A study evaluated the effects of the early use of Alprostadil ( Muse ) urethral suppository on erectile dysfunction ( ED ) subsequent to a bilateral nerve-sparing radical prostatectomy ( RP ) in men with prostate cancer.

A total of 91 preoperatively sexually active patients who developed erectile dysfunction due to a bilateral nerve-sparing radical prostatectomy were enrolled in the study.
A single surgeon performed the radical prostatectomy for all study patients.

Fifty-six patients were treated with Alprostadil, three times per week for six months.
Treatment was initiated approximately three weeks after surgery with 125 mcg of Alprostadil; after 6 weeks, the dose of Alprostadil was either increased to 250 mcg or was maintained at 125 mcg for an additional 4 months.
The remaining 35 patients received no treatment and comprised the control group.
Both groups had similar baseline levels of erectile function before surgery.

Thirty-eight patients in the Alprostadil-treated group continued treatment for the duration of the study, and of these, 39% were able to achieve natural erections sufficient for intercourse without the use of erectogenic agents. In contrast, only 11% of subjects in the observational control group were able to achieve erections sufficient for intercourse without treatment six months after surgery.

Erectile function was assessed before and at six months after surgery in both groups using the Sexual Health Inventory for Men ( SHIM ), a patient questionnaire that determines the degree of erectile dysfunction in which higher scores indicate better function.

The six-month SHIM scores for the Alprostadil-treated group was 18.9 ( baseline of 21.2 ) compared to the score of 12.1 ( baseline of 22.0 ) for the control group ( p<0.05 ).

The study also showed that 74% of patients who completed six months of Alprostadil treatment were able to resume sexual activity.

" Results from this study suggest that early treatment with Muse after a radical prostatectomy may improve penile function recovery," commented Raina, lead author of the study. " The approximate four-fold improvement in the ability to have natural erections without the use of erectogenic aids in the Muse group is clinically significant in this group of subjects.
As erectile dysfunction associated with a radical prostatectomy can persist for 12 to 24 months, any treatment that would reduce this time would be of significant benefit to the patient."

A total of 18 men in the Muse group discontinued treatment prior to the end of the study, nine for insufficient erections, five for reduced sexual interest and four for local pain/burning.

According to the American Cancer Society, more than 230,000 men were diagnosed with prostate cancer in 2004. Research from the 2002 National Hospital Discharge Survey found that 195,000 prostatectomy procedures were performed in 2002 as a means of treating prostate cancer.
Sexual dysfunction is a frequent consequence of this type of surgery, most likely due to damage to local nerves and blood vessels.

Muse ( Alprostadil ) is a medicated pellet that is placed in the urinary opening using a disposable plastic applicator.
Muse was approved by the FDA in 1997 for the treatment of erectile dysfunction.
It has not been approved by the FDA for the recovery of normal erectile function following radical prostatectomy.
Muse should not be used by men who have sickle cell anemia or trait, leukemia or tumor of the bone marrow, allergy to Alprostadil ( the active ingredient in Muse ), or abnormal penile anatomy.
Muse should not be used in men for whom sexual activity is inadvisable due to cardiac fitness.
Muse should not be used for intercourse with a pregnant woman without a condom.
Muse does not protect against sexually transmitted diseases.
Because of the potential for symptomatic hypotension and syncope, which occurred in 3% and 0.4%, respectively, of patients during in-clinic dosing, Muse titration should be carried out under medical supervision.
During post-marketing surveillance syncope occurring within one hour of administration has been reported. Patients should be cautioned to avoid activities such as driving or hazardous tasks, where injury could result if hypotension or syncope were to occur after Muse administration.
Side effects can include penile pain.

Source: 100th Annual Meeting of the American Urological Association ( AUA ), 2005


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