DISAPPOINTING INITIAL RESULTS WITH TRANSURETHRAL ALPROSTADIL FOR ERECTILE DYSFUNCTION IN A UROLOGY PRACTICE SETTING

Purpose: We evaluate the response to intraurethral alprostadil adminis tration using the Medicated Urethral System for Erection (MUSE) in un select men with a history of erectile dysfunction. We determine the ef fects on blood pressure during in office monitoring and assess safety of this form of treatment. We compare the efficacy of MUSE in an offic e setting with the placebo controlled pivotal study. Materials and Met hods: A total of 115 men with erectile dysfunction underwent in office testing with MUSE following the algorithm recommended by the manufact urer and outlined in the original pivotal study. Patients were asked t o rate the rigidity of erection from 1 to 5 with scores 4 and 5 for er ections sufficient for intercourse, and level of discomfort from 1 (ve ry uncomfortable) to 5 (very comfortable) at 15-minute intervals. Pati ents who did not achieve a sufficient erection were scheduled to retur n for in office testing using the next higher dose up to 1,000 mu g. P atient supine and sitting blood pressures were recorded by a nurse bef ore and every 15 minutes after administration. Telephone contact with patients 2 to 3 months after the last in office testing was made to de termine whether they were using the system. Results: Mean plus or minu s standard deviation rigidity scores independent of dosage increased f rom 2.34 +/- 0.99 at 15 minutes to 2.49 +/- 0.96 at 30 minutes and dec reased thereafter. Although the 1,000 mu g. dosage resulted in highest mean score at all times, the differences between dosages were not sig nificant. Rigidity score 4 or 5 was achieved in 13.2% (500 mu g.) and 30% (1,000 mu g.) of patients at 30 minutes. Mean level of discomfort was 3.6 +/- 1.2 at 15 minutes and improved thereafter. Comfort levels were not significantly different among dosages. Overall, at 15 minutes 16.8% of patients were uncomfortable (score 1 or 2) and 41.3% were so mewhat uncomfortable (1, 2 or 3). For all dosages supine and sitting s ystolic and diastolic blood pressures decreased significantly from bef ore treatment to 15 minutes and stayed lower during monitoring. Define d by strict criteria 41.2% of patients experienced orthostatic hypoten sion during in office testing. A total of 21 patients had adverse even ts, including pain, discomfort and burning in the penis (the most comm on), dizziness and chest pain. One patient had a syncopal episode and fell in the office. At last followup only 18.6% of the tested patients continued to use MUSE at home, while the remainder discontinued treat ment due to pain, insufficient erections for intercourse and cost. Con clusions: We were unable to achieve similar results to the pivotal stu dy following manufacturer instructions and the algorithm provided by t hat study. Independent of age and etiology no more than 30% of patient s at any given time using any dose achieved erections sufficient for i ntercourse during in office testing. Because of this limited efficacy, discomfort, pain and burning associated with treatment, and cost, mor e than 80% of patients did not continue to use MUSE at home.