enile cancer is an aggressive squamous cell carcinoma of the skin of the glans or of the inner layer of the prepuce, characterized by invasive growth and early metastatic spread to lymph nodes. While penile cancer is uncommon in Europe, incidence rates are very high in parts of South America and Africa. Since its treatment is often associated with significant cosmetic and functional defects, the disease is of critical importance to the affected men. Early metastatic spread to regional lymph nodes can be life-threatening. It is not uncommon that factors, both from the patient and the treating physician, are causing delays in diagnosis and start of treatment. With penile cancer being a comparatively rare disease, many physicians are unfamiliar with its management. Thus, several countries have centralized the treatment of this rare tumor. Penile cancer is an orphan disease. Due the low numbers of patients, no prospective randomized studies have become available. Most of the available data is from small retrospective studies; larger studies result from retrospective multicenter data collections. Thus, the level Summary Background: The incidence of penile cancer in Europe lies in the range of 0.9 to 2.1 cases per 100 000 persons per year. Carcinogenesis is associated with human papilloma virus (HPV) infection and with chronic inflammation. Methods: This review is based on publications (2010-2017) retrieved by a selective search in PubMed and EMBASE and on the guidelines of the European Association of Urology, the European Society of Medical Oncology, the National Comprehensive Cancer Network, and the National Institute for Health and Care Excellence (NICE). Results: 95% of cases of penile cancer are accounted for by squamous cell carcinoma, whose numerous subtypes have different clinical courses. Chronic preputial inflammation due to phimosis or lichen sclerosus is often associated with penile cancer. Circumcision lowers the risk of penile cancer (hazard ratio: 0.33). Maximally organ-preserving surgery with safety margins of no more than a few millimeters is the current therapeutic standard, because a local recurrence, if it arises, can still be treated locally with curative intent. Local radiotherapy can be performed in early stages. Lymphogenic metastasis must be treated with radical lymphadenectomy and adjuvant chemotherapy. Patients with clinically unremarkable inguinal lymph nodes nonetheless need invasive lymph node staging because of the high rate of lymphogenic micrometastasis. Conclusion: Penile cancer is curable in all early stages with the appropriate treatment, but its prognosis depends crucially on the proper management of the regional (i.e., inguinal) lymph nodes. In many countries, the treatment of this rare disease entity has been centralized.
Introduction Clinical practice guidelines for management of erectile dysfunction (ED) provide limited direction in defining appropriate treatment goals with phosphodiesterase type 5 (PDE5) inhibitor therapy. Aim To establish an evidence-based position on treatment goals in ED, including the role of erection hardness, with the potential to improve self-esteem, confidence, and overall sexual and relationship satisfaction. Main Outcome Measure The target of ED therapy is optimization of a rigid erectile response, as assessed by the 4-point Erection Hardness Score (EHS). Methods An international panel of experts in urology, psychology, and primary care convened to evaluate retrospective data from worldwide phase 2, 3, and 4 clinical trials, involving over 10,000 men with ED, as well as data from recent prospective studies, concerning the role of erection hardness in defining the response to treatment with PDE5 therapy. Results Significant positive correlations were found between EHS and the Quality of Erection Questionnaire and the International Index of Erectile Function (IIEF) erectile function domain score and other IIEF measures. Significant positive correlations were also found between erection hardness and psychosocial measures such as self-esteem, confidence, and relationship satisfaction (assessed by the Self-Esteem And Relationship questionnaire), and satisfaction with medical treatment (assessed by the Erectile Dysfunction Inventory of Treatment Satisfaction). A shift in most frequent erection from EHS 3 (hard enough for penetration but not fully hard) at baseline to EHS 4 (completely hard and fully rigid) at the end of treatment was accompanied by significant improvements in intercourse and relationship satisfaction, psychosocial benefits, and satisfaction with ED treatment. Conclusion Support is found for monitoring and treating patients with ED to their full erectile potential. Quantitative assessment of erection hardness in clinical practice will lead to improved outcomes in overall sexual experience and optimal treatment satisfaction.
primary endpoints (UUI episodes/24 h and treatment response), several secondary endpoints (severe urgency plus UUI per 24 h, mean VV (MVV)/void, and continent days/ week), HRQoL, using the King's Health Questionnaire (KHQ) and the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), and self-reported bladder-related problems. A subanalysis also assessed all endpoints for patients who were incontinent at baseline. Tolerability and safety were assessed by evaluating adverse events, residual urine volume, laboratory variables and treatment withdrawals. RESULTSBy week 12, patients with OAB in both active-treatment groups showed significant improvements in most bladder diary variables and treatment response rates compared with placebo. Fesoterodine 8 mg was statistically significantly better than tolterodine ER 4 mg for improving UUI episodes, severe urgency plus UUI, mean VV, and number of continent days/week. In addition, the fesoterodine and tolterodine ER groups showed significantly greater improvements in HRQoL than the placebo group, with positive changes in most domains of the KHQ and an improvement in ICIQ-SF score. The fesoterodine 8-mg group had statistically significant improvements over placebo in eight of nine KHQ domains. A major improvement in the severity of bladder-related problems was reported by 39% of the fesoterodine 8 mg and 34% of the tolterodine ER groups vs 25% of those on placebo ( P ≤ 0.01). Results for the subgroup of incontinent patients at baseline were similar to the overall results. Adverse events reported most commonly with active treatment included dry mouth, constipation, dry eye, dry throat, and nausea. CONCLUSIONSBoth fesoterodine and tolterodine ER significantly improved OAB symptoms and HRQoL, with statistically significant advantages for fesoterodine 8 mg compared with tolterodine ER on several important endpoints. KEYWORDSoveractive bladder, incontinence, quality of life, antimuscarinic Study Type -Therapy (RCT) Level of Evidence 1b OBJECTIVETo compare, in a post hoc analysis of a phase III trial, the maximum recommended doses of fesoterodine (8 mg) and tolterodine (4 mg) for improving overactive bladder (OAB) symptoms and health-related quality of life (HRQoL), as fesoterodine effectively reduces OAB symptoms vs placebo. PATIENTS AND METHODSEligible patients with frequency ( ≥ eight voids/24 h) and either urgency ( ≥ six episodes over 3 days) or urgency urinary incontinence (UUI; ≥ three episodes over 3 days) were randomized to placebo, fesoterodine 4 or 8 mg, or tolterodine extended-release (ER) 4 mg for 12 weeks; fesoterodine 4 mg data were published elsewhere. Patients completed a 3-day bladder diary in which they recorded the time of each void, voided volume (VV), and the severity of urgency. A post hoc inferential analysis was conducted on the primary endpoint (voids/24 h), the two co-
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