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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’
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: paolo.gontero@unito.it
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.
Citing Literature
Number of times cited according to CrossRef: 26
- Marah C. Hehemann, Maxwell Towe, Linda My Huynh, Farouk M. El-Khatib and Faysal A. Yafi, Penile Girth Enlargement Strategies: What’s the Evidence?, Sexual Medicine Reviews, 10.1016/j.sxmr.2018.11.003, (2019).
- Stefan Schill, Dimitrjie Panfilov and Ursula Mirastschijski, Intimchirurgie beim Mann, Intimchirurgie, 10.1007/978-3-662-57392-1_5, (49-68), (2019).
- J.D. Rebibo, Comment je prescris un stretching de verge par traction thérapie (Andropenis ® ) ?, Progrès en Urologie - FMC, 27, 4, (F80), (2017).
- Henry Tran, Robert Goldfarb, Anika Ackerman and Robert J. Valenzuela, Penile Lengthening, Girth, and Size Preservation at the Time of Penile Prosthesis Insertion, Sexual Medicine Reviews, 10.1016/j.sxmr.2016.11.005, 5, 3, (403-412), (2017).
- Shahryar Cohanzad, Penile Improvement Protocol in Postoperative Management of Patients Undergoing Metoidioplasty, Aesthetic Plastic Surgery, 40, 6, (947), (2016).
- Eric Chung, David Ralph, Ates Kagioglu, Guilio Garaffa, Ahmed Shamsodini, Trinity Bivalacqua, Sidney Glina, Lawrence Hakim, Hossein Sadeghi-Nejad and Gregory Broderick, Evidence-Based Management Guidelines on Peyronie's Disease, The Journal of Sexual Medicine, 10.1016/j.jsxm.2016.04.062, 13, 6, (905-923), (2016).
- Oliver Hakenberg and Michael Sohn, Ästhetisch-plastische Eingriffe am Penis, Die Urologie, 10.1007/978-3-642-39940-4_18, (1461-1469), (2016).
- Margareth de Mello Ferreira dos Reis, Sidney Glina and Carmita Helena Najjar Abdo, Perceptions about penis size among supposedly healthy 40 to 60-year-old Brazilian men: a cross-sectional pilot study, Sao Paulo Medical Journal, 133, 2, (84), (2015).
- David Veale, Sarah Miles, Julie Read, Andrea Troglia, Kevan Wylie and Gordon Muir, Sexual Functioning and Behavior of Men with Body Dysmorphic Disorder Concerning Penis Size Compared with Men Anxious about Penis Size and with Controls: A Cohort Study, Sexual Medicine, 3, 3, (147-155), (2015).
- David Veale, Sarah Miles, Julie Read, Andrea Troglia, Lina Carmona, Chiara Fiorito, Hannah Wells, Kevan Wylie and Gordon Muir, Penile Dysmorphic Disorder: Development of a Screening Scale, Archives of Sexual Behavior, 44, 8, (2311), (2015).
- Marco Oderda and Paolo Gontero, Comment On: Applying Extender Devices in Patients with Penile Dysmorphophobia: Assessment of Tolerability, Efficacy, and Impact on Erectile Function, The Journal of Sexual Medicine, 12, 5, (1248-1248), (2015).
- Mohammad Reza Nowroozi, Erfan Amini, Mohsen Ayati, Hassan Jamshidian, Kayvan Radkhah and Shahab Amini, Applying Extender Devices in Patients with Penile Dysmorphophobia: Assessment of Tolerability, Efficacy, and Impact on Erectile Function, The Journal of Sexual Medicine, 12, 5, (1242-1247), (2015).
- David Veale, Sarah Miles, Julie Read, Andrea Troglia, Lina Carmona, Chiara Fiorito, Hannah Wells, Kevan Wylie and Gordon Muir, Phenomenology of men with body dysmorphic disorder concerning penis size compared to men anxious about their penis size and to men without concerns: A cohort study, Body Image, 13, (53), (2015).
