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Side Effects


1. Local side effects

Andropenis penis extender has no significant side-effects with a success rate of 97.5% if it is used as instructed. It is an effective and safe approach to maximize penile length in patients undergoing PD surgery [ claim 1 ]

In studies on patients using the Andro-penis for up to 9 hours per day for 6 months, local penile side effects have been reported as occasional and self resolving, rarely leading to discontinuation of treatment. These include mild penile bruising and penile skin reaction in the distal part of the shaft (site of application of the silicon band) and at base (site of application of the plastic ring).

In a recent series of 18 patients complaining of short penis [ claim 2 ] the treatment resulted generally well tolerated: one case of penile bruising and one of temporary penile dyscromic changes were recorded with only one patient withdrawing from the study because of pain. The authors concluded that the favourable safety profile supports the use of the Andropenis penile enhancement device use as a feasible, conservative and first-line treatment option in men seeking penile lengthening.

The excellent safety profile of Andropenis was further confirmed in patients with Peyronie's disease, where the device was tested with the primary aim to reduce penile curvature. Out of the 21 patients enrolled in a phase II study [ claim 3 ], only one discontinued treatment with the Andropenis after a few days due to discomfort caused by the device. There were no reported side effects in the remaining patients.

2. No side effects on sexual function

In a Chinese study, 30 males aged 16-40 years old, were involved with the aim to investigate the effects of a penis extensor (Andropenis) in order to lengthen the penis. None of the patients reported erectile dysfunction or urination dysfunction .The device has been demonstrated to be safe and free of adverse side effects [ claim 4 ].

In the study by Gontero et al [ claim 2 ] sexual function was assessed by administering the erectile function (EF) domain of the validated International Index of Erectile Function (IIEF) questionnaire [ claim 5 ] at baseline and at the end of the study (after 12 months). IIEF EF domain scores significantly improved from a mean baseline value of 19.9 (SD 8.77) to 27.1 (SD 1.4) at 12 months (Wilcoxon Z test: -2.677; p=.007). Specifically, after the 6-month post-treatment period, the IIEF EF domain scores normalized in 5 out of 6 patients with mild ED at baseline, in 1/1 with moderate ED at baseline and in 2/2 with severe ED at baseline and it was unchanged in 1/6 with mild ED. None of the 9 patients with normal pre-treatment erectile function scored abnormal IIEF EF domain values at 1 year. The favourable impact of the Andropenis on sexual function was further underlined by the post-treatment non-validated satisfaction questionnaire (table 1). Mean reported score for question 4 that asked: "How would you rate your sexual life?" was consistent with mild to significant improvement. The authors suggest that the improved sexual performance after the use of the Andropenis is likely to be due to the increased penile size.

When the Andropenis was assessed in Peyronie's disease patients [ claim 3 ], only slight improvements in sexual function were observed. EF domain scores of the IIEF increased from a mean baseline value of 23.8 (SD 4.07) to 24.7 (SD 4.11) at 12 months (p=0.23). The authors underlined that these findings corroborate the safety profile of the Andropenis as opposed to the detrimental effect of surgery on sexual function in Peyronie's disease.

Conclusion

Taking these points into consideration, we confirm that Andropenis has no negative side effects on sexual activity on a short or long-term basis. On the contrary, using Andropenis would transmit confidence to the patient, with the reassurance that his penis will grow and that the quality of his erection will also improve. [ claim 6 ] Consequently, his confidence and self-esteem will increase steadily, which, in turn, can enhance foreplay and improve positive expectations from sexual intercourse.

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References

1. MANAGEMENT OF PENILE SHORTENING AFTER PEYRONIE'S DISEASE SURGERY. Dr Moncada, Madrid (ES). 10th Congress of the European Society for Sexual Medicine (ESSM). Dr Moncada, 25 - 28 November, 2007. Lisboa Congress Center, Lisbon (Portugal).

2. 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, Massimiliano Di Marco, Gianluca Giubilei, Giovanni Pappagallo, Andrea Zitella, Alessandro Tizzani, Nicola Mondaini. BJU Int, in press.

3. PENILE EXTENDER DEVICE IN THE TREATMENT OF PENILE CURVATURE DUE TO PEYRONIE'S DISEASE - PHASE II PROSPECTIVE STUDY. Paolo Gontero, Massimiliano Di Marco, Gianluca Giubilei, Giovanni Pappagallo, Andrea Zitella, Alessandro Tizzani, Nicola Mondaini. J Sex Med, second revision submitted; Oral presentation at the ESSM Congress, Lisbon (Portugal) 2007.

4. EFFECTS ON PENILE SIZE WITH PENILE EXTENSOR BY TRACTION FORCE. (Report of 30 cases) Z Lee, XB Zhu, YD Liu, WJ Ye, YX Wang. Shanghai Institute of Andrology, Renji Hospital Affiliated to Medical. College, Shanghai Jiaotong University, Shanghai (China) 2001

5. Cappellieri JC: Diagnostic evaluation of the erectile function domain of the International Index of Erectile Function. Urology 1999; 54: 346.

6. PENIS ENLARGEMENT; PATIENT CLASSIFICATION BASED ON A PSYCHOLOGICAL STUDY. Fernando Molina-Campuzano, clinic psychologist, Madrid (Spain).

Mean scores of the satisfaction questionnaire following 6 months treatment with the Andropenis. The questionnaire was administered to 17 patients after 6 months wash out from treatment.

Question: after treatment... Mean score Min score Max score SD
How would you rate your flaccid penile length?* 2.31 0 3 1.2
How would you rate your penile length during erection?* 2.37 0 3 1.2
How would you rate your penile girth?* 1.1 0 3 0.4
How would you rate your sexual life?* 2.3 0 3 0.94
How would you rate the overall result achieved?** 2.8 0 4 1.5

Legend
* Scores:0=reduced, 1=unchanged, 2=mild improvement, 3=significant improvement
** Scores: 0=no result, 1=very mild, 2=acceptable, 3=good, 4=optimal

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CN 163175.6
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IT

Dr. Paolo Gontero

Urologist, Department of Urology, University of Piemonte Orientale, Novara, Italy.

BRITISH JOURNAL OF UROLOGY

A pilot phase-II prospective study to test the 'efficacy' and tolerability of a penile...
ES

Dr. Martinez-Salamanca

Urologist, Department of Urology, Puerta de Hierro University Hospital, Majadahonda, Madrid, Spain.

JOURNAL OF SEXUAL MEDICINE

Acute Phase Peyronie's Disease Management with Traction Device...