International Journal of Impotence Research (2000) 12, Suppl 5, S1±S12 ß 2000 Macmillan Publishers Ltd All rights reserved 0955-9930/00 $15.00 www.nature.com/ijir ORAL PRESENTATIONS 12 SEXUAL REHABILITATION: CLINICAL EXPERIENCE WITH WITHDRAWN SILDENAFIL CITRATE (VIAGRA TM) IN SPINAL CORD INJURED PATIENTS. ·- G Raviv, RJ Heruti, A Shaked, H Katz, A Ohry, J Ramon and I Madgar. Department of Urology, the Andrology Unit and the Neuro-Rehabilitation department, Sheba Medical Center, Tel-Hashomer, ISRAEL. Introduction & Objectives: Sexual dysfunction in spinal cord injured patients (SCIP) inflicts significant emotional and physical stress upon the patients. Recently Viagra. a potent inhibitor of cyclic guanosine monophosphate in the corpus cavemosum, was introduced as a new drug for conservative treatment of sexual dysfunction. The aim of this study was to assess the clinical efficacy of Viagra nl in SCIP. Subjects and Methods: 60 patients were included in the study. The patients underwent a complete evaluation process consisting of medical history, physical examination and blood tests. Rigiscan and EMG and SSEP of BCR were performed in patients with incomplete lesions and in those suspected to be of mixed origin. Each patient entering the stvdy completed the International fndex of Erectile Function questionnaire (IIEF). All patients were given 50mg as astarting dose that \vas increased to 1OOmg based on efficacy and tolerance except for quadriplegic and psychogenic erectile dysfunction patients in whom the starting dose was 25mg. Success was defined as improvement in the ability to have sexual intercourse. and the wish to continue the treatment. Results: The average age was 35.2::!::: 11.7 years (range I 9-58). The average age at injury was :!6.8±10.2 years (range 4-56). 35 patients had upper motor lesion. 13 \Vith quadriplegia. The rest 25 patients had lower motor lesion In Group-! 22 out of 35 patients had reflexogenic erection. In Group-11 10 out of25 did not have erection at all. 49 of the patients were able to maintain erection and penetration. The liEF score in this group increased from 11=5.48 to I 8=6.55 {P<O.OO I). The success rates in and -II were 31 35 (89%) and 18/25 (72%) respectively. Conclusions: Oral VIAGRA T\r is o.n effective. tre:J.tment of erectile dysfunction in SCIP. A higher success rate was seen among patients \vith UlvfN lesions (89%). though patients with Uv£N lesions have demonstrated also a remarkable success Quadriplegics may particularly bene tit from this drug. Our recommend initial titration dose of 50 mg and only :s mg for quodripleg:ic patients. Oral presentations S2 34 EFFECf OF IC35l ON ERECTll.E RESPONSE TO VISUAL EFFICACY AND SAFETY STUDY COMPARING ESCALATING DOSES OF APOMORPHINE SUBLINGUAL (SL) TABLETS TO S MG OR 6 MG OF SEXUAL STIMULATION 1 APOMORPI;IINE SL OR PLACEBO IN THE TREATMENT OF MALE Lycklama a Nijeholt AAB , Slob A Koos, Dohle Gert, Forest ERECTILE DYSFUNCTION (MED) Christopher, Rosen Raymond, Padma-Nathan Harin, Meuleman Eugene Dula, Van Nuys CA, William Keating, Scotland PA, Paul Siami, 1 Eric. Academisch Ziekenhuis Lei den, Leiden NL Evansville, IN, Janet O'Neil and Arunima Shukla, Deerfield IL and the Apomorphine SL Study Group (Presented by Dr. Dula) IC35l is a potent, selective, phosphodiesterase type 5 (PDE5) INTRODUCTION AND OBJECTIVES: Apomorphine is a dopaminergic agent inhibitor. The effect on erectile response of IC35l was assessed having erectogenic properties. AP<\morphine has been formulated in a vehicle for by RigiscanTM penile plethysmography. sublingual (SL) administration that ·has been demonstrated to maintain its Baseline erectile response to placebo and visual sexual erectogenic effects while minimizing the side effects associated with other routes of administration. This Phase Ill study was conducted to determine the efficacy and stimulation (VSS) was recorded by Rigiscan during a single­ safety of. apomorphine SL in an expanded of males with erectile blind placebo test dose. Eligible patients then entered a double­ dysfunction. The resultS of ·this study compare two fixed dosing regimens of blind, placebo controlled, single crossover phase. In each apomorphine SL and a voluntary optimization regimen versus placebo. treatment period the patient received placebo or IC351 (100 mg) METHODS: This was a multi-center, double-blind, randomized, placebo­ controlled, four-group parallel, dose-optimization study. Five hundred and sixty­ followed by RigiscanTM with VSS. The patient also evaluated nine (569) patients were enrolled into this study. Patients were randomized to one of the quality of the erection on a 5-point scale. four treatment groups (placebo, 6 mg fixed dose, 5 mg fixed dose, or a voluntary Forty-four patients having mild to moderate erectile optimization regimen consisting of 2 mg, 4 mg, 5 mg or 6 mg apomorphine SL). dysfunction completed the study. At the base of the penis, the The number of attempts resulting in an erection firm enough