Delineating patient errors in an intracavernosal injection program.

BACKGROUND: Intracavernosal injection therapy (ICI) is a well-established therapeutic strategy for men with erectile dysfunction. Complications are often related to patient error when performong ICI. AIM: The objective of this study was to examine patient errors in an established patient training program for performing ICI and identify factors that could predict major errors. METHODS: Patients enrolled in our ICI program are trained on technical aspects, and dose titration is begun. Patients are given explicit instructions during training, both verbally and in written form. Records were reviewed for men using ICI for ≥6 months. Multivariable analysis was used to define predictors of major errors. OUTCOMES: Errors were listed as minor (zero-response injection, penile bruising, expired medication) and major (errors potentially leading to priapism: dose self-titration, double injecting). RESULTS: Overall, 1368 patients met the inclusion criteria and were included in the analysis. The mean patient age was 66 ± 22 (range 29-91) years. Regarding education, 41% of patients had graduate-level education, 48% had college education, and 11% high school education. Mean follow-up was 3.2 ± 7.6 (range 0.5-12) years. The agents used were trimix (62%), bimix (35%), papaverine (2%), and prostaglandin E1 monotherapy (1%). At least 1 error occurred during self-administration in 42% of patients during their time in the program. Errors included zero response to medication due to technical error (8% of patients), penile bruising (34%), use of an expired bottle (18%), self-titration (5%), and double injecting (4% of patients); 12% of men committed ≥1 error during their time in the program. On multivariable analysis, independent predictors of the occurrence of a major error included: young age, graduate-level education, and <12 months of injection use. CLINICAL IMPLICATIONS: To the best of our knowledge, this is the first reported study to investigate ICI errors and risk factors. The identification of factors predictive of major errors allows for more tailored and intensive training in this subset of patients. STRENGTHS AND LIMITATIONS: Strengths of this study include a large patient population (1386 men) with a considerable follow-up time. Additionally, the rigorous training, education, and monitoring of the participants, as well as the use of formal definitions, enhances the accuracy and reliability of the results. Despite the strengths of the study, recall bias may be a limitation concern. CONCLUSION: The majority of patients were error free, and the majority of the errors were minor in nature. Major errors occurred in <10% of patients. Younger age, graduate-level education, and less experience with ICI were independent predictors of major errors.

Erectile response profiles of men using PDE5 inhibitors combined with intracavernosal injections as part of a penile rehabilitation program after radical prostatectomy.

BACKGROUND: Phosphodiesterase type 5 (PDE5) inhibitor labeling states that these agents should not be used in conjunction with other erectogenic medications for fear of priapism occurring. AIM: We explored the risk of priapism and prolonged erections in men in our post-radical prostatectomy (RP) penile injection program who were using regular PDE5 inhibitor and intracavernosal injections (ICIs) as part of their rehabilitation program. METHODS: The study cohort included men on penile injection therapy who (1) were taking tadalafil 5 mg daily or taking sildenafil 25 mg on noninjection days, (2) had an RP, (3) were using their respective PDE5 inhibitor regularly at the time of penile injection training, and (4) complied with the program instructions regarding penile injection use. Demographics, comorbidity details, PDE5 inhibitor dose and utilization, and injection dose and utilization data were collected. All patients underwent in-office injection training and used trimix (papaverine/phentolamine/prostaglandin E1) as the intracavernosal medication. OUTCOMES: Priapism was defined as a patient self-reported penetration hardness erection ≥4 hours in duration, while prolonged erection was defined as a penetration hardness erection lasting ≥2 hours. RESULTS: A total of 112 tadalafil users and 364 sildenafil users were compared. Mean age and duration post-RP were 62 ± 14 years and 5.2 ± 12 months, respectively, and there was no difference between tadalafil and sildenafil groups. The mean trimix dose was tadalafil 24 ± 24 units and sildenafil 31 ± 37 units (P < .05). Priapism occurred in 2 (1.7%) of 112 tadalafil users and 5 (1.4%) of 364 sildenafil users (P = .47). Excluding those men experiencing priapism on any occasion, those with any reported penetration hardness erection lasting ≥2 hours were 7 (6.3%) of 112 tadalafil users and 12 (3.3%) of 364 sildenafil users (P < .01). A total of 53% of these prolonged erections occurred within the first 6 injections at home (no difference between tadalafil and sildenafil groups). CLINICAL IMPLICATIONS: We emphasize the need for continued monitoring and education on proper injection techniques to minimize the risk of adverse events in ICI and PDE5 inhibitor combination therapy. STRENGTHS & LIMITATIONS: This study has a relatively large patient population with a considerable follow-up time. Additionally, the rigorous training, education, and monitoring of the participants, as well as the use of formal definitions for priapism and prolonged erections, enhances the accuracy and reliability of the results. However, there are some limitations, such as social desirability, confounding factors, and recall bias. CONCLUSION: There is no significant difference in the incidence of priapism in an ICI program in which men combine ICI with tadalafil or sildenafil. However, tadalafil patients had a higher rate of prolonged erections, which was found to occur mostly early during the titration phase.

