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EFFICACY AND SAFETY OF TRANSURETHRAL ALPROSTADIL IN PATIENTS WITH ERECTILE DYSFUNCTION FOLLOWING RADICAL PROSTATECTOMY
Authors:RAYMOND A COSTABILE  MARIANNE SPEVAK  IRVING J FISHMAN  FRED E GOVIER  WAYNE JG HELLSTROM  RIDWAN SHABSIGH  KERRY J NEMO  JOSHUA L RAPPORT  PETER Y TAM  KARA LM WELDON  NEIL GESUNDHEIT
Institution:From the Urology Service, Department of Surgery, Military Andrology Research Center, Walter Reed Army Medical Center, Washington, D. C., Baylor College of Medicine, Houston, Texas, Virginia Mason Medical Center, Seattle, Washington, Tulane University Medical Center, New Orleans, Louisiana, Columbia-Presbyterian Medical Center, New York, New York, and VIVUS, Inc., Mountain View, California
Abstract:

Purpose

A retrospective analysis of the MUSE* clinical trial was performed to evaluate the efficacy and safety of transurethral alprostadil in patients with erectile dysfunction after radical prostatectomy.

Materials and Methods

Patients received doses of transurethral alprostadil in the clinic and those for whom a suitable dose was determined were treated at home with active drug or placebo for 3 months. Patients had undergone radical prostatectomy no less than 3 months before study entry.

Results

Of the 384 patients in whom radical prostatectomy was identified as a cause of erectile dysfunction 70.3% had an erection believed sufficient for intercourse in the clinic and 57.1% on active medication had sexual intercourse at least once at home. The product of clinic and home success rates (70.3 x 57.1%) was an overall success rate (the likelihood of active treatment to lead to intercourse at home) of 40.1%. The frequency of most adverse effects of radical prostatectomy was comparable to that of other organic etiologies of erectile dysfunction (1,127 patients). The percentage of patients with hypotension in the clinic was lower after radical prostatectomy compared to other erectile dysfunction etiologies (0.8 versus 4.2%, p <0.001) but the percentage of patients with urethral pain/burning was higher (18.3 versus 10.4%, p = 0.027). No urinary tract infection, fibrosis or priapism occurred in the post-radical prostatectomy patients.

Conclusions

Transurethral alprostadil is a well tolerated and efficacious method of treating erectile dysfunction after radical prostatectomy, although psychological changes associated with cancer and surgery may limit home response. The severe neurovascular deficit associated with prostatectomy neither limits the efficacy of transurethral alprostadil nor increases the risks.
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