectively. A total of 37 patients responded to the questionnaires prior to linear Pd-103 implant. Very mild urinary symptoms were reported following implant, including mild increase in frequency and urgency. These symptoms resolved prior to 6 month follow up. The average baseline IPSS for all patients is 9.1. The average post implant IPSS change from baseline was 11.3, 3, 1.9, 3.1 and 0.3 for months 1, 6, 12, 18 and 24, respectively. The IPSS reported for Pd-103 linear sources indicate that return to baseline may occur more rapidly than with traditional seeds. No adverse events related to rectal toxicity were reported. The average change from baseline RFAS and IIEF were 2 and 5, respectively, at one month post implant and returned to baseline by 6 months. No statistically significant changes from baseline in the RFAS or IIEF over the 2 year follow up period. Patients tolerate Pd-103 line source brachytherapy with minimal side effects. Immediate symptoms from the procedure resolve quickly and patients routinely return to baseline function.

149 Extent of Female Partner Sexual Function Improvement in Female Partners of Men With Peyronie's Disease Who Received Collagenase Clostridium Histolyticum

To examine the impact of erectile dysfunction severity in men with Peyronie's disease (PD) on improvement of female partner satisfaction after collagenase clostridium histolyticum (CCH) treatment. Men with PD (penile curvature ≥30° and ≤90°) who previously received placebo during the IMPRESS I or II trials and their female partners, who were willing to participate, were included in a separate subsequent open-label, phase 3 study. Men received up to 4 treatment cycles; cycles were separated by 6 weeks. Each treatment cycle consisted of 2 injections of CCH 0.58 mg separated by 24 to 72 hours. The second injection was followed by 6 weeks of daily penile plaque modeling. Men completed the International Index of Erectile Function (IIEF) at baseline and week 36. The IIEF is a 15-item questionnaire that assesses 5 domains (erectile function, orgasmic function, sexual desire, intercourse satisfaction, and overall satisfaction) of male sexual function. Female sexual function was assessed at baseline and week 36 using the Female Sexual Function Index (FSFI), a 19-item questionnaire that measures desire or arousal, lubrication, orgasm, satisfaction, and pain. The relationship between baseline IIEF male erectile dysfunction and improvement of female sexual function after CCH therapy in males was examined using regression analysis (Pearson correlation coefficient [r]).

Antiplatelet (aspirin) therapy as a new option in the treatment of vasculogenic erectile dysfunction: a prospective randomized double-blind placebo-controlled study.

To investigate the efficiency of antiplatelet (aspirin) therapy in vasculogenic erectile dysfunction (VED) patients with a high mean platelet volume. A total of 184 patients diagnosed with VED between the ages of 18 and 76 were randomly divided into two groups and treated for 6weeks [group 1: 120 patients (mean age 48.3), aspirin 100mg/day; group 2: 64 patients (mean age 47.7), placebo 100mg/day]. The changes from baseline to end point in erectile function scores on the International Index of Erectile Function (IIEF-EF) and the number of patients who answered "yes" to questions 2 and 3 of the sexual encounter profile (SEP) were compared statistically. The mean baseline IIEF-EF scores in groups 1 and 2 were 14.1±4.9 and 14.3±5.2, respectively (p=0.7966), the number of patients who answered "yes" to SEP-2 was 62 (51.6%) in group 1 and 32 (50%) in group 2 (p=0.8366), and the number of patients who answered "yes" to SEP-3 was 38 (31.6%) in group 1 and 20 (31.2%) in group 2 (p=0.9557). In the aspirin group, the changes from baseline to end point in the IIEF-EF, SEP-2, and SEP-3 scores were 7.2, 36.6, and 46.6%, respectively. In the placebo group, these changes were 2.0, 9.4, and 12.5%, respectively. When compared with the placebo group, aspirin-treated subjects showed a significant improvement in all three efficacy measures (p<0.0001). 100mg of aspirin administered once a day significantly improved EF in men with VED.