Acceptance and Commitment Therapy to Increase Adherence to Penile Injection Therapy-Based Rehabilitation After Radical Prostatectomy: Pilot Randomized Controlled Trial.

INTRODUCTION: Despite the importance of using penile injections as part of a penile rehabilitation program, men have difficulty complying with these programs. AIM: To test a novel psychological intervention based on Acceptance and Commitment Therapy for erectile dysfunction (ACT-ED) to help men utilize penile injections. METHODS: This pilot randomized controlled trial (RCT) recruited men who were beginning a standard care (SC) structured penile rehabilitation program following radical prostatectomy. The SC program instructed patients to use penile injections 2 to 3 times per week. Participants were randomized to SC+ACT-ED or SC+enhanced monitoring (EM). Over 4 months, patients in the SC+ACT-ED group received SC plus 4 ACT sessions and 3 ACT phone calls; those in the EM group received SC plus 7 phone calls from an experienced sexual medicine nurse practitioner. Participants were assessed at study entry and at 4 and 8 months. For this pilot study, the goal was to determine initial efficacy (ie, effect sizes, where d = 0.2 is small, d = 0.5 is medium, and d = 0.8 is large). MAIN OUTCOME MEASURE: Primary outcomes were feasibility and use of penile injections. Secondary outcomes were ED treatment satisfaction (ie, Erectile Dysfunction Inventory of Treatment Satisfaction, or EDITS), sexual Self-Esteem and Relationship (SEAR) quality, sexual bother (SB), and prostate cancer treatment regret. RESULTS: The 53 participants were randomized (ACT, n = 26; EM, n = 27). The study acceptance rate was 61%. At 4 months, the ACT-ED group utilized more penile injections per week (1.7) compared to the EM group (0.9) (d = 1.25; P = .001) and was more adherent to penile rehabilitation compared to the EM group (ACT, 44%; EM, 10%; relative risk [RR], 4.4; P = .02). These gains were maintained at 8 months for injections per week (ACT, 1.2; EM, 0.7; d = 1.08; P = .03) and approached significance for adherence (ACT, 18%; EM, 0%; P = .10). At 4 months, ACT-ED, compared to EM, reported moderate effects for greater satisfaction with ED treatment (d = 0.41; P = .22), greater sexual self-esteem (d = 0.54; P = .07) and sexual confidence (d = 0.48; P = .07), lower sexual bother (d = 0.43; P = .17), and lower prostate cancer treatment regret (d = 0.74; P = .02). At 8 months, moderate effects in favor of ACT-ED were maintained for greater sexual self-esteem (d = 0.40; P = .19) and less treatment regret (d = 0.47; P = .16). CLINICAL IMPLICATIONS: ACT concepts may help men utilize penile injections and cope with the effects of ED. STRENGTHS AND LIMITATIONS: Strengths include use of an innovative intervention utilizing ACT concepts and pilot RCT. Limitations include the pilot nature of the study (eg, small samples size, lack of statistical power). CONCLUSION: ACT-ED is feasible and significantly increases the use of penile injections. ACT-ED also shows promise (moderate effects) for increasing satisfaction with penile injections and sexual self-esteem while decreasing sexual bother and prostate cancer treatment regret. Nelson CJ, Saracino RM, Napolitano S, et al. Acceptance and Commitment Therapy to Increase Adherence to Penile Injection Therapy-Based Rehabilitation After Radical Prostatectomy: Pilot Randomized Controlled Trial. J Sex Med 2019; 19:1398-1408.

Sexual Function in Cancer Survivors: Updates to the NCCN Guidelines for Survivorship.

