Long-term ef®cacy and safety of Alprostadil-Alfadex (EDEX R /VIRIDAL R ) in intracavernous selfinjection therapy for chronical erectile failure was investigated in a four year running multicenter European trial. Of the 16 886 protocolled injections 93% (15 713) resulted in rigid erections followed by successful sexual intercourse. Reported side effects by patients were prolonged erections b 6 h only occurring during the ®rst year in 1.2% (2 out of 162), painful erections in 29% (47 out of 162) during the ®rst year and decreasing to 12.1% by year 4, hematomas, neither requiring therapeutic measures nor impeding sexual performance in 33.3% (54 out of 162) in year 1 with a decrease to 12.1% by year 4, ®brotic penile alterations such as nodules, plaques or deviations in 11.7% (19 out of 162) with spontaneous healing in 48% (9 out of 19). Of the 162 patients involved in this trial 54 completed the 4 y. Of the 54 completers 91.4% considered the tolerability good or very good and were satis®ed or very satis®ed with self-injection therapy with Alprostadil-Alfadex. The respective rates of the female partners were 51.7% very satis®ed and 39.7% satis®ed.These data of the world-wide longest running prospective trial with a vasoactive drug in selfinjection therapy provided impressive proof that Alprostadil-Alfadex represents a very effective and safe treatment for erectile dysfunction of both psychogenic and organogenic origin.
An angiographic method has been developed for x-ray visualization of the arteries supplying the cavernous bodies of the penis, namely, the internal iliac, internal pudendal, and penile artery and its branches (dorsal, deep, and bulbocavernous arteries). Under normal conditions the technique makes pulsations in both dorsal penile arteries palpable, and the flow rate of fluid into the cavernous bodies necessary to produce and maintain erection can be determined. The principle of the method involves artificial passive erection or semierection, during which we perform selective or semiselective arteriography of the bed supplied by the internal iliac artery, or retrograde arteriography by puncture of the dorsal artery of the penis.Thirty males complaining of more than 1 year of impotence (including 12 diabetics) were investigated, 29 by our standard technique and 1 by translumbar pelvic arteriography with retrograde arteriography of the dorsal penile artery. All patients showed severe stenosis or obliteration of the vessels supplying the cavernous bodies. There was agreement between absence of pulsation in the dorsal penile arteries and the angiographic findings. Flow rates necessary to produce erection varied from 45 to 160 ml/min, with a mean of 90 ml/min. For controls, angiographic studies were performed in 4 men with clearly psychogenic impotence, all of whom were found to have normal-appearing arteries supplying the cavernous bodies.On the basis of these findings and previously reported histological investigations, we believe that most impotence is the symptomatic and functional result of arterial disease. The arteriographic technique described allows a precise anatomical diagnosis to be made, and can indicate surgical and microsurgical correction.
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