Abstract
Abstract Introduction Various therapies have been utilized to increase penile length and girth, with some exhibiting significant adverse event profiles, including fillers, fat transfers, suspensory ligament ligation, and silicon augmentation. Our team sought to evaluate a novel combination therapy to enhance penile characteristics using platelet-rich plasma (PRP) as a source of autologous growth factors, penile traction for lengthening, a vacuum erection device for girth enhancement, and nitric oxide precursor supplements to augment penile vascular smooth muscle function. Objective To evaluate the safety and efficacy of combination therapy with PRP, traction, vacuum device, and nitric oxide boosting nutritional supplements to increase penile length, girth, and function in healthy men. Methods A prospective, non-randomized study was designed (NCT04231422) to evaluate the efficacy of combination therapy in healthy men aged 20-55 with baseline normal erectile function and no penile pathology. Penile length and girth measurements were obtained using at-home photography of an erect penis with maximal tumescence. Measurements were obtained at baseline and at monthly intervals x 6 months. PRP (a modified P-Shot ® Procedure) was administered in the right and left corpora under ultrasound guidance once a month for six months using PureSpin double spin system (60cc blood drawn). Centrifuge technical data show an average platelet recovery of 84% and an average concentration of 6.6 times that of the whole blood sample. Using this data, the injection of 10cc of PRP, assuming a starting platelet count of 250K/microliter, would contain approximately 1.65 billion platelets. Subjective erectile function was assessed with a 5 point Likert Scale. RestoreX traction device was utilized for 20 minutes, twice daily, and a Dr Joel Kaplan vacuum erection device was applied with 5-10 mmHg pressure x 12 minutes (1 min x 2, 5 min x 2). Oral nitric oxide boosting supplementation was with AFFIRM, consisting of 3 gm L-Citrulline and 1 gm beet extract. Results A total of 32 men have been enrolled, with 16 having complete data available for review. The 6-month mean increase in the size of the erect penis was 0.85 inches in length (95% CI: 0.75 to 0.94, p-value < 0.01) (range 0.5-1.44) with a linear increase in size. The 6-month mean increase in circumference was 0.47 inches (95% CI: 0.37 to 0.57, p-value <0.01) (range 0.2-0.75). Mean age was 32 and mean baseline erect penile length was 5.70 and girth was 5.25. All 16 participants reported better penile rigidity with erections. No adverse events were reported. Conclusions Results from a pilot study using a novel combination therapy (P-Long Protocol) in healthy men demonstrated increases in penile length, girth, and subjective rigidity improvement compared to baseline with no adverse effects. External validation is warranted. The P-Long Protocol does not require any synthetic injectables or foreign bodies. It does not preclude additional augmentation procedures. The slope of the growth curve indicates possible continued growth with additional treatments. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: BTL Inc.
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