By the year 2024, predictions estimate that there will be approximately 19 million cancer survivors in the United States, many of whom will experience the physical and/or psychosocial long-term effects of cancer and its treatment. Although sexual dysfunction is common among these individuals, causing increased distress and negatively impacting quality of life, this critical part of survivorship care is often underrecognized and undertreated. At the NCCN 21st Annual Conference, Drs. Melisko and Narus reviewed the sexual function recommendations in the NCCN Guidelines for Survivorship, offering practical strategies for assessing and managing both female and male sexual dysfunction.

Erectile dysfunction in men treated for testicular cancer.

OBJECTIVE: To study the unique characteristics of erectile dysfunction (ED) in a population of men who developed ED after testicular cancer (TC) diagnosis and treatment. PATIENTS AND METHODS: All men treated for TC who presented for sexual function evaluation were included in an institutional database. All men underwent standard evaluation including a history/physical examination, completion of the International Index of Erectile Function (IIEF) questionnaire, testosterone/gonadotropin measurement and penile duplex Doppler ultrasonography (DUS). RESULTS: The study population comprised 76 men whose mean (SD) age was 29 (8) years and of whom 25% were married/had a partner. In all, 39% of the patients had seminoma and 61% had non-seminomatous germ-cell tumour (NSGCT). A total of 66% of patients with seminoma underwent radiation therapy. Of the patients with NSGCT, 79% received chemotherapy, 18% underwent primary retroperitoneal lymph node dissection (RPLND) and 20% underwent post-chemotherapy RPLND. The mean (SD) time before seeking sexual medicine consultation was 12 (7) months after treatment completion, the median (range) number of vascular risk factors was 0 (0-2) and the mean (SD) remaining testis volume was 16 (8) mL. Mean (SD) total testosterone, luteinizing hormone, follicle-stimulating hormone levels were 312 (186) ng/dL, 9 (7) IU/mL, 17 (12) IU/mL. A total of 26% of patients had total testosterone levels <300 ng/dL. In all, 84% of patients complained primarily of loss of erection-sustaining capability and 24% had episodes of transient ED before TC diagnosis. The mean (SD) IIEF erectile function domain score was 16 (7). All the patients (100%) had a normal DUS. Mean (SD) peak systolic and end-diastolic velocities were 48 (16) and 1.2 (2.2) cm/s, respectively. A total of 88% of patients responded to phosphodiesterase type 5 inhibitor (PDE5i) use with erections sufficient for penetration, but 12% did not (mean [SD] erectile function domain score 27 [5] vs 17 [6]). There were no differences in haemodynamics between those men with and without hypogonadism. CONCLUSIONS: Men with TC presenting with ED after treatment appear uniformly to have normal erectile haemodynamics, suggesting adrenaline-mediated ED. While the majority of TC survivors with ED respond successfully to PDE5i, a significant minority do not.

Prospective analysis of penile length changes after radical prostatectomy.

OBJECTIVES: To assess the impact of radical prostatectomy (RP) on penile dimensions. To assess the impact of phosphodiesterase-5 inhibitor (PDE5i) use on penile length changes. PATIENTS AND METHODS: Men undergoing RP were enrolled in this prospective study before surgery. Demographic, clinical and PDE5i frequency-of-use data were collected. Erectile function was measured using the erectile function domain (EFD) of the International Index of Erectile Function. A single evaluator measured stretched flaccid penile length (SFPL) before RP, and at 2 and 6 months after RP. Repeated measures analysis was used to test differences in SFPL between timepoints. Pearson correlation was used for univariate analyses and multiple regression was used for multivariable analysis. RESULTS: A total of 118 patients were evaluated at baseline, with 76 and 63 patients evaluated at 2 and 6 months, respectively. At 2 months, there was a 2.4-mm mean decrease in SFPL, while at 6 months there was no significant difference. At 6 months, those subjects who took a daily PDE5i had no SFPL loss (n = 36, 1±6.7 mm gain, P = 0.37 compared with baseline), while those subjects who did not consistently take a PDE5i had SFPL loss (n = 27, 4.4±6.6 mm loss, P < 0.002 compared with baseline). In multivariable analysis, PDE5i use at 6 months and 6-month EFD score without on-demand PDE5i were significant predictors of 6-month SFPL loss, suggesting that an increase in these variables leads to SFPL preservation. CONCLUSIONS: In this rigorously conducted prospective study of SFPL changes after RP, there was evidence of SFPL loss at 2 months, but not at 6 months after RP. PDE5i use moderated SFPL loss, with patients who regularly used PDE5i having no loss in SFPL.