MP47-02 SEXUAL FUNCTION AFTER HYPOFRACTIONATED VERSUS CONVENTIONALLY FRACTIONATED RADIOTHERAPY FOR PROSTATE CANCER: RESULTS OF THE PROSPECTIVE, RANDOMIZED PHASE 3 HYPRO TRIAL

You have accessJournal of UrologySexual Function/Dysfunction: Evaluation1 Apr 2016MP47-02 SEXUAL FUNCTION AFTER HYPOFRACTIONATED VERSUS CONVENTIONALLY FRACTIONATED RADIOTHERAPY FOR PROSTATE CANCER: RESULTS OF THE PROSPECTIVE, RANDOMIZED PHASE 3 HYPRO TRIAL Ruud Wortel and Luca Incrocci Ruud WortelRuud Wortel More articles by this author and Luca IncrocciLuca Incrocci More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.02.321AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Oncologic outcomes following hypofractionated radiotherapy (19x 3.4 Gy) for prostate cancer are comparable to conventionally fractionated treatment (39x 2 Gy). Hypofractionated radiotherapy is delivered in less fractions, offering economic and logistical advantages. The effects of hypofractionation on sexual function, however, are unknown. Here, we present results on sexual function from the Dutch randomized HYPRO trial. METHODS Between 2007-2010, we conducted a multicenter phase 3 trial, including men with intermediate-to high risk localized T1b-4NX-0MX-0 prostate cancer. Patients were randomized (1:1) to conventional treatment (39x 2 Gy in 8 weeks) or hypofractionated treatment (19x 3.4 Gy in 6.5 weeks), in order to compare both regimens with respect to the relapse rate. Sexual function was assessed at baseline, and at 6, 12, 24 and 36 months after radiotherapy using the International Index of Erectile Function (IIEF). Patients were included if they returned the baseline IIEF and ≥1 during follow-up. IIEF domains (erectile function (EF), orgasmic function, sexual desire, intercourse- and overall satisfaction) were compared between treatment arms using the independent t-test. The minimal clinically important difference (MCID) for the EF domain is 4. We used this MCID cut-off value to calculate the prevalence of ″erectile deterioration,″ which we defined as an EF score during follow-up of ≥4 below baseline, among the sexually active men. RESULTS Of the enrolled 820 patients, 671 men returned the required questionnaires and were included in this analysis. Mean age at inclusion was 70 years. Hormone therapy was prescribed to 432 patients (64%). Fifty-one patients died during follow-up. The IIEF at 36 months was completed by 67% (n=413). Mean EF scores (Fig. 1, solid lines), and other IIEF domains scores decreased during the first 12 months, but subsequently stabilized. No significant differences between treatment arms were found at any point. EF scores in hormone-naive patients (n=239) (Fig. 1, dotted lines) were comparable at all times, whereas orgasmic function scores were significantly higher in patients treated with hypofractionation at 24 (p=0.048) and 36 months (3.81 vs. 2.40, p=0.043). Among sexually active men (n=326), ″erectile deterioration″ rates ranged from 59-65% during follow-up, and were comparable between both arms. CONCLUSIONS Sexual function following hypofractionated radiotherapy (19x 3.4 Gy) is comparable to conventional treatment (39x 2Gy). © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e626-e627 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Ruud Wortel More articles by this author Luca Incrocci More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Safety and Efficacy of Prostate Artery Embolization in Small-Volume Benign Prostatic Hyperplasia

