Tratamentos efectivos para pacientes com um tamanho reduzido do pénis

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Paolo Gontero, Massimiliano Di Marco, Gianluca Giubilei, Giovanni Pappagallo, Andrea Zitella

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Tratamentos efectivos para pacientes com um tamanho reduzido do pénis

  1. 1. 2008 THE AUTHORS. JOURNAL COMPILATION 2008 BJU INTERNATIONALSexual MedicineEFFICACY AND TOLERABILITY OF A PENILE-EXTENDER DEVICEGONTEROet al. A pilot phase-II prospective study to test the BJUI BJU INTERNATIONAL ‘efficacy’ and tolerability of a penile-extender device in the treatment of ‘short penis’ 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 size of >0.8. Eligible patients were counselled were consistent with acceptable to good Study Type – Therapy (case series) how to use the penile extender for at least improvement in all items, except for penile Level of Evidence 4 4 h/day for 6 months. Penile dimensions girth, where the score was either ‘no change’ were measured at baseline and after 1, 3, 6 or ‘mild improvement’. OBJECTIVE and 12 months (end of study). The erectile function (EF) domain of the International CONCLUSIONS To assess a commonly marketed brand Index of EF was administered at baseline of penile extender, the Andro-Penis® and at the end of the study. Treatment Penile extenders should be regarded as a (Andromedical, Madrid, Spain), widely used satisfaction was assessed using an minimally invasive and effective treatment devices which aim to increase penile size, in institutional unvalidated five-item option to elongate the penile shaft in a phase II single-arm study powered to questionnaire. patients seeking treatment for a short penis. detect significant changes in penile size, as despite their widespread use, there is little RESULTS KEYWORDS scientific evidence to support their potential clinical utility in the treatment of patients After 6 months the mean gain in length was penile extender, penile dysmorphophobia, with inadequate penile dimensions. significant, meeting the goals of the effect penile size, short penis size, at 2.3 and 1.7 cm for the flaccid and PATIENTS AND METHODS stretched penis, respectively. No significant changes in penile girth were detected. The EF Fifteen patients were required to test the domain scores improved significantly at the efficacy of the device, assuming an effect end of study. Treatment satisfaction scores INTRODUCTION with the aim of elongating the shaft or in the treatment of patients complaining of enlarging the penile girth [2,6] but at present inadequate penile size [9,10]. In the present In recent years penile size has become a the drawbacks of these techniques are a lack study we assessed a commonly marketed matter of great debate, with an increasing of standardization, the potential risk of penile extender in a phase II single-arm study number of patients seeking urological advice complications [7], and a high rate of patient that was powered to detect significant for a so-called ‘short penis’. In a clinical dissatisfaction [8]. Given these premises, changes in penile size. setting, the definition of ‘short penis’ is more methods to increase penile dimensions which often attributed to a condition termed ‘penile are less invasive than surgery would be dysmorphophobia’, i.e. the perception of preferable. PATIENTS AND METHODS inadequacy of the penis even though the true dimensions of the organ fall within the It has been claimed that the penile extender, a Patients complaining of ‘small penis’ and normal range [1,2]. A ‘clinically relevant’ nonsurgical device that used progressive highly motivated to receive effective short penis, definable as any length of <4 cm mechanical traction to the penis, produces a treatment were considered eligible for the for the flaccid penis and <7 cm for the significant improvement in penile length and study. Patients seeking exclusively an stretched penis [3,4], is quite unusual in men circumference, both in the flaccid and the augmentation of circumference were seeking medical treatment for inadequate erect state. Little scientific evidence and no excluded. For study entry, psychosexual penile size [5]. Several augmentation peer-reviewed clinical study supports the counselling was required to select those for phalloplasty procedures have been proposed potential clinical utility of the penile extender whom the treatment was deemed beneficial © 2008 THE AUTHORS JOURNAL COMPILATION © 2 0 0 8 B J U I N T E R N A T I O N A L | 1 0 3 , 7 9 3 – 7 9 7 | doi:10.1111/j.1464-410X.2008.08083.x 793
