[Perceptions of benign prostatic hyperplasia according to the perspective of patients and general practitioners - the Trophée study]. / Perceptions de l'hypertrophie bénigne de la prostate par le patient et le médecin généraliste - étude Trophée.

OBJECTIVE: To compare the perception of benign prostatic hypertrophy (BPH) between patients and general practitioners (GPs) in terms of severity and evolution of symptoms and medication adherence. METHODOLOGY: A cross-sectional observational study was performed in France in a sample of GPs who included patients for whom a BPH treatment was prescribed. Data were collected on patient and GP characteristics, diagnosis, BPH management, severity and evolution of symptoms and medication adherence. RESULTS: One thousand and ninety-eight patients were recruited by 247 GPs. In 87.4% of cases, diagnosis was performed by GPs. Among them, 82.7% of patients were treated by monotherapy. The choice of a treatment was mainly based on treatment efficacy and the patient's opinion was taken into account by 5% of GPs. The patient's evaluation of symptoms severity was consistent with the GP's in 53.9% of cases. A worsening of symptoms was reported significantly more frequently by patients (18.5%) than by GPs (8.8%). Among 94 patients who reported poor adherence, GPs estimated that the level of medication adherence was good for 72 of these (77%). CONCLUSION: There was discordance between the evaluation made by GPs and by patients on the perception of BPH symptoms and medication adherence. The patient's opinion was rarely taken into account in the therapeutic decision, reflecting a lack of shared medical decision-making, which would be helpful for the physician in order to optimize BPH management.

Can benign prostatic hyperplasia be identified in the primary care setting using only simple tests? Results of the Diagnosis IMprovement in PrimAry Care Trial.

AIMS: Diagnosis IMprovement in PrimAry Care Trial (D-IMPACT) was a prospective, multicentre epidemiological study in three European countries to identify the optimal subset of simple tests applied in primary care to diagnose benign prostatic hyperplasia (BPH) in men who spontaneously present with lower urinary tract symptoms (LUTS). METHODS: Consecutive male patients aged ≥ 50 years who spontaneously attended their regular general practitioner (GP) office with LUTS were eligible for inclusion if they had not previously undergone BPH diagnostic tests or received treatment for BPH. Patients were assessed on three occasions, twice by their regular GP (visits 1 and 2) and once by a urologist (visit 3). The diagnostic accuracy of each variable was determined using the urologists' final BPH diagnosis (at visit 3) as gold-standard. Independent variables analysed were as follows: age; BPH diagnosis performed by GP in visit 1 (yes/no); probability of BPH diagnosis assessed by GP in visit 1; urinalysis (normal/abnormal); prostate-specific antigen (PSA); International Prostate Symptom Score (IPSS); diagnosis of BPH performed by GP in visit 2 (yes/no); and probability of BPH diagnosis assessed by GP in visit 2. Statistically significant variables (p < 0.1) were included in a logistic regression model to identify the best algorithm and describe each test contribution. RESULTS: The most frequent spontaneously reported LUTS were nocturia and weak urinary stream. BPH study prevalence was 66.0% (95%CI: 62.3-69.5) and 32% of patients were at risk of BPH progression (PSA > 1.5 ng/ml and prostate volume ≥ 30 cm(3)). Among the independent variables analysed, only age, IPSS and PSA showed a statistically significant relationship with BPH diagnosis. In a logistic regression model including age, IPSS, PSA and probability of BPH (based on physical examination and symptoms), positive predictive value (PPV) was 77.1%. Exclusion of BPH probability resulted in a PPV of 75.7%. CONCLUSIONS: A diagnostic algorithm including only objective variables (age, IPSS and PSA), easily implemented in any GP office, allows GPs to accurately diagnose BPH in approximately three-quarters of patients spontaneously reporting LUTS.

Can simple tests performed in the primary care setting provide accurate and efficient diagnosis of benign prostatic hyperplasia? Rationale and design of the Diagnosis Improvement in Primary Care Trial.

