Evaluation of transurethral application of alprostadil for erectile dysfunction in Indonesians

To evaluate the efficacy and safety of transurethral application of alprostadil (MUSE) for the treatment of erectile dysfunction in Indonesians.

Twenty erectile dysfunction patients aged between 32-74 years old were recruited in this study. The inclusion criteria were as follows: 1) adult males 18 years or older with a subjective complaint or erectile dysfunction, 2) to provide written informed consent, 3) to agree not to use other forms of treatment for erectile dysfunction, 4) fulfill the screening laboratory values. Part 1, eligible patients were titrated in the clinic starting with a dose of 250 microg and proceed in a stepwise manner to 500 microg and 1,000 microg on separate clinic visits until they identified a dose that produced a satisfactory response. The interval between each in-clinic titration was 2-3 days. Each in-clinic titration dose was evaluated at 15 min intervals over a one hour period for erection assessment, blood pressure and pulse. Part 2, patients used MUSE at home for three months at the dose identified during the in-clinic titration. Monthly interim visits were required for patient follow-up and drug distribution. At the end of the study, patients had another laboratory (except testosterone, only assayed in screening procedure) and physical examination.

The etiology of erectile dysfunction was psychological in 5 patients and organic in 15 patients. The 65% of the patients achieved the erection scale of 4 or 5 either in the clinic or at home, 10% achieved the scale of 4 at home, but not in the clinic, and 25% only achieved the scale of 2 or 3 with the highest dose of 1,000 microg either in the clinic or at home. No significant differences were found in biochemical examination before and after the study. The 60% of the patients who achieved erection scale 4 or 5 continued to use MUSE until the end of the study, while 40% of them complained of pain at the time of MUSE application, during erection and/or during intercourse. They withdrew from the study.

Transurethral application of alprostadil (MUSE) is effective and safe to produce erection sufficient for intercourse in erectile dysfunction of various etiologies. Pain during application, erection and intercourse is a common side effect and a cause of withdrawal.