Comorbid Erectile Dysfunction Research Articles

Evaluation of the Efficacy and Safety of On-Demand Tadalafil Alone or Combined With Lidocaine Spray for Treating Patients With Comorbid Erectile Dysfunction and Premature Ejaculation: A Randomized Controlled Trial

Background To evaluate the efficacy and safety of on-demand 20 mg tadalafil alone or combined with lidocaine spray for treating patients with comorbid erectile dysfunction (ED) and premature ejaculation (PE). Methods This randomized controlled trial included 98 patients with comorbid ED and PE, randomly assigned to the experimental group (n = 50, tadalafil alone) or the active control group (n = 48, tadalafil combined with lidocaine spray). Patients took tadalafil 30 min before sexual intercourse, while the combination therapy group also used lidocaine spray 5 min before intercourse. After 12 weeks of treatment, changes in the International Index of Erectile Function (IIEF-5), Chinese Index of Premature Ejaculation (CIPE-5), Intravaginal Ejaculatory Latency Time (IELT), and Sexual Satisfaction Score (SSS) were evaluated. Results Both groups showed significant improvement in IIEF-5 scores, but the difference between groups was not significant (F = 0.89, p = 0.45). The active control group showed significant improvement in CIPE-5 scores (p < 0.001), while the experimental group showed no significant change (p > 0.05). IELT in the active control group increased significantly from 25.7 s to 198.6 s (Z = 6.03, p < 0.001), while the experimental group showed no significant change (Z = 0.74, p = 0.46). SSS improved significantly in the active control group (p < 0.001) but not in the experimental group (p > 0.05). The incidence of adverse events was similar in both groups (14% vs 20.8%, p = 0.575). Conclusion Tadalafil combined with lidocaine spray is superior to tadalafil alone in improving symptoms, prolonging IELT, and enhancing sexual satisfaction in patients with comorbid ED and PE, with comparable safety. This combination therapy provides a new approach for improving treatment strategies for patients with comorbid ED and PE. Large-scale, multi-center randomized controlled trials are needed to further validate these findings.

Evaluation of efficacy and safety of low-intensity pulsed ultrasound in patients with concurrent erectile dysfunction and chronic prostatitis/chronic pelvic pain syndrome: a prospective, randomized controlled study

ObjectiveThe primary objective of this clinical trial is to investigate the effect of low-intensity pulsed ultrasound (LIPUS) on patients suffering from comorbid erectile dysfunction (ED) and chronic prostatitis/chronic pelvic pain syndrome(CP/CPPS).MethodsThe clinical trial was conducted in the andrology outpatient treatment room of the Department of Urology, Xiangya Hospital, Central South University from August to November 2022 A total of 60 patients who met the research criteria for comorbid ED combined with CP/CPPS were recruited and randomly assigned to three treatment groups. They were treated with LIPUS (Group A), drug therapy(Group B), and LIPUS combined with drug therapy (Group C), respectively. Each group comprised 20 patients. Statistical analysis was performed on the five-item version of International Index of Erectile Function (IIEF-5), Erection Hardness Score (EHS), National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI), the nine-item Patient Health Questionnaire (PHQ-9), the seven-item Generalized Anxiety Disorder Scale (GAD-7), and the incidence of adverse events to comprehensively evaluate the efficacy and safety of LIPUS.ResultsThe positive response rate of ED and CP/CPPS treatment in Group A is 40%(8/20) and 45%(9/20), while those in Group B is 55%(11/20) and 60%(12/20), and those in Group C is 85%(17/20) and 85%(17/20). A notable increase in IIEF-5 scores was observed across the three groups post-treatment (10.45 ± 2.50 vs. 13.65 ± 3.03, P = 0.008; 11.80 ± 3.21 vs. 16.40 ± 3.20, P = 0.011; 12.90 ± 3.92 vs. 19.40 ± 2.35, P = 0.042) with a concomitant significant decrease in NIH-CPSI scores (16.75 ± 4.53 vs. 14.65 ± 4.51, P = 0.016; 16.35 ± 4.32 vs. 12.20 ± 4.74, P = 0.007; 16.00 ± 4.40 vs. 8.15 ± 4.28, P = 0.021). Notably, the most pronounced changes were seen in the group receiving LIPUS combined with tadalafil and doxazosin. Additionally, all groups exhibited marked improvements in anxiety and depression symptoms post-treatment. No adverse events were observed during treatment.ConclusionLIPUS can improve erectile function and CP/CPPS symptoms with good safety, and LIPUS combined with tadalafil and doxazosin is more effective during the treatment. However, its long-term efficacy remains to be seen.Trial RegistrationChinese Clinical Trial Registry; approval number: ChiCTR2200063038 (https://www.chictr.org.cn/) on August 29, 2022.