Effective treatment of benign prostatic hyperplasia (BPH) improves lower urinary tract symptoms (LUTS) and patient quality of life, and reduces the risk of complications arising from disease progression. However, treatment can only be initiated when men with BPH are identified by accurate diagnostic tests. Current evidence suggests that diagnostic procedures employed by primary care physicians vary widely across Europe. The expected increases in BPH prevalence accompanying the gradual aging of the population, coupled with greater use of medical therapy, mean that general practitioners (GPs) are likely to have an increasingly important role in managing the condition. The GP/primary care clinic is therefore an attractive target location for strategies designed to improve the accuracy of BPH diagnosis. The Diagnosis Improvement in Primary Care Trial (D-IMPACT) is a prospective, multicentre, epidemiological study that aims to identify the optimal subset of simple tests applied by GPs in the primary care setting to diagnose BPH in men who spontaneously report obstructive (voiding) and/or irritative (storage) LUTS. These tests comprise medical history, symptom assessment with the International Prostate Symptom Score questionnaire, urinalysis, measurement of serum levels of prostate-specific antigen and subjective GP diagnosis after completing all tests including digital rectal examination. GP diagnoses and all other tests will be compared with gold-standard diagnoses provided by specialist urologists following completion of additional diagnostic tests. D-IMPACT will establish the diagnostic performance using a non-subjective and reproducible algorithm. An adjusted and multivariate analysis of the results of D-IMPACT will allow identification of the most efficient combination of tests that facilitate accurate BPH diagnosis in the primary care setting. In addition, D-IMPACT will estimate the prevalence of BPH in patients who present spontaneously to GPs with LUTS.

Benign prostatic hyperplasia as a progressive disease: a guide to the risk factors and options for medical management.

Benign prostatic hyperplasia (BPH) is a complex disease that is progressive in many men. BPH is commonly associated with bothersome lower urinary tract symptoms; progressive disease can also result in complications such as acute urinary retention (AUR) and BPH-related surgery. It is therefore important to identify men at increased risk of BPH progression to optimise therapy. Several factors are associated with progression, including age and prostate volume (PV). Serum prostate-specific antigen level is closely correlated with PV, making it useful for determining the risk of BPH progression. Medical therapy is the most frequently used treatment for BPH. 5-alpha-reductase inhibitors impact the underlying disease and decrease PV; this results in improved symptoms, urinary flow and quality of life, and a reduced risk of AUR and BPH-related surgery. Alpha-blockers achieve rapid symptom relief but do not reduce the overall risk of AUR or BPH-related surgery, presumably because they have no effect on PV. Combination therapy provides greater and more durable benefits than either monotherapy and is a recommended option in treatment guidelines. The Combination of Avodart and Tamsulosin (CombAT) study is currently evaluating the combination of dutasteride with tamsulosin over 4 years in a population of men at increased risk of BPH progression. A preplanned 2-year analysis has shown sustained symptom improvement with combination therapy, significantly greater than with either monotherapy. CombAT is also the first study to show benefit in improving BPH symptoms for combination therapy over the alpha-blocker, tamsulosin, from 9 months of treatment.

[How to operate kidney puncture in percutaneous nephrolithotomy?]. / Comment ponctionner un rein pour réaliser une néphrolithotomie percutanée?

Obtaining a precise percutaneous calyceal puncture gave way to the development of percutaneous nephrolithotomy, one of the first micro-invasive techniques described in urology. Both radiologist and urologist can perform puncture, sometimes in a collaborative effort. However, being followed by a true surgical procedure, it should be done in the O.R; perfect knowledge of the procedure is mandatory for every urologist. Standard guidance uses a fluoroscopic C-arm device, only able to guide the needle precisely towards the apex of the chosen calyx. Moving the C-arm with cephalad tilting will provide 3-D imaging. Ultrasound guidance is an alternative, but might be difficult with non dilated upper tract. CT guidance and retrograde puncture are rarely used. The access is to be adapted according to the patient (adult or child), type of stone (single or multiple access), or kidney position (eutopic or ectopic). Direct ad stable puncture entering the apex of the chosen calyx is a pre-requisite for easy and efficient subsequent nephrolithotomy.