- David Veale, Ertimiss Eshkevari, Julie Read, Sarah Miles, Andrea Troglia, Rachael Phillips, Lina Maria Carmona Echeverria, Chiara Fiorito, Kevan Wylie and Gordon Muir, Beliefs about Penis Size: Validation of a Scale for Men Ashamed about Their Penis Size, The Journal of Sexual Medicine, 11, 1, (84-92), (2013).
- Eric Chung and Gerald Brock, Penile traction therapy and Peyronie’s disease: a state of art review of the current literature, Therapeutic Advances in Urology, 5, 1, (59), (2013).
- Hussein Ghanem, Sidney Glina, Pierre Assalian and Jacques Buvat, Position Paper: Management of Men Complaining of a Small Penis Despite an Actually Normal Size, The Journal of Sexual Medicine, 10, 1, (294-303), (2012).
- Oliver Kayes, Majid Shabbir, David Ralph and Suks Minhas, Therapeutic strategies for patients with micropenis or penile dysmorphic disorder, Nature Reviews Urology, 9, 9, (499), (2012).
- James Rybak, Dimitri Papagiannopoulos and Laurence Levine, A Retrospective Comparative Study of Traction Therapy vs. No Traction Following Tunica Albuginea Plication or Partial Excision and Grafting for Peyronie's Disease: Measured Lengths and Patient Perceptions, The Journal of Sexual Medicine, 9, 9, (2396-2403), (2012).
- Marco Oderda and Paolo Gontero, Non‐invasive methods of penile lengthening: fact or fiction?, BJU International, 107, 8, (1278-1282), (2010).
- Mohammadreza Nikoobakht, Alireza Shahnazari, Maedeh Rezaeidanesh, Abdolrasoul Mehrsai and Gholamreza Pourmand, Effect of Penile‐Extender Device in Increasing Penile Size in Men with Shortened Penis: Preliminary Results, The Journal of Sexual Medicine, 8, 11, (3188-3192), (2010).
- Laurence A. Levine and James Rybak, Traction Therapy for Men with Shortened Penis Prior to Penile Prosthesis Implantation: A Pilot Study, The Journal of Sexual Medicine, 8, 7, (2112-2117), (2011).
- Daniel J. Moskovic, Alexander W. Pastuszak, Larry I. Lipshultz and Mohit Khera, Revision of Penile Prosthesis Surgery after Use of Penile Traction Therapy to Increase Erect Penile Length: Case Report and Review of the Literature, The Journal of Sexual Medicine, 8, 2, (607-611), (2010).
- David Ralph, Nestor Gonzalez‐Cadavid, Vincenzo Mirone, Sava Perovic, Michael Sohn, Mustafa Usta and Laurence Levine, Trauma, Gender Reassignment, and Penile Augmentation, The Journal of Sexual Medicine, 7, 4pt2, (1657-1667), (2010).
- Yoram Vardi and Ilan Gruenwald, The status of penile enhancement procedures, Current Opinion in Urology, 10.1097/MOU.0b013e3283318f31, 16, 6, (601-605), (2009).
- Jonas S. Benson, Michael R. Abern and Laurence A. Levine, Penile shortening after radical prostatectomy and Peyronie’s surgery, Current Urology Reports, 10.1007/s11934-009-0074-z, 10, 6, (468-474), (2009).
- Gabriele Antonini, Ettore De Berardinis, Gian Maria Busetto, Francesco Del Giudice, Benjamin I. Chung, Simon L. Conti, Matteo Ferro, Gennaro Musi, Ramiro Fragas, Ottavio De Cobelli, Isabella Sperduti, Martin S. Gross and Paul E. Perito, Postoperative vacuum therapy following AMS™ LGX 700® inflatable penile prosthesis placement: penile dimension outcomes and overall satisfaction, International Journal of Impotence Research, 10.1038/s41443-019-0125-z, (2019).