Self-reported reasons for having difficulty reaching orgasm in men with diverse etiologies

Abstract Background Difficulty reaching orgasm/ejaculation during partnered sex, a primary characteristic of delayed or absent ejaculation, affects about 5% to 10% of men, but the reasons underlying this problem are poorly understood. Aim The study sought to gain insight into possible etiologies of delayed ejaculation by assessing men’s self-perceptions as to why they experience difficulty reaching orgasm. Methods We drew 351 men reporting moderately severe to severe difficulty reaching orgasm during partnered sex from a sample of over 3000 respondents obtained through an online survey. As part of the 55-item survey, participants responded to 2 questions asking about their self-perceived reasons for having difficulty reaching orgasm and selected from a list of 14 options derived from the research literature, a series of men’s focus groups, and expert opinion. The first question allowed respondents to select all the reasons that they felt contributed to the problem, the second to select only the most important reason. In addition, both men with and without comorbid erectile dysfunction were investigated and compared. Outcomes Hierarchical ordering of men’s self-pereceived reasons for having difficulty reaching orgasm, including typal reasons established through principal component analysis. Results The major reasons for difficulty were related to anxiety/distress and lack of adequate stimulation, with relationship and other factors endorsed with lower frequency. Further exploration using principal components analysis identified 5 typal reasons, in descending order of frequency: anxiety/distress (41%), inadequate stimulation (23%), low arousal (18%), medical issues (9%), and partner issues (8%). Few differences emerged between men with and without comorbid ED other than ones related to erectile problems, such as higher level of endorsement of medical issues. Typal reasons showed correlations, albeit mostly weak, with a number of covariates, including sexual relationship satisfaction, frequency of partnered sex, and frequency of masturbation. Clinical Implications Until supplemental medical treatments for delayed ejaculation are developed and approved, a number of men’s purported reasons for difficult or absent ejaculation/orgasm—anxiety/distress, inadequate stimulation, low arousal, relationship issues—fall into areas that can be addressed in couples counseling by a trained sex therapist. Strengths and Limitations This study is unique in scope and robust in sample size. Drawbacks include those associated with online surveys, including possible bias in sample selection, limitation to Western-based samples, and the lack of differentiation between men with lifelong and acquired difficulty. Conclusion Men who have difficulty reaching ejaculation/orgasm identify putative reasons for their problem, ranging from anxiety/stress, inadequate stimulation, and low arousal to partner issues and medical reasons.

Characteristics of men who report symptoms of delayed ejaculation: providing support for empirically derived diagnostic criteria.

Little is known regarding the demographic, sexual, and relationship characteristics of men with symptoms of delayed ejaculation (DE). To identify differences between men with and without DE symptomology to validate face-valid diagnostic criteria and to identify various functional correlates of DE. A total of 2679 men meeting inclusion criteria were partitioned into groups with and without DE symptomology on the basis of their self-reported "difficulty reaching ejaculation/orgasm during partnered sex." Men were then compared on a broad array of demographic and relationship variables, as well as sexual response variables assessed during partnered sex and masturbation. Outcomes included the identified differences between men with and without DE symptomology. Men with DE-whether having comorbid erectile dysfunction or not-differed from men without DE on 5 face-valid variables related to previously proposed diagnostic criteria for DE, including ones related to ejaculation latency (P < .001); self-efficacy related to reaching ejaculation, as assessed by the percentage of episodes reaching ejaculation during partnered sex (P < .001); and negative consequences of the impairment, including "bother/distress" and (lack of) "orgasmic pleasure/sexual satisfaction" (P < .001). All such differences were associated with medium to large effect sizes. In addition, men showed differences on a number of functional correlates of DE, including anxiety, relationship satisfaction, frequency of partnered sex and masturbation, and level of symptomology during partnered sex vs masturbation (P < .001). Face-valid criteria for the diagnosis of DE were statistically verified, and functional correlates of DE relevant to guiding and focusing treatment were identified. In this first comprehensive analysis of its kind, we have demonstrated widespread differences on sexual and relationship variables relevant to the diagnosis of DE and to its functional correlates between men with and without DE symptomology during partnered sex. Limitations include participant recruitment through social media, which likely biased the sample; the use of estimated rather than clocked ejaculation latencies; and the fact that differences between men with acquired and lifelong DE were not investigated. This well-powered multinational study provides strong empirical support for several face-valid measures for the diagnosis of DE, with a number of explanatory and control covariates that may help shed light on the lived experiences of men with DE and suggest focus areas for treatment. Whether or not the DE men had comorbid erectile dysfunction had little impact on the differences with men having normal ejaculatory functioning.

