Volume 103, Issue 6 p. 793-797

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

Paolo Gontero

Paolo Gontero

Dipartimento di Discipline Medico Chirurgiche, Urologia 1, San Giovanni Battista Hospital, University of Turin, Turin, Italy

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Massimiliano Di Marco

Massimiliano Di Marco

Dipartimento di Discipline Medico Chirurgiche, Urologia 1, San Giovanni Battista Hospital, University of Turin, Turin, Italy

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Gianluca Giubilei

Gianluca Giubilei

Dipartimento di Discipline Medico Chirurgiche, Urologia 1, San Giovanni Battista Hospital, University of Turin, Turin, Italy

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Riccardo Bartoletti

Riccardo Bartoletti

Dipartimento di Discipline Medico Chirurgiche, Urologia 1, San Giovanni Battista Hospital, University of Turin, Turin, Italy

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Giovanni Pappagallo

Giovanni Pappagallo

Dipartimento di Discipline Medico Chirurgiche, Urologia 1, San Giovanni Battista Hospital, University of Turin, Turin, Italy

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Alessandro Tizzani

Alessandro Tizzani

Dipartimento di Discipline Medico Chirurgiche, Urologia 1, San Giovanni Battista Hospital, University of Turin, Turin, Italy

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Nicola Mondaini

Nicola Mondaini

Dipartimento di Discipline Medico Chirurgiche, Urologia 1, San Giovanni Battista Hospital, University of Turin, Turin, Italy

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First published: 23 February 2009
Citations: 44
Paolo Gontero, Senior Lecturer and Consultant Urologist, Dipartimento di Discipline Medico Chirurgiche, University of Turin, Urologia 1, San Giovanni Battista Hospital, C.so Dogliotti, 14, Torino, Italy. e-mail: [email protected]

Abstract

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 effect size 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 improvement in all items, except for penile girth, 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.