Sustainable long-term results on postoperative sexual activity after radical prostatectomy when a clinical sexologist is included in the sexual rehabilitation process. A retrospective study on 7 years postoperative outcome.

INTRODUCTION: The aim of this study was to perform a retrospective evaluation of long-term sustainability of a postoperative combined penile and sexual rehabilitation program involving a clinical sexologist (CS) for preoperative fully potent men undergoing daVinci robotic radical prostatectomy (dVRP) regardless of whether preservation of the neurovascular bundles was performed or not. MATERIAL AND METHODS: The study included 79 preoperatively potent and sexually active patients (aged 45-74 years, mean 61) that had undergone a dVRP due to localized prostate cancer and during the 1st postoperative year participated in a combined penile and sexual rehabilitation program involving a CS. The subjects were followed up with the same interview and questionnaires at approximately 1, 3 and 7 years postoperatively. The interview and questionnaires addressed erectile function (EF), erectile dysfunction (ED) treatment, frequency of penetrating sexual activity, patient's perceptions of sexual life (LISAT-8). RESULTS: One year postoperatively, 84% of patients were sexually active with penetrating sex, 15% with unassisted normal erections. 45% found their postoperative sexual life satisfactory (LISAT-8, question #6). Three years postoperatively, 76 patients were evaluable, 73% were sexually active with penetrating sex, 19% with unassisted normal erections. Furthermore, 56% of patients found their postoperative sexual life to be satisfactory. Seven years postoperatively, 74 patients were evaluable, 74% were sexually active with penetrating sex, 44% with unassisted normal erections. A total of 59% of patients found their postoperative sexual life to be satisfactory. The reasons for not having penetrating sex were diverse. CONCLUSIONS: Involvement of a CS in a postoperative combined penile and sexual rehabilitation program appears to improve the possibility of an acceptable sexual life and function one year after surgery. These results appear to be sustainable in the long-term.

Are TRUS-guided prostate biopsies in clinical practice robust enough to make a correct assessment of the surgical strategy in prostatectomies? Poor correlation between preoperative prostate biopsies and postoperative specimens.

Objective: TRUS-guided prostatic biopsies are the mainstay procedure to diagnose prostatic cancer. The aim was to investigate how accurate and reliable these biopsies are by comparing them with the final pathology results after prostatectomy.Materials and methods: One hundred consecutive patients diagnosed with localized prostatic cancer using this technique and who subsequently underwent a radical prostatectomy in Västerbotten County were included in this study. From the pathological-anatomical diagnosis (PAD) of core needle biopsies, data was extracted on the location of the tumour within the prostate, the tumour volume and the Gleason score, and compared with the characteristics of the prostatectomy specimen. The frequency and type of deviation between the pre-operative and post-operative examinations was recorded.Results: In 95% of the cases there was a poor correlation between the pre-operative and post-operative pathological reports. In the final report, 48% had a higher Gleason score and 88% had deviations in localization when compared with the information from the biopsies. If known prior to surgery, a total of 104 of these deviations might have had a significant impact on the surgical strategy.Conclusions: The pre-operative biopsies in this setting rarely match the final prostate PAD results (5%). The most common deviations were in localization and in Gleason score, where the majority consisted of a higher Gleason score and/or tumour presence in a previously unknown location. This information, if known prior to surgery, might have altered the treatment strategy and ultimately the outcome of the treatment.

Quality of Life and Sexual Function Benefits of Long-Term Testosterone Treatment: Longitudinal Results From the Registry of Hypogonadism in Men (RHYME).