Premature Ejaculation Measures During Partnered Sex and Masturbation: What These Findings Tell Us About the Nature and Rigidity of Premature Ejaculation

Men with premature ejaculation (PE) during partnered sex (as defined by poor ejaculatory control) show significantly reduced PE symptomology during masturbation, but the reasons for this disparity are not clear. This study investigated the other two PE-related diagnostic criteria, namely ejaculatory latency (EL) and bother/distress, in order to explore possible explanations for this disparity between types of sexual activity. Specifically, 1,447 men with either normal or poor ejaculatory control were compared on EL parameters, bother/distress, and sexual satisfaction/pleasure during both partnered sex and masturbation. Results indicated that men with PE reported longer ELs during masturbation than partnered sex, in contrast with men without PE who reported shorter ELs during masturbation. Bother/distress was lower for both groups during masturbation, but bother/distress in men with PE during masturbation was comparable to that of men without PE during partnered sex. Minimal difference in these patterns was found across lifelong and acquired PE subtypes, whereas men with PE with comorbid erectile dysfunction appeared to represent a distinct group. These findings have implications for PE management or treatment as well as for the overall conceptualization of PE as a pathophysiological condition.

A Cross-Sectional Observational Study on the Coexistence of Erectile Dysfunction and Premature Ejaculation.

IntroductionThe interplay between erectile dysfunction (ED) and premature ejaculation (PE) needs more studies to clarify.AimTo evaluate the risk factors and temporal relationship for the coexistence of ED and PE.MethodsThe data were derived from clinical history.Main Outcome MeasureThe diagnosis of ED and PE was based on self-report and validated questionnaires.ResultsBased on the chief complaint, 1,893 participants were recruited as ED group and 483 participants as PE group from 2014 to 2020. One third of ED and PE groups reported comorbid PE and ED. Of the ED group, 4.1% (n = 77) had lifelong PE, 18.0% (n = 341) had acquired PE and 9.7% (n = 184) had subjective or natural variable PE. Of the PE group, ED was reported in 22.0% (n = 40) of lifelong PE, 33.9% (n = 65) of acquired PE, and 37.6% (n = 41) of subjective or natural variable PE, P < .01. With adjustment of potential confounders, the ED severity was associated with increased risk of acquired PE, while acquired PE was associated with higher risk of ED than lifelong PE. In cases of comorbid lifelong PE and ED (n = 117), 22.2% reported the onset of both dysfunctions being about the same time, whereas 77.8% reported ED occurred behind PE with an average 23.3 years lag. In cases of comorbid acquired PE and ED (n = 406), 52.2% reported the onset of both dysfunctions being about the same time, 34.2% reported ED happened behind PE and 13.5% reported PE emerged behind ED.ConclusionOrganic pathogenesis was least likely to be responsible for the link between PE and ED. When acquired PE and ED coexist, treating ED first or concomitantly according to their temporal order is an appropriate management algorithm.Chieh‑Wen Chin, Chia Mu Tsai, Jen-Tai Lin, et al. A Cross-Sectional Observational Study on the Coexistence of Erectile Dysfunction and Premature Ejaculation. Sex Med 2021;9:100438.

Validity of Erectile Function Assessment Questionnaires in Premature Ejaculation Patients: A Comparative Study Between the Abridged Forms of the International Index of Erectile Function and Proposal for Optimal Cutoff Redefinition

BackgroundPatients with premature ejaculation (PE) are often diagnosed as having a comorbid erectile dysfunction (ED). When evaluating erectile function in PE patients with the popular International Index of Erectile Function-5 (IIEF-5, or Sexual Health Inventory for Men [SHIM]), question #5 (Q5) about sexual satisfaction in the intercourse often lowers the total score of the questionnaire, giving false-positive results for the presence of ED. AimWe aimed to compare SHIM with the other abridged form of IIEF, which is IIEF-EF, and to discriminate which tool has the best diagnostic accuracy in the evaluation of erectile function in PE patients. MethodsThe study was conducted from March 2019 to January 2020. A total of 189 heterosexual males with lifelong PE (117, 61.9%) or acquired PE (72, 38.1%) were included. They all compiled Premature Ejaculation Diagnostic Tool, IIEF-15, SHIM, and IIEF-EF and underwent a full clinical examination to evaluate their erectile function. OutcomesThe scores of the 2 erectile function assessment questionnaires (SHIM and IIEF-EF) were compared in terms of their sensitivity and specificity in the diagnosis of ED in PE patients. ResultsIn terms of diagnosing ED in PE patients, the sensitivity of SHIM is 100% while the specificity is only 36%; meanwhile, the sensitivity of IIEF-EF is 100% but specificity is 77.2%. Further analysis demonstrates that decreasing cutoff of SHIM to 17.5 would provide an increased specificity of 82.5%, while sensitivity would lower to 96.0%. However, the highest area under the curve (0.966 vs 0.941) is given by the IIEF-EF with 100% sensitivity and 80.7% specificity at the cutoff of 24.5, which is one point lower than the usual cutoff value of 25.5. Clinical ImplicationsOur study suggests that when evaluating erection function in PE patients, the cutoff of both SHIM and IIEF-EF should be amended. Strengths & Limitations.We proposed the solution for the bias of erectile function assessment in PE patients. However, other trials are needed to further validate in larger cohorts of PE patients. ConclusionWe suggest that the cutoff of SHIM and IIEF-EF should be amended (SHIM at 17.5 and IIEF-EF at 24.5, respectively) when assessing erectile function among PE population.Y Xi, E Colonnello, G Ma1, et al. Validity of Erectile Function Assessment Questionnaires in Premature Ejaculation Patients: A Comparative Study Between the Abridged Forms of the International Index of Erectile Function and Proposal for Optimal Cutoff Redefinition. J Sex Med 2020;XX:XXX–XXX.

