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150 Predictors of Increased Intracavernosal Injection Requirements at Penile Ultrasound
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SMSNA Abstracts 1
Department of Urology, University of Michigan, USA; 2Pfizer Inc, USA Objectives: Sildenafil (SILD) treatment has been evaluated in more than 16,000 men with erectile dysfunction (ED) in doubleblind (DB), placebo (PBO)-controlled clinical trials. We assessed the efficacy and safety of SILD in 7,834 men with ED by ethnicity (White, Black, and Asian) and age (18e45, 46e60, and 61 years). Materials and Methods: Data were pooled from 38 DB, PBOcontrolled, flexible-dose, SILD trials. The starting SILD dose in most trials was 50 mg, not more than once daily, w1 hour before sexual activity, with dose adjustment to 100 or 25 mg as needed. Men with blood pressure <90/50 or >170/110 mmHg, taking nitrates/nitric oxide donors, or severe cardiac failure, unstable angina, or recent stroke/myocardial infarction were excluded. Efficacy outcomes were change from baseline (BL) to endpoint in International Index of Erectile Function (IIEF) scores and a Global Assessment Question (GAQ; “Did the treatment improve your erections?”). Results: 4,120 men received SILD (2,740 White; 407 Black; 973 Asian) and 3,714 men received PBO (2,671 White; 385 Black; 658 Asian). Significant treatment-by-age group and treatment-by-ethnicity interactions were observed for change from BL in IIEF Erectile Function Domain, Q3 (achieving erection), and Q4 (maintenance of erection) scores with SILD vs PBO (all P<0.05). Treatment differences were greater in men aged 61 y and lower in men aged 18e45 y. The treatment effect in White and Asian men was similar and greater than that in Black men. Improvement assessed with the GAQ for SILD vs PBO was significant in each age group (all P<0.0001), with similar results in men aged 18e45 y (odds ratio [OR]¼7.86), 46e60 y (OR¼8.89), and 61 y (OR¼10.08). A significant treatment-by-ethnic group interaction was observed for the GAQ (P¼0.0004). GAQ improvement was greater in White (OR¼11.22) and Asian (OR¼12.37) men than in Black men (OR¼5.08) (all P<0.0001 SILD vs PBO). The incidence of all-cause and treatment-related adverse events was generally similar in White, Black, and Asian men, with some small variations among the 3 age groups. Conclusions: Sildenafil is an effective and well-tolerated treatment for ED regardless of ethnicity or age. However, sildenafil treatment effects can vary with ethnicity and age. Disclosure: Work supported by industry: yes, by Pfizer Inc (industry initiated, executed and funded study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry. 150 PREDICTORS OF INCREASED INTRACAVERNOSAL INJECTION REQUIREMENTS AT PENILE ULTRASOUND Avant, R.; Ziegelmann, M.; Savage, J.; Trost, L. Mayo Clinic, USA J Sex Med 2017;14:e1ee104
Objective: Penile duplex Doppler ultrasound (PDDU) with intracavernosal injection (ICI) of erectogenic agents is commonly used to evaluate vascular parameters in men with erectile dysfunction (ED). Recent studies have suggested significant variability in outcomes based on ICI dosing protocols, suggesting a need for standardization of injection protocols. Given a lack of literature on this topic, we sought to identify predictors for increased dosing requirements to achieve adequate rigidity at the time of PDDU. Materials and Methods: A retrospective chart review was performed for all patients undergoing PDDU for evaluation of ED from January 2014 to November 2015. At the time of PDDU, men received a combination of papaverine(30 mg/mL), phentolamine(1 mg/mL), and alprostadil(10 mcg/mL) in 0.1 mL increments until an erection sufficient for penetration was achieved or 1.0 cc was administered. Clinicopathologic and demographic variables were reviewed, and univariate and multivariate analyses were used to identify characteristics associated with increased erectogenic requirements. Results: A total of 262 men (mean age 53;) underwent PDDU during the study period. Mean IIEF-6 score was 12.4 (SD 10.2), and a mean 2.1 injections (SD 1.1) with 0.34 cc (SD 0.34) were administered. On multivariate analysis, lower IIEF-ED domain score (p<0.0001), coronary artery disease (p<0.01), and diabetes (p¼0.02) were associated with increased requirement for erectogenic medications. Conclusion: Patients with lower IIEF scores, coronary disease, and diabetes mellitus may require higher volumes of erectogenic medications at the time of PDDU. This information may help to create standardized and efficient protocols for repeated dosing regimens. Disclosure: Work supported by industry: no. 151 SEXUAL FREQUENCY IN A CARDIOVASCULAR CLINIC POPULATION Baas, W.; Mueller-Luckey, G.; Kohler, T.S. SIU School of Medicine, USA Objective: After men develop cardiac conditions, they often refrain from sex because of fear from activity induced cardiovascular events. They may also be unable to have sex secondary to medication side effects and/or restrictions such as nitroglycerin use. We sought to assess how often men seen in a cardiology clinic attempted sexual intercourse and determine which variables would predict sexual frequency. Materials and Methods: We analyzed the previously described CUPPID database of 200 men prospectively enrolled from a cardiovascular clinic. Data from IIEF-15, ADAM, AUA-SS questionnaires along with serum lab tests and standard cardiovascular related variables abstracted from chart review were utilized. Results: The average subject engaged in sexual activity 1-2 times per month based off of IIEF-15 question 6 responses. Of all
