Multicentric international study to validate the digital inflection rigidometer in the diagnosis of erectile dysfunction

Ronald Virag, Paris - France, Giovanni Colpi, Milan - Italy, Khaled L. Dabees, Cairo - Egypt, Dimitrios Hatzichristou, Thessalonica - Greece, Osvaldo Mazza, Buenos Aires - Argentina, Ignacio Moncada, Madrid - Spain, Jose Pererira, Lisbon - Portugal, Claude Schulman, Brussels - Belgium, Fernando Ugarte, Mexico DF - Mexico

American Urological Association (AUA) Convention, Anaheim (California), June 1-6, 2001

Introduction and Objectives: Penile axial rigidity is the result of the erection mechanisms in which there is an adequate arterial inflow, an integrity of the corpora veno occlusive system, an hormonal balance, an integrity of the sympathetic and parasympathetic system, an anatomical integrity, incorporating the sensorial stimulus (sight, hearing, sense of smell and touch). The aim of this study is to incorporate to the diagnosing procedure a new device, the Digital Inflection Rigidometer (DIR), able to provide us in a painless and fast way the axial penile rigidity in grams, the relative intracavernosal pressure, the time of erection and the temperature of the glans. These parameters allowed us to evaluate the degree of erectile dysfunction, to define arterial pathology, venous leak, arterial/venous, psychological reasons or deformations of the penis.

Method: This study has been carried out by nine centrums. We herewith present the preliminary results of four centrums from a total of a hundred patients. The selection criteria has been as follows: Impotent patients with a documented clinical history; impotent patients of less than six months of evolution; impotent patients that have answered to the IIDE, patients that can understand the management of the device and patients that had been diagnosed by the standard tests usually performed by each Centrum .The patient has done the test by himself in complete privacy following doctor’s instructions. The doctor carries out the first measurement.
Vasoactive substances injected in the corpora cavernosa and video sex stimulation have been used as stimulation according to the doctors criteria. Patients have measured the axial rigidity by pressing the penis against the sensor every two minutes and during fifteen seconds , a total of seven times.

Results: Diagnosis of each patient according to the classic methodology usually followed by each Centrum has been compared to the results of the Digital Inflection Rigidometer and its graphics and they match in 80 per cent of the cases. In curvature cases, the DIR graphic detects axial rigidity deficiency though having good circumferential rigidity; also, it detects venous leakage. Arterial insufficiency is also well illustrated in its different levels.

Conclusions: The DIR offers us the axial rigidity, the relative intracavernosal pressure without pain for the patient and the rest of parameters in a fast, accurate and reliable way. The DIR is a device that provides us the parameters of the quality of the erection incorporating the sensorial stimuli without the psychological inhibition of the patient as he does the test by himself.