Comparative Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil versus Tadalafil alone for BPH Patients with Lower Urinary Tract Symptoms and Erectile Dysfunction

Abstract Background benign prostatic hyperplasia (BPH) is a disorder histologically characterized as the nonmalignant hyperplasia of prostatic cells. Most of patients with benign prostate hyperplasia present with lower urinary tract symptoms (LUTS). Aim of the Study to assess the efficacy and safety of fixed-dose combinations therapy of Tamsulosin &amp; Tadalafil versus Tadalafil alone in treatment for BPH patient with lower urinary tract symptoms (LUTS) and erectile dysfunction (ED). Patients and Methods this is a randomized controlled clinical study at Urology Department, Faculty of Medicine, Ain Shams University (El Demerdash Hospital) &amp; Damanhour National Institute Hospital from 1-1-2018 till 1-9-2018. It concluded men of 45 years old or older with a history of LUTS secondary to BPH of at least 6 months were eligible for this study. Patients agreed not to use BPH medications during the research other than the study medications. Results the study showed that the fixed-dose combinations of Tamsulosin and Tadalafil significantly improve IPSS score and Qmax more than with Tadalafil 5 mg/day alone. Furthermore, PVRU significantly decreased with the fixed-dose combinations of Tamsulosin and Tadalafil more than with Tadalafil alone. Fixed-dose combinations of Tamsulosin 0.4 mg plus Tadalafil 5 mg were determined to be safe, efficacious, and well tolerated in the subjects investigated, which suggests the new fixed-dose combinations therapy can offer clinically relevant benefits for patients with LUTS complaints and desiring amelioration for comorbid ED complaints. Conclusion the study shows that the fixed- dose combination of Tamsulosin 0.4 mg/day and Tadalafil 5 mg/day are significantly superior to Tadalafil 5 mg/day alone for the treatment of BPH patients with LUTS and non-inferiority in treatment of ED Without showing any clinically significant safety issues, supporting favorable benefit-risk balance of the fixed-dose combinations of therapy for the treatment of BPH patients with LUTS and ED because of its synergistic effects, well toleration and its safety.

Epidemiology Update of Erectile Dysfunction in Eight Countries with High Burden.

Prior epidemiology studies on erectile dysfunction (ED) have varied in geography/place, time period, and methodology. Due to this variability, comparisons of data across studies are greatly limited. Additionally, little is known about the rates of comorbid ED and benign prostatic hyperplasia (BPH). To update the prevalence of ED and patient characteristics using a single methodology in 8 countries: Brazil, China, France, Germany, Italy, Spain, the United Kingdom, and the United States. This retrospective cross-sectional study included men (≥18 years) who self-reported experiencing difficulty in achieving or maintaing an erection in the past 6 months in the 2015 and 2016 National Health and Wellness Surveys (N= 97,159). Pairwise comparisons between the United States and each of the other countries were performed among respondents with ED and no BPH, aged ≥18 years, and within the subset of men aged 40-70 years. ED prevalence (with BPH, with no BPH, and overall), health characteristics, and ED risk factors were assessed. ED with BPH was found to be < 6.0% in all countries. ED prevalence overall varied from 37.2% (Brazil) to 48.6% (Italy). Similar patterns were observed for the subset of men aged 40-70 years. Patients in Brazil were younger (aged ≥18: 43.85 vs. 52.35; aged 40-70: 52.94 vs. 56.76 years; for both, P < .05) than those in the United States. ED-related comorbidities were more common in European countries, comparatively. This study provides an important update and outlook to ED epidemiology in Brazil, China, France, Germany, Italy, Spain, the United Kingdom, and the United States. Overall, ED prevalence is high, relative to some previous estimates. Findings from this study highlight the continued burden ED plays in the lives of men in these countries. Goldstein I, Goren A, Li VW, etal. Epidemiology Update of Erectile Dysfunction in Eight Countries with High Burden. Sex Med Rev 2020;8:48-58.

