Outcomes and general health-related quality of life among patients medically treated in general daily practice for lower urinary tract symptoms due to benign prostatic hyperplasia.

OBJECTIVE: This study's aim was to describe and evaluate outcomes of medical strategies used for lower urinary tract symptoms (LUTS) treatment in general practice and to assess impact of LUTS on patients' general health-related quality of life (HRQoL). METHODS: This cross-sectional observational study was conducted by French general practitioners. Eligible patients were males aged ≥50 years, diagnosed for at least one year and currently treated for LUTS due to benign prostatic hyperplasia (BPH). Several validated questionnaires were documented by patients to assess severity of LUTS (IPSS), specific quality of life (IPSS-Q8), impact of LUTS (BII), LUTS evolution (VNS) and general HRQoL (EQ-5D). RESULTS: Among 1,098 patients included, 82.7% were treated with monotherapies and 17.3% with combinations. Mean treatment duration was 5.2 ± 3.2 years, and 47.2% of patients had at least one treatment modification since initiation. Patients reported diminished quality of life (IPSS-Q8 ≥3) (42.3%), persisting symptoms (IPSS-score ≥12) (35.5%), symptoms worsening (VNS-score ≤-1) (18.8%) and high bother (BII-score ≥9) (2.6%). Globally, 52.8% had at least one of these unsatisfactory outcomes. Regarding general HRQoL, mean EQ-5D utility significantly decreased with LUTS severity (mild: 0.90 ± 0.12; moderate: 0.81 ± 0.21; and severe symptoms: 0.73 ± 0.25; P < 0.001). As well, all five-dimensions of EQ-5D were significantly altered in patients with moderate-to-severe LUTS (<0.001), especially 'Pain/Discomfort' and 'Anxiety/Depression'. In multivariate analyses including age and comorbidities, EQ-5D utility index remained negatively associated with each additional unit in the IPSS-score. CONCLUSIONS: This study shows that around half of BPH patients medically treated report unsatisfactory outcomes, suggesting consequential unmet medical needs in general practice. Also, moderate-to-severe LUTS significantly impact on general HRQoL.

Treatment costs of prostate cancer in the first year after diagnosis: a short-term cost of illness study for France, Germany, Italy, Spain and the UK.

OBJECTIVE: To calculate the total cost per patient of prostate cancer treatment and the economic cost burden by stage, in the first year after diagnosis, for five European countries. METHODS: Data from the Information Management Systems, Inc. database, survival data, expert opinion, published data and unit costs from various published official sources were used to calculate total costs per patient by stage for each country, from a payer's perspective. Diagnostic costs, first surgery, radio-, chemo- and hormonal therapy costs were included. Costs were aggregated for incident cases. RESULTS: The mean direct costs per patient for initial treatment were euro3698 in Germany, euro3256 in Spain, euro3682 in the UK, euro5226 in Italy and euro5851 in France. The total costs for all diagnosed patients in the first year from diagnosis were (million euro) 116.7 (UK), 244 (Germany), 385 (France), 202 (Italy) and 114.6 (Spain). CONCLUSIONS: The direct initial healthcare cost burden of the most common non-skin-related male cancer, prostate cancer, in France, Germany, Italy, Spain and the UK is considerable. Given the high and increasing prevalence of prostate cancer due to ageing populations in Europe, and the significant cost burden of the disease, national health policy makers should be aware of prostate cancer as a priority disease area.

Profile and management of patients treated for the first time for lower urinary tract symptoms/benign prostatic hyperplasia in four European countries.