Purpose Traditional urologic surgery of small-volume benign prostatic hyperplasia (BPH) is associated with high failure rates and complications such as bladder neck strictures and contractures. While prostate artery embolization (PAE) is postulated to be effective secondary to gland size reduction, we hypothesize that it may be equally effective in patients with small volume glands. We present our experience of PAE in prostate sizes Material and Methods An Institutional Review Board approved a retrospective study of 78 consecutive PAE patients from January 2011 to July 2014. Patients were evaluated at baseline, 1, 3, and 6 months with the American Urological Association (AUA-SI) symptom index including quality of life-related symptoms (QoL), International Index of Erectile Function (IIEF), and prostate imaging (magnetic resonance imaging, ultrasound, or computed tomography at baseline). Analysis was performed for each stratified group (Group 1, prostate volume 50 cc) individually from baseline to 1, 3, and 6 months and between groups at each follow-up to assess for differences in outcome. Results There were no significant differences in baseline age, AUA score, QoL, or IIEF between groups (mean age 65.2 years, 26.4 AUA, 4.9 Qol, 14 IIEF; n = 78). Baseline volumes were: group 1 (37.5 cc, 25.9 to 48.0 cc, n = 16) and group 2 (108.5 cc, 52.0 to 274.0 cc, n = 62 }. Technical success was achieved in 16/16 patients in Group 1 and 59/62 in Group 2, with 2 unilateral embolizations and 1 unsuccessful secondary to bilateral atherosclerotic occlusion in the latter group. A statistically significant reduction in AUA was achieved in both groups from baseline to 1, 3 and 6 months (n = 77): Group 1: Baseline 27.2 to 12.7, 12.0, and 11.2 at 1, 3, and 6m (p Conclusions PAE appears to offer similar positive clinical benefits to 6 months in patients with small-volume BPH. This may offer crucial benefit to those patients with limited surgical options. Future study aimed at evaluating recurrence rates is suggested.

Nightly vs on‐demand sildenafil for penile rehabilitation after minimally invasive nerve‐sparing radical prostatectomy: results of a randomized double‐blind trial with placebo

To clarify the role of phosphodiesterase type 5 (PDE5) inhibitors in post-prostatectomy penile rehabilitation (PPPR). To compare nightly and on-demand use of PDE5 inhibitors after nerve-sparing minimally invasive radical prostatectomy (RP). We conducted a single-institution, double-blind, randomized controlled trial of nightly vs on-demand 50-mg sildenafil citrate after nerve-sparing minimally invasive RP. A total of 100 preoperatively potent men, aged <65 years, with scores on the Erectile Function domain of the International Index of Erectile Function (IIEF-EF) ≥26, underwent nerve-sparing surgery. The patients were randomized to either nightly sildenafil and on-demand placebo (nightly sildenafil group), or on-demand sildenafil and nightly placebo (on-demand sildenafil group; maximum on-demand dose six tablets/month) for 12 months. Patients then underwent a 1-month washout period. Validated measures of erectile function (IIEF-EF score and the Expanded Prostate Cancer Index Composite [EPIC]) were compared between treatment groups over the entire 13-month time course, using multivariable mixed linear regression models. The treatment groups were well matched preoperatively (mean age 54.3 vs 54.6 years, baseline IIEF-EF score 29.4 vs 29.3, for the nightly vs the on-demand sildenafil groups, respectively). No significant differences were found in erectile function between treatments (nightly vs on-demand sildenafil) at any single timepoint after RP, after adjusting for potential confounding factors. When evaluated over all timepoints simultaneously, no significant effects of treatment group (nightly vs on-demand sildenafil) were found on recovery of potency, as assessed by absolute IIEF-EF scores (P = 0.765), on percentage of men returning to an IIEF-EF score >21 (P = 0.830), or on IIEF-EF score recovery to a percentage of baseline value (P = 0.778). When evaluated over all timepoints simultaneously, no significant effects of treatment group were found on secondary endpoints such as assessment of potency (including EPIC item 59 response 'erections firm enough for intercourse'), attempted intercourse frequency or confidence. Erectile recovery up to 1 year after RP does not differ between previously potent men who use sildenafil nightly compared to on-demand. This trial does not support chronic nightly sildenafil as being any better than on-demand sildenafil for use in penile rehabilitation after nerve-sparing minimally invasive RP.