Injection anxiety and pain in men using intracavernosal injection therapy after radical pelvic surgery.

INTRODUCTION: Intracavernosal injection (ICI) therapy is a well-recognized treatment strategy with high success rates for men with erectile dysfunction. Despite this, injection anxiety and pain related to injection are significant barriers to its use. AIMS: This study aims to examine injection anxiety and injection pain in patients using ICI. METHODS: Men starting ICI therapy post radical pelvic surgery completed questionnaires at initial visit, at each of the two ICI training sessions and at a 4-month follow-up visit. MAIN OUTCOME MEASURES: Injection Anxiety Scale, Injection Pain Scale, Injection Reaction Inventory, and the Erectile Function Domain of the International Index of Erectile Function. RESULTS: Average age of the 68 men was 60±8 years. At 4 months, the self-reported frequency of ICI use was: 29%<1/week, 26% 1/week, 40% 2/week, and 5% 3/week. Mean injection anxiety score at first injection was 5.7±2.8 (range 0-10) and significantly decreased to a 4.1±3 at 4 months (P<0.001). At first injection, 65% reported high injection anxiety (≥5) and this significantly decreased to 42% (P=0.003) at 4 months. Anxiety at first injection was negatively related to ICI frequency at 4 months (r=-0.23, P=0.08). Mean injection pain score at first injection was low (2.2±1.8, range 0-10) and 59% rated injection pain≤2. Injection pain remained consistent across time periods. At first injection, injection anxiety (assessed prior to injection) was related to injection pain (r=0.21, P=0.04) and subjects (n=21) who reported high injection anxiety (≥5) across time points, reported an increase in injection pain scores from first injection to 4 months (2.7 vs. 3.7, P=0.05). CONCLUSIONS: Although injection anxiety decreased with ICI use, mean injection anxiety remained at a moderate level (4.4) and 42% of men continued to report "high" injection anxiety at 4 months. While injection pain was low, injection anxiety and pain were related. These data suggest the need for a psychological intervention to help lower injection anxiety related to ICI.

A review of outcomes of an intracavernosal injection therapy programme.

UNLABELLED: Study Type--Therapy (outcomes research) Level of Evidence 2b. What's known on the subject? and What does the study add? Intracavernosal injection (ICI) therapy is an important treatment option for erectile dysfunction. However, high discontinuation rates have been reported for ICI therapy, and a risk of priapism has long been a concern. There has never been a large sample study performed with multivariate analysis to characterise outcomes of ICI therapy. The present paper reviews ICI therapy outcomes in a very large population of men at a tertiary care Sexual Medicine Clinic over 5 years. Multivariate analysis was used to further characterise these outcomes. The present study shows that for a large percentage of our sample of patients, ICI therapy is a successful treatment strategy. And, while discontinuation rates are still high, many of those not continuing ICI therapy achieved success with phosphodiesterase inhibitors. Also, the incidence of priapism was less in the present study than previously reported. OBJECTIVES: • To review the outcomes, adverse events and discontinuation rates of intracavernosal injection (ICI) therapy in men with erectile dysfunction (ED) in a sexual medicine practice over a 5-year period at a tertiary referral centre. • Since 1983, ICI has become a staple therapeutic option and high success rates have been reported. However, priapism is a significant concern and discontinuation rates are estimated to be >50%. PATIENTS AND METHODS: • Men presenting with ED who were enrolled in our ICI programme between September 2002 and August 2006 were followed at least annually. • Patient demographic information, agents used, erectile function outcomes and adverse events were recorded. • Failure was defined as the inability to have penetrative sex. Discontinuation was defined as patient declaration of such, failure to attend an annual follow-up visit or failure to call for a repeat prescription. • Multivariable analysis was used to define predictors of failure to respond to ICI therapy, as well as predictors of discontinuation within 36 months of starting ICI in those patients responding. RESULTS: • In all, 1412 patients had complete data and constituted the study population. Most patients were using Trimix and 89% of Trimix users were capable of having sexual intercourse. • Response rates were lower in pelvic radiation and diabetic patients. • However, the discontinuation rate was significant; it was lower in men who had not undergone radical prostatectomy (RP). Of note, many RP patients discontinued ICI because of recovery of natural or phosphodiesterase type 5 inhibitor-assisted erections. CONCLUSIONS: • ICI therapy is associated with very high success rates even in men with high comorbidity profiles; however, the discontinuation rates, even in men who had not undergone RP, by the end of the third year are significant. • Of note, the recorded priapism rate was extremely low (0.5%).

