A pilot phase-II prospective study to test the ‘efficacy’ and tolerability of a penile-extender device in the treatment of ‘short penis’
Article first published online: 17 OCT 2008
© 2008 THE AUTHORS. JOURNAL COMPILATION © 2008 BJU INTERNATIONAL
Volume 103, Issue 6, pages 793–797, March 2009
How to Cite
Gontero, P., Di Marco, M., Giubilei, G., Bartoletti, R., Pappagallo, G., Tizzani, A. and Mondaini, N. (2009), A pilot phase-II prospective study to test the ‘efficacy’ and tolerability of a penile-extender device in the treatment of ‘short penis’. BJU International, 103: 793–797. doi: 10.1111/j.1464-410X.2008.08083.x
- Issue published online: 23 FEB 2009
- Article first published online: 17 OCT 2008
- Accepted for publication 9 July 2008
- penile extender;
- penile dysmorphophobia;
- penile size;
- short penis
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.
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’.
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.