Weight loss is a major contributor to improved sexual function after bariatric surgery

The relative contribution of anthropometric, hormonal, and metabolic changes after bariatric surgery (BS) on sexual function (SF) in severely obese subjects is not well established. Prospective observational case series study of 39 men undergoing BS. SF was assessed by means of the international index of erectile function (IIEF) before and at 1 year after surgery. At the same time points, anthropometric (body mass index, waist circumference), hormonal (testosterone, sex hormone binding globulin, estradiol, gonadotropins, inhibin B, prolactin, leptin), and metabolic parameters (insulin sensitivity, C-reactive protein, lipid profile, hemoglobin A1c, presence of hypertension or sleep apnea) were assessed. BS was associated with marked weight loss (77.18% excess weight loss), improved IIEF score (baseline: 54.85 ± 16.59, 1 year: 61.21 ± 14.10; p < 0.01), gonadal function (testosterone: baseline 256.36 ± 120.98, 1 year: 508.01 ± 161.90; p < 0.001), and improved metabolic profile. However, on multivariate regression analysis whereas changes in body mass index (beta: -0.677, p = 0.001), and baseline IIEF score (beta: -0.397, p = 0.023), were independent predictors of the changes in the IIEF score at 1 year after surgery, changes in hormonal and metabolic factors were not. Variables in the model accounted for 66% of the postsurgical variation in the IIEF score. Similar results were found when the different IIEF-sexual domains were evaluated, except for intercourse satisfaction for which no independent predictor was identified. Weight loss's beneficial effects on SF occurring after BS are beyond the parallel improvement in gonadal and metabolic profiles.

Erectile function, incontinence, and other quality of life outcomes following proton therapy for prostate cancer in men 60 years old and younger

BACKGROUNDThis study sought to evaluate patient-reported health-related quality of life following proton therapy for prostate cancer in men ≤60 years old.METHODSBetween August 2006 and January 2010, 262 hormone-naive men ≤60 years old were treated with definitive proton therapy for prostate cancer. Before treatment and every 6 months after treatment, patients filled out the Expanded Prostate Index Composite (EPIC) and the International Index of Erectile Function (IIEF) questionnaires. Potency was defined as successful sexual intercourse in the prior month or an EPIC sexual summary (SS) score ≥60.RESULTSMedian follow-up was 24 months; 90% of men completed follow-up EPIC forms within the last year. For EPIC urinary, bowel, and hormone subscales, the average decline from baseline to 2 years was ≤5 points, except for bowel function (5.2 points). SS scores declined 12.6 points after 2 years. Potency rates declined by 11% from baseline at 2 years, but 94% of men were potent with a baseline IIEF > 21, body mass index < 30, and no history of diabetes. At 2 years after treatment, only 1.8% of men required a pad for urge incontinence. On multivariate analysis, factors associated with a significant decline in SS score were mean penile bulb dose ≥40 cobalt Gy equivalents (P = .012) and radiation dose ≥80 cobalt Gy equivalents (P = .017); only diabetes was significantly associated with impotence (P = .015).CONCLUSIONSYoung men undergoing proton therapy for treatment of prostate cancer have excellent outcomes with respect to erectile dysfunction, urinary incontinence, and other health-related quality of life parameters during the first 2 years after treatment. Longer follow-up is needed to confirm these findings. Cancer 2012. © 2012 American Cancer Society.

Testosterone Gel Replacement Improves Sexual Function in Depressed Men Taking Serotonergic Antidepressants: A Randomized, Placebo-Controlled Clinical Trial

