[Results of an epidemiologic surgery carried out with men 50-80 years of age to study urinary disorders, quality of life and sexual function]. / Résultats d'une enquête épidémiologique menée chez des hommes âgés de 50 à 80 ans étudiant troubles mictionnels, qualité de vie et fonction sexuelle.

OBJECTIVE: The prevalence of urinary symptoms, their impact on quality of life and sexuality and the man's attitude in relation to these problem were studied by a self-administered questionnaire (including I-PSS, 6 questions of DAN-PSS-1, BPHQL9 and IIEF). MATERIAL AND METHODS: This questionnaire was sent by mail to a national representative sample of 3,500 French men aged 50 to 80 years. Of the 2,372 men who returned an interpretable questionnaire, 21%, 33% and 42% belonged to the severe or moderate category for symptoms, tolerance of symptoms, and alteration of quality of life, respectively. RESULTS: 81% of men reported sexual activity during the last 4 weeks. 8.3% of men were treated with "antiprostate" medical treatments, and 8% had been operated (16% of them were treated medically after the operation). Only 29% and 17% of men had talked about their sexual and urinary problems, respectively. CONCLUSION: Alteration of functional and perceived sexuality was correlated with age and the severity of symptoms in non-operated patients, but the poor correlations between scales evaluating sexuality and symptoms indicate that sexuality is a difficult aspect to investigate.

History of 7,093 patients with lower urinary tract symptoms related to benign prostatic hyperplasia treated with alfuzosin in general practice up to 3 years.

OBJECTIVES: As we have previously published 4 articles reporting the treatment of 7,093 clinical benign prostatic hyperplasia (BPH) patients treated with alfuzosin in a 3-month open-labelled study which was subsequently extended to 12, 24, and 36 months, the objective of this article is to provide additional data on dropouts, acute urinary retention (AUR), progression to surgery, and safety under the natural conditions of general practice, paying special attention to the predictive factors. METHODS: 7,093 patients were initially enrolled by 1,812 centers for up to 3 months. Subsequently 1,508, 1,325, and 812 general practitioners agreed to extend the study up to 12, 24, and 36 months, respectively, which corresponds to 4 patient populations. RESULTS: The baseline symptom profile of patients who completed the study was identical to that of patients who dropped out (because the center resigned or during treatment). In the 4 patient populations, the percentage of patients per month who dropped out, experienced adverse effects, AUR and surgery were 0. 6-1.6, 0.1-0.5, 0.01-0.03, and 0.1-0.3%, respectively. The classes of symptom severity were not predictive for dropouts: 3.5, 12.6, 20, and 14.3% of the severe patients dropped out during treatment versus 4.2, 13.7, 22.9, and 14.0% of the moderate patients who dropped out up to 3, 12, 24, and 36 months, respectively. Safety was satisfactory regarding the number of adverse events and blood pressure measurement. No retrograde ejaculation was reported. CONCLUSION: Under the natural conditions of general practice the reasons for dropping out were not correlated with symptom severity.

One-year follow-up of 2829 patients with moderate to severe lower urinary tract symptoms treated with alfuzosin in general practice according to IPSS and a health-related quality-of-life questionnaire. BPM Group in General Practice.

OBJECTIVES: To determine the effectiveness of alfuzosin on symptom reduction, patients' perceived health-related quality of life (HRQL) improvement, adverse outcomes, treatment failure, and progression to acute urinary retention and prostate surgery in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH) in a 1-year prospective, open-labeled study. METHODS: A total of 2829 patients (mean age 65.9 years) were included in the study and received either alfuzosin 2.5 mg three times daily or alfuzosin slow release 5 mg twice daily. The evaluation was based on the International Prostate Symptom Score (IPSS), the eighth IPSS question, and a nine-item BPH HRQL questionnaire (BPHQL9) exploring well-being, the patient's perceived sexual life, and BPH-specific interferences with activities. RESULTS: A total of 2442 patients (86. 3%) completed the study; the main reasons for noncompletion were adverse events (n = 141, 5.0%), lack of efficacy (n = 136, 4.8%), and death (n = 48, 1.7%); 121 patients (4.3%) underwent prostate surgery, and 33 patients (1.2%) experienced acute urinary retention. No correlation was found between noncompletion and prostate volume or baseline severity. The distribution of patients (in percentages) according to the IPSS, IPSS question 8, and BPHQL9 classes of severity (mild/moderate/severe) at baseline was 1.9/49.0/49.1, 0. 7/65.5/33.8, and 7.7/50.4/41.9, respectively, and at 1 year was 47. 4/50.3/2.4, 34.1/64.9/1.0, and 39.0/50.9/10.1, respectively. The IPSS (19.5 +/- 0.1) was reduced by 49.6% (9.9 +/- 0.1) at 6 months and by 53.8% (11.1 +/- 0.1) at 12 months. Symptom reduction strongly correlated with the initial symptom severity (P <0.0001). The BPHQL9 score (34.6 +/- 0.3) gradually improved up to 12 months (52 +/- 0.4; +93.3%), and this improvement involved all three dimensions. Vertigo (n = 53, 1.9%), hypotension (n = 47, 1.6%), and dizziness (n = 16, 0. 6%) were the most frequent adverse events. CONCLUSIONS: This study confirms the effectiveness of alfuzosin and the need to include HRQL measurement in the decision-making process when assessing patients with lower urinary tract symptoms.

