Beginning October 1985, 111 men agreed to enter a prospective study of the side effects of low dose papaverine/phentolamine therapy. A total of 46 men dropped out, 30 during the initial phase. The percentage of men with painless nodules almost consistently doubled from one followup examination to the next: 8 per cent at 1 month, 17 per cent at 3 months, 32 per cent at 6 months and 57 per cent at 12 months. The average injection frequency of those with nodules was 2 1/2 times higher than those without nodules. Of the men 41 per cent required an increased dose of medications during followup, and 40 per cent of 50 men had at least 1 abnormality of liver function, most of these involving mild to moderate elevations of alkaline phosphatase and lactic dehydrogenase. Priapism was not encountered during self-injection but it did occur twice in 329 physician-administered injections. Careful regular monitoring of patients should continue as some patients enter the second year of treatment.

We prospectively delineated and contrasted the sexual, marital and psychological responses of women to their partner's use of 2 treatments for erectile dysfunction: 1) self-injection of papaverine and phentolamine, and 2) vacuum tumescence therapy. The women were assessed at 5 points during a 12-month period with psychometric questionnaires and clinical interviews. Statistical analysis indicated that the women responded equally well to both treatments. They demonstrated significant increases in frequency of intercourse, sexual arousal, coital orgasm and sexual satisfaction. No significant changes were noted on the psychometric questionnaires. The women reported feeling more at ease in their relationships and characterized sex as more leisurely, relaxed and assured. Negative responses focused on the lack of spontaneity and hesitation about initiating sex. Self-injection and vacuum pump therapy restore potency in men and secondarily facilitate improved sexual function in women.

Although intracavernous injection of vasoactive substances has been shown to be a reasonable and reliable method of reversing impotence, studies assessing patient acceptance of this new technology are lacking. By prospectively following patients and willing partners over a 2-year period, this study sought to document patient utilization rates and the reasons why patients decline or discontinue injection therapy. The cumulative dropout rate was 46%, with patients being most at risk for leaving the program after evaluation or during the trial dose phase. Patients decline treatment because they are unable to accept the idea of injecting themselves or because of potential side effects. Patients discontinue treatment because of perceived lack of efficacy. Patient and programatic obstacles to utilization of self-injection therapy are analyzed.