Testosterone replacement is the most effective treatment for sexual dysfunction in hypogonadal men. Comorbid depression and antidepressant side effects may reduce its influence. The authors conducted a 6-week, double-blind, placebo-controlled clinical trial of testosterone gel versus placebo gel in men with major depressive disorder who were currently taking a serotonergic antidepressant and exhibited low or low-normal testosterone level. A total of 100 men were enrolled at 2 study sites (Boston, Massachusetts, USA, and Tel Aviv, Israel). The effects of testosterone augmentation on sexual functioning were determined using domain scores on the International Index of Erectile Function (IIEF). Complete pre- and posttrial IIEF data were available for 63 subjects. Men randomized to testosterone (n = 31) and placebo (n = 32) were similar in age, baseline testosterone levels, and baseline IIEF scores. At study termination, men randomized to placebo showed virtually no change from baseline in mean (95% CI) IIEF score (−0.7 [−6.5, 5.2]), whereas those receiving testosterone exhibited a substantial increase (15.8 [8.5, 23.1]). The estimated mean difference between groups was 16.8 [7.5, 26.1]; p = .001 by linear regression with adjustment for age and study site. There were also significant between-group differences in each of the 5 IIEF subscales, as well as on the single question involving ejaculatory ability (p ≤ .03 in all cases). Effect sizes in these comparisons remained little changed, and generally remained statistically significant, when we further adjusted for change in depression scores on the Montgomery Asberg Depression Rating Scale. It is notable that the subgroup of men with the highest baseline testosterone levels showed virtually the same improvement as those with lower levels, suggesting that the observed improvement was unlikely to be due simply to correction of hypogonadism alone. In depressed men with low or low-normal testosterone levels who continued to take serotonergic antidepressants, treatment with exogenous testosterone was associated with a significant improvement in sexual function, particularly including ejaculatory ability.

Prospective evaluation of sexual function after open and laparoscopic surgery for rectal cancer

Sexual function may be harmed after treatment for rectal cancer. This study aimed to evaluate prospectively the incidence of sexual dysfunction after rectal cancer treatment and to compare the effects of laparoscopic and traditional open approaches in terms of postoperative sexual function. Baseline and 3-, 6-, and 12-month assessments of sexual dysfunction using the International Index of Erectile Function (IIEF) and its specific domains prospectively took place for 56 patients who underwent rectal cancer surgery (38 open vs. 18 laparoscopic procedures, 38 low anterior vs. 18 abdominoperineal resections). The preliminary results are presented. The average total IIEF and isolated IIEF response domain scores were significantly decreased after surgery (p < 0.01) except for the intercourse satisfaction and overall satisfaction scores at 12 months. An improvement in IIEF scores was observed between the 3- and 6-month assessment points (p < 0.01) except for the erectile function and orgasmic function scores. No significant differences were observed between the open and laparoscopic groups in the total IIEF and domain scores preoperatively and at the 3- and 6-month assessment points. The rates of sexual dysfunction did not differ significantly preoperatively or at 3 months postoperatively when open and laparoscopic procedures were compared, although there was a trend in favor of laparoscopic surgery at 6 months (p = 0.076). The baseline IIEF score and the baseline, 3-, and 6-month sexual desire scores were better (p = 0.035, 0.004, 0.017, and 0.061, respectively) in the low anterior resection group than in the abdominoperineal resection group. Rectal cancer resections were postoperatively associated with a significant reduction in IIEF scores and high rates of sexual dysfunction at 3 and 6 months. The IIEF and domain scores at different assessment points were comparable between the laparoscopic and open surgery groups. Extending the monitoring period and adding more patients in this ongoing prospective study will further elucidate postoperative sexual dysfunction after rectal cancer surgery.

Renal Transplantation Does Not Improve Erectile Function in Hemodialysed Patients

BackgroundEffects of renal transplantation (RT) on erectile dysfunction (ED) is a controversial issue. ObjectiveTo verify the efficacy of RT in restoring erectile function (EF) in hemodialysed patients. Design, setting, and participantsWe conducted a prospective, interventional, nonrandomised study from September 2001 to September 2005 on 78 hemodialysed male patients undergoing RT. EF was evaluated during the baseline visit and 1 yr after RT, using the International Index of Erectile Function (IIEF) questionnaire. A subanalysis was performed by splitting the total cohort into two age groups: <45 yr and ≥45 yr. InterventionRT was performed. MeasurementsEF was evaluated using the IIEF scoring system. Results and limitationsBefore RT, 68 patients with a mean total IIEF score of 42.46 complained about ED. One year after RT, 71 patients reported ED, and the mean total IIEF score had decreased to 39.97. The mean pre-RT IIEF EF domain score was 18.48, and it decreased to 17.55 after RT. Patients aged ≥45 yr reported no significant variations in any IIEF domain, while patients aged <45 yr reported a significant decrease in mean total IIEF score due to variations in domain scores for erectile function, sexual desire, and overall satisfaction. In the younger age group, we found significant differences between baseline and post-RT IIEF scores in dyslipidaemic patients and in those patients using immunosuppressive (methylprednisolone and cyclosporin) or antihypertensive (ACE-inhibitors, β-blockers, and Ca-antagonists) drugs. The main limitations were the absence of any aetiological characterisation of ED and the small number of patients. ConclusionsAfter RT, EF worsens in patients <45 yr but is not modified in patients ≥45 yr.