  2. 2. G O N T E R O ET AL.from a psychological perspective. A history of device consists of a plastic ring, where the TABLE 1 The baseline characteristics of the 21major psychiatric disorder, anatomical penile penis is introduced, with two dynamic patientsdeformity or reduced manual dexterity that metallic rods which produce the traction. Inmight prevent the correct use of the device the superior part there is a plastic support Variable Mean (SD) or n (%)were exclusion criteria. Penile shortening after where a silicone band holds the glans in place. Age, years 45.7 (11.1)corporoplasty for curvature of the shaft was Detailed instructions on how to increase the Penile dimensions, cman inclusion criterion, provided ≥6 months traction force from 600 g during the first Flaccid 7.15 (1.43)had elapsed since surgery, with no residual month, 900 g during the second, up to 1200 g Stretched 9.62 (1.56)curvature. A hypoplastic penis was defined as during the fifth and sixth months, were Circumference 10.4 (1.34)any flaccid and stretched length of ≤4 and provided, following the manufacturer’s Aetiology of short penis7 cm, respectively, the lower threshold of instructions. Dysmorphophobic 12 (57)the normal reference value [3]. Any size After penile surgery 8 (38)above these led to the definition of penile Patients were requested to wear the device Hypoplastic penis 1 (5)dysmorphophobia, a condition where preferably for 6 h (and at least 4 h) daily, and IIEF EF domain scorea patient with a normal-sized penis is for an optimum duration of 6 months, Normal (26–30) 9 (43)dissatisfied with its dimensions in the flaccid according to the manufacturer’s suggestions Mild ED (17–25) 9 (43)and/or erect state [1]. [12]. Patients were asked to sign an informed Moderate ED (11–16) 1 (5) consent before study entry. They were told Severe ED (1–10) 2 (10)Changes in flaccid and stretched penile length that, according to the scant published dataand circumference over baseline after available [9,10], the use of the penile stretcher6 months of treatment and durability of the following the suggested protocol mightresponse after 1 year, i.e. after an additional elongate the shaft by at least as much as6 months without treatment, were considered surgery, and that a gain in circumference, of RESULTSthe primary study endpoint. Treatment lower magnitude, was also to be expected. Ittolerability, patient compliance and was further specified that the treatment was Of 30 patients referred with a complaint ofsatisfaction, and changes in the International safe but that any adverse reaction must be ‘short penis’ between March 2005 and AprilIndex of Erectile Function (IIEF) EF domain immediately reported to the investigators. The 2006, 21 were eligible and entered the study.scores after 12 months constituted secondary devices were provided free of charge to Reasons for exclusion from the protocol wereendpoints. patients by the Andromedical. The protocol refusal of the patient to comply with the was granted institutional Ethical Committee proposed treatment (five) and ineligibilityThe baseline patient assessment included a Approval in January 2005. resulting during psychosexual counsellingfull medical and sexual history, physical (four). The baseline characteristics of theexamination and psychosexual counselling. Follow-up visits were scheduled at 1 (t1), 3 (t3), sample for age, aetiology of the disease, EFThe EF domain of the IIEF was scored at 6 (t6) and 12 months (t12) (end of study, after a domain of the IIEF and penile measurementsbaseline and at the end of the study (after ‘wash-out’ period of 6 months) to record are listed in Table 1. Only one patient could be12 months). Patients scoring abnormal side-effects, treatment compliance and carry categorized as having a hypoplastic penis.values (IIEF EF <25) [11] were offered a out a genital examination and penile None of the patients scoring abnormal IIEF EFdiagnostic evaluation, including sexual measurements. At the end of the study the EF domain values (12/21) agreed to undergohormone profile and appropriate treatment IIEF and an unvalidated satisfaction specific assessments, as they related theirwhere needed. Penile measurements before questionnaire were completed. The latter sexual dysfunction to the inadequate peniletreatment (t0) were obtained by two consisted of a set of five questions designed size. Four patients discontinued treatment,physicians using the standard technique by the investigators asking about subjective three at 3 months (one for achievingvalidated by Wessells et