Aims: The aim of this study was to investigate the efficacy and safety of 10 mg vardenafil orodispersible tablet (ODT) vs. placebo in a general population of men with erectile dysfunction (ED). Methods: This was a double-blind, multicentre, randomised, parallel-group, placebo-controlled study conducted at 35 centres in Australia, Canada, Mexico and the United States. Subjects aged >= 18 years, with ED for at least 6 months, were randomised to receive 12 weeks of on-demand treatment with either 10 mg vardenafil ODT or placebo. Each treatment group was stratified such that approximately half of the subjects were aged >= 65 years. Primary efficacy variables were the erectile function domain of the International Index of Erectile Function (IIEF-EF) and Sexual Encounter Profile questions 2 (SEP2) and 3 (SEP3). Secondary variables included SEP diary questions 1, 4, 5 and 6, the patient version of the Treatment Satisfaction Scale (TSS) and the Global Assessment Question (GAQ). Results: Of the 473 men enrolled in the study (51.4% aged >= 65 years), 331 were included in the intent-to-treat population (vardenafil ODT, n = 169; placebo, n = 162). Vardenafil ODT therapy was statistically significantly superior to placebo for all primary (i.e. IIEF-EF, SEP2, SEP3) and secondary efficacy variables (p < 0.0001). Treatment-emergent adverse events were mostly mild to moderate in severity, and comparable in both incidence and type with those of the film-coated tablet formulation. Conclusions: Treatment with 10 mg vardenafil ODT, taken on demand, significantly improved erectile function and was effective and well tolerated in a broad population of men with ED.

Overactive bladder (OAB) is a prevalent condition that has a significant negative impact on almost all aspects of health-related quality of life (HRQoL). Urgency is the core symptom experienced by all patients who have OAB, either with or without urgency urinary incontinence (UUI).To describe the assessment and impact of UUI on patients’ HRQoL.A nonsystematic review of the literature including PubMed and congress abstracts was performed in 2010.Urodynamic measures are not necessarily predictive of the impact of OAB symptoms on the individual patient. Thus the use of validated, disease-specific instruments to assess patient-reported outcomes such as symptom bother, HRQoL, treatment satisfaction, and symptom frequency and severity has become standard in the diagnosis and treatment of OAB. Use of these measures in clinical research has shown that OAB with UUI has a greater impact on HRQoL than OAB without UUI, and reduction of UUI episodes is an important goal for patients with OAB with UUI. The impact of UUI on HRQoL is also greater than that of stress urinary incontinence or other types of urinary incontinence. Furthermore, UUI episodes contribute substantially to the personal and societal cost burden of OAB.Effective treatment of OAB symptoms, focussing on UUI, is essential to improve patient HRQoL and to minimise the costs associated with this condition.

INTRODUCTION:Men with erectile dysfunction (ED) are typically older and have one or more underlying cardiovascular conditions.AIM:To determine the efficacy and safety of a new orodispersible tablet (ODT) formulation of vardenafil for the treatment of ED, and whether age, or the presence of underlying conditions affects treatment outcomes.METHODS:This is an integrated analysis of data from two phase III, double-blind, multicenter, randomized, parallel-group, placebo-controlled studies that compared 10 mg on-demand vardenafil ODT with placebo in a general population of men with ED, stratified so that approximately 50% of patients were aged ≥ 65 years. Results were reported by age (<6 5 vs. ≥ 65 years) and presence/absence of diabetes, dyslipidemia, or hypertension.MAIN OUTCOME MEASURES:Primary measures were the erectile function domain of the International Index of Erectile Function (IIEF-EF) and Sexual Encounter Profile questions 2 (SEP2) and 3 (SEP3).RESULTS:Of the 701 men randomized (51% aged ≥ 65 years), 686 were included in the intent-to-treat population (placebo, n = 334; vardenafil ODT, n = 352). Vardenafil ODT was significantly superior to placebo for all primary efficacy measures, regardless of age, baseline ED severity, or underlying condition (P < 0.0001 for vardenafil vs. placebo for each endpoint). IIEF-EF scores and SEP2/3 success rates in older patients and men with underlying conditions were not significantly different to those of younger patients or men without underlying conditions. Adverse events (AEs) were mostly mild to moderate in severity, occurring with higher incidence in the vardenafil vs. placebo group. The most frequently reported drug-related AEs in the vardenafil group were headache, flushing, nasal congestion, dizziness, and dyspepsia, consistent with the known safety profile of phosphodiesterase type 5 inhibitors.CONCLUSIONS:Vardenafil ODT significantly improves erectile function in men with ED regardless of age, baseline ED severity, or underlying condition.

