FastSize Medical Extender for the treatment of Peyronie's disease.
This paper reports on the scientific principles, treatment protocol and initial trial results of the FastSize Medical Extender, a new medical device developed for the treatment of Peyronie's disease and phalloplasty utilizing controlled periodic stretching of the penis; other uses of the device are also mentioned. Initial Institutional Review Boards monitored clinical trials of the device indicate that significant (10-45 degrees ) improvement in curvatures are achievable and that larger scale trials are therefore justified. The device appears to meet a previously unmet need within the population of Peyronie's disease sufferers for a noninvasive, nonsurgical first-option treatment modality. The device works by holding the penis in a cradle and subjecting it to gentle stretching, the tension being provided by small metal extensions that are added to the cradle frame to provide traction against internal springs. Patient education is minimal for the device, but patient compliance with the extended daily treatment procedure is critical for significant curvature change. While a review of appropriate reimbursement codes has not been conducted, the pricing of the device makes it easily affordable. Although it has not yet been formally studied, the device also appears to have applications beyond Peyronie's disease; such as offering potential for offsetting penile shortening prior to implant surgery, preventing shortening following PD penile reconstruction and after radical prostatectomy where loss of penile length is commonly reported. The recent trial noted that, over a 6-month period, patients reported increases in penile length of 1-2.0 cm, with an accompanying increase in girth. There are no alternative devices available that have proven efficacy as a result of a clinical trial and, given reproducible results, the device will begin to play an important role in treatments that require penile tissue remodeling. Future developments should include larger scale, multicenter trials aimed at reproducing the results of the initial study on Peyronie's disease, also trials in conjunction with pharmacological treatment involving plaque remodeling agents such as verapamil and interferon, and trials that will investigate the possible benefits of the device for penile enlargement that may help pre- and postsurgical candidates for penile implants and penile reconstruction following prostatectomy.
Levine
Laurence A
LA
Rush University Medical Center, 1725 W Harrison Street, Chicago, IL 60612, USA. drlevine@hotmail.com
Newell
Mark M
MM
D004864:Equipment and Supplies / Q000191:economics; D006801:Humans; D008297:Male; D010349:Patient Compliance; D010353:Patient Education as Topic; D010411:Penile Induration / Q000628:therapy*; D011358:Product Surveillance, Postmarketing