al. [4]. Using a tape improvements in flaccid penile length (Q1), satisfactory results, one for lack of efficacyruler to the nearest 0.5 cm, the penis was erect penile length (Q2), circumference (Q3), and one for inability to comply with theinitially measured in the flaccid state and overall penile size (Q4) on a 0–3 scale (0, protocol), and one at 1 month for side-effectsthen while applying tension to maximally worsening; 3, significant improvement) and (pain and penile bruising). One patient did notstretch it, from the pubopenile skin junction sexual life (Q5) on a 0–4 scale (0, no result; 4, attend the visit after 6 months and was lost toto the meatus. The circumference was optimal result). follow up. All patients were included in themeasured at the mid-shaft. Inter-operator intention-to-treat analysis, but only the 16agreement was assessed by making a set of Given the objective difficulty of estimating completing the 6-month treatment periodmeasurements on a small sample of eight the SD of baseline penile measurements in a were evaluable for the primary endpoint. Theyoung volunteers; the individual variability series of patients with presumed ‘short penis’, median time of daily use of the device was 5 hwas always <0.5 cm. the sample size was based on the ‘effect size’ at 1 month, 5 h at 3 months and 4 h at method [13]. Thus 15 evaluable patients were 6 months, respectively (chi-square, P = 0.104).Patients were instructed in the use of required for the study to have 80% statisticalthe penile extender, the Andro-Penis® power of detecting an ‘important’ change Figure 1a,b shows the changes after 6 months(Andromedical, Madrid, Spain), a device in penile dimensions (defined by an effect in the flaccid and stretched penile length,designed to exert a continuous and gradually size = 0.8), with an α error of <5% (two-sided respectively. At the end of treatmentincreasing traction force on the penis. The Wilcoxon test). (6 months), there was a significant overall © 2008 THE AUTHORS794 JOURNAL COMPILATION © 2008 BJU INTERNATIONAL
  3. 3. EFFICACY AND TOLERABILITY OF A PENILE-EXTENDER DEVICEFIG. 1. Box plots showing changes over baseline at 6 a penile extender, and suggests that the results TABLE 2 Mean changes in stretched and flaccidmonths in (a) flaccid penile length; (b) stretched are maintained after an additional 6 months penile length and circumference at differentpenile length; and (c) in penile circumference. with no treatment. The magnitude of the intervals (t0, baseline, t1, 1 month of treatment; elongating effect (1.7 and 2.3 cm for the a Flaccid Penis t3, 3 months; t6, 6 months; t12, 12 months) and stretched and the flaccid length, respectively) corresponding 95% CI was less than the 3.3 cm gain in erect state14 achieved in a market study [12], where the Interval Mean (95% CI) change, cm Andropenis was prescribed for 10 h daily for12 Stretched penis 6 months, but was still impressive when t0–t1 0.94 (0.62–1.26) compared with the modest results of penile-10 t1–t3 0.44 (0.05–0.82) lengthening surgery. In a recent prospective t3–t6 0.38 (0.02–0.73) 8 study [2] the mean gain was 1.6 cm in penile t6–t12 0.06 (−0.10–0.23 length, documented in 11 patients receiving Flaccid penis 6 the standard Z-plasty suprapubic skin incision, t0–t1 1.13 (0.72–0.53) together with suprapubic lipectomy and 4 t1–t3 0.71 (0.42–1.00) incision of the suspensory ligament of the t3–t6 0.41 (0.14–0.69) basal 6 months penis. In another series of 42 patients operated t6–t12 −0.09 (−0.24–0.05) with the same technique, mean increases in b Stretched Penis Circumference penile length of 1.1 (1.2) cm were not t0–t1 0.13 (0.01–0.24) statistically significant [8]. Moderately better14 t1–t3 0.16 (0–0.32) elongating effects of 2–3 cm have been t3–t6 −0.09 (−0.24–0.05) reported with an experimental technique that12 t6–t12 0.0 (−) involves a major surgical approach, with penile disassembly and the interposition of rib10 cartilage between the glans and the corpora 8 statistically significant (P = 0.034), were cavernosa [14]. The notable risk of morbidity negligible (+ 0.03 cm) (Fig. 1c; Table 2). There with all the above procedures needs to be 6 were no significant changes in any of the added to the conflicting results of surgery. penile measurements after the 6-month off- Wessells et al. [7] reported 12 cases of major 4 treatment period (t6–t12). complications, including wound infections, basal 6 months scar deformities and sexual dysfunction, that IIEF EF domain scores improved from a mean were referred at their centre over a 1-year c Circumference baseline