Effect of correcting serum cholesterol levels on erectile function in patients with vasculogenic erectile dysfunction

This study evaluated the effect of correction of serum cholesterol levels on erectile function and sildenafil treatment in patients with erectile dysfunction who have only hypercholesterolaemia as a risk factor for erectile dysfunction. Twenty-five patients with a single risk factor (hypercholesterolaemia, serum cholesterol > 200 mg/dl) for erectile dysfunction were included in the study. The patients were recommended to take sildenafil (minimum two 100 mg tablets/week) 1 h before sexual intercourse for 4 weeks. After 1 month washout period, the patients received a single dose of atorvastatin 10 mg/day for 1 month. Similarly, after a 1 month washout period, atorvastatin 10 mg/day and sildenafil (minimum two 100 mg tablets/week) were administered for 1 month as combination therapy. Erectile function was evaluated before and after all treatment regimens using the International Index of Erectile Function (IIEF). Following each treatment modality mean IIEF scores were significantly higher than baseline IIEF scores (p < 0.01). The IIEF score after sildenafil treatment was significantly higher than in the atorvastatin treatment group (p < 0.01); and the IIEF score after combined treatment was significantly higher than in the sildenafil and atorvastatin treatment groups. Correction of serum cholesterol levels with atorvastatin could improve erectile function in patients who have only hypercholesterolaemia as a risk factor for erectile dysfunction. Furthermore, atorvastatin could improve sildenafil's effects on erectile function in hypercholesterolaemic patients with erectile dysfunction.

Efficacy and Safety of Tadalafil in Men With Erectile Dysfunction Following Spinal Cord Injury

To determine the efficacy and safety of tadalafil when taken on demand by men with erectile dysfunction (ED) secondary to traumatic spinal cord injury (SCI). Multicenter, randomized, double-blind, placebo-controlled, flexible dose-titration, parallel-group study in clinical practices in Europe. Patients Enrolled patients had ED secondary to SCI (all spinal levels) and sustained 6 months or longer before visit 1. After a 4-week run-in period, patients were randomly assigned to tadalafil, 10 mg, (n = 142) or placebo (n = 44) for a 12-week, on-demand treatment period with assessments at 4-week intervals. The dose of tadalafil was maintained or titrated (10 or 20 mg) at 4 and 8 weeks. Efficacy was measured using the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and Global Assessment Question (GAQ). Treatment-emergent adverse events and vital signs were collected at each visit. Mean age was 38 years. Mean baseline IIEF erectile function domain score was 13.4, and following 12 weeks of treatment, 22.6 for tadalafil and 13.6 for placebo (P < .001). After treatment, the tadalafil group compared with the placebo group was significantly greater (P < .001) in mean per-patient percentage of successful penetration attempts (SEP question 2; 75.4% vs 41.1%) and intercourse attempts (SEP question 3; 47.6% vs 16.8%); percentage of improved erections (GAQ question 1; 84.6% vs 19.5%); and ejaculatory frequency (IIEF question 9; P = .03). The 2 most common treatment-emergent adverse events in the tadalafil group compared with placebo were headache (8.5% vs 4.5%) and urinary tract infection (7.7% vs 6.8%). Tadalafil (10 mg and 20 mg) improved erectile function and was well tolerated by men with ED secondary to traumatic SCI.