Klinische Studien zeigten positive Effekte der Phosphodiesterase- (PDE-)5-Inhibitoren Sildenafil, Tadalafil und Vardenafil auf die irritative Symptomatik des benigen Prostatasyndroms. Unklar ist bisher, ob diese Substanzen auf die glatte Muskulatur in der Transitionalzone der Prostata und/oder auf den Detrusormuskel wirken. Das Ziel der Studie war die Darstellung der Expression der PDE-Isoenzyme 1, 4 und 5 in der Detrusormuskulatur und die Untersuchung der Effekte selektiver PDE-Inhibitoren auf die muskarinerge Tension isolierter glatter Muskulatur des humanen Detrusors.

Objectives. The use of inhibitors of phosphodiesterase (PDE) isoenzymes 1 and 5 to treat overactive bladder has been suggested. To further evaluate the significance of PDE isoenzymes in detrusor smooth muscle relaxation, we investigated the effects of selective PDE inhibitors on the tension induced by carbachol of isolated human detrusor tissue. Using immunohistochemical methods, the expression of PDE1, PDE4, and PDE5 in human detrusor was also investigated. Material and Methods. The expression of PDE1, PDE4, and PDE5 was evaluated by means of conventional immunohistochemistry (IHC). Using the organ bath technique, the effects of the PDE inhibitors vinpocetine, rolipram, sildenafil, tadalafil, and vardenafil on the tension induced by the muscarinic agonist carbachol (1 mu M) were investigated. Results. The tension induced by carbachol was dose-dependently reversed by the PDE inhibitors; the maximum reversal of tension ranged from 7% (tadalafil) to 34% (vardenafil). IHC revealed that the expression of PDE isoenzymes was limited to the smooth musculature of the detrusor. While there was prominent expression of PDE4 and PDE5, immunoreactions indicating the presence of PDE1 were less abundant. Conclusion. Despite the fact that inhibitors of PDE1, PDE4, and PDE5 exerted only a weak relaxant response on detrusor strips precontracted by carbachol, our findings indicate that both the cAMP and cGMP pathways might be involved in the relaxation mechanism of human detrusor smooth muscle.

Purpose: To assess the feasibility and efficacy of Veritas (TM) Collagen-Matrix implants for the treatment of persistent rectocele. Material and Methods: Eighteen patients who underwent posterior vaginal wall repair for persistent rectocele via a vaginal approach with Veritas bovine collagen matrix (Synovis, St. Paul, MN, USA) were evaluated retrospectively. The women were post-menopausal and used vaginal estrogen for at least two weeks preoperatively. The posterior vaginal wall was reinforced with Veritas collagen matrix in all patients. Healing was assessed based on the incidence of prolapse recurrence, the presence of infection, granulation tissue, and eroded suture materials in the vagina postoperatively. Results: None of the 18 patients developed a postoperative vaginal infection, and none had vaginal erosion of the material. No patient had tissue disruption at the suture lines. Follow-up examinations were carried out after 6, 12 and 18 months (median 15 months). There were no vessel or bladder injuries and no postoperative complications. One non-symptomatic recurrent rectocele was observed. Conclusion: Veritas (TM) Collagen-Matrix implants do not appear to impede heating in vaginal urogynecologic surgery. These preliminary results suggest that bovine collagen implantation is a safe and effective treatment for posterior vaginal wall prolapse. Further studies are needed.

