A Critical Analysis of Methodology Pitfalls in Duplex Doppler Ultrasound in the Evaluation of Patients With Erectile Dysfunction: Technical and Interpretation Deficiencies.

BACKGROUND: Penile duplex Doppler ultrasound (PDDU) is a minimally invasive tool to evaluate erectile hemodynamics in patients with erectile dysfunction (ED). Despite decades of use, there is still a large variability in PDDU protocols, and a high rate of false diagnosis is reported. AIM: Review of PDDU methodology in the published literature addressing protocol heterogeneity, technical and interpretation challenges. METHODS: A PubMed literature search was performed using the search terms "penile doppler ultrasound", "penile duplex ultrasound" or "penile ultrasound", and "Erectile dysfunction". Studies were analyzed for the presence of the following elements in reporting of the PDDU protocol: (i) intracavernosal vasoactive agents used, (ii) use of a redosing protocol, (iii) means of rigidity assessment, (iv) report of at-home best-quality erection, (v) normative criteria for peak systolic velocity (PSV) and end-diastolic velocity (EDV), and (vi) use of time-based hemodynamics assessment. Inclusion criteria were studies available in English, from 2005 onwards, and with full text. Exclusion criteria were review, descriptive or short communication articles, animal studies, and studies in populations other than those with ED. OUTCOMES: A critical review of the heterogeneity in published literature was performed to guide a structured discussion of methodological challenges and to create a list of recommendations. RESULTS: Significant heterogeneity was seen in key methodological aspects. Fifty percent of studies reported the use of prostaglandin E1 only, and 12% of studies did not mention the agent used. Redosing as part of the PDDU protocol was mentioned in only 26% of studies. The majority (56%) did not mention any form of rigidity assessment. The most frequently used grading system was the Erection Hardness Score (14%). Overall, most studies (59%) used a timed-base protocol for hemodynamic assessment. No clear consensus was defined for normative criteria for PSV and EDV, 39% defining a normal PSV as ≥30 cm/s, and 57% using EDV values ≤5 cm/sec as normal. CLINICAL IMPLICATIONS: The absence of standardization has led to inadequate reporting of key factors which has rendered data interpretation and comparison between studies challenging. STRENGTHS AND LIMITATIONS: Our strengths include an extensive review of literature, with a structured analysis of the impact of each methodological pitfall. Our main limitation is the fact that protocol reporting, and not its application, was assessed. CONCLUSION: Despite its widespread use, analysis of the literature on PDDU use in the ED population shows marked protocol heterogeneity, rendering data interpretation a problem. Nascimento B, Miranda EP, Terrier JE, et al. A Critical Analysis of Methodology Pitfalls in Duplex Doppler Ultrasound in the Evaluation of Patients With Erectile Dysfunction: Technical and Interpretation Deficiencies. J Sex Med 2020;17:1416-1422.

Testosterone Recovery Profiles After Cessation of Androgen Deprivation Therapy for Prostate Cancer.

INTRODUCTION: Androgen deprivation therapy (ADT) is frequently used in the treatment of prostate cancer worldwide. Variable testosterone (T) recovery profiles after ADT cessation have been cited. AIM: To evaluate T recovery after cessation of ADT. METHODS: We reviewed our institutional prospectively maintained database of patients with prostate cancer who received ADT. Serum early morning total T (TT) levels, collected at baseline and periodically after ADT cessation, were analyzed. Patient age, baseline T level, duration of ADT, and presence of diabetes and sleep apnea were selected as potential predictors of T recovery. 3 metrics of T recovery after 24 months of ADT cessation were analyzed: return to non-castrate level (TT > 50 ng/dL), return to normal (T > 300 ng/dL), and return back to baseline level (BTB). Multivariable time-to-event analysis (Cox proportional hazards), χ2 test, logistic regression model, and Kaplan-Meier curve were performed to define impact of the above predictors on time and chance of T recovery. MAIN OUTCOME MEASURES: Time and chance of T recovery to non-castrate level (TT > 50 ng/dL), return to normal (T > 300 ng/dL), and return BTB. RESULTS: 307 men with a mean age of 65 ± 8 years were included. Mean duration of ADT was 17 ± 25 months, and median follow-up was 31 ± 35 months. Mean TT values were 379 ng/dL at baseline and 321 ng/dL at >24 months. At 24 months after cessation of ADT, 8% of men remained at castrate level, 76% returned to TT >300 ng/dL, and 51% had returned BTB. Lower baseline T levels (TT < 400 ng/dL) and ADT duration >6 months were associated with a lower likelihood of recovery to normal TT at 24 months. Age >65 years and receiving ADT for >6 months were significantly associated with a slower T recovery. CLINICAL IMPLICATIONS: T recovery after ADT is not certain and may take longer than expected. Considering the range of side effects of low T, we believe that these findings must be discussed with patients before initiating such therapies. STRENGTHS & LIMITATIONS: Our strengths consisted of a relatively large database, long follow-up, and clinically meaningful endpoints. Limitations included the retrospective design of the study. CONCLUSION: T recovery rates after ADT cessation vary according to patient age, ADT duration, and baseline T levels. Approximately one-quarter of patients failed to normalize their TT level, and one-tenth of men remained at castrate levels 24 months after ADT cessation. Nascimento B, Miranda EP, Jenkins LC, et al. Testosterone Recovery Profiles After Cessation of Androgen Deprivation Therapy for Prostate Cancer. J Sex Med 2019;16:872-879.

Sexual habits of men with ED who take phosphodiesterase 5 inhibitors: a survey conducted in 7 countries.

