PURPOSE:RestoreX is a novel penile traction therapy device, with randomized, controlled data demonstrating improvements in penile length and erectile function after 30 to 90 minutes of daily use in men with Peyronie's disease. We sought to determine if similar improvements could be achieved post prostatectomy. MATERIALS AND METHODS:Men post prostatectomy were randomly assigned to control or one of 2 penile traction therapy protocols for 6 months, followed by a 3-month open-label phase. The current study presents data from the randomized phase. The primary outcome was changes in stretched penile length; secondary outcomes were changes in International Index of Erectile Function (IIEF) scores, adverse events, satisfaction and subjective measures. RESULTS: In all, 82 men (mean age 58.6 years) were randomized, with 6-month data available in 25 controls and 30 penile traction therapy cases. At 6 months, penile traction therapy achieved greater improvements/preservation of penile length (+1.6 vs +0.3 cm, p <0.01), erectile function (IIEF-Erectile Function +0 vs -6.5, p=0.03), intercourse satisfaction (IIEF-Intercourse Satisfaction +1 vs -3.5, p <0.01) and overall sexual satisfaction (IIEF-Overall Sexual Satisfaction 0 vs -3, p <0.01). Erectogenic therapy use was lower in penile traction therapy men (phosphodiesterase-5 inhibitors 86% vs 94%, p=0.44; intracavernosal injections 19% vs 50%, p <0.05). More penile traction therapy men reported satisfaction or improvement in penile length than controls. Adverse events were transient and mild; 87% would choose to repeat therapy, and 93% would recommend it to others. CONCLUSIONS: The use of a novel penile traction therapy device results in significant improvements in objective and subjective penile length post prostatectomy and measures of erectile function, intercourse satisfaction and overall sexual satisfaction. External validation is warranted.
RCT Entities:
PURPOSE: RestoreX is a novel penile traction therapy device, with randomized, controlled data demonstrating improvements in penile length and erectile function after 30 to 90 minutes of daily use in men with Peyronie's disease. We sought to determine if similar improvements could be achieved post prostatectomy. MATERIALS AND METHODS:Men post prostatectomy were randomly assigned to control or one of 2 penile traction therapy protocols for 6 months, followed by a 3-month open-label phase. The current study presents data from the randomized phase. The primary outcome was changes in stretched penile length; secondary outcomes were changes in International Index of Erectile Function (IIEF) scores, adverse events, satisfaction and subjective measures. RESULTS: In all, 82 men (mean age 58.6 years) were randomized, with 6-month data available in 25 controls and 30 penile traction therapy cases. At 6 months, penile traction therapy achieved greater improvements/preservation of penile length (+1.6 vs +0.3 cm, p <0.01), erectile function (IIEF-Erectile Function +0 vs -6.5, p=0.03), intercourse satisfaction (IIEF-Intercourse Satisfaction +1 vs -3.5, p <0.01) and overall sexual satisfaction (IIEF-Overall Sexual Satisfaction 0 vs -3, p <0.01). Erectogenic therapy use was lower in penile traction therapy men (phosphodiesterase-5 inhibitors 86% vs 94%, p=0.44; intracavernosal injections 19% vs 50%, p <0.05). More penile traction therapy men reported satisfaction or improvement in penile length than controls. Adverse events were transient and mild; 87% would choose to repeat therapy, and 93% would recommend it to others. CONCLUSIONS: The use of a novel penile traction therapy device results in significant improvements in objective and subjective penile length post prostatectomy and measures of erectile function, intercourse satisfaction and overall sexual satisfaction. External validation is warranted.