value of 19.9 (8.77) to 27.1 (1.4) at period. They concluded that the lack of well- 12 months (Wilcoxon Z-test, P = 0.007). designed, prospective trials should lead14 Specifically, after the 6-month period off- clinicians to regard penile-lengthening12 treatment, the IIEF EF domain scores procedures as still experimental. The normalized in five of six patients with mild application of a penile extender in the current10 erectile dysfunction (ED) at baseline, in one study caused only minimal and self-resolving with moderate ED at baseline and in both men side-effects, leading to discontinuation of 8 with severe ED at baseline, and it was treatment in only one patient. This favourable unchanged in one of six with mild ED. None of safety profile further supports its use as a 6 the nine patients with normal EF before feasible conservative and hence first-line treatment had abnormal IIEF EF domain treatment option in men seeking penile 4 values at 1 year. lengthening. This statement is particularly true basal 6 months when considering that the vast majority of The mean patient satisfaction scores, patients complaining of ‘short penis’ have a measured using the five-item questionnaire, penile size falling within the normal referencemean gain in length of 2.3 cm and of 1.7 cm are reported in Table 3. The treatment was values [5], making the role of treatment morefor the flaccid and stretched (Wilcoxon Z-test, generally well tolerated; one case of penile a cosmetic issue than a functional goal. In theboth P < 0.001) penile length, respectively. bruising and one of temporary penile present series all but one of the eligibleThe changes which occurred across all discoloration changes were recorded, while patients had normal penile dimensionsintervals for the whole group are reported in one patient withdrew from the study because according to the definition of Wessells et al.Table 2. The gain in length was maximal at of pain. [4], and the American Guidelines stronglyt0–t1 and slowed in t1–t3 and t3–t6. The mean discourage the use of surgery for such cases(SD) gains in flaccid and stretched penile [4]. Based on previous experience, the penilelength were 2.05 (1.32) and 1.30 (0.75) cm in DISCUSSION extender provokes a linear and time-dysmorphophobic and 2.58 (1.02) and 2.50 dependent gain in length of ≈0.5 cm per(0.89) cm in penises shortened by surgery. The present study shows effective elongation month, according to the manufacturer’s leafletChanges in penile girth at 6 months, albeit of the penis after 6 months of treatment with [12]. By contrast, we documented a maximum© 2008 THE AUTHORSJOURNAL COMPILATION © 2008 BJU INTERNATIONAL 795
  4. 4. G O N T E R O ET AL. 2 Spyropoulos E, Christoforidis C, TABLE 3 The mean scores of the satisfaction questionnaire administered after 12 months (17 patients) Borousas D, Mavrikos S, Bourounis M, Athanasiadis S. Augmentation Question Mean (SD, range) score phalloplasty surgery for penile After treatment, how would you rate your: dysmorphophobia in young adults: Q1: flaccid penile length? 2.31 (1.2, 0–3) considerations regarding patient Q2: penile length during erection? 2.37 (1.2, 0–3) selection, outcome evaluation and Q3: penile girth? 1.1 (0.4, 0–3) techniques applied. Eur Urol 2005; 48: Q4: your sexual life? 2.3 (0.94, 0–3) 121–7 Q5: overall result achieved? 2.8 (1.5, 0–4) 3 Ponchietti R, Mondaini N, Bonafè M, Di Loro F, Biscioni S, Masieri L. Penile Scores are rated as described in Patients and methods. length and circumference. A study on 3300 young Italian men. Eur Urol 2001; 39: 183–6 4 Wessells H, Lue TF, McAnich JW. Penileelongating effect after the first month that satisfaction detected by the IIEF length in the flaccid and erect states:progressively decreased in the subsequent questionnaire. In the absence of validated guidelines for penile augmentation. J Urolintervals. It is possible that the shorter daily instruments to assess the patient’s perception 1996; 156: 995use of the device in the present study of the efficacy of the device, we designed a 5 Mondaini N, Ponchietti R, Gonterocompared with other studies [12] might specific five-item questionnaire. The mean P et al. Penile length is normal in mostexplain these discrepancies. Notably, the mean reported scores were consistent with mild to men seeking penile lengtheningtime of daily use of the device in the present good improvement in all items except for procedures. Int J Impot Res 2002; 14:study tended to be close to the minimum penile girth, where the score was consistent 283–6required for study entry. It is likely that