OBJECTIVE: To describe the profile and management of patients medically treated for benign prostatic hyperplasia (BPH) in primary care in four European countries, as the diagnosis and management of BPH have developed dramatically in the last decade, and recent information from actual practice is insufficient. PATIENTS AND METHODS: This observational, cross-sectional study was carried out by general practitioners in France (141 patients), Spain (127) and Portugal (50), and by office-based urologists in Germany (162 patients) between July 2005 and June 2006. The physicians were unaware of the study sponsor. Patients aged >or=50 years were recruited if a decision for medical treatment of BPH was taken for the first time on that day. The patient and the investigator had to complete one questionnaire each. RESULTS: The physicians included 480 patients, with a mean (sd) age of 65.0 (7.8) years. The mean (sd) International Prostate Symptom Score (IPSS) was 16.0 (7.3). There were geographical differences in age (P = 0.009; patients in Germany being the youngest), IPSS (P = 0.017; patients in Spain having the highest score), quality of life (QoL; IPSS item 8, P < 0.001, the least altered being in Germany), and sexual activity (P = 0.010; the highest proportion of sexually active patients being in Portugal), but not for comorbidities and concomitant medication. The IPSS correlated poorly with age (r = 0.21) and moderately with QoL (r = 0.47). Severe symptoms (IPSS > 19) were not linked with sexual activity (age-adjusted P = 0.378). Serum prostate specific antigen testing, although not recommended for BPH, was widely used (83.8% overall). All other examinations were carried out disparately depending on the country (P < 0.001 each). Digital rectal examination (DRE) and excluding urinary tract infection (urine culture) were used in approximately 75% of study patients, but only half the patients in France had a urine culture, and 52% in Portugal had a DRE. A standardized assessment of symptoms and/or QoL was reported in 45% of study patients, with wide discrepancies among countries, i.e. 77.2% in Germany and 6.0% in Portugal. alpha-blocker monotherapy was the most frequently prescribed treatment (62.5% overall, 87.1% in Germany, 46.1% in France), followed by phytotherapy (23.5%), and 5 alpha-reductase inhibitor monotherapy (3.75%); combinations were rare. Treatment varied according to the severity of the symptoms (P = 0.008), phytotherapy being given to patients with the lowest IPSS, and combinations to those with the highest IPSS. CONCLUSION: There were geographical discrepancies that could be attributed to either different cultural habits or merely organisational differences, e.g. the presence of office urologists in Germany or diverse modes of access to phytotherapy (prescription vs 'over the counter') in the various countries.

[Factors determining treatment strategies for patients with benign prostatic hyperplasia. The DUO study]. / Facteurs déterminant le choix thérapeutique des urologues pour la prise en charge des patients ayant une hypertrophie bénigne de la prostate. L'étude DUO.

OBJECTIVES: The DUO study sought to identify the factors determining diagnostic and treatment strategies for benign prostatic hyperplasia (BPH) in daily practice. METHODS: Observational study conducted in France (from June 2004 through March 2005) among a representative sample of French urologists. RESULTS: Two hundred two urologists included 1027 BPH patients (mean age: 68 years +/-9), 856 of whom were seen again six months later. The mean International Prostatic Symptom Score (IPSS) was 14.9 (+/-6.7) at inclusion and 10.5 (+/-6.7) at the follow-up visit. At inclusion, pharmacologic treatment was prescribed to 84% of patients, surgery was recommended to 13% and no treatment to 3%. Factors favoring surgery (versus drugs) were BPH severity (OR=2.5 for IPSS>or=20), patient choice (OR=2.5), expected quality of life improvement (OR=2.2), post-void residual (OR=2.1) and dribbling (OR=1.6). This choice was not associated with patient age, prostatic volume or active sex life. Choice of a 5alpha reductase inhibitor (versus alpha-blocker) was associated with large prostatic volume (OR=7.6), PSA results (OR=5.8), and patient age (OR=5.5 for >or=74 years, OR=2.1 for >or=68 years). Prescription of a combination of alpha-blocker plus 5alpha-reductase inhibitor (versus alpha-blocker alone) was associated with severity of BPH (OR=7.9), prostatic volume (OR=7.8), prevention of complications (OR=3.1), patient age (OR=3.0 if >or=74 years) and post-void residual (OR=2.3). DISCUSSION: Both medical and surgical treatment of BPH resulted in improved IPSS scores at 6 months. Patient age and prostatic volume are reasons urologists prescribe 5alpha reductase inhibitors, but they do not affect the decision about surgical treatment. Surgery is performed in severe BPH or when patients choose surgery in the expectation of improving their quality of life. The factors determining treatment strategies identified in this study are patient age, BPH severity, prostatic volume, patients' wishes, PSA results and post-void residual.