[Early prostate cancer 2005. New 2005 data]. / Nouveaux résultats du programme early prostate cancer 2005.

The Early Prostate Cancer (EPC) Program consists of three randomised, double blind, placebo-controlled trials that assess bicalutamide either as adjuvant to treatment of curative intent or alone (radical prostatectomy, radiotherapy or watchful waiting) in patients with non-metastatic prostate cancer. In total, 8113 men have been enrolled in a 1/1 ratio to receive bicalutamide 150 mg/day orally or a matching placebo. We present the results at a median follow-up. No significant results are yet observed on overall survival in the localised, low-risk disease groups. For patients with locally advanced disease, adjuvant hormonal therapy significantly improves objective progression-free survival over placebo. Moreover, adjuvant bicalutamide offers a significant benefit in terms of overall survival in radiotherapy treated patients for locally advanced prostate cancer.

[Management of patients with benign prostatic hyperplasia by urologists: the DUO study]. / Prise en charge, par les urologues, des patients présentant une hypertrophie bénigne de prostate: l'etude DUO.

UNLABELLED: The DUO study intended to define the factors determining diagnostic and treatment strategies for benign prostatic hyperplasia (BPH) management. METHODS: This longitudinal, observational study was conducted in France (June 2004 to March 2005), with a representative sample of private and hospital urologists. RESULTS: 1027 BPH patients were included by 202 urologists and 856 were followed-up 6 months later. Mean I-PSS 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 the patients, surgery to 13% and no treatment to 3%. Factors in favour of surgery (versus drugs) were BPH severity (OR = 2.5 if IPSS = 20), patients' choice (OR = 2.5), quality of life improvement (OR = 2.2), post-void residual (OR = 2.1) and dribbling (OR = 1.6). Patients' age and prostatic volume have no impact on this choice. Factors in favour of a combination of an alpha-blocker plus an 5alpha-reductase inhibitor (versus an alpha-blocker) were prostate volume (OR = 7.8), patient's age (OR-3.0 if age = 74) and post-void residual (OR = 2.3) and those in favour of a 5alpha reductase inhibitor (versus an alpha-blocker) were prostate volume (OR = 7.6), PSA results (OR = 5.8), patients' age (OR = 5.4 if > 74 years, OR = 2.1 if > 68 years). CONCLUSION: Medical or surgical treatment of BPH results in IPSS improvement at 6 months. Patients' age and prostatic volume favour 5alpha-reductase inhibitor initiation and have no impact on surgical treatment decision. Surgery is performed in severe BPH or when patients expecting a quality of life improvement do that choice.

[Is volume of surgical activity relevant for surgeon's evaluation?]. / Les volumes opératoires sont-ils des critêres pertinents pour l'evaluation des chirurgiens?

"Often done, better done" is a popular saying that may lead health authorities to use the volume of surgical activity to assess surgical quality, including eventually this criteria in their certification manual. Very few data indeed support this idea in Urology. On the other hand, well-conducted studies clearly show that high volume activity does not always avoid surgical complications. Moreover, fair statistics should be applied to urologists, with proper calculation of confidence intervals, before scrutinizing reasons why they may appear "to differ" from the assigned goal or their colleagues' average. This, for major urologic operations, can only be done after a prolonged observation period, sometimes reaching over a decade.

[The UrEpik study: a descriptive epidemiological approach to lower urinary tract symptoms, sexual disorders and urinary continence in four countries]. / L'étude urEpik: une approche d'épidémiologie descriptive des troubles mictionnels, sexuels et de la continence à travers quatre pays.

