OBJECTIVE: The relationship between lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) has recently received increased attention. The aim of this study was to evaluate the efficacy of the Alfa-5® association of Serenoa repens, Pinus massoniana Bark Extract (PMBE) and Crocus sativus (IDIProst® Gold) in improvement of patient's quality of life, when compared with Serenoa repens alone. MATERIALS AND METHODS:All patients with clinical and instrumental diagnosis of LUTS due to Benign Prostatic Hyperplasia (BPH) and ED, attending 5 Italians Urological Institutions from May to December 2012 were enrolled in this prospective, multicentre, phase 3 study. Participants were assigned to receive oral capsules of IDIProst® Gold (one capsule q24 h) or Serenoa repens 320 mg (one capsule q24h) for 3 months. Clinical and instrumental analyses were carried out at the enrollment and at the end of therapy. IPSS, IIEF-5 and SF-36 questionnaires have been used. The main outcome measure was the improvement of quality of life at the end of the whole study period. RESULTS: 129 (mean age 45-71 ± 4.36) men were randomly allocated to IDIProst® Gold (n = 83) or Serenoa repens (n = 46). The baseline questionnaire mean scores were 17.1 ± 6.4, 14.9 ± 3.7, 96.3 ± 1.2 for IPSS, IIEF-5 and SF-36, respectively. At the follow-up examination, statistically significant differences have been reported in terms of IPSS (11.9 vs 13.8; p < 0.001), IIEF-5 and SF-36mean scores (19.3 vs 16.1; 99.7 vs 96.3; p < 0.003; p < 0.001). Moreover, statistically significant differences were then reported between the two visits, in terms of IPSS, IIEF-5 and SF-36 scores (p < 0.003; p < 0.001; p < 0.001), only in the IDIProst® Gold group. CONCLUSIONS: In conclusions, we found that IDIProst® Gold significantly improve the quality of life of patients affected by LUTS due to BPH and ED, specifically in terms of sexual function, highlighting that a better sexual quality of life is correlated with an higher overall quality of life regardless of the urinary function.
RCT Entities:
OBJECTIVE: The relationship between lower urinary tract symptoms (LUTS) and erectile dysfunction (ED) has recently received increased attention. The aim of this study was to evaluate the efficacy of the Alfa-5® association of Serenoa repens, Pinus massoniana Bark Extract (PMBE) and Crocus sativus (IDIProst® Gold) in improvement of patient's quality of life, when compared with Serenoa repens alone. MATERIALS AND METHODS: All patients with clinical and instrumental diagnosis of LUTS due to Benign Prostatic Hyperplasia (BPH) and ED, attending 5 Italians Urological Institutions from May to December 2012 were enrolled in this prospective, multicentre, phase 3 study. Participants were assigned to receive oral capsules of IDIProst® Gold (one capsule q24 h) or Serenoa repens 320 mg (one capsule q24h) for 3 months. Clinical and instrumental analyses were carried out at the enrollment and at the end of therapy. IPSS, IIEF-5 and SF-36 questionnaires have been used. The main outcome measure was the improvement of quality of life at the end of the whole study period. RESULTS: 129 (mean age 45-71 ± 4.36) men were randomly allocated to IDIProst® Gold (n = 83) or Serenoa repens (n = 46). The baseline questionnaire mean scores were 17.1 ± 6.4, 14.9 ± 3.7, 96.3 ± 1.2 for IPSS, IIEF-5 and SF-36, respectively. At the follow-up examination, statistically significant differences have been reported in terms of IPSS (11.9 vs 13.8; p < 0.001), IIEF-5 and SF-36 mean scores (19.3 vs 16.1; 99.7 vs 96.3; p < 0.003; p < 0.001). Moreover, statistically significant differences were then reported between the two visits, in terms of IPSS, IIEF-5 and SF-36 scores (p < 0.003; p < 0.001; p < 0.001), only in the IDIProst® Gold group. CONCLUSIONS: In conclusions, we found that IDIProst® Gold significantly improve the quality of life of patients affected by LUTS due to BPH and ED, specifically in terms of sexual function, highlighting that a better sexual quality of life is correlated with an higher overall quality of life regardless of the urinary function.