BACKGROUND: The benefits and risks of long-term testosterone administration have been a topic of much scientific and regulatory interest in recent years. AIM: To assess long-term quality of life (QOL) and sexual function benefits of testosterone replacement therapy (TRT) prospectively in a diverse, multinational cohort of men with hypogonadism. METHODS: A multinational patient registry was used to assess long-term changes associated with TRT in middle-age and older men with hypogonadism. Comprehensive evaluations were conducted at 6, 12, 24, and 36 months after enrollment into the registry. OUTCOMES: QOL and sexual function were evaluated by validated measures, including the Aging Males' Symptom (AMS) Scale and the International Index of Erectile Function (IIEF). RESULTS: A total of 999 previously untreated men with hypogonadism were enrolled at 25 European centers, 750 of whom received TRT at at least one visit during the period of observation. Patients on TRT reported rapid and sustained improvements in QOL, with fewer sexual, psychological, and somatic symptoms. Modest improvements in QOL and sexual function, including erectile function, also were noted in RHYME patients not on TRT, although treated patients showed consistently greater benefit over time in all symptom domains compared with untreated patients. AMS total scores for patients on TRT were 32.8 (95% confidence interval = 31.3-34.4) compared with 36.6 (95% confidence interval = 34.8-38.5) for untreated patients (P < .001). Small but significant improvements in IIEF scores over time also were noted with TRT. Approximately 25% of treated and untreated men also used phosphodiesterase type 5 inhibitors, with notable differences in the frequency of phosphodiesterase type 5 inhibitor prescription use according to physician specialty and geographic site location. CLINICAL IMPLICATIONS: TRT-related benefits in QOL and sexual function are well maintained for up to 36 months after initiation of treatment. STRENGTHS AND LIMITATIONS: The major strengths are the large, diverse patient population being treated in multidisciplinary clinical settings. The major limitation is the frequency of switching from one formulation to another. CONCLUSION: Overall, we confirmed the broad and sustained benefits of TRT across major QOL dimensions, including sexual, somatic, and psychological health, which were sustained over 36 months in our treatment cohort. Rosen RC, Wu F, Behre H, et al. Quality of Life and Sexual Function Benefits Effects of Long-Term Testosterone Treatment: Longitudinal Results From the Registry of Hypogonadism in Men (RHYME). J Sex Med 2017;14:1104-1115.

Improvement in sexual function after robot-assisted radical prostatectomy: A rehabilitation program with involvement of a clinical sexologist.

INTRODUCTION: To prospectively evaluate if the inclusion of a clinical sexologist in a penile and sexual rehabilitation program improves sexual function one year after prostate cancer surgery. MATERIAL AND METHODS: Twelve months after da Vinci Radical Prostatectomy (dVRP) for prostate cancer, 28 fully potent (IIEF-5 >21) and sexually active men (ages 47-69 years, mean 61) who, in 2008, were enrolled in a prospectively monitored penile rehabilitation program (reference group) were compared with 79 fully potent (IIEF-5 >21) and sexually active men (ages 45-74 years, mean 61) enrolled in 2009 (study group); whose program differed by the inclusion of evaluation and treatment by a clinical sexologist. RESULTS: Twelve months after dVRP, seventeen patients in the reference group (61%) were sexually active with regular penetrating sexual activity compared to sixty-six (84%) in the study group (p = 0.02). These findings were independent of whether they had undergone a nerve sparing or non-nerve sparing procedure. Almost 94% (74 patients) in the study group had at some time been able to perform penetrating sexual activity; 14 patients required additional visits to the clinical sexologist beyond the routine follow-up, 9 for short-term cognitive behavior therapy. CONCLUSIONS: Inclusion of a clinical sexologist in a penile and sexual rehabilitation program appears to improve the ability to have regular sexual activity with penetrating sex one year after da Vinci Robotic Radical Prostatectomy.

Sildenafil citrate 100 mg starting dose in men with erectile dysfunction in an international, double-blind, placebo-controlled study: effect on the sexual experience and reducing feelings of anxiety about the next intercourse attempt.