Objective: To determine the efficacy and tolerability of flexible dosing with vardenafil in a broad population of men with erectile dysfunction (ED). Methods: 10-week, open-label, flexible-dose study starting with vardenafil 10 mg, titrating to 5 mg or 20 mg at weeks 2 and 6 based on efficacy and tolerability, set in 78 community practice centers in Germany and France. Participants comprised 398 men aged ≥18 years with ED. Main outcome measures were self-reported improvement in erections according to a Global Assessment Question (GAQ), diary questions from the Sexual Encounter Profile (SEP2 and SEP3), and the erectile function domain score from the International Index of Erectile Function (IIEF) questionnaire. Results: In a last observation carried forward (LOCF) analysis, a total of 92% (336/366) of men with ED reported an improvement of erections according to the GAQ. Per-patient success rates for penetration (SEP2) and maintenance (SEP3) of erection for intercourse were 89% (348/390) and 78% (303/390), respectively. Mean erectile function domain scores increased from 13.9 at baseline to 25.9 at LOCF. Vardenafil was generally well tolerated; headache (6%, 25/398) and flushing (6%, 24/398) were the most frequent adverse events. Conclusions: In this community practice setting, vardenafil was shown to be a highly effective and generally well-tolerated treatment for men with ED when dosing was titrated by the physician to individual patient requirements.

This randomised, double-blind study assessed the long-term efficacy and tolerability of vardenafil 10 and 20 mg in men with erectile dysfunction (ED). A total of 566 men who completed an initial 12-month treatment period entered a 12-month extension. In these men, both doses of vardenafil produced improvement in scores for the 'erectile function' Domain of the International Index of Erectile Function, evident from week 4 and maintained through 2 years. Sexual Encounter Profile diary responses indicated that following treatment, penetration was achieved on 92-94% of attempts and erections that lasted long enough for successful intercourse were achieved on 87-89% of attempts. In response to the General Assessment Question, 90-92% of patients reported improved erections with vardenafil. Most treatment-emergent events were mild and transient with no cardiovascular safety concerns. These results support the long-term efficacy, reliability and tolerability of vardenafil 10 and 20 mg in men with ED.

You have accessJournal of UrologyDiscussed Poster, Monday, May 10, 2004, 8:00 am - 12:00 pm1 Apr 2004906: Influence of Prior Sildenafil Use on the Efficacy of Vardenafil in Men with Erectile Dysfunction: Retrospective Analysis of a Two Year Study Gerald B. Brock, Hartmut Porst, Christian G. Stief, Manfred Beneke, Ernst Ulbrich, and Inigo Saenz de Tejada Gerald B. BrockGerald B. Brock More articles by this author , Hartmut PorstHartmut Porst More articles by this author , Christian G. StiefChristian G. Stief More articles by this author , Manfred BenekeManfred Beneke More articles by this author , Ernst UlbrichErnst Ulbrich More articles by this author , and Inigo Saenz de TejadaInigo Saenz de Tejada More articles by this author View All Author Informationhttps://doi.org/10.1016/S0022-5347(18)38155-2AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail "906: Influence of Prior Sildenafil Use on the Efficacy of Vardenafil in Men with Erectile Dysfunction: Retrospective Analysis of a Two Year Study." The Journal of Urology, 171(4S), p. 240 © 2016 by American Urological AssociationFiguresReferencesRelatedDetails Volume 171Issue 4SApril 2004Page: 240 Advertisement Copyright & Permissions© 2016 by American Urological AssociationMetricsAuthor Information Gerald B. Brock More articles by this author Hartmut Porst More articles by this author Christian G. Stief More articles by this author Manfred Beneke More articles by this author Ernst Ulbrich More articles by this author Inigo Saenz de Tejada More articles by this author Expand All Advertisement Loading ...

We have studied the dV/dI vs. V characteristics of point contacts between the heavy fermion superconductor URu2Si2 and the conventional superconductors Zn and NbTi. Contacts between URu2Si2 and Zn do not show Josephson effects; instead Andreev reflection type structures occur, which are related to both, the heavy fermion and the conventional superconductor. In contrast, contacts between URu2Si2 and NbTi become superconducting at low currents. A closed-loop setup with two NbTi contacts on URu2Si2 showed SQUID oscillations in a small magnetic field. Our data give evidence that the contacts should be described as superconductor/ normal/superconductor junctions with a thick normal layer on the URu2Si2 side of the contact with proximity induced superconductivity in the N-layer in the case of NbTi. With such a model the occurrence or absence of superconductivity can be explained and also the suppression of Andreev-scattering which is frequently observed for contacts between heavy fermion superconductors and normal metals.