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

Published on Mar 1, 2009in BJUI4.52
· DOI :10.1111/j.1464-410X.2008.08083.x
Paolo Gontero30
Estimated H-index: 30
(UNITO: University of Turin),
Massimiliano Di Marco3
Estimated H-index: 3
(UNITO: University of Turin)
+ 4 AuthorsNicola Mondaini27
Estimated H-index: 27
(UNITO: University of Turin)
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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.
  • References (13)
  • Citations (32)
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References13
Newest
#1Nicola Mondaini (UniFI: University of Florence)H-Index: 27
#2Roberto Ponchietti (UniFI: University of Florence)H-Index: 11
Last.M. Rizzo (UniFI: University of Florence)H-Index: 16
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#1Roberto Ponchietti (UNIBO: University of Bologna)H-Index: 1
#2Nicola Mondaini (UNIBO: University of Bologna)H-Index: 1
Last.Lorenzo Masieri (UNIBO: University of Bologna)H-Index: 1
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#1Joseph C. Cappelleri (Pfizer)H-Index: 53
#2Raymond C. Rosen (UMDNJ: University of Medicine and Dentistry of New Jersey)H-Index: 96
Last.Ian H. Osterloh (Pfizer)H-Index: 12
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#1Kiran L. Sharma (Mayo Clinic)
#2Manaf Alom (Mayo Clinic)H-Index: 3
Last.Landon Trost (Mayo Clinic)H-Index: 14
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#1Marah C. Hehemann (UW: University of Washington)
#2Maxwell Towe (UCI: University of California, Irvine)
Last.Faysal A. Yafi (UCI: University of California, Irvine)H-Index: 14
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#1Giancarlo Marra (UNITO: University of Turin)H-Index: 5
#2Andrew Drury (National Health Service)
Last.Gordon Muir ('KCL': King's College London)H-Index: 35
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Last.Ursula Mirastschijski (University of Bremen)H-Index: 3
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#1Henry Tran (CUMC: Columbia University Medical Center)H-Index: 1
#2Robert Goldfarb (CUMC: Columbia University Medical Center)H-Index: 1
Last.Robert J. Valenzuela (CUMC: Columbia University Medical Center)H-Index: 1
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#1Eric Chung (Memorial Hospital of South Bend)H-Index: 18
#2David Ralph (UCLH: University College Hospital)H-Index: 44
Last.Gregory A. Broderick (Mayo Clinic)H-Index: 35
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