[Prospective follow-up of 3,228 patients suffering from clinical benign prostatic hyperplasia (BPH) treated for 3 years wi alfuzosin in general practice. BPH Group in General Practice]. / Suivi prospectif de 3.228 patients souffrant d'une hypertrophie bénigne de la prostate (HBP) clinique traités pendant 3 ans par l'alfuzosine en médecine générale. Groupe HBP en Médecine Générale.

OBJECTIVE: To determine (a) the amplitude and duration of reduction of the symptom score and improvement of the HRQL score (including sexual function), (b) the adverse effects and (c) the incidence of acute urinary retention and prostatic surgery during the 3 years of alfuzosin treatment. MATERIAL AND METHODS: 3,228 patients suffering from BPH were included by 812 centers in a 3-year open prospective study and were treated with alfuzosin (immediate release) at the recommended dosage. A symptom score (modified Boyarsky) and a specific HRQL score, comprising 20 items including 3 questions on sexuality (Urolifetm BPH Qol20) were self-administered on inclusion and after 3, 6, 12, 18, 24, 30 and 36 months. RESULTS: 2,579 patients (79.9%) completed the 3 years of the study. The symptom score was significantly decreased by 54% at 3 months and this reduction was maintained until 36 months (-48.4%); the HRQL score was significantly improved by 45.4% at 12 months and this improvement was maintained until 36 months (+43.4%). Alfuzosin was well tolerated: the qualitative and quantitative distribution of adverse effects was identical to that previously observed in placebo-controlled trials (vertigo-dizziness: 2.1%). Adverse effects were responsible for 4.2% of drop-outs from the trial. 120 patients (3.7%) were operated for BPH and 9 patients (0.3%) developed acute urinary retention. CONCLUSION: This prospective study confirms the long-term safety of use of alfuzosin under routine general practice conditions and emphasizes the need to measure HRQL in the context of the patient's opinion.

Clinical uroselectivity: a 3-year follow-up in general practice. BPH Group in General Practice.

The objectives of this open-labeled study were to assess the clinical uroselectivity of alfuzosin in a long-term follow-up study in general practice. A total of 3,228 patients with clinical benign prostatic hyperplasia (BPH) from 812 centers were included in a prospective 3-year open-labeled study and treated with alfuzosin (immediate-release formulation) at the recommended dosage. Symptom score (Boyarsky, modified) and a 20-item BPH-specific health related quality of life (HRQL) score (Urolife BPH QoL 20), which included three questions on sexuality, were self-administered at baseline, 3, 6, 12, 18, 24, 30 and 36 months. Symptom score was significantly reduced by 54% at 3 months and this reduction was maintained up to 36 months; the HRQL score was significantly improved by 45.4% at 12 months and this improvement was also maintained up to 36 months. Alfuzosin was well tolerated: the quantitative and qualitative distribution of adverse events (AEs) was similar to that previously observed in placebo-controlled studies. 4.2% of the patients dropped out due to AEs. This study confirms the long-term safety profile of alfuzosin in general practice and highlights the need to measure HRQL in the context of clinical uroselectivity.

Three-year prospective study of 3228 clinical BPH patients treated with alfuzosin in General Practice.

Objectives: To investigate (a) the magnitude and durability of symptom score reduction and HRQL score improvement (including sexual drive); (b) adverse outcomes; and (c) progression to acute urinary retention and prostate surgery up to three years of treatment with alfuzosin. Methods: Three thousand two hundred and twenty-eight BPH-patients out of 812 centers were included in a prospective three-year open-labelled study and treated with alfuzosin (immediate release formulation) at the recommended dosage. A symptom score (Boyarsky modified) and a 20-item BPH specific HRQL score including three questions of sexuality (Urolife(TM) BPH QoL 20) were self-administered at baseline, 3, 6, 12, 18, 24, 30, and 36 months. Results: Two thousand five hundred and seventy-nine patients (79.9%) completed the study at the end of three years. Symptom score was significantly reduced by 54% at 3 months and this reduction was maintained up to 36 months (-48.4%); HRQL score was significantly improved by 45.4% at 12 months and this improvement was maintained up to 36 months (+43.4%). Alfuzosin was well tolerated: the quantitative and qualitative distribution of adverse events was similar to that previously observed in placebo-controlled studies (vertigo/dizziness: 2.1%). Adverse events accounted for 4.2% of the drop-outs. 120 patients (3.7%) were operated on for BPH and nine patients (0.3%) experienced acute urinary retention. Conclusion: This medical outcomes study confirms the long-term safety profile of alfuzosin in the naturalistic conditions of general practice and highlights the need to measure HRQL in the context of patient's preferences.

