Use of restorex penile traction therapy for treatment of penile length loss in diabetic men

INTRODUCTION AND OBJECTIVE: Penile length loss and erectile dysfunction (ED) are common complaints among men with diabetes mellitus (DM), with some data suggesting a mean 1 cm loss. Recently, a randomized controlled trial evaluating the efficacy of a novel penile traction device, RestoreX (PTTRx), demonstrated significant improvements in penile length and erectile function in men with Peyronie's Disease. Given these findings, we sought to determine the efficacy of RestoreX in improving penile length and erectile function in DM men. METHODS: A randomized, controlled trial (NCT18006696) is ongoing to evaluate the impact of PTT with RestoreX in 100 men with DM. Men are randomized to one of four groupings for 6 months: Group 1 ‐ no therapy (control); Group 2 ‐ Restorex for 30 minutes 2x/day x 3 months, followed by no use x 3 months; Group 3 ‐ Restorex for 30 minutes 2x/day x 3 months, followed by once weekly x 30 minutes x 3 months; Group 4 ‐ Restorex for 30 minutes 2x/day x 6 months. Assessments of stretched penile length, erectile function, and standardized and non‐standardized questionnaires are administered at each visit to evaluate sexual function. RESULTS: A total of 88 men (mean age 54.9) have been enrolled to date, with 3‐month data available on 56 (control=17, traction=39). Mean duration of DM was 10.7 years (HbA1c 7.1), with men taking a median of 2 medications (33% on insulin). Seventy‐four percent of men had ED (median duration 3 years), while 84% reported penile shortening (mean 4.1 cm). Baseline International Index of Erectile Function Erectile Function Domain (IIEF‐EFD) scores were 19 (median), and baseline penile length to corona and tip were 13 cm and 16 cm, respectively. Following 3‐months of treatment, PTT men demonstrated a 0.9 cm greater improvement in penile length compared to controls (p<0.01), with 79% of PTT men experiencing length gains. Among men with baseline ED, PTT resulted in a 5 point IIEF‐EFD improvement vs 0.3 in controls (p<0.05). The Intercourse Satisfaction Domain demonstrated nonstatistically significant improvements (+1.75 vs ‐0.7, p=0.12), while the Overall Satisfaction Domain was significantly improved (+1.8 vs ‐0.5, p<0.01). There were no significant or long‐term adverse events associated with device use. CONCLUSIONS: Based on preliminary data, PTT with RestoreX results in statistically significant objective and subjective improvements in penile length, erectile function, and overall sexual satisfaction in men with DM. RestoreX therefore represents a viable treatment option for this common but difficult to treat problem.