for intercourse was the primary endpoint. increase in duration of erection rigidity compared to RESULTS: The average percentage of attempts resulting in an erection firm baseline was 1.43±6.34 minutes (mean±STD) for placebo and enough for intercourse was statistically significantly higher for each of the three 9.43±12.66 minutes (mean±STD) for IC35l The apomorphine SL treatment groups than for placebo, with mean values of 54.0% for mean increase in the area under the rigidity curve at the base was the dose-optimization group, 53.6% for the 6 mg fixed dose, 54.1% for the 5 mg fixed dose versus 34.5% for the placebo group (all p values were <0.001 ). Results 179.0±558.7 (mean±STD) for placebo and 723.8±830.0 from both patients and partners were similar. Nausea was the most commonly (mean±STD) for IC35l Similar treatment effects reported adverse event (mostly mild to moderate) in this trial by 29.3% of patients were observed at the tip of the penis for all variables). taking apomorphine SL 2, 4, 5 and 6 mg in the dose-optimization group versus 48.3% in the 6 mg fiXed dose, 37.8% in the 5 mg fiXed dose and 2.5% in the Eighty-six percent of patients (38/44) reported improved placebo group, respectively. Only 1.7%, 2.2% and 1.7% of the patients experienced erections on IC35l. The patients' median rating of their severe nausea in the dose-optimization, 6 mg fixed dose and the 5 mg fixed dose erections at baseline and on placebo was 2 (partial erection) group, respectively. Four hundred and forty-four (444) patients completed the compared with a median rating of 4 (rigid but bendable) on study. IC35l (p<O.OOl). CONCLUSIONS: Apomorphine SL 5 and 6 mg fixed doses, as well as a vOluntary dose-optimization, are well-tolerated and effective treatments for erectile IC35l significantly enhances penile erections in response to dysfunction. The dose-optimization regimen demonstrated a statistically significant visual sexual stimulation in men with mild to moderate erectile decrease in the incidence of nausea, compared to the 6 mg fixed treatment dysfunction. group.(Source of funding: TAP Holdings Inc.) 56 RESULTS OF A PROSPECTIVE MUL TJCENTER TRIAL ON THE SILDENAFIL vs INTRACA VERNOSAL INJECTION (ICI): EFFICACY EFFICACY AND SAFETY OF INTRACAVERNO US ALPROSTADIL­ AND PREFERENCE IN PATIENTS FOLLOWING ICI FOR> I YEAR ALF ADEX (EDEx" IVIRIDAL ®) IN PATIENTS FAILING TREATMENT Apostolos Apostolidis, Vasilios Tzortzis. Stamatis Papaharitou, Aleka Portseli, WITH SILDENAFIL (VIAGRA®) Konstantinos Yannakogiorgos and Dimitrios G. Hatzichristou Ridwan Shabsigh, Harin Padma-Nathan, Marc Gittelman, James Department of Urology, School of Medicine and Center for Sexual Dysfunction, McMurray, Joel Kaufman, Irwin Goldstein, (R. Shabsigh, NY Male Aristotle University ofThessaloniki, Greece Reproductive Center, Columbia University, New York, N.Y. 10034) Introduction: Comparative data between ICI and sildenafil are still not available. In INTRODUCTION AND AIM OF THE STUDY: Little is known about an the present srudy we evaluated the efficacy of sildenafil, as well as patients adequate alternative for those patients not responding, being not satisfied or preference. in a group of ED patients treated with ICI for more than a year. having contra-indications to sildenafil (Viagra®). This prospective trial Material and methods: Inclusion criterion was history of ICI for more than a year. investigated the efficacy ofintracavernous alprostadil-alfadex (EDEx"/ Patients with contraindication for sildenafil use were excluded from the present VIRIDAL®)in patients not responding to sildenafil (Viagra.. ). sTudy. The design of the sTudy included two phases: during the first phase, patients METHODS: During a four-week at-home screening phase patients were were asked to attempt sexual intercourse at least two times using sildenafil at a dose advised to use sildenafil starting with a 50mg dose. In case patients did not of 50mg, or lOOmg for non-responders (unable to have sexual intercourse). At phase satisfactorily respond the dose was increased to I OOmg sildenafil. If at the 2. responders were asked to use sildenafil for a month period at the preferred dose. end of the screening phase an liEF score of <4 was recorded for question 3 At the end of the month, patients were asked to choose between ICI and sildenafil. and/or 4, and the patients were not satisfied with the Viagra® treatment, the Results: 144 patients (mean age 58±I2.6 years) were recruited, using ICI for a patients were enrolled into the EDEx"!VIRIDAL®phase. Patients were period of20+10 months. Overall, 110 (76.4%)_1Jatients to sildenafil. titrated and used their individual optimal dose for 6 weeks at-home. Efficacy Alprostadil Alprostadi Tri-mix Tri-mix Tri-mix RESULTS: A total of 99 patients (mean age of screened patients 57.9 :010 fig >IOS20f1 0.05-0.3ml 0.35-0.6ml 0.7-lml years and mean duration of ED 5.3 years) were non-responders to sildenafil n=60 n=30 n=21 n=21 n=l2 according to the protocol.