INTRODUCTION: Sildenafil citrate 50 mg is the recommended starting dose for men with erectile dysfunction (ED); however, most men are later titrated to sildenafil 100 mg for improved efficacy. AIM: Assess the tolerability and efficacy of sildenafil initiated at the 100-mg dose in men with ED. METHODS: Men with ED (score < or =25 on the Erectile Function domain of the International Index of Erectile Function) who had received < or =6 total doses of a phosphodiesterase type 5 inhibitor and none within 4 weeks were randomized to 8 weeks of double-blind, placebo-controlled (DBPC), fixed-dose treatment (50 or 100 mg sildenafil or placebo) followed by 4 weeks of open-label flexible-dose sildenafil (50 or 100 mg). MAIN OUTCOME MEASURES: Efficacy, tolerability, treatment satisfaction, and other end points were measured at baseline and/or the end of the double-blind and open-label phases and compared between placebo and sildenafil initiated at doses of 50 and 100 mg. RESULTS: Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and 100 mg compared with placebo. At the end of DBPC treatment, 56% of men on the 100-mg dose felt no anxiety about the next intercourse attempt compared with 39% in the 50-mg group (odds ratio 2.03; P = 0.0197). Changes in functional scores from baseline were not statistically significant with the 100-mg dose compared with the 50-mg dose in the DBPC. Measures of treatment satisfaction and sexual experience significantly favored the 100-mg dose compared with the 50-mg dose in the DBPC. There was no increase in adverse events with the higher dose. CONCLUSIONS: Sildenafil at 50 mg or 100 mg significantly improved erection quality, treatment satisfaction, anxiety levels, and the sexual experience compared with placebo during DBPC. Sildenafil 100 mg improved the sexual experience and treatment satisfaction, and reduced feelings of anxiety compared with the 50-mg dose.

In men with erectile dysfunction, satisfaction with quality of erections correlates with erection hardness, treatment satisfaction, and emotional well-being.

INTRODUCTION: The validated Quality of Erection Questionnaire (QEQ) evaluates satisfaction with erection quality. AIM: To collate QEQ data, including correlations between QEQ outcomes and outcomes assessing emotional well-being, treatment satisfaction, and erection hardness after sildenafil citrate treatment. METHODS: In four trials, men older than 18 years and with erectile dysfunction, a stable sexual partner, and no recent phosphodiesterase type 5 inhibitor use were randomized to double-blind flexible-dose sildenafil or placebo (1:1 ratio) for 6 or 10 weeks (two trials), fixed-dose 50 mg, 100 mg, and placebo (1:1:1 ratio) for 8 weeks (one trial), and 50 mg and 100 mg (1:1 ratio) for 4 weeks after 4 weeks of single-blind sildenafil 50 mg. Exclusion criteria included recent significant cardiovascular disease, use of nitrates, nitric oxide donors, cytochrome P450 3A4 inhibitors, or other erectile dysfunction treatment, and sildenafil hypersensitivity or previous severe or serious treatment-related adverse event. MAIN OUTCOMES MEASURES: Scores on the QEQ, QEQ Question 5 (satisfaction with erection hardness), the Self-Esteem and Relationship Questionnaire, and the Erectile Dysfunction Inventory of Treatment Satisfaction; the percentage of occasions with Erection Hardness Score 3 (EHS 3, hard enough for penetration but not completely hard) and/or EHS 4 (completely hard and fully rigid); and Pearson correlation coefficients. RESULTS: 1,296 men (18-80 years) were randomized. Except for the percentage of occasions with EHS 3, all outcomes improved in men treated with sildenafil and correlated positively with the change in QEQ scores in all trials. CONCLUSIONS: Satisfaction with the quality of erections, which is easily monitored with the QEQ, correlated positively with measures of emotional well-being and treatment satisfaction and with the change in percentage of erections that were completely hard and fully rigid, but not with the change in percentage of erections that were hard enough for penetration but not completely hard.

Giving patients with erectile dysfunction the opportunity to try all three available phosphodiesterase type 5 inhibitors contributes to better long-term treatment compliance.

INTRODUCTION: There are three phosphodiesterase type 5 (PDE5) inhibitors marketed, sildenafil, Vardenafil, and tadalafil for oral treatment of erectile dysfunction (ED). Although the treatment is simple and mostly effective, around 50% has ceased to use the medication within 2 years. One recently described way to improve the compliance is to let the patient try all the three PDE5 inhibitors and to prescribe the drug(s) he and his partner desires. AIM: To study long-term compliance among patients who were treated according to this "three-drug regime." MAIN OUTCOME MEASURES: Compliance and reasons for discontinuation after >2 years. METHODS: The men who, during 2003, were enrolled in a treatment regime, where they had the opportunity to test all the three drugs and to chose the one(s) they preferred, were interviewed in 2006 by telephone concerning their ongoing ED treatment and the reason for discontinuation. RESULTS: Of the 138 men, mean age 60 years (36-79 years), who had been enrolled and successfully treated with the three-drug regime, 127 (92%) could be reached. The mean follow-up time was 27 months (23-34 months). Of the 127 men, as many as 109 (86%) were still using PDE5 inhibitors. A few (8%) used more than two tablets per week. The majority (44%) used one to two tablets per week or one to two per month (43%), the others (5%) less often. The causes for discontinuation were varying. The most common reason (N = 7) was return of a satisfactory non-assisted erection. Seventy-five percent of the men used only one drug; the others switched between a short- and long-acting drug depending on the situation. It was not uncommon (25%) that the preference had changed during the 3 years of PDE5 inhibitor use. CONCLUSION: To let patients with ED test the three available PDE5 inhibitors results in an unusually high compliance even under an extended period of time (>2 years).