UrEpik is a cross-sectional, epidemiological study undertaken in four cities (Auxerre, Birmingham, Nijmegen and Seoul) to determine the prevalence of lower urinary tract symptoms, urinary incontinence and erectile dysfunction in men aged from 40 to 80 years and their female partners, if applicable. Numerous evaluation questionnaires were collected by post, telephone or direct contact from 4876 men and 3657 women. The prevalence of lower urinary tract disorders was significantly different from one country to another, but increased constantly with age in particular in men with an I-PSS between 8 and 19 for whom it increased by approximately 10% per decade. Incontinence in men seems to be an important problem both in terms of discomfort score and wearing of protection and it increases with age. Analysis of erectile dysfunction (ED) gave different results depending on the method of investigation used. The SFI (sexual functional index) showed a positive correlation between ED and age, which was not found by direct questioning. The psychological impact of ED varied according to culture and age of the subject.

[The PCPT study: the viewpoint of an urologist involved]. / L'etude PCPT: regards d'un urologue intéressé.

The PCPT study investigating the possibility of decreasing the incidence of prostate cancer by daily administration of 5 mg of finasteride for 7 years appears to be a major clinical study in the management of this disease. Recently published in the New England Journal of Medicine, it makes difficult reading. The current article aims to demonstrate the main methodological characteristics of this study, to describe the most significant results and to discuss its clinical applications in daily urological practice.

The association between lower urinary tract symptoms and erectile dysfunction in four centres: the UrEpik study.

OBJECTIVE: To report a large-scale multinational investigation of lower urinary tract symptoms (LUTS) and sexual function, designed to investigate the independent association between them, as recent small-scale epidemiological studies suggest an association between benign prostatic hyperplasia and sexual dysfunction; both conditions are strongly associated with age and no study has been able to exclude age as a confounding factor in this relationship. SUBJECTS AND METHODS: Culturally and linguistically validated versions of standard questionnaires were used to estimate the prevalence of LUTS (using the International Prostate Symptom Score, IPSS) and erectile dysfunction (ED) score (using O'Leary's Sexual Function Inventory) in regions of the UK (Birmingham), the Netherlands (Boxmeer), France (Auxerre) and Korea (Seoul). In each centre, stratified random samples were selected from population registers to provide representative samples of the population of men aged 40-79 years (and their partners) in each community. Direct interviews were held in Seoul and postal questionnaires used in the three European centres. The samples were selected randomly, providing representative samples in each community. RESULTS: In all, 4800 men and 3674 women responded; the response rates among men were 77% in Boxmeer, 21% in Auxerre, 42% in Birmingham and 65% in Seoul. The overall prevalence of ED for men aged 40-79, estimated as an ED score of 0-4, was 21.1%. There was evidence of a linear increase with age (P < 0.001) and the pattern was very similar in the four centres. From the weighted logistic model, there was evidence of an association between sexual dysfunction, other self-reported diseases and lifestyle. From the ED score, after adjusting for age and country, men with diabetes were more likely to score of 0-4 (odds ratio 1.57, 95% confidence interval 1.09-2.25), as were those with high blood pressure (1.38, 1.09-1.75) and with an IPSS of 8-35 (1.39, 1.10-1.74). For lifestyle, smokers were more likely to score 0-4 (1.54, 1.23-1.92), while physical activity during leisure time was slightly associated with a reduction in the chance of scoring 0-4 (0.87, 0.77-0.99). The analysis gave the same results when repeated using self-reported ED instead of the dichotomised score. CONCLUSIONS: ED is clearly age-related and a problem for a large proportion of men in the community. It can have a profound impact on the quality of life of the man and on his partner. Were all men with this problem to seek medical help there would be a large burden on healthcare systems. There are cultural and age effects on the assessment of this problem.

The prevalence of male urinary incontinence in four centres: the UREPIK study.