F124EPIGENETIC AGING IN BLOOD IS AFFECTED IN SCHIZOPHRENIA

Patients with premature ejaculation (PE) are often diagnosed as having a comorbid erectile dysfunction (ED). When evaluating erectile function in PE patients with the popular International Index of Erectile Function-5 (IIEF-5, or Sexual Health Inventory for Men [SHIM]), question #5 (Q5) about sexual satisfaction in the intercourse often lowers the total score of the questionnaire, giving false-positive results for the presence of ED.We aimed to compare SHIM with the other abridged form of IIEF, which is IIEF-EF, and to discriminate which tool has the best diagnostic accuracy in the evaluation of erectile function in PE patients.The study was conducted from March 2019 to January 2020. A total of 189 heterosexual males with lifelong PE (117, 61.9%) or acquired PE (72, 38.1%) were included. They all compiled Premature Ejaculation Diagnostic Tool, IIEF-15, SHIM, and IIEF-EF and underwent a full clinical examination to evaluate their erectile function.The scores of the 2 erectile function assessment questionnaires (SHIM and IIEF-EF) were compared in terms of their sensitivity and specificity in the diagnosis of ED in PE patients.In terms of diagnosing ED in PE patients, the sensitivity of SHIM is 100% while the specificity is only 36%; meanwhile, the sensitivity of IIEF-EF is 100% but specificity is 77.2%. Further analysis demonstrates that decreasing cutoff of SHIM to 17.5 would provide an increased specificity of 82.5%, while sensitivity would lower to 96.0%. However, the highest area under the curve (0.966 vs 0.941) is given by the IIEF-EF with 100% sensitivity and 80.7% specificity at the cutoff of 24.5, which is one point lower than the usual cutoff value of 25.5.Our study suggests that when evaluating erection function in PE patients, the cutoff of both SHIM and IIEF-EF should be amended.We proposed the solution for the bias of erectile function assessment in PE patients. However, other trials are needed to further validate in larger cohorts of PE patients.We suggest that the cutoff of SHIM and IIEF-EF should be amended (SHIM at 17.5 and IIEF-EF at 24.5, respectively) when assessing erectile function among PE population.Xi Y, Colonnello E, Ma G, et al. Validity of Erectile Function Assessment Questionnaires in Premature Ejaculation Patients: A Comparative Study Between the Abridged Forms of the International Index of Erectile Function and Proposal for Optimal Cutoff Redefinition. J Sex Med 2021;18:440–447.

Co-Morbid Erectile Dysfunction (ED) and Antidepressant Treatment in a Patient - A Management Challenge?

Throughout the world, antidepressants (AD) and phosphodiesterase-5 inhibitors (PDE-5i) are the commonly prescribed psychopharmacological agents for treating patients with co-morbid mental health problem and sexual dysfunction (SD). The serotonergic and noradrenergic ADs, although effective, are not without any SD adverse-effects, especially erectile dysfunction (ED). ED is a failure to obtain a satisfactory erection for rewarding sexual coitus during the phases of male's sexual arousal. It is recognized as an important reason why non-adherence to treatment was observed in patients who were on AD. AD intervention caused remission to some of the pre- treatment psychopathology of ED. However, in many patients, AD potentially magnified the unwanted sexual sideeffects. This made the situation challenging for the mental health professional. These challenges are based on the complexity of ED, its etiology and the associated risk factors, which further add to its AD side-effect. The neuro-psychopharmacological basis for AD treatment selection was deliberated. Bio-psycho-social interventions are recommended at two pivotal stages. Firstly, a step should be taken for proper assessment (e.g. detailed history, psychosocial and laboratory investigations); and identify few modifiable risk factors for ED and associated mental health issues. Secondly, with guidance of an algorithm pathway, a practical intervention should include strategies such as dose reduction, augmentation or changing to an AD with lesser or no sexual adverse-effects. It is recommended that bupropion and mirtazepine to be prescribed when patients develop adverse sexual effects with serotonin selective reuptake inhibitor (SSRI), serotonin norepinephrine reuptake inhibitor (SNRI) and tricyclic antidepressant (TCA). Few suggestions which may be borne in mind are revising sexual scripts and improving sexual techniques, life-style modifications, psychotherapy and other nonpharmacological approaches which may be beneficial to both patients and their partners.

