[Alpha-blockers or phytotherapy as first-line treatment of LUTS/BPH in general medicine: The PERSAT non-interventional study]. / Alpha-bloquants ou phytothérapie en traitement de première intention des SBAU/HBP en médecine générale : l'étude non interventionnelle PERSAT.

PURPOSE: The objective of the PERSAT study was to evaluate first-line treatment of BPH-associated LUTS in real-life conditions. METHODS: This prospective observational study was conducted in France by general practitioners (GP) on patients with moderate to severe LUTS (IPSS ≥12). GPs freely decided to prescribe either an alpha-blocker (AB) or phytotherapeutic treatment (PT). The main criterion was the percentage of responding patients (decrease in total IPSS score ≥3) at 6 months. RESULTS: Of the 849 patients included, 759 were analysed (381 treated with AB and 378 with PT); 718 were followed up at 6 months, 90% of which had no treatment modification. Their inclusion characteristics were similar between the AB and PT groups (mean IPSS: 18.6±4.5 and 17.8±4.1, respectively). Treatment response rates at 6 months were 94.2% [91.2%; 96.4%] in AB and 92.5% [89.2%; 95.1%] in PT. The IPSS decreased by 10.0±5.6 points, with no difference between groups. The proportion of patients bothered by their LUTS (IPSS-QoL ≥4) evolved from 88.5% to 6.5% at 6 months. The improvement of LUTS was perceived by more than 94% of patients (PGI-I) and doctors (CGI-I), 93% of patients were satisfied with the treatment at 6 months, regardless of the treatment initiated. The most reported adverse reactions were ejaculation disorder (3.9% for AB and 0.9% for PT). CONCLUSION: PERSAT confirms in current practice the effectiveness of AB and PT treatments, recommended as first-line treatment in LUTS/BPH. LEVEL OF PROOF: 3.