OBJECTIVES: To report the results of the prevalence and health status associated with male urinary incontinence (UI) in a population-based, multicentre study in four countries, and to assess the epidemiology of this condition. SUBJECTS AND METHODS: A standard questionnaire asking about frequency and amount of urine loss, use of pads and stress incontinence, was used to measure the prevalence of UI among men in four countries (Boxmeer, The Netherlands; Auxerre, France; Birmingham, UK; and Seoul, Korea). Self-reported urinary leakage was also recorded, with details of visits to the doctor for the symptoms. The samples were selected randomly from population registers of men aged 40-79 years, which provided representative samples in each community. RESULTS: In all, 4979 men responded; from incontinence symptom scores, 7.3% of men aged 40-79 years in Auxerre, 16.3% in Boxmeer, 14.4% in Birmingham and 4.3% in Seoul reported mild to severe UI. On a self-reported question, 14.8% and 14.5% of men in Birmingham and Boxmeer thought that they had urinary leakage, compared with 7.5% and 7.1% of men in Auxerre and Seoul, but typically the reported incontinence was leaking drops of urine a few times a week. Of men with urinary leakage in the three European centres, 25.9% visited the doctor with this problem, compared with only 9.0% of men in Seoul. Of men in the European centres, 5.9% used pads at least occasionally, compared with only 1.6% of men in Seoul. UI was age-related and the reporting of it varied among centres, with 14.4% of men in Birmingham and 12.7% of men in Boxmeer aged 40-49 years reporting mild to severe UI, compared with 5.2% in Auxerre and 1.9% in Seoul. Among men aged 60-69 years the corresponding percentages were 13.7% in Birmingham, 22.6% in Boxmeer, 9.2% in Auxerre and 8.0% in Seoul. CONCLUSIONS: UI is more common in older men and relatively uncommon among younger men. Some men reported no problems on the symptom questionnaire but replied positively to a direct question. Surprisingly many men wear protective pads at least occasionally as a result of their problem. UI appears to be a problem for men and which remains largely untreated; this may partly be a result of cultural differences.

The relationship between lower urinary tract symptoms and health status: the UREPIK study.

OBJECTIVES: To assess the hypothesis that as lower urinary tract symptoms (LUTS) increase in severity, the impact as measured by the BPH impact index (BII) would also increase. SUBJECTS AND METHODS: The UREPIK survey collected information on this relationship from men and their partners in the Netherlands, Korea, France and the UK. Culturally and linguistically validated versions of three standard questionnaires, the SF-12, the BII and the International Prostate Symptom Score (IPSS) were used to assess the distribution of symptoms and the impact on health status. Stratified random samples of men aged 40-79 years in each community were recruited. Response rates were 72% in Boxmeer, 28% in Auxerre, 60% in Birmingham and 68% in Seoul. Regression analyses were undertaken on total SF-12, BII and IPSS. RESULTS: In all, 4800 index men and 3674 women responded; the BII increased with increasing IPSS. The correlation coefficients were; Boxmeer 0.69, Auxerre 0.56, Birmingham 0.60 and Seoul 0.68. For women, the correlations were slightly lower except in Birmingham, at 0.65 (Boxmeer), 0.44 (Auxerre), 0.71 (Birmingham), 0.57 (Korea). BII scores were higher in women than in men with the same level of IPSS. Adjusting for IPSS there was no association between age and BII. There was an association between IPSS quality-of-life (QoL) score and BII; for men the correlation was 0.62 and for women 0.60. Men and women with the same score on the IPSS QoL reported the same bother. Among those with an IPSS of 20-35 women expressed significantly more bother (P < 0.001). The SF-12 scores decreased as the IPSS and the BII increased in both men and women. Furthermore, the SF-12 mental score decreased with increasing symptoms in the partner. CONCLUSIONS: The relationship between the severity of LUTS and BII was similar in all centres. There is a clear association between the BII and the IPSS QoL question in men and women. The BII discriminates between people who are unhappy about their urinary condition compared with those who are pleased. Although designed for use in men with benign prostatic hyperplasia, the index also appears to be a useful among women. The severity of symptoms of LUTS has an adverse effect on the health status of the individual and his/her partner.

The prevalence of lower urinary tract symptoms in men and women in four centres. The UrEpik study.