140 Comparison of the Effects and Side Effects Between PDE-5 Inhibitors Combined with Dapoxetine and Single PDE-5 Inhibitor for Patients with Premature Ejaculation Comorbid Erectile Dysfunction

140 Comparison of the Effects and Side Effects Between PDE-5 Inhibitors Combined with Dapoxetine and Single PDE-5 Inhibitor for Patients with Premature Ejaculation Comorbid Erectile Dysfunction

Penile sensory thresholds in subtypes of premature ejaculation: implications of comorbid erectile dysfunction.

Penile hypersensitivity plays an important role in premature ejaculation (PE), but differences in penile sensitivity among subtypes of PE are unknown. Therefore, we compared penile sensory thresholds in PE subtypes of lifelong and acquired PE, PE with and without erectile dysfunction (ED), PE with an intravaginal ejaculation latency time ≤1 min and >1 min, and PE with and without orgasmic pleasure perceptual dysfunction. During August 2014 to January 2016, 136 patients with PE were included. Penile warm, cold, and vibratory thresholds were measured. Data of clinical characteristics, sexual life, Premature Ejaculation Diagnostic Tool (PEDT) score, and the 5-item version of the International Index of Erectile Function (IIEF-5) score were collected. Vibratory thresholds of the PE with ED group were higher in the right coronal sulcus (median amplitude: 4.92 vs 3.65 μm, P = 0.02) and the right penile shaft (median amplitude: 3.87 vs 3.30 μm, P = 0.03), while differences in penile sensory thresholds between other subtypes were not significant. The median PEDT score was lower in the PE without ED group (12 vs 14, P < 0.001). The IIEF-5 and PEDT scores were negatively correlated (r = −0.29, P < 0.001). Patients with orgasmic pleasure perceptual dysfunction had a lower median IIEF-5 score (20 vs 21, P = 0.02). Patients with PE and ED had lower penile sensitivity, and ED was associated with more severe symptoms and weaker orgasmic pleasure perception. In men with PE, management of comorbid ED is necessary. In case of side effects in erectile function, topical anesthetics should be cautiously used in men with PE and ED.

Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil for Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Randomized, Double-Blinded, Active-Controlled Trial

BackgroundPhosphodiesterase type 5 inhibitors and α-adrenergic blocking agents (α-blockers) are widely used for the treatment of erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). AimsTo assess the efficacy and safety of fixed-dose combinations (FDCs) of tamsulosin and tadalafil compared with tadalafil monotherapy in patients with comorbid BPH-associated LUTS and ED. MethodsA randomized, double-blinded, active-controlled trial was conducted of 510 men with BPH-associated LUTS and ED. Patients were treated with FDCs of tamsulosin 0.4 mg plus tadalafil 5 mg (FDC 0.4/5 mg), tamsulosin 0.2 mg plus tadalafil 5 mg (FDC 0.2/5 mg), or tadalafil 5 mg for a 12-week treatment period. For a subsequent 12-week extension period, the patients were administered FDC 0.4/5 mg. OutcomesThe primary outcomes were changes from baseline in total International Prostate Symptom Score (IPSS) and International Index of Erectile Function erectile function domain (IIEF-EF) score at week 12 to prove superiority and non-inferiority of FDCs compared with tadalafil 5 mg. The safety assessments were adverse reactions, laboratory test results, and vital signs at week 24. ResultsThe mean changes in total IPSS and IIEF-EF scores were −9.46 and 9.17 for FDC 0.4/5 mg and −8.14 and 9.49 for tadalafil 5 mg, respectively, which indicated superiority in LUTS improvement (P = .0320) and non-inferiority in ED treatment with FDC 0.4/5 mg compared with tadalafil 5 mg. However, the results from FDC 0.2/5 mg failed to demonstrate superiority in LUTS improvement. No clinically significant adverse events regarding the investigational products were observed during the 24-week period. Clinical ImplicationsThe FDC 0.4/5 mg is the first combined formulation of an α-blocker and a phosphodiesterase type 5 inhibitor that offers benefits in patient compliance and as add-on therapy in patients with comorbid BPH-associated LUTS and ED. Strengths and LimitationsThe study clearly demonstrated the advantage of FDC 0.4/5 mg. The main advantage of FDC 0.4/5 mg was the enhanced efficacy on BPH-associated LUTS comorbidity with ED, the lower incidence of side effects, and the simplification and convenience of therapy, which led to better overall patient compliance. However, the lack of a tamsulosin monotherapy control group was a limitation of this study. ConclusionThe FDC 0.4/5 mg therapy was safe, well tolerated, and efficacious, indicating that combination therapy could provide clinical benefits for patients with BPH-associated LUTS complaints and ameliorate the comorbidity of ED.Kim SW, Park NC, Lee SW, et al. Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil for Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Randomized, Double-Blinded, Active-Controlled Trial. J Sex Med 2017;14:1018–1027.

