A pilot phase-II prospective study to test the ‘efficacy’ and tolerability of a penile-extender device in the treatment of ‘short penis’

Doctors: Paolo Gontero, Massimiliano Di Marco, Gianluca Giubilei, Riccardo Bartoletti, Giovanni Pappagallo, Alessandro Tizzani and Nicola Mondaini Dipartimento di Discipline Medico Chirurgiche, Urologia 1, San Giovanni Battista Hospital, University of Turin, Turin, Italy
Accepted for publication 9 July 2008

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OBJECTIVE
To assess a commonly marketed brand of penile extender, the Andro-Penis® (Andromedical, Madrid, Spain), widely used devices which aim to increase penile size, in a phase II single-arm study powered to
detect significant changes in penile size, as despite their widespread use, there is little scientific evidence to support their potential clinical utility in the treatment of patients with inadequate penile dimensions.

PATIENTS AND METHODS
Fifteen patients were required to test the efficacy of the device, assuming an effectsize of > 0.8. Eligible patients were counselled how to use the penile extender for at least 4 h/day for 6 months. Penile dimensions were measured at baseline and after 1, 3, 6 and 12 months (end of study). The erectile
function (EF) domain of the International Index of EF was administered at baseline and at the end of the study. Treatment satisfaction was assessed using an institutional unvalidated five-item questionnaire.

RESULTS
After 6 months the mean gain in length was significant, meeting the goals of the effect size, at 2.3 and 1.7 cm for the flaccid and stretched penis, respectively. No significant changes in penile girth were detected. The EF domain scores improved significantly at the end of study. Treatment satisfaction scores were consistent with acceptable to good mprovement in all items, except for penile grth, where the score was either ‘no change’ or 'mild improvement’.

CONCLUSIONS
Penile extenders should be regarded as a minimally invasive and effective treatment option to elongate the penile shaft in patients seeking treatment for a short penis.

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