Is sex only for the healthy and wealthy?

OBJECTIVE: To study reasons for Sildenafil (a phosphodiesterase type 5 inhibitor) treatment abortion in erectile dysfunction (ED), with special regard to the relation between cost and use. METHODS: Men (N = 132) with ED, where treatment with Sildenafil was instituted between 1998 and 2000, were mailed a questionnaire in February 2003, regarding their current ED treatment, including frequency of use, reasons for change or discontinuation, effect on partner relations, and total income of the household. RESULTS: The response rate was 69%. Nearly every second man (47%) still used Sildenafil at least twice per month. The remaining 53% had aborted oral ED treatment: 10% due to return of normal erections, 43% due to (either alone or in combination): cost of treatment, impaired health, loss of efficacy, change to another ED treatment, or side-effects. Cost was the most common cause (48%) for discontinuation. In low-income households, rationing of treatment or abortion due to the cost was reported significantly (P < 0001) more often (86%) than in high-income households (35%). CONCLUSION: Just under half of all the patients (47%) used Sildenafil for more than 2 years after initiation of treatment. The cost of the treatment is an important factor for patient compliance in households with a low income, despite the fact that the treatment is highly effective and improves the partner relationship.

Relationships between lower urinary tract symptoms, the bother they induce and erectile dysfunction.

OBJECTIVE: To study the relationships between lower urinary tract symptoms (LUTS), LUTS-induced bother, age and erectile dysfunction. MATERIAL AND METHODS: A survey consisting of two questionnaires, the International Prostate Symptom Score (IPSS) (reflecting LUTS) and the International Index of Erectile Function (IIEF)-5 (reflecting erectile function), together with instructions on how to perform timed micturition, was sent to 2000 randomly selected men (age range 60-70 years) living in the five counties surrounding our hospital. The IPSS questionnaire included a question concerning the degree of bother induced by LUTS. RESULTS: The survey was answered by 1096 men; after the exclusion of incomplete answers, 924 surveys were evaluated. Of these 924 men, 725 (78%) were sexually active and included in the analyses. The prevalence of moderate-to-severe LUTS (IPSS>or=8) was 45%. The prevalence of erectile dysfunction (ED), defined as an IIEF-5 score of

Prescribing all phosphodiesterase 5 inhibitors to a patient with erectile dysfunction--a realistic and feasible option in everyday clinical practice--outcomes of a simple treatment regime.

OBJECTIVE: In clinical practice, to apply and evaluate outcomes of a treatment regime, in which the patient had the opportunity to try all the available phosphodiesterase 5 (PDE5) inhibitors. METHODS: Patients eligible for treatment with PDE5 inhibitors were prescribed 8 tablets with a shorter-acting substance (four tablets sildenafil 100mg and four tablets vardenafil 20mg) and eight tablets with a long-acting substance (tadalafil 20mg). Outcomes of the regime were recorded. RESULTS: Of the 186 patients, 64 (34%) had not been treated previously (naïve), and 122 (66%) were undergoing treatment for their erectile dysfunction. The overall treatment response was 89% (165 of 186 patients); 78% (n=145 of 186 patients) tested all three substances. No significant difference in choice between long- and shorter-acting medications in the overall material was observed. Two thirds of the naïve patients (n=64) preferred a shorter-acting substance (p<0.01). Every fifth man requested both a shorter- and a long-acting medication to accommodate his need. CONCLUSION: If patients are given the opportunity in clinical practice to try all three available PDE5 inhibitors, the overall response rate is very high, almost 90%. No significant difference in patient preference between long- and shorter-acting drugs was observed. Treatment choice was based mainly on efficacy or duration of effect.

