American Urological Association: Alprostadil Urethral Suppository for Erectile Dysfunction After Radical Prostatectomy

In: Disease

12 May 2010

Speaker: Craig Zippe, MD, Staff Surgeon, Section of Urologic Oncology, and Co-Director, Prostate Center and Center for Advanced Research in Human Reproduction, Infertility, and Sexual Function, The Cleveland Clinic, Cleveland, Ohio.

The early use of an alprostadil urethral suppository (Muse®, Vivus, Inc.) in men following bilateral nerve-sparing radical prostatectomy appears to facilitate a rapid return to and a high rate of early recovery of normal sexual function.

Ninety-one men who had undergone the procedure participated in a trial to determine whether early, frequent Muse® treatment, at least three times weekly, would speed the recovery time of sexual function. Fifty-six patients received Muse® 125 mcg at least three times a week for six weeks. The treatment was started during the first month after surgery. At six weeks, patients received either 250 mcg at least three times a week, or they continued to take 125 mcg, depending on their tolerability, for another four months or more. The control group consisted of 35 men who refused treatment post-operatively, except for erectogenic aids when sexual intercourse was attempted.

Overall, 28 of 38 evaluable patients who received the study drug (73%) were able to undergo successful vaginal intercourse, with a corresponding satisfaction rate of 67% for the patients’ sexual partners. In addition, 55% of these men reported the recovery of spontaneous erections sufficient for vaginal intercourse after six months of early use of Muse®. Eighteen of the 56 Muse® patients dropped out of the study, citing insufficient erections (50%), reduced sexual interest (28%), or pain and burning associated with the product (22%).

In the control group, 13 of the 35 men reported some degree of success; four reported a return of spontaneous erections sufficient for intercourse without adjuvant treatment. Another nine men reported that they had the ability to perform successful vaginal intercourse but required adjuvant erectogenic aids, including Muse®.

Lidocaine Jelly for Penile Aching Induced by Muse®

Speaker: James K. Dow, MD, Urologist, Urology Section, Veterans Administration Northern California Health Center System, Martinez, California.

Although a sterile bacteriostatic surgical lubricant (Surgilube®, AstraZeneca) and 2% lidocaine HCl (Xylocaine® Viscous, AstraZeneca) can provide improved quality of delivery of intraurethral alprostadil (Muse®, Vivus, Inc.) for the management of erectile dysfunction (ED), only a combination treatment with lidocaine jelly has proved effective in eliminating Muse®-induced penile aching.
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A total of 74 men with organic ED who responded favorably to a three-month period of Muse® therapy alone but who complained of penile aching were selected for a comparison of 2% lido-caine jelly and Surgilube® in combination with Muse® for the reduction of penile aching. The patients were randomly assigned to one of two groups; 24 patients received Surgilube®, and 50 men received 2% lidocaine jelly. Both preparations were applied to the Muse® applicator stem before insertion into the urethra.

After six months of treatment, the outcome variables assessed included the frequency of episodes of penile aching, the Erection Quality Scale, dual activity as a selective pain inhibitor and erection enhancer, Patient Global Impression of impotence-related quality of life, quality of drug delivery, general improvement with Muse®, and frequency of side effects.

Overall, 98% (49/50) of the patients reported complete disappearance of penile aching with 2% lidocaine jelly; only 4% of patients (1 of 24) who received Surgilube® experienced relief. Furthermore, 33% of men (17 of 50) in the combination treatment group with lidocaine stated that their erection quality was significantly improved, in contrast to 8% of patients (2 of 24) in the Surgilube® group.
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All of the men who received lidocaine with Muse® expressed improved sexual satisfaction, psychological benefits, and impotence-related quality of life. Both preparations equally provided an enhanced delivery quality of Muse®, and neither product was associated with any adverse reactions.

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