the with no changes. Our assessment of patient 6 Shaeer O, Shaeer K, el-Sebaie A.prescription of longer daily use would greatly satisfaction is limited by the absence of a Minimizing the losses in penilereduce patients’ compliance to the treatment. comparative analysis before and after lengthening: ‘V-Y half-skin half-fatThe gain in length was maintained after treatment, and lack of validation. advancement flap’ and ‘T-closure’6 months off-treatment, suggesting that the Notwithstanding these limitations, the combined with severing the suspensorytraction forces do indeed produce a permanent questionnaire used suggests a favourable ligament. J Sex Med 2006; 3: 155–elongating effect. The possibility of an acceptance of the device on the part of the 60effective elongation of body structures after patients, which is in stark contrast with the 7 Wessels H, Lue TF, McAninch JW.applying prolonged and progressive tension high dissatisfaction rates reported by patients Complications of penile lengtheningforces holds its rationale both in anecdotal who have had surgery [1,8]. and augmentation seen at 1 referralphotographs of the Polynesian technique of center. J Urol 1996; 155: 1617–elongating the penis using a heavy tube [15], In conclusion, the penile extender device 20and in the well-documented generation of provides an acceptable, minimally invasive 8 Li C-Y, Christopher N, Minhas S,new tissue after applying skin expanders in method that can produce an effective and Ralph D. The role of surgery for penileplastic surgery [16]. It is less clear why the durable lengthening of the penis, both in the dysmorphophobia. J Sex Med 2005; 2device should also be effective in increasing flaccid and in the stretched state. There were (Suppl. 1): MP-2–1penile girth, as suggested by the 0.6–1 cm/ no measurable changes in penile girth. If 9 Colpi GM, Martini P, Scroppo FI,month gain in circumference in the these results are confirmed, use of the device Mancini M, Castiglioni F. Efficacymanufacturer’s study [12]. In the present study should be proposed as a first-line treatment of the daily penis-stretching techniquewe failed to detect clinically relevant changes option for patients seeking a penile to elongate the ‘small penis’. Int J Imp Resin penile circumference and this was lengthening procedure. 2001; 13 (Suppl. 4): 47confirmed by the patients themselves, who 10 Moncada I, Jara J, Martinez-Salamancareported their penile girth as unchanged after JI, Cabello R, Herenandez C.treatment. The device is therefore not CONFLICT OF INTEREST Management of penile shorteningappropriate for patients requesting exclusively after Peyronie’s disease surgery. J Sex Medan increase in the girth of their penis. None declared. 2005; 2 (Suppl. 1): MP 2–5 11 Cappellieri JC. Diagnostic evaluation ofA notable finding of the current study was the the erectile function domain of thesignificant improvement in the IIEF EF domain REFERENCES International Index of Erectile Function.score after treatment, by contrast with the Urology 1999; 54: 346potential risk of ED inherent in any additive 1 Austoni E, Guarneri A, Cazzaniga A. 12 Gomez EA. Penile enlargement withoutpenile surgery [7]. As any change in the A new technique for augmentation surgery with the Andro-Penis®.stretched penile length can be translated to phalloplasty: albugineal surgery with Hispanoamerican Sexual Educationthe penis in the erect state [7], it is likely that bilateral saphenous grafts – three years Congress, 2001the increased penile size might account for of experience. Eur Urol 2002; 42: 245– 13 Cohen J. Statistical Power Analysis forthe improved sexual performance and/or 53 the Behavioural Sciences, 2nd edn. © 2008 THE AUTHORS796 JOURNAL COMPILATION © 2008 BJU INTERNATIONAL
  5. 5. EFFICACY AND TOLERABILITY OF A PENILE-EXTENDER DEVICE Hillsdale: Lawrence Earlbaum Associates, 16 Hudson DA. Other ways to use tissue Chirurgiche, University of Turin, Urologia 1, 1988 expanded flaps. Br J Plast Surg 2004; 57: San Giovanni Battista Hospital, C.so Dogliotti,14 Perovic SV, Djordjevic ML. Penile 336–41 14, Torino, Italy. lengthening. BJU Int 2000; 86: 1028–33 e-mail: paolo.gontero@unito.it15 Griffin G. Penis Enlargement Methods – Correspondence: Paolo Gontero, Senior Facts and Phallusy. Palm Springs: Added Lecturer and Consultant Urologist, Abbreviations: IIEF, International Index of Dimension, 1993 Dipartimento di Discipline Medico Erectile Function; ED, erectile dysfunction.© 2008 THE AUTHORSJOURNAL COMPILATION © 2008 BJU INTERNATIONAL 797

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