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Management Practices and Newly Approved Treatments for Premature Ejaculation
reported with the SS-cream, which is reported to have a unpleasant compared with placebo.
43,44
The primary concern with opiate therapy
smell and colour. Furthermore, the SS-cream has only been evaluated is abuse and dependency, as well as potential sedation. These
by the originator and there are no confirmatory trials published.
16
aspects need to be addressed in the clinical development of
There seem to be insufficient data to conclude that patients with PE tramadol as a potential on-demand therapy for PE.
have increased penile sensitivity, and the importance of peripheral
afference in the ejaculatory reflex is not clear. Topical application of Phosphodiesterase (PDE5) inhibitors have also been proposed for the
anaesthetics has the advantage of lack of systemic side effects, treatment of PE, in addition to their use for treatment of erectile
although the loss of sensation may lead to loss of erection and also dysfunction. The theoretical rationale is the presence of PDE5 in the vas
diminished satisfaction with intercourse despite a prolonged IELT. deferens and prostate, and that PDE5 inhibitors can relax smooth
muscle in these structures and counteract the adrenergic impulses
Tramadol and other opiates have been used off-label in the driving the emission phase of ejaculation.
16
Unfortunately, a systematic
treatment of PE as well as an unknown illicit use of opiates to review of 14 published studies revealed that 13 of them failed criteria
achieve longer IELT. Tramadol is currently under clinical development for evidence assessment, which limits the ability to make any
in phase II for PE. Two smaller but well designed studies
43,44
suggest conclusion regarding the role of PED5 inhibitors in the treatment of PE.
45
that it might be effective for the treatment of PE. Tramadol has a There are two studies that fulfil criteria for evidence-based medicine:
complex mode of action and its metabolites can inhibit noradrenalin one that demonstrated that on-demand vardenafil 10mg significantly
and serotonin re-uptake; it also has direct action on µ-opoid increased IELT over placebo in men with lifelong PE,
46
and another that
receptors. A dose of 50mg tramadol (which is rapidly taken up) showed that sildenafil improved patient-related outcomes but did not
significantly increased IELT and satisfaction with intercourse significantly increase IELT
47
in a group of men with lifelong PE. n
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