OBJECTIVE: To evaluate the epidemiology of lower urinary tract symptoms (LUTS) among men and women, as there are significant unanswered questions about the prevalence and impact of LUTS in different populations. SUBJECTS AND METHODS: A population-based, cross-sectional survey was completed in Boxmeer (the Netherlands), Auxerre (France), Birmingham (UK) and Seoul (Republic of Korea), using culturally and linguistically validated versions of the International Prostate Symptom Score (IPSS). The aim was to estimate the distribution of symptoms of LUTS in men and women. Stratified random samples of men aged 40-79 years in each community were collected. Postal questionnaires were used in Europe and direct interviews in Korea. RESULTS: In all, 4979 index men and 3790 women were recruited, with age-adjusted response rates among men of 72% in Boxmeer, 28% in Auxerre, 60% in Birmingham and 68% in Seoul. The percentages of men and women with an IPSS of 8-35, indicating moderate to severe symptoms, were, respectively, 20.7 and 18.0 (Boxmeer); 19.2 and 12.6 (Auxerre); 25.1 and 23.7 (Birmingham); 16.2 and 19.9 (Seoul). Among women the relationship between symptoms and age was not as strong as in men. The percentages of men and women with moderate to severe symptoms were by age group, respectively, 10.6, 15.5 (40-49); 19.0, 18.2 (50-59); 30.5, 23.8 (60-69); 40.4, 28.7 (70-79). Among those aged 40-49 the main differences between men and women were in the questions about frequency of urination during the day and holding back urine. Among the older groups men reported more symptoms on all questions apart from urination at night and difficulty in holding back urine, both of which were equally prevalent among men and women. CONCLUSIONS: The overall prevalence of LUTS was high and showed no marked cultural variation. Prevalence increased with age, with severe LUTS commoner in older men. Women reported similar levels of the symptoms traditionally associated with LUTS in men. In each age group there were no major cultural differences in the frequency of LUTS. There were differences with age between men and women; younger men had a lower prevalence of LUTS than younger women but older men a much higher prevalence than older women. These findings emphasize that the IPSS should be confined to within-patient comparisons and not used as a diagnostic tool. The IPSS performs very similarly regardless of gender.

The management of localized prostate cancer.

At this point in time, the only possibility of curing prostate cancer is through the early detection and treatment of localized disease. The large number of treatment options available for localized prostate cancer, including radical prostatectomy, radiotherapy (either external beam or interstitial), hormone therapy and watchful waiting, can be confusing for the patient. These treatments are associated with different adverse effects, further complicating the treatment decision. As there will inevitably be a trade-off between expected cure and acceptable adverse effects, it is important to discuss all options with the patient. The doctor and patient must together decide the appropriate treatment for him and his tumor.

The value of patient-doctor dialog in the treatment of early prostate cancer.

A lack of information about the characteristics of prostate cancer, the treatment options available, and the negative effects associated with each treatment option leaves many newly diagnosed patients feeling anxious, depressed and confused, and can ultimately lead to feelings of distrust towards the treating physician. Improving patient-doctor dialog increases the chances of successfully achieving the patient's goals in managing their disease. Factors considered important for improving patient-doctor dialog include an individualized approach to care, providing the patient with complete, comprehensive and unbiased information on treatment options, and allowing the patient sufficient time to come to a treatment decision.

[Prevalence of lower urinary tract disorders and incontinence in Auxerre. French segment of the UrEpik study]. / Prévalence des troubles du bas appareil urinaire et de l'incontinence chez les adultes auxerrois. Volet français de l'étude UrEpik.