Lengthening strategies for Peyronie's disease.

Loss of penile length is a common complaint of men with Peyronie’s disease (PD), both before and after corrective intervention, which has a significant negative effect on patient quality of life. We sought to identify and describe the methods by which penile length can be preserved or increased. We conducted an extensive, systematic literature review, based on a search of the PUBMED database for articles published between 1990 and 2015. Articles with the key words “Peyronie’s disease”, “penile length” and/or “penile lengthening” were reviewed if they contained subjective or objective penile length outcomes. Only English-language articles that were related to PD and penile size were included. We found no evidence in the literature that medical therapy alone increases penile length. Classic inflatable penile prosthesis (IPP) placement, plication procedures, and the Nesbit procedure appear likely to maintain or decrease penile length. Plaque incision (PI) and grafting appears likely to maintain or increase penile length, but is complicated by risk of post-operative erectile dysfunction (ED). There are several surgical procedures performed concomitantly with IPP placement that may be suitable treatment options for men with comorbid ED, and consistently increase penile length with otherwise good outcomes concerning sexual function. These include the subcoronal penile prosthesis (scIPP), Egydio circumferential technique, the sliding technique, the modified sliding technique (MoST), and the multiple slice technique (MuST). In addition, adjuvant therapies such as penile traction therapy (PTT), post-operative inflation protocols, suspensory ligament relaxation, lipectomy, and adjuvant medical therapy for glans engorgement appear to increase subjective and/or objective penile length for men at high risk of decreased penile length after PD surgery. Considering the psychological burden of length loss in men with PD, providers with adequate volume and expertise should attempt, if possible, to maintain or increase penile length for men undergoing surgical intervention. There are several evidence-based, safe, and effective ways to increase penile length for these men and multiple emerging adjuvant therapies that may help ensure adequate length.

A Pilot Study Using a Web Survey to Identify Characteristics That Influence Hypogonadal Men to Initiate Testosterone Replacement Therapy.

Men with hypogonadism (HG) who choose testosterone replacement therapy (TRT) may have distinct characteristics that provide insight as to why they may/may not initiate therapy. The aim of the current study was to identify trends in patient characteristics and attitudes in men diagnosed with HG who initiated TRT (TRT+) compared with men who were diagnosed with HG but did not initiate TRT (TRT-). The market research-based online survey conducted between 2012 and 2013 included patients from a Federated Sample, a commercially available panel of patients with diverse medical conditions. The current analysis was composed of two groups: TRT+ ( n = 155) and TRT- ( n = 157). Patient demographics, clinical characteristics, and attitudes toward HG and TRT were examined as potential predictors of primary adherence in men with HG; cohorts were compared by using Fisher's exact test. Significant associations among sexual orientation, relationship status, educational level, presence of comorbid erectile dysfunction, area of residence, and TRT initiation were present ( p ≤ .05). College-educated, heterosexual, married men with comorbid erectile dysfunction living in suburban and urban areas were more likely to initiate treatment. The most bothersome symptoms reported were lack of energy (90% vs. 81%, p = .075), decreased strength and endurance (86% vs. 76%, p = .077), and deterioration in work performance (52% vs. 31%, p = .004); lack of energy prompted men to seek help. Patients (48%) in the TRT+ group were more knowledgeable regarding HG as compared with TRT- respondents (14%, p < .001), and most men obtained their information from a health care professional (89% vs. 82%, p = .074). The current analysis identified distinct demographic and clinical characteristics and attitudes among TRT users compared with men who were diagnosed with HG yet remained untreated.

Adjuvant Maneuvers for Residual Curvature Correction During Penile Prosthesis Implantation in Men with Peyronie's Disease.

The surgical treatment of comorbid erectile dysfunction and Peyronie's disease has long included the implantation of an inflatable penile prosthesis as well as a number of adjuvant maneuvers to address residual curvature after prosthesis placement. To review the various surgical options for addressing curvature after prosthesis placement, with specific attention paid to an original article by Wilson et al. reporting on modeling over a penile prosthesis for the management of Peyronie's disease. A literature review was performed analyzing articles reporting the management of penile curvature in patients undergoing implantation of an inflatable penile prosthesis. Reported improvement in Peyronie's deformity as well as the complication rate associated with the various surgical techniques described. Modeling is a well-established treatment modality among patients with Peyronie's disease undergoing penile prosthesis implantation. A variety of other adjuvant maneuvers to address residual curvature when modeling alone is insufficient has been presented in the literature. Over 20 years of experience with modeling over a penile prosthesis have proven the efficacy and safety of this treatment option, providing the surgeon a simple initial step for the management of residual curvature after penile implantation which allows for the use of additional adjuvant maneuvers in those with significant deformities.

