[Intraurethrally applicated alprostadil for the treatment of organic erectile dysfunction in practice: a multicenter clinical monitoring study (noninterventional investigation)].

In a multicenter clinical monitoring study (observation of use investigation according to 67.6 of the German Drug Law), which was conducted between 2003 and 2005 in 105 urological practices in 314 patients with organic erectile dysfunction (ED), efficacy, safety, convenience and acceptance of intraurethral administered alprostadil (CAS 745-65-3; MUSE - Medicated Urethral System for Erection) was studied. 306 patients could statistically be evaluated. The patients were 61.3 +/- 9.2 years old (median+/- SD) (181 patients between 60 and 80 y). The time of ED was from 2 to 120 months with a mean duration of 21.5 +/- 22 months (median+/-SD. Genesis of the ED was in 55 % of the patients a local damage, which followed in 42.8 % a prostate cancer surgery. 46 % of the patients had vascular, 28 % metabolic diseases including diabetes and 11% neural damages. In 51.3% of the patients drugs, which were known to induce ED, were suspected to have caused or partially caused the impairment. The degree of the disturbance was in 93 % of the cases moderate to severe. Alprostadil (MUSE) was applicated three times in doses of 250, 500 or 1000 microg. The dosage of 1000 microg was used for the third application by 65 % of the patients. Very good and good efficacy increased from 45.8% of the patients after the first through 63.7 % after the second to 69.3 % after the third application. In patients after surgery because of prostate cancer very good and good efficacy improved in comparison to the first application about 20% and concerned 53.9 % of the patients after the third application. Sexual intercourse was possible by 67% of the patients after the first, 83 % after the second and 87 % after the third use. Tolerability of alprostadil (MUSE) was very good and good in 90% of the patients. 81.1% intended to continue the treatment. The handling of alprostadil (MUSE) was assessed very good and good by 75%, the acceptance was very good and good in 96% of the patients. In a retrospective comparison with other drugs for the treatment of ED intracavernosal alprostadil ("SKAT") was slightly more effective than intraurethral alprostadil (MUSE) (32.1% vs 25 %), but alprostadil (MUSE) was assessed more useful by 82.1% and preferred by 78.6% of the patients. In comparison to phosphodiesterase-5- (PDE-5)-inhibitors alprostadil (MUSE) was more effective in 77.7 %, and 79.6 % of the patients preferred it. In comparison to apomorphin 94.1% preferred alprostadil (MUSE). 98 % of the patients reported better efficacy of alprostadil (MUSE), and 94.1% preferred it. Five adverse events were reported (slight urethral pain). No patient dropped out. In this non-interventional investigation the good efficacy and tolerability of intraurethral applicated alprostadil (MUSE) as a second-line therapy after failure or minor efficacy of PDE-5 inhibitors and other oral drugs was comparable with the results of the clinical trials. The patients in the urological practices assessed handling and acceptance of the system high.