OBJECTIVES: To estimate the prevalence of low urinary tract symptoms (LUTS) and urinary incontinence among men and women aged 40 to 79 years. METHODS: A postal survey was carried out in a community-dwelling random sample, in Auxerre, France. LUTS were assessed using the International Prostate Symptom Score (IPSS). Urinary incontinence (UI) was assessed using a score based upon four questions. RESULTS: 1216 men and 591 women participated in the survey. 19.2% of men and 13.7% of women reported moderate to severe LUTS (IPSS > 7). 73% of men and 29% of women suffered from UI. Among men and women reporting severe symptoms of UI (0.4 and 5.4% respectively), one third had been prescribed medications for urinary disorders within the previous six months. CONCLUSION: This survey confirms the high prevalence of LUTS and urinary incontinence among a community-dwelling sample of men and women, and highlights the need for management of these disorders.

[Prevalence of nocturia among people in Auxerre: the French part of the UrEpik study]. / Prévalence de la nycturie chez les adultes auxerrois: volet français de l'étude UrEpik.

OBJECTIVES: To estimate the prevalence of nocturia among men and women aged 40 to 79 years old. MATERIAL AND METHODS: A postal survey was carried out in a community-dwelling random sample in Auxerre, France. Nocturia was assessed using the item 7 of the International Prostate Symptom Score (IPSS). RESULTS: 1216 men and 591 women participated in the survey. Average nocturnal urinary frequency was 0.98 and 0.95 among men and women, respectively. Between the age ranges 40-49 years and 70-79 years, the frequency increased from 0.70 to 1.61 among men, and from 0.72 to 1.31 among women. In the age range 70-79 years, 48.1% of men and 31% of women awakened from sleep to urinate at least twice per night. CONCLUSION: Patients and primary care physicians should be more informed about screening and management options, and impact of nocturia on quality of life and related morbidity.

[Efficiency and tolerance of terazosine in ambulatory patients with benign prostatic hypertrophy: comparative randomized and double-blind trial versus alfuzosin. The MG Terazosine Group]. / Efficacité et tolérance de la térazosine chez des patients ambulatoires présentant une hypertrophie bénigne de la prostate: essai comparatif contre alfuzosine, randomisé, en double-aveugle. Le Groupe MG Térazosine.

OBJECTIVE: To compare, in general practice, the efficacy and safety of terazosin (5 mg per day in single dose) versus alfuzosin (7.5 mg per day in 3 doses) in patients with symptomatic benign prostatic hyperplasia (BPH) treated for 16 weeks. MATERIAL AND METHODS: Thirteen investigators included patients over the age of 50 years presenting with BPH with an International Prostate Symptom Score (IPSS) greater than 12 and a post-voiding residual volume less than 300 ml. After a one-week observation period, these patients were randomized to receive either terazosin or alfuzosin for 16 weeks (112 days) under double-blind conditions. The primary endpoint was the percentage reduction of the IPSS score at 3 weeks and 16 weeks; the secondary endpoint was the IPSS quality of life score. Safety was evaluated by recording adverse events and monitoring blood pressure. RESULTS: Seventy four patients were included: 39 in the terazosin group, 35 in the alfuzosin group. The 2 groups were not significantly different before treatment. Improvement of the IPSS score was similar in the 2 treatment groups (p = 0.97 at 3 weeks, and p = 0.29 at 16 weeks), as was the improvement of the quality of life score (p = 0.47 at 3 weeks and p = 0.71 at 16 weeks). Treatment was considered to be "effective or very effective" in 31 patients (86%) in the terazosin group, and in 28 patients (82%) in the alfuzosin group. The IPSS score was greater than or equal to 12 before treatment for all patients included in the study. Twenty-five patients had a score < 12 at 3 weeks versus 56 at 16 weeks (p = 0.0001). Seven patients had a quality of life score less than 2 before treatment, versus 38 at 3 weeks, and 56 at 16 weeks (p = 0.0001). No significant difference was observed between the 2 groups in terms of the number of adverse events reported, or the course of blood pressure and prostate specific antigen. No patient dropped out of the study because of treatment-related adverse events. Two deaths were observed in the terazosin group (2 patients aged 86 and 93 years), but any relation to treatment was excluded. CONCLUSION: During this study, terazosin appeared to be as effective and as well tolerated as alfuzosin.