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Clinical studies: Vasoderm™

  • Service of Andrology and Clinical Neurophysiology — Policlinico di Monza, Monza (MI) — Italy

Vasoderm™
Vasoderm™
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Ciba Laboratories
Policlinico di Monza, Monza (MI) — Italy

Topical Vasoderm™ in the treatment of mild to moderate male Erectile Dysfunction

Pietro Lattarulo M.D.
Service of Andrology and Clinical Neurophysiology — Policlinico di Monza, Monza (MI)
Italy




Fig.    shows the OPVC picture before and after a cycle of Vasoderm™ therapy:

Before treatment After treatment

Left: Stasis microangiopathy. Note capillary dilation, saccular apical aneurysms, stasis blood flow.
Right: the same after 1 month of treatment. Note improvement of capillary network, blood flow and redness of background, to indicate better arteriolar vascularization.

LDF and oxymetry data, also showed a significant increase in PU and tcpO2 in penile microcirculation both after a single dose and at the end of treatment. Fig. 4 shows LDF and tcpO2 traces.

Fig. 4, LDF and tcpO2 traces

Fig.    values increase after Vasoderm™ administration (about 15 min.).

Summary

Purpose: To study the effect of a topical serum (Vasoderm™) on penile microcirculation and its therapeutic efficacy in mild or moderate Erectile Dysfunction (ED).

Materials and Methods: From Nov. 1999 to Feb. 2000, a total of 10 patients suffering from mild to moderate ED on the basis of subjective symptoms and penile Eco Color Duplex Scanning data were selected for the present study. All patients (mean age 40) underwent to a complete andrological examination, blood chemistry, hormonal assessment (Total and Free Testosterone, Prolactin, TSH), Dynamic Eco Color Duplex Scanning. Neurophysiologic study (Sympathetic Skin Responses) was also performed to exclude Dysautonomia. Inclusion criteria for mild/moderate ED were based on the entity of subjective symptoms and extension of endothelial thickness of the penile macrovascular system. The selected patients were then submitted to a complete Microcirculatory evaluation (Optic Probe Videocapillaroscopy — OPVC, Laser Doppler Fluximetry — LDF, Transcutaneous Oxymetry — tcpO2), before, after 30 min of a topical single dose (20 drops) and after the complete therapy with Vasoderm™ (ten drops slowly drop by drop over the glans penis until complete absorption, twice daily for 1 month). Active ingredients of this product (L-Arginine Hcl, Gingko biloba, Vasoactive Intestinal Peptide) have been tested microangiologically to evaluate their vasoactive action also by single topical administration. All patients were asked 4 questions on an anonymous questionnaire about the drug and the outcome of the treatment. T-test of Student was used for statistical analysis and p<0.05 considered of significance.

Results: The etiology of ED was of vascular origin in 8 patients (4 Hypertension, 3 heavy smokers, 1 NID Diabetes), classified as psychological in the remaining two. Microangiological assessment pointed out Hypertensive Microangiopathy in 4 patients, Aspecific Microangiopathy in 4, Diabetic Macroangiopathy in 1, Stasis Microangiopathy in 1 and clearly demonstrated the vasomotor activity of Vasoderm™ on microvessels. Data analysis pointed out a significant increase in Perfusion Unit, in tcpO2, and in capillary density, either after 30 min of a topical single dose, or after the complete treatment (p<0.05). All patients showed also an improvement of sexual intercourse at the end of therapy, with better penile rigidity and reappearing of nocturnal and morning spontaneous erections. Regarding side effects, 1 patient showed mild irritation of glans penis extinguished spontaneously and not such to stop the therapy.

Conclusion: Many clinical studies have been performed to prove the efficacy of various vasoactive drugs in ED with inconstant results. These contradictions rise from the concept that it has been thought topical treatments to evoke immediate erection, like Intracavernous injection or oral administration can do. On the contrary, the aim of the present study has been to prove that improvement of Microcirculation with Vasoderm™ can lead to restoration of physiologic erections, after a cycle of therapy, in men with mild to moderate ED. Active ingredients used in this trial (L-Arginine HCL, Gingko Biloba, VIP) are known to influence vascular system by means of its vasomotor activity I confirmed by improvement of microcirculatory parameters (increase in blood perfusion and tissue oxygen tension). The formulation of a serum acting as a carrier for their better transcutaneous absorption allow them to reach cavernous compartment through venules drainage in a retrograde manner as described by Saenz de Tejada. Absence of side effects, improvement of subjective parameters with achievement of physiologic erections and the possibility to get a simple therapy in a more comfortable familiar environment, consent Vasoderm™ therapy can be done in association with other therapies for ED to improve results and to reduce possible side effects and time of therapy.


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