Depression and anxiety in men with sexual dysfunction: a retrospective study

BackgroundComorbid anxiety disorders and depression are commonly seen in men with sexual disorders such as erectile dysfunction (ED) and premature ejaculation (PE). However, they are often undiagnosed and untreated, and their relationship to sexual dysfunction is complex. This study examines the frequency and correlates of comorbid anxiety and depression in men with ED or PE. MethodsThe case records of 64 men with ED or PE attending a clinic for psychosexual disorders in a general hospital psychiatry unit during the period 2010–14 were reviewed. Information on comorbid anxiety disorders and depression was extracted from these records, and their clinical and demographic associations were analyzed. ResultsEight (12.5%) men had comorbid depressive disorders, and fifteen (23.4%) had anxiety disorders. These disorders predated the onset of sexual dysfunction in the majority of patients. Generalized anxiety disorder was the commonest anxiety disorder. Men with comorbid depression had significantly elevated rates of suicidal ideation or behavior related to their sexual dysfunction, and were more likely to report a lack of libido. Men with pre-existing anxiety disorders were more likely to experience performance anxiety related to sex, and to have PE without comorbid ED. ConclusionsDepression and anxiety affect a substantial minority of men with sexual dysfunction. Men presenting for the evaluation of ED and PE should be carefully screened for these disorders. The links between anxiety disorders and sexual performance anxiety merit further investigation in this patient group.

Are phosphodiesterase type 5 inhibitors effective for the management of lower urinary symptoms suggestive of benign prostatic hyperplasia?

To review the efficacy of phosphodiesterase type 5 inhibitors (PDE5-Is) in lower urinary tract symptoms (LUTS) suggestive of benign prostate hyperplasia (LUTS/BPH). A comprehensive research was conducted to identify all publications relating to benign prostate hyperplasia and treatment with sildenafil, vardenafil and tadalafil. To assess the efficacy, the changes in total international prostate symptom score (IPSS), IPSS subscore including voiding, storage and quality of life (QoL), Benign prostatic hyperplasia Impact Index (BII), maximum urinary flow rate (Qmax) and the International Index of Erectile Function (IIEF) were extracted. A meta-analytical technique was used for the analysis of integrated data from the included studies to evaluate the mean difference in the results. Total IPSS score, IIEF and BII showed a significant improvement in trials in which LUTS/BPH with or without erectile dysfunction (ED) were compared with the placebo. For LUTS/BPH, the mean differences of total IPSS score, IIEF and BII are -2.17, 4.88 and -0.43, P < 0.00001, respectively. For LUTS/BPH with comorbid ED, the mean difference are -1.97, 4.54 and -0.52, P < 0.00001, respectively. PDE5-Is appear to improve IPSS storage, voiding and QoL subscore (mean difference = -0.71, -1.23 and -0.33, P < 0.00001, respectively). Although four doses of tadalafil (2.5, 5, 10 and 20 mg) failed to reach significance in Qmax (mean difference = 0.22, P = 0.10), the 5 mg dose of tadalafil significantly improved the Qmax (mean difference = 0.33, P = 0.03). PED5-Is demonstrated efficacy for improving LUTS in BPH patients with or without ED and could be considered to be the first line treatment for LUTS/BPH.

Which Is First? The Controversial Issue of Precedence in the Treatment of Male Sexual Dysfunctions

In male sexual dysfunction (MSD), the presence of sexual comorbidities is relatively frequent. However, what is still a matter of controversy is what the first-line therapy in these patients should be. Three scientists and the editor of the Controversies section, all experts in the medical treatment of MSD, present different perspectives on the use of phosphodiesterase type 5 inhibitors (PDE5), testosterone and dapoxetine in erectile dysfunction (ED), hypogonadism, and premature ejaculation (PE). The psychological aspects are discussed by an outstanding expert in psychosexology. Expert opinion supported by the critical review of the currently available literature. Testosterone should be used before PDE5s in hypogonadal men with comorbid ED; PDE5s should be used before dapoxetine in PE patients with comorbid ED, and counseling should be offered to all subjects with MSD. Although the answer to the question "which should be first?" is controversial in almost all MSDs, intuition, experience, and evidence should guide the choice of which treatment should be used first. This decision is highly critical in influencing the therapeutic outcome as well the patient's and couple's adherence to treatment.