Assessment of a New Formulation of Sildenafil on Common Practice: An Observational Study.

Erectile dysfunction (ED) has a significant impact on the quality of life of patients. Xybilun® (IBSA Pharma SAS, France) is a new formulation of sildenafil in an orodispersible film (ODF). This study aims to assess the response rate (RR), satisfaction with, and safety of sildenafil-ODF in daily practice in France. Patients aged ≥18 years with ED were included in four groups: Group 1 mild, Group 2 moderate, Group 3 severe ED, according to the International Index for Erectile Function (IIEF)-6 subscore, never treated with phosphodiesterase inhibitors (PDE)5-I; Group 4, patients previously treated with another PDE5-I. Patients were evaluated at baseline (V1), one (V2), and three (V3) months. The RR and satisfaction were assessed using the IIEF-6 subscore questionnaire, a 5-point Likert scale, and a Global Assessment Question (GAQ). The primary endpoint for Groups 1 to 3 was the RR according to Rosen criteria at V3 compared to V1. For Group 4, the primary endpoint was the RR, defined as the satisfaction compared with previous treatment. Secondary endpoints were the RR at V2 compared to V1, the evolution of IIEF-6 and IIEF-15 scores, dose adjustment, satisfaction, convenience, and safety. One hundred and five patients were enrolled, 83 analysed. The RR at V3 was 100% (Group 1); 75% (Group 2); 65.2% (Group 3); and 84.2% (Group 4). The overall RR was 78.3%. Secondary parameters confirmed the satisfaction with sildenafil-ODF, with 81.6% of patients very satisfied at V3. No Serious Adverse Events (SAEs) were observed. In conclusion, sildenafil-ODF seems beneficial for patients irrespective of the severity of the ED. This study confirms in the context of daily clinical practice the satisfaction of patients with sildenafil-ODF. Data suggest that the availability of the intermediate dose of 75 mg could add greater flexibility to the therapy.

EQUINOXE study: Impact of relational cohesion and sexuality on the quality of life of patients treated with gonadotropin-releasing hormone agonist for prostate cancer.

Objectives: To measure the effect of dyadic adjustment on changes in patients' quality of life when initiating treatment with gonadotropin-releasing hormone (GnRH) agonist. Patients and methods: A prospective, multicenter, longitudinal, and non-interventional study (NCT02630641) that included patients with prostate cancer starting GnRH agonist therapy, and their partners, in 157 centers in France. Data were collected at inclusion and after 6 months of treatment on quality of life (WHOQOL-BREF), disease perception (B-IPQ), disease symptoms (QLQ-PR25), and perception of cohesion within the couple (dyadic adjustment, DAS-16). Results: The Full Analysis Set included 492 patients (median age [Q1;Q3]: 74 [68;80] years). An improvement of the quality of life (defined as the improvement of at least one of the four dimensions of WHOQOL-BREF) was reported in 290/434 (67%) patients between baseline and follow-up. Quality of life was better at baseline and follow-up in patients with good cohesion within the couple than in those with medium or poor cohesion. Factors associated with improvement in quality of life of patients were the following: initial presence of QLQ-PR25 hormonal treatment-related symptoms (OR [95% CI]: 3.00 [1.46, 6.17]) suggesting testosterone deficiency symptoms at baseline and initial low level (2.04 [1.12, 3.72]) or absence of sexual activity (2.23 [1.11, 4.50]) before GnRH agonist initiation. Conclusion: Men with the greatest improvement in quality of life after initiating hormone therapy were those with, at baseline, testosterone deficiency symptoms (identified by QLQ-PR25 treatment-related symptoms score) or no/low sexual activity. Cohesion within the couple was not confirmed as an influence on the evolution of quality of life.

[Sexual dysfunction and antihypertensive treatment: Involvement of the different therapeutic classes and what to do about the treatment of hypertension]. / Dysfonction érectile et traitement antihypertenseur : impact des différentes classes thérapeutiques et conduite à tenir à l'égard du traitement.

Erectile dysfunction (ED) is not routinely discussed with patients in cardiology practices whereas it may impact the ability of patients to stay on therapy. Most of the studies about ED and antihypertensive therapies have several methodological limitations. Diuretics and beta-blockers have been shown to have a deleterious effect on ED. ISRA inhibitors, calcium antagonists, vasodilator beta-blockers and alpha-blockers have been shown to have a neutral impact on ED. Angiotensin 2 inhibitors, nebivolol and alpha-blockers use has sometimes beneficial effect on ED. In case of ED due to antihypertensive treatment, drugs can be switched each other but careful attention in patients with a high cardiovascular risk is required.

[Erectile dysfunction : up-date data and clinical guidelines]. / Nouvelles recommandations pour la prise en charge de la dysfonction érectile à l'usage du praticien.

In this paper, we are presenting a synthetic version of the third updated version of Guidelines for the first-line management by the non-sexologist practitioner of a man with erectile dysfunction (ED). This work applied the methodology recommended by the French High Authority of Health (in-depth documentary search of medical and scientific bibliographic data and review by a group of experts). Among the points to be highlighted since 2010, an important part has been devoted to updating epidemiological data that focus on the strong correlation between ED and vulnerable populations, on the question of the role of the partner's role in triggering or maintaining erectile dysfunction, previously poorly documented, and on the evolution of ED treatments and management algorithms.

Nous présentons dans cet article une synthèse de la troisième version actualisée des « Recommandations pour la prise en charge en première intention par le praticien non sexologue d'un homme souffrant de dysfonction érectile (DE) ¼. Ce travail a appliqué la méthodologie recommandée par la Haute autorité de santé française (analyse de la littérature par un groupe de travail et relecture par un groupe d'experts). Parmi les points à souligner depuis 2010, une part importante a été faite à l'actualisation des données épidémiologiques qui mettent l'accent sur la forte corrélation entre DE et populations vulnérables, sur la question du rôle du partenaire dans le déclenchement ou le maintien de la DE, auparavant peu documenté, ainsi que sur l'évolution des traitements de la DE et de ses algorithmes de prise en charge.