[The prostate: how to treat this symbol of male vulnerability? An Association Française d'Urologie (AFU)-IPSOS qualitative survey]. / La prostate: identification des attentes du médecin généraliste. Une enquête qualitative. Association Française d'Urologie (AFU)-IPSOS.

INTRODUCTION: Information on prostate diseases, including prostate cancer, has been promoted by the Association Française d'Urologie (AFU) for several years, but is developing slowly in France. In 2005, a first communication was targeted to the male public and identified the reasons for the fatalistic attitude of men, and paradoxically, why the prostate incarnates the vulnerability of their sexual capital. As part of a second phase, this article presents the results of a complementary study conducted among general practitioners to identify their expectations and the most appropriate levers to promote screening. MATERIAL AND METHOD: The Ipsos survey company developed a Krisis qualitative protocol in October 2005 (after the first French prostate day on 15 September 2005). Three groups of general practitioners were defined: doctors who are very active in terms of screening, doctors who are uncomfortable with this problem and doctors who systematically refer their patients to urologists. RESULTS: The management of prostate diseases often highlights the ageing process for the patient. The ability to discuss these problems during the consultation depended on the doctor's degree of comfort with this subject, which is related to his/her training and relationships with urologists. To initiate the question of screening, general practitioners involved in this process asked simple questions about everyday practices without being afraid of making jokes or basing their approach on mediatization of the disease. Digital rectal examination is one of the important clinical elements but is not always easy to perform. PSA was found to be an examination that is not always appropriate, characterized by a lack of information on the conditions for ordering this test, its usefulness and its relevance for screening. Ultrasound could be a way of alerting the patient without dramatizing the situation, letting the urologist perform digital rectal examination. Female general practitioners preferred PSA and ultrasound. The doctors surveyed relied on mediatization of prostate diseases, a high level of interactivity with urologists and documents and brochures to be placed in waiting rooms to relay screening messages. CONCLUSION: General practitioners need their authorities, specialists and public health institutions to develop and mediatize andrology in the same way as gynaecology. Urologists play a major supportive role by means of conferences, postgraduate training or AFU invitations.

[Effect of bicalutamide 150 mg, after 3 years of median follow-up, in non-metastatic prostatic cancer]. / Effet du bicalutamide 150 mg, à trois ans de suivi médian, dans le cancer de la prostate non métastatique.

OBJECTIVE: To determine the efficacy and safety of bicalutamide, at the dose of 150 mg per day, as first-line monotherapy or as curative adjuvant therapy in patients with non-metastatic prostate cancer, and to investigate the possibility of a greater benefit for certain patient subgroups. MATERIAL AND METHODS: This article recalls the preliminary results of an international endocrine therapy programme comprising three double-blind placebo-controlled clinical trials in patients with non-metastatic prostate cancer (T1-T4. Nx/N0/N1, M0). Patients were randomized to receive either 150 mg/day of bicalutamide, or placebo, as an adjuvant to radical prostatectomy, external beam radiotherapy or in the context of watchful waiting. The main endpoints were the time to objective clinical progression and overall survival. The combined data of the three trials were submitted to intent-to-treat analysis. The authors also report the results of exploratory studies performed as a function of the type of treatment and prognostic factors. RESULTS: After a median follow-up of 3 years of a sample size of 8,113 patients, objective clinical progression was observed in 9% of patients of the bicalutamide group (4,052 patients) and in 13.8% of patients of the placebo group (4,061 patients), corresponding to a 42% relative risk reduction (RR: 0.58; p << 0.0001). Reduction of the risk of disease progression was observed for the entire study population regardless of primary treatment, stage of disease or usual prognostic factors. This reduction was more marked for patients presenting poor prognostic factors. Data concerning overall survival are not available due to insufficient follow-up. Treatment was well tolerated. The adverse effects most frequently reported in the bicalutamide group were gynaecomastia and breast pain. CONCLUSION: After a median follow-up of three years, bicalutamide, as first-line monotherapy or as curative adjuvant therapy, significantly reduced the risk of objective clinical disease progression in patients with non-metastatic prostate cancer. Exploratory analyses demonstrate that the benefit of bicalutamide appeared to be greater for patient with poor prognostic factors. Survival data are not yet available.