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Alprostadil - topical

Clinical bottom line

Topical alprostadil works, though there is not a large evidence-base from randomised trials. It is associated with genital burning for man and partner.


Background

Alprostadil is a prostaglandin that can be used to treat erectile dysfunction. There are different methods of using it, by injection into the penis (intracavernosal), by inserting a pellet into the urethra (transurethral), or by a cream or gel applied to the glans penis (topical). This article looks at topical application.

Searching

Searching was done using PubMed, Medline and the Cochrane Library, up to September 2005. Randomised trials in which alprostadil was compared with placebo were sought. Details of the trials were abstracted and quality scoring done with a 5 point scale. For crossover or partial crossover designs, details of the first phase were used (as a parallel group trial) where possible, and where this was not possible the full crossover data was used.

The outcome sought was patient/partner judgement of satisfactory erections suitable for intercourse, or actual intercourse, at home. Ideally this was on a patient basis, rather than on event basis, which was a secondary outcome. Relative risk and NNT were calculated using standard methods.

Results

One laboratory study, and one meta-analysis of two randomised trials (published twice) were found (Table 1). Studies were not large, nor were they of long duration. Higher doses of topical alprostadil clearly work with penetration enhances, though penile erythema for men and vaginal burning for partners may be a problem.

Table 1: Randomised trials of topical alprostadil

Study Design Quality score Patients Treatment Outcome Result Adverse events
Goldstein et al. Urology 2001 57: 301-305
USA
Randomised, double blind, crossover, laboratory study R=1
DB=2
WD=1
Total=4
Men (24 to 78 years) with history of erectile dysfunction Clear gel with 1% alprostadil or placebo, applied to glans penis in laboratory, with stimulation, in 62 men Patient and physician assessment of erection Erection sufficient for penetration
alprostadil 39%
placebo 7%
Significantly greater erthyema in alprostadil
Steidle et al. Urology 2002 60:1077-1082.
Padma-Nathan et al. Int J Impot Res 2003 15: 19-17 (duplicate)
USA
Two randomised, double-blind, studies of various doses of topical alprostadil R=1
DB=1
WD=1
Total=3
Men aged 21-70 years with IIEF EF domain scores 14-21 in one study, and <14 in another 1 0.05 mg (n=36)
2 0.1 mg (n=66)
3 0.2 mg (n=61)
4 0.3 mg (n=29)
5 placebo (n=73)
Men without adverse events given 10 treatments to be used over 6 weeks
IIEF scoring, global assessment Two higher doses had significant improvement over placebo
Those maintaining erections for intercourse
1 40%
2 36%
3 48%
4 47%
5 28%
Genital burning in about 40% of men with effective doses, and vaginal burning was a problem for the partner

 

Comment

There is only limited evidence concerning the efficacy of topical alprostadil