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Treating men with predominantly nonpsychogenic erectile dysfunction with intracavernosal vasoactive intestinal polypeptide and phentolamine mesylate in a novel auto-injector system: a multicentre double-blind placebo-controlled study.

Author(s): Dinsmore WW, Gingell C, Hackett G, Kell P, Savage D, Oakes R, Frentz GD

Affiliation(s): Department of Genito-Urinary Medicine, Royal Victoria Hospital, Belfast, Northern Ireland.

Publication date & source: 1999-02, BJU Int., 83(3):274-9.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVE: To study the effect of intracorporeal injection (IC) of vasoactive intestinal polypeptide (VIP) and phentolamine mesylate (PM) on men with erectile dysfunction (ED) of nonpsychogenic aetiology. PATIENTS AND METHODS: The study comprised 236 men with primarily nonpsychogenic ED attending sexual dysfunction clinics at eight institutions. In an initial dose-assessment phase, the men were given IC injections of 25 micrograms VIP combined with PM 1.0 mg (VIP/P-1) or 2.0 mg (VIP/P-2) in a prefilled, single-use auto-injector. The main aetiologies of ED were arteriogenic (38), diabetes mellitus (DM) (39), neurogenic (35), mixed (90), and venous leakage (30). In a placebo-controlled phase, 171 patients were subsequently treated and self-administered up to 12 injections over a 6-month interval. RESULTS: In the dose-assessment phase there was an overall response rate of 82%, with responses by aetiology as follows: arteriogenic (82%), DM (85%), neurogenic (86%), mixed (80%), and venous leakage (77%). In a subgroup of 159 patients who withdrew from previous IC therapies for ED, 64% responded with an erection suitable for intercourse. Of the 171 patients treated in the placebo-controlled phase, 75% responded to VIP/P-1 and 12% to placebo (P<0.001); 66% responded to VIP/P-2 and 18% to placebo (P<0. 001), with a median duration of erection of 56 min. The principal adverse event was transient facial flushing accompanying 40% of 1711 injections. There was no pain after injection and one episode of priapism (0.06%); only seven patients withdrew because of adverse events. Over 88% and 92% of patients were satisfied with the drug and auto-injector, respectively. More than 85% of patients and 77% of partners reported an improved quality of life. CONCLUSION: The combination of VIP and PM at the dose used is a safe and effective means of treating male ED of primarily nonpsychogenic aetiology.

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