Construction and validation of a short-form benign prostatic hypertrophy health-related quality-of-life questionnaire. BPH Group in General Practice.

OBJECTIVE: To construct and validate a short-form benign prostatic hypertrophy (BPH) health-related quality-of-life (HRQL) questionnaire which is more practical in use and as informative as the 20-item visual analogue scale questionnaire (QOL20) previously validated in French. PATIENTS AND METHODS: From the factorial structure of the QOL20, a nine-item questionnaire (QOL9) was constructed using stepwise linear regression and factorial analysis. The feasibility and reliability of the QOL9 were analysed in a cross-sectional case-control study and a longitudinal cohort study, including symptomatic patients with BPH treated for 6 months with an alpha 1-blocker (alfuzosin). RESULTS: The reduction of the QOL20 to QOL9 showed a minimal loss of information (90-95% of the variance of QOL20 was explained by QOL9) and lead to a three-dimensional structure: well being, patients' perceived sexual-life status, and BPH interference with activities. The QOL9 was practical in use (completion rate 87-100%; duration of completion at inclusion 11.6, SD 2.0 min), consistent (Cronbach's alpha > 0.7), reliable (intraclass correlation coefficient > 0.80) and responsive (effect-size index 0.9, SD 0.01 in the longitudinal study). CONCLUSIONS: The QOL9 is a good BPH HRQL questionnaire, including an assessment of patients' perceived sexual-life status; it easy to administer, accurate, reproducible and responsive to change with treatment. We suggest that the QOL9 be substituted for the QOL20 and administered in addition to the International Prostate Symptom Score to obtain a better assessment of the patients' perception of their disease.

Long-term quality of life in patients with benign prostatic hypertrophy: preliminary results of a cohort survey of 7,093 patients treated with an alpha-1-adrenergic blocker, alfuzosin. QOL BPH Study Group in General Practice.

In recent years, considerable attention has been paid to the patient's point of view by monitoring medical care outcomes in terms of quality of life (QOL). The objective of this study was to evaluate the QOL of a representative population of patients undergoing medical treatment for symptoms of benign prostatic hypertrophy (BPH). A French BPH-specific QOL scale was constructed by a group of experts to assure content validity. A self-administered questionnaire consisting of 20 visual analogue scales exploring the physical, mental, social and general aspects of QOL was designed and validated. A total of 7,093 patients (mean age 66.7 years) was included in an open, prospective, 1-year study. The evaluation was based on symptoms and QOL questionnaires filled in by the patient at inclusion and after 3 months of treatment with alfuzosin (7.5 mg/day). 6,780 patients (96%) completed the study: 129 (1.8%) dropped out because of intolerance; 53 were or had to be operated on, and 14 had prostate carcinoma. After 3 months, the results of the symptom questionnaire confirmed the efficacy of alfuzosin on symptoms of BPH observed in previous placebo-controlled studies. The irritative symptom score improved by 57% and the obstructive score by 40%. The physical subscore of the QOL questionnaire was most improved (+44%). The mental subscore improved by 29% and the social subscore by 32%. Principal component analysis revealed 3 main components in the QOL of the population: BPH-specific interference with activities; general QOL, and sexuality, a domain which is not usually explored in studies of BPH patients. A reduced QOL score was defined to be used in future studies.(ABSTRACT TRUNCATED AT 250 WORDS)

[Adverse or toxic effects of drugs in medical practice: a one-year follow-up]. / Effets indésirables ou toxiques des médicaments en médecine générale: un an de recueil.

In order to analyse the response of pharmaceutical companies to adverse drug reaction reports, 37 suspected side effects were sent by mail to the 30 companies concerned. The time period involved was 1 year and corresponded to a total of 3341 consultations in general practice. Companies answered in 29 cases (78.3%), sent 21 reply forms and returned 3 evaluations of adverse drugs reactions to the reporting doctor. The high percentage of adverse drug reactions (1.07 per one hundred consultations), the doctor's work-load and poor feed-back lead one to reflect on the usefulness of systematic adverse drug reaction reporting by general practitioners.