INTRODUCTION: Western cultural perceptions that favour spontaneous sex may create unrealistic expectations for erectile dysfunction (ED) treatment. Little is known about how users of phosphodiesterase type 5 inhibitors (PDE5Is) plan sexual activity and timing of their preactivity PDE5I ingestion. Because various PDE5Is vary in their duration of action and dosage regimen, this may be an important consideration in selecting the optimal agent for the ED patient. AIM: To better understand the sexual habits of PDE5I users. METHODS: Men from 7 countries (Brazil, China, Italy, Japan, Russia, Taiwan, Turkey) were screened online for age, self-reported comorbidities and ED medication use in the prior 3 months. After screening, eligible participants were asked to complete a 7-question, self-administered online survey containing questions regarding sexual habits and behaviours. MAIN OUTCOME MEASURES: Survey questions focused primarily on advanced planning of sexual intercourse and timing of PDE5I ingestion but also addressed the frequency of sexual intercourse and ED medication use. RESULTS: Of the 1458 respondents (response rate: 48%; median age: 48 years [interquartile range (IQR), 44-55]), 83% always/sometimes planned a specific time for intercourse in advance; 72% planned a specific time for sexual intercourse up to several hours in advance. Of respondents who planned in advance, more than half planned specific days of the week (55%) and times of the day (60%) for sexual intercourse. The time to sexual intercourse after dosing was ≤1 hour for 70% and ≤4 hours for 96% of men. The median frequency of sexual intercourse was 6 times/month (IQR, 4-10), with ED medication taken a median of 5 times/month (IQR, 3-8). CONCLUSIONS: Sexual activity is usually planned by ED medication users several hours in advance, and the vast majority are attempting activity within a short time after ingestion of the agent. These data should aid clinicians in the selection of the optimal PDE5I.

Post-radical prostatectomy pharmacological penile rehabilitation: practice patterns among the international society for sexual medicine practitioners.

INTRODUCTION: Despite the fact that there is minimal evidence-based data supporting it, the concept of pharmacological penile rehabilitation following radical prostatectomy (RP) is receiving great attention. AIM: To define attitudes and practice patterns of clinicians who were members of the International Society for Sexual Medicine (ISSM) and/or its affiliated societies. METHODS: Members of the ISSM and its regional affiliates were invited to participate in a web-based survey. MAIN OUTCOME MEASURES: Demographic factors, current practice status, and opinions regarding post-RP erectile dysfunction and penile rehabilitation. The statistical methods used included chi-square, Student's t-tests, and logistic regression analysis. RESULTS: Three hundred-one physicians from 41 countries completed the questionnaire (82% were urologists). Sixty-five percent of the responders had formal sexual medicine specialty training, 44% had uro-oncology specialty training, and 60% performed RPs. Eighty-seven percent performed some form of rehabilitation. As part of the primary rehabilitation strategy, 95% used phosphodiesterase type 5 inhibitors (PDE5), 30% used vacuum device, 75% used intracavernosal injections, and 9.9% used intraurethral prostaglandin. Fifty-four percent commenced rehabilitation immediately/just after urethral catheter removal, and 37% within the first 4 months after RP. Neither the number of years in medical practice, clinician age, nor country/region of practice differed between rehabilitation performers and non-performers. With regard to the primary reason for avoiding rehabilitation: 50% responded said it is the cost; 25% said the fact that it is not evidence-based; and 25% said they were not familiar with the concept. Performing rehabilitation was positively associated with urologic oncology training (P = 0.03), performing RP (P < 0.001), and seeing over 50 post-RP patients per year (P = 0.011). CONCLUSIONS: Among ISSM members post-RP penile rehabilitation is widely practiced, commenced early, and based predominantly on PDE5 inhibitors and intracavernosal injections. Clinicians who perform RP or see over 50 such patients per year are the most likely to perform rehabilitation. Cost represents the most common reason for rehabilitation neglect.

The correlation between erectile function and patient satisfaction.

INTRODUCTION: The International Index of Erectile Function (IIEF) has become the gold standard inventory for the assessment of sexual function in drug trials and in clinical research. Normalization of the erectile function domain (EFD) score, an end of treatment score of 26 or higher, is an end-point that is currently being used routinely in drug trials. It has been our experience that some men with scores less that 26 on a sexual pharmaceutical are content with their sexual function. We undertook this study to define what proportion of men with EFD scores <26 are satisfied with their therapeutic response. METHODS: 100 consecutive patients who had presented to a sexual health clinic and who had used sildenafil citrate on at least 4 occasions completed the IIEF pertaining to their sildenafil response. They were also asked questions, pertaining to their ability to have sexual intercourse (Q1), their satisfaction with their erectogenic medication (Q2), the ability of the medication to improve erectile rigidity (Q3), and the ability of the medication to improve their ability to have sexual intercourse (Q4). Patients were subcategorized into 4 groups based on treatment IIEF scores (>/=26, 22-25, 18-21, and 11-17). The IIEF scores were compared to the responses to the global assessment questions. MAIN OUTCOME MEASURES: The mean patient age was 58 +/- 22 years. For Q1 and Q2, for each subcategory, there was a significant difference in the percentage of men answering definitely, somewhat, or not at all. In the group with EFD scores 22-25, 67% agreed at least somewhat with Q1 and 66% with Q2. In this group 84% and 78% responded in the affirmative to Q3 and Q4, respectively. No patient with an EFD score <22 definitely agreed with Q1 or Q2. CONCLUSIONS: These data indicate that a significant proportion of patients with EFD scores 21-25 can have sexual relations that are satisfactory and that they are satisfied with their erectogenic medication.