SMSNA Abstracts 1
Department of Urology, University of Michigan, USA; 2Pfizer Inc, USA Objectives: Sildenafil (SILD) treatment has been evaluated in more than 16,000 men with erectile dysfunction (ED) in doubleblind (DB), placebo (PBO)-controlled clinical trials. We assessed the efficacy and safety of SILD in 7,834 men with ED by ethnicity (White, Black, and Asian) and age (18e45, 46e60, and 61 years). Materials and Methods: Data were pooled from 38 DB, PBOcontrolled, flexible-dose, SILD trials. The starting SILD dose in most trials was 50 mg, not more than once daily, w1 hour before sexual activity, with dose adjustment to 100 or 25 mg as needed. Men with blood pressure <90/50 or >170/110 mmHg, taking nitrates/nitric oxide donors, or severe cardiac failure, unstable angina, or recent stroke/myocardial infarction were excluded. Efficacy outcomes were change from baseline (BL) to endpoint in International Index of Erectile Function (IIEF) scores and a Global Assessment Question (GAQ; “Did the treatment improve your erections?”). Results: 4,120 men received SILD (2,740 White; 407 Black; 973 Asian) and 3,714 men received PBO (2,671 White; 385 Black; 658 Asian). Significant treatment-by-age group and treatment-by-ethnicity interactions were observed for change from BL in IIEF Erectile Function Domain, Q3 (achieving erection), and Q4 (maintenance of erection) scores with SILD vs PBO (all P<0.05). Treatment differences were greater in men aged 61 y and lower in men aged 18e45 y. The treatment effect in White and Asian men was similar and greater than that in Black men. Improvement assessed with the GAQ for SILD vs PBO was significant in each age group (all P<0.0001), with similar results in men aged 18e45 y (odds ratio [OR]¼7.86), 46e60 y (OR¼8.89), and 61 y (OR¼10.08). A significant treatment-by-ethnic group interaction was observed for the GAQ (P¼0.0004). GAQ improvement was greater in White (OR¼11.22) and Asian (OR¼12.37) men than in Black men (OR¼5.08) (all P<0.0001 SILD vs PBO). The incidence of all-cause and treatment-related adverse events was generally similar in White, Black, and Asian men, with some small variations among the 3 age groups. Conclusions: Sildenafil is an effective and well-tolerated treatment for ED regardless of ethnicity or age. However, sildenafil treatment effects can vary with ethnicity and age. Disclosure: Work supported by industry: yes, by Pfizer Inc (industry initiated, executed and funded study). The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry. 150 PREDICTORS OF INCREASED INTRACAVERNOSAL INJECTION REQUIREMENTS AT PENILE ULTRASOUND Avant, R.; Ziegelmann, M.; Savage, J.; Trost, L. Mayo Clinic, USA J Sex Med 2017;14:e1ee104
Objective: Penile duplex Doppler ultrasound (PDDU) with intracavernosal injection (ICI) of erectogenic agents is commonly used to evaluate vascular parameters in men with erectile dysfunction (ED). Recent studies have suggested significant variability in outcomes based on ICI dosing protocols, suggesting a need for standardization of injection protocols. Given a lack of literature on this topic, we sought to identify predictors for increased dosing requirements to achieve adequate rigidity at the time of PDDU. Materials and Methods: A retrospective chart review was performed for all patients undergoing PDDU for evaluation of ED from January 2014 to November 2015. At the time of PDDU, men received a combination of papaverine(30 mg/mL), phentolamine(1 mg/mL), and alprostadil(10 mcg/mL) in 0.1 mL increments until an erection sufficient for penetration was achieved or 1.0 cc was administered. Clinicopathologic and demographic variables were reviewed, and univariate and multivariate analyses were used to identify characteristics associated with increased erectogenic requirements. Results: A total of 262 men (mean age 53;) underwent PDDU during the study period. Mean IIEF-6 score was 12.4 (SD 10.2), and a mean 2.1 injections (SD 1.1) with 0.34 cc (SD 0.34) were administered. On multivariate analysis, lower IIEF-ED domain score (p<0.0001), coronary artery disease (p<0.01), and diabetes (p¼0.02) were associated with increased requirement for erectogenic medications. Conclusion: Patients with lower IIEF scores, coronary disease, and diabetes mellitus may require higher volumes of erectogenic medications at the time of PDDU. This information may help to create standardized and efficient protocols for repeated dosing regimens. Disclosure: Work supported by industry: no. 151 SEXUAL FREQUENCY IN A CARDIOVASCULAR CLINIC POPULATION Baas, W.; Mueller-Luckey, G.; Kohler, T.S. SIU School of Medicine, USA Objective: After men develop cardiac conditions, they often refrain from sex because of fear from activity induced cardiovascular events. They may also be unable to have sex secondary to medication side effects and/or restrictions such as nitroglycerin use. We sought to assess how often men seen in a cardiology clinic attempted sexual intercourse and determine which variables would predict sexual frequency. Materials and Methods: We analyzed the previously described CUPPID database of 200 men prospectively enrolled from a cardiovascular clinic. Data from IIEF-15, ADAM, AUA-SS questionnaires along with serum lab tests and standard cardiovascular related variables abstracted from chart review were utilized. Results: The average subject engaged in sexual activity 1-2 times per month based off of IIEF-15 question 6 responses. Of all