Treatment for erectile dysfunction based on patient-reported outcomes: to every man the PDE5 inhibitor that he finds superior.

Erectile dysfunction (ED) is a common medical condition linked both to aging and to many medical conditions such as diabetes mellitus and cardiovascular disease. Although a common condition, treatment for ED has in the past been conducted by a few specialists, mostly urologists and sex therapists. The revolutionary introduction of oral therapy, and the massive amount of research into sexual dysfunction that followed, has led to paradigm shift in the treatment of ED. This is no longer something done by a few for a few; it involves all disciplines of medicine and more patients are being treated by a greater number of physicians. Several medications administered by different routes are available for treating ED but oral pharmacotherapy represents the first-line option. Phosphodiesterase (PDE) type 5 inhibitors are the most widely prescribed oral agents and they have a satisfactory efficacy-safety profile in patients of all categories. An alternative for men who do not respond to PDE5 inhibitors is intracavernosal injection therapy with alprostadil, a prostaglandin analogue. Other alternatives include sublingual apomorphine and intraurethral alprostadil. Both agents have a less satisfactory efficacy profile than PDE5 inhibitors and a low compliance rate. The aim of ED treatment is to restore an erection satisfactory for the sexual needs of the patient. Thus, the patient-reported outcome is the gold standard in efficacy evaluation. There are now three PDE inhibitors available, all with satisfactory efficacy-safety profiles, but with different pharmacokinetic properties. The availability of three different agents has initiated studies aiming to evaluate them regarding patient preference. However, the results are rather conflicting with some studies suggesting that tadalafil has the best patient preference, while others fail to demonstrate a clinically significant difference between the three agents. However, there is a tendency for younger men to choose tadalafil because it gives them a broader window of opportunity, while older men tend to prefer vardenafil or sildenafil. These data could be used when making a decision on which PDE5 inhibitor to prescribe, although another option is to let the patient try all three available agents and make his own choice.

Relationship between benign prostatic hyperplasia and lower urinary tract symptoms and correlation between prostate volume and serum prostate-specific antigen in clinical routine.

OBJECTIVES: To evaluate how often benign prostatic hyperplasia (BPH) was diagnosed in men referred as a result of lower urinary tract symptoms (LUTS) and to investigate the correlation between prostate volume and serum prostate-specific antigen (s-PSA). MATERIAL AND METHODS: The study subjects comprised men (n = 119; mean age 68 years) consecutively referred to a urological clinic as a result of LUTS for whom the information in the referral forms gave no indications of malignant disease or infection. The patients were evaluated according to regional guidelines. RESULTS: BPH was estimated to be the main etiological agent in less than every second man. There was a statistically significant correlation between s-PSA and prostate size. However, among men with s-PSA < 1.5 ng/ml, one-third had a prostate volume of > 30 ml and 17% a prostate volume of > 40 ml. Among men with s-PSA > or = 1.5 ng/ml, as many as 18% had a prostate volume of < or = 30 ml and 42% a prostate volume of < or = 40 ml. Bladder and/or prostate cancer was diagnosed in 8% of men, mostly as a coincidental finding. CONCLUSIONS: BPH was considered to be the etiological factor in < 50% of men referred as a result of LUTS. The correlation between prostate volume and s-PSA was verified. However, interindividual variation in s-PSA was so large that its usefulness for making treatment decisions in men with LUTS must be questioned.

Is erectile dysfunction really a clinically useful predictor of cardiovascular disease?

