Clinical experience with intraurethral alprostadil (MUSE (R)) in the treatment of men with erectile dysfunction - A retrospective study

Objective: The Food and Drug Administration (USA) approved the transurethra l administration of prostaglandin (alprostadil in January 1997), which had an efficacy of approximately 50% in clinical trials. We studied its effecti veness in clinical practice. Methods: Patient and partner education was followed by an initial office tr ial of a medicated urethral system for erection (MUSE(R)) after other medic al risk factors were corrected during a 2- to 4-month period. The initial t itration dose of alprostadil was usually 125 or 250 mug. Further titration, if needed, was instituted by the patient at home. Success was determined a s the satisfactory completion of sexual intercourse in more than 66% of att empts, with a minimum of two being required. Results: Two hundred and seventy patients entered the trials, and follow-up information was available in 229 (85%). The overall success rate was 56%. The dose required was 500 mug in 49.2% and 1,000 mug in 42.2%. Of the 44% i n whom treatment failed, 61.4% did so because of lack of efficacy and 38.6% because of side effects (genital pain or urethral bleeding). Minor urogeni tal symptoms, which did not interfere with treatment, occurred in an additi onal 40% of patients. Conclusions: The efficacy of transurethral administration of alprostadil (5 6%) is higher than the initial published clinical trial data and higher tha n recent reported clinical experiences, although higher doses were required in our study. Men over 50 years of age, having an organic cause for erecti le dysfunction, had better responses. Patient and partner education is impo rtant for successful treatment, and the in-office initial titration is an i ntegral part of this success. Prior correction of medical risk factors may enhance the success rate. Copyright (C) 2000 S. Karger AG, Basel.