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Table 111 Overview of the literature on VCD therapy outcome Mean age (years) 64 32 75 55 524 65 61 665 66 Follow-up (months) up to 72 86 128 1974 1992 3 weeks 6 29 2 weeks 27 48
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Author Nadig[12] 1987 Witherington[17] 1989 Blackard[14] 1993 Derouet[15] 1993 Baltaci[16] 1995 Lewis[11] 1997 Meinhardt[17] 1993 Fedel[18] 1995 Cookson[19] 1993 Graham[20] 1998 Droupy[21] 1998 Opsomer[22] 1998
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Device Osbon ErecAid Osbon ErecAid Osbon ErecAid Osbon ErecAid Osbon ErecAid Osbon ErecAid Post-T VED Innovital
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N 302 15,000 47 90 61 34,777 74 100 216 323 53 (RRP) 170
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Evaluable 81% (244) 10% (1517) 96% (45) 100% 80% (49) 17% (5847) 100% 40% 53% (115) 100% 55% (29)
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Satisfaction 83% 92% good erections 42% 37% 67% 65 83% 30% 90% 84% 23% 52% 55%
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cotherapy compared to responders (45% vs 22%) [15]
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Contraindications
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Contraindications in the use of vacuum therapy are few and primarily include patients with a tendency for spontaneous priapisms/prolonged erections [11] Originally, bleeding disorders were considered a contraindication [11], but a prospective trial showed that the adverse effects of vacuum therapy, especially hematoma and petechiae, in patients on warfarin, did not exceed those observed in the general urologic population [23] In addition VCD therapy is contraindicated in severe penile anomalies, especially in marked penile deviations either congenital or acquired as a consequence of Peyronie s disease
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Complications
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Side effects such as occasional numbness, pain,
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penile bruising, or petechiae, are the most common complications of VCD Painful ejaculation, due to the constriction ring, has been commonly reported [11,13] As mentioned, although VCD are able to give suf cient penile rigidity in the majority of patients, vaginal penetration can be impaired because of the instability of the phallus at the penis base, and ejaculation is achieved in less than twothirds of men due to the fact that passage through the urethra is blocked by the constriction ring [11] In addition, satisfaction with sexual intercourse may be impaired because the whole situation may not be accompanied by a subjective state of physical or mental sexual arousal Thus, the mere physical presence of an erection does not seem to evoke bodily or mental feelings of sexual arousal, especially in the partners [24] Rarely, the use of VCD has been associated with Peyronie s disease [25] In a prospective trial the use of VCD for spinal cord-injured men with erectile dysfunction did not increase the risk of adverse events [26] Other anecdotal complications linked to
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11 shortening [30,31] Chronic intermittent stretching with a vacuum erection device was used in a small trial to lengthening shortened penises caused by severe Peyronie s disease, after venous grafting [36] Moreover, as mentioned before, VCD may be used successfully in conjunction with self-injection therapy, and may add to its ef cacy [37,38]
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VCD were skin necrosis and urethral bleeding [27] Sometimes, continuous use of VCD may result in hyperpigmentation of the penile skin due to repeated skin bruising, with subsequent hemosiderin deposition It is important to advise patients to use only prescription devices Others devices have no pressure control or safety valves to release the pressure, which can increase the rate and severity of complications [25]
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Acceptance, Long-term Use and Drop-out Rates of VCD
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Although VCD therapy is able to produce erections suf cient for sexual intercourse in more than 75% of users [29], the main reasons for discontinuation of VCD therapy were ineffectiveness, side effects, the time-consuming nature of the procedure, lack of acceptance by patient and partner, and the relatively high costs of the devices [28] Once VCD turned out to be effective, signi cant increase in frequency of intercourse, sexual arousal, coital orgasm and sexual satisfaction was reported by patients partners [30] In a minority of patients (8 16%) the continuing use of VCD therapy may result in recovery of spontaneous erections [11,16,18,19,21]
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