OBJECTIVE: To evaluate the possible connection between erectile dysfunction (ED) and cardiovascular disease (CVD) in one of its more severe forms, namely myocardial infarction (MI). MATERIAL AND METHODS: The incidence of ED in men hospitalized due to MI (n=100) was compared with that reported in a questionnaire sent to an age-matched control population (n=129). RESULTS: The incidence of ED before MI (34%) was similar to that in the control population (30%). After MI, 53% reported ED. Smoking was much more common among the men with MI (82%) than among the controls (45%). Smoking was, however, only slightly more common among controls with (50%) than without (40%) ED. None of the men in the study group had consulted a physician due to ED before the MI and only 10/53 (19%) with ED after the MI had consulted a physician for this reason. Among the controls without a history of CVD, 18% reported ED, compared to 34% of the men before the MI but without clinical evidence of CVD and/or diabetes (p=NS). CONCLUSIONS: The well-known association between CVD and ED was confirmed. However, the lack of a sharp rise in the prevalence of ED prior to MI does not support the idea that ED is a clinically useful predictor of MI.

Switching patients with erectile dysfunction from sildenafil citrate to tadalafil: results of a European multicenter, open-label study of patient preference.

BACKGROUND: Three inhibitors of phosphodiesterase 5 (PDE5) are now available for the treatment of erectile dysfunction (ED): sildenafil citrate, vardenafil, and tadalafil. Pharmacologic differences between these compounds may result in patient preferences for one over another and may influence treatment decisions made by the physician and patient. Therefore, clinical research is needed to investigate whether individual properties of the PDE5 inhibitors play a role in shaping patient preference. OBJECTIVES: The goal of this study was to determine what proportion of ED patients currently taking sildenafil would, after a period of treatment with tadalafil, elect to resume treatment with sildenafil at the customary dose and what proportion would elect a switch to tadalafil 20 mg for a longer period. The tolerability of both treatments was also investigated. METHODS: This was a short-term, multicenter, open-label, 1-way crossover trial conducted in Sweden and Italy. Eligible patients included men aged >or=18 years with a minimum 3-month history of ED who had been taking sildenafil at stable fixed doses of 25, 50, or 100 mg as needed for at least 6 weeks and up to 24 weeks. The study consisted of 6 phases: a 1-week screening phase, a 3-week sildenafil assessment phase, a 1-week washout phase, a 6-week tadalafil initiation phase, a 3-week tadalafil assessment phase, and a 6-month extension phase, during which patients received their treatment of choice free of charge. The primary outcome measure was the proportion of patients electing to take sildenafil or tadalafil during the extension phase. RESULTS: Of 155 men enrolled, 147 (97.8%) completed the assessment phases of the trial. Of these 147 men, 133 (90.5%) elected to receive tadalafil in the 6-month extension phase and 14 (9.5%) elected to receive sildenafil (P < 0.001). The proportions preferring tadalafil to sildenafil were similar irrespective of age group (>or=50 years, 92%; <50 years, 90%), severity of ED (mild, 95%; moderate, 88%; severe, 96%), etiology of ED (psychogenic, 94%; organic, 91%; mixed, 87%), and sildenafil dose at study entry (50 mg, 90%; 100 mg, 89%). Both medications were well tolerated. The most common treatment-emergent adverse events occurring in >or=2% of patients during the tadalafil assessment phase included headache (4.8%), nasal congestion (4.1%), dyspepsia (3.4%), flushing (2.7%), back pain (2.0%), diarrhea (2.0%), and nausea (2.0%); the most common treatment-emergent adverse events during the sildenafil assessment phase were flusing (7.1%), nasal congestion (6.5%), headache (4.5%), and nasopharyngitis (3.2%). CONCLUSIONS: In this short-term, open-label study, patients who were currently taking sildenafil for ED and then received tadalafil preferred to continue oral therapy with tadalafil over sildenafil by a ratio of approximately 9:1. Although the study sought to mimic the experience of actual patients receiving treatment for ED, the results are subject to potential limitations due to the design of the study, which included differences in dosing instructions and dosages for sildenafil and tadalafil. Both sildenafil and tadalafil were well tolerated.

[Uneven quality of referrals for lower urinary tract symptoms in men]. / Ojämn kvalitet på remisser för blåstömningsproblem hos män.

Referrals (N = 126) for LUTS (lower urinary tract symptoms) in men over 40 years of age were scrutinized. Descriptions regarding symptom duration, type and intensity were unsatisfactory in 25% of the forms. Not a single work-up prior to referral was completed in accordance with the established protocol. One quarter of the men had previously been referred for LUTS.