Hypogonadal men nonresponders to the PDE5 inhibitor tadalafil benefit from normalization of testosterone levels with a 1% hydroalcoholic testosterone gel in the treatment of erectile dysfunction (TADTEST study).

INTRODUCTION: Addition of testosterone (T) may improve the action of phosphodiesterase type 5 inhibitors (PDE5-Is) in patients with erectile dysfunction not responding to PDE5-Is with low or low-normal T levels. AIMS: To confirm this add-on effect of T in men optimally treated with PDE5-Is and to specify the baseline T levels at which such an effect becomes significant. METHODS: A multicenter, multinational, double-blind, placebo-controlled study of 173 men, 45-80 years, nonresponders to treatment with different PDE5-Is, with baseline total T levels ≤ 4 ng/mL or bioavailable T ≤ 1 ng/mL. Men were first treated with tadalafil 10 mg once a day (OAD) for 4 weeks; if not successful, they were randomized in a double-blind, placebo-controlled design to receive placebo or a 1% hydroalcoholic T gel (50 mg/5 g gel), to be increased to 10 mg T if results were clinically unsatisfactory. Main Outcomes Measures. Mean change from baseline in the Erectile Function Domain Score of the International Index of Erectile Function and rate of successful intercourses (Sexual Encounter Profile 3 question). RESULTS: Erectile function progressively improved over a period of at least 12 weeks in both the placebo and T treatment groups. In the overall population with a mean baseline T level of 3.37 ± 1.48 ng/mL, no additional effect of T administration to men optimally treated with PDE5-Is was encountered. The differences between the T and placebo groups were significant for both criteria only in the men with baseline T ≤ 3 ng/mL. CONCLUSIONS: The maximal beneficial effects of OAD dosing with 10 mg tadalafil may occur only after as many as 12 weeks. Furthermore, addition of T to this PDE5-I regimen is beneficial, but only in hypogonadal men with baseline T levels ≤ 3 ng/mL.

Sexual behaviors and mental perception, satisfaction and expectations of sex life in men and women in France.

AIM: To analyze behaviors, mental perception, satisfaction, and expectations relating to sexuality in France. METHODS: A total of 1,002 subjects (483 men and 519 women) aged 35 years and over in a representative sample of the French population were surveyed by phone using a dedicated questionnaire in November 2003. MAIN OUTCOME MEASURES: Sexual behaviors and mental perception, satisfaction and expectations concerning sexual life. RESULTS: Of the population, 80.2% reported having a sexual partner. The mean number of times subjects had sex per week was 1.8 (2.0 in men, 1.6 in women). The decision preceded the act by a few seconds or minutes in 82.7% of subjects. Thinking about sex was "frequent" in 47.1% of subjects, especially for men (60.8%). Regardless of gender, sexuality was more synonymous with pleasure (44.0%) and love (42.1%) than with procreation, children, or motherhood (7.8%). During sexual intercourse, simultaneous orgasms and feelings of closeness were important for the majority of subjects, 35.8% (41.6% of men) and 22.8%, respectively; foreplay, enjoyment, and vaginal penetration were the most important accomplishments for 13.1%. Regardless of gender, 83.0% of subjects expressed relative or full satisfaction with their sex life. However, only 38.7% of subjects (31.6% of men and 45.2% of women) did not wish to change anything, while 17.2% would like to have more time for it. Of the subjects, 63.0% reported a decrease in sexual desire during periods of work-related stress, especially in women (72.3%). The main sexual complaints reported by men were diminution of sexual desire (24.9%), early ejaculation (23.7%), and erectile problems (14.4%). In women, they were diminution of sexual desire (45.7%), orgasm disorders (15.5%), and dyspareunia (15.5%). CONCLUSIONS: This survey showed that the attitude of subjects, especially men, toward sexuality is changing through years and highlighted the extent of sexual problems in the general population.

[Women faced with the problem of erectile dysfunction: women's view on a male problem]. / Les femmes face a la dysfonction erectile: problème d'homme, regards de femme.

MATERIAL AND METHODS: This study is based on an opinion survey conducted with the support of the Société d'Etudes Française Louis Harris, performed by telephone on a final sample of 507 women, representative of the population of French women between the ages of 20 and 65 years, interviewed about their sexuality. In particular we studied their perception and behaviour in relation to their partner's erection problems. RESULTS: 25% of women reported that they had experienced such problems, and although it was impossible to define a predictive profile pre-disposing to this problem, their attitude in relation to this event was found to be globally positive with an attitude designed to reassure and stimulate the partner experiencing erectile dysfunction (92%). In contrast, 66.4% of women considered that their partner's attitude tended to reinforce their sexual difficulties (insistence, withdrawal, avoidance, absence of dialogue). Erectile dysfunction (ED) does not affect the sexual satisfaction of the partner concerned (satisfied in 84% of cases), who report that they suffer much more from the lack of communication, frequent in this type of situation, well than from the absence of penetration (3%). CONCLUSION: Medical consultation is still relatively rare, and is essentially requested by the woman when her partner withdraws and refuses any assistance. It is often prevented by negative cognitions concerning the irreversibility of ED, for example when it is attributed to age. There is also a significant difference between women who say that they would encourage their partner to consult for this type of problem (87%), and those who actually encourage their partner to consult when specifically faced with this problem (8%). Women faced with the problem of ED are largely more in favour of the use of erectile drugs that those of the other group.