The false diagnosis of venous leak: prevalence and predictors.

INTRODUCTION: As a vascular test, dynamic infusion cavernosometry (DIC) has lost popularity, and in the urologic community, penile duplex Doppler ultrasound (DUS) has become the sole test to investigate a vascular etiology of erectile dysfunction. Vasoactive agent redosing has been shown to increase the accuracy of DUS. AIM: To define the erectile hemodynamics in men with previously diagnosed venous leak on DUS. METHODS: Prospective data were collected on patients who (i) had been given a diagnosis of venous leak based on an outside DUS; (ii) elected to undergo a repeat DUS; and (iii) when the repeat DUS suggested venous leak, underwent DIC. MAIN OUTCOME MEASURES: DUS: peak systolic velocity and end-diastolic velocity. DIC: flow to maintain. RESULTS: 292 patients were included. Mean ± standard deviation age was 44 ± 26 years. On repeat DUS, 19% (56/292) had completely normal hemodynamics and 7% (20/292) had arterial insufficiency only without venous leak. DIC revealed normal hemodynamics in 13% (38/292), while in 58% (152/292) of patients, the venous leak diagnosis was confirmed. Overall, 47% (137/292) of patients who had been given a diagnosis of venous leak had completely normal hemodynamics, and in only 43% (126/292), the venous leak diagnosis was confirmed upon repeat vascular testing. On multivariable analysis, younger age (<45 years), failure to obtain an adequate erection during the original DUS, and having <2 vascular risk factors were predictive of a false diagnosis of venous leak. CONCLUSIONS: Penile DUS has a propensity to inaccurately assign a diagnosis of venous leak. Great care should be taken when performing DUS especially in younger men without a significant vascular risk factor history, and the failure to obtain a good erection should make the clinician cautious in assigning a diagnosis of venous leak. Furthermore, there still exists a role for cavernosometry, which appears to have a greater accuracy at diagnosing venous leak.

Satisfaction profiles in men using intracavernosal injection therapy.

INTRODUCTION: Intracavernosal injection therapy (ICI) is a well-established second-line therapy used in the treatment of erectile dysfunction (ED). Controversy exists as to whether oral phosphodiesterase type 5 inhibitors (PDE5i) or injection therapy lead to higher satisfaction. AIM: This study addressed ICI satisfaction in a modern cohort of patients in the PDE5i era. METHODS: Patients on ICI for at least 6 months were included in our study. Patients were administered the International Index of Erectile Function (IIEF) at the initial visit. On subsequent visits, patients were administered the IIEF and the Erection Hardness Scale (EHS). MAIN OUTCOME MEASURES: Study end points were change in baseline scores in the satisfaction domains (SD) of the IIEF, type of injection medication used, and predictors of satisfaction. Multiple logistic regressions were performed for predictors of satisfaction. RESULTS: One hundred twenty-two patients met inclusion criterion. Mean time to follow-up was 25±12 months (range 6-106 months). Sixty-five percent of patients continued injections at the time of follow-up. When SD scores were examined, intercourse SD scores increased from 4.8±1.7 at baseline to 12.3±3.1 (P<0.01); overall SD scores increased from 4.1±1.8 to 7.2±2.0 (P<0.05). On multivariate analysis, predictors of satisfaction included older age (odds ratio [OR]=2.1), younger partner age (OR=2.5), clinically significant increase in the erectile function domain score (OR=3.1), and attainment of a "fully rigid" erection (EHS 4) (OR=6.8). CONCLUSIONS: We have evaluated satisfaction in a modern cohort of ICI patients. While dropout rates are significant, for those patients who continue to inject, we have found high levels of satisfaction using the IIEF, the gold standard for evaluation of erectile function. On multivariate analysis, we found that older age, younger partner age, and fully rigid erections were predictors of increased satisfaction. ICI remains a robust second-line therapy in the treatment of ED even in the era of PDE5i.