Clinical Results

RestoreX® for Lengthening, Post-Prostatectomy

Overall Study

The current study is a randomized, controlled trial of men who underwent prostatectomy. Men are randomized to either receive no treatment (control) or RestoreX for 5 months, beginning one month after prostatectomy. At 6-months following prostatectomy, men are allowed to freely use the device or do nothing for an additional 3 months. The data below are reporting outcomes at the 6-month time point (end of the randomization phase). The study is designed to enroll 70 men. Currently, 6-month results are available on a total of 33 men, with data presented below. These results were presented at the Western Section meeting of the AUA, November 2019.

Changes in Penile Length

Following prostatectomy, many men report decreases in penile length. Reduced penile length can be associated with worsened hygiene in these men (penile retraction with urinary leakage on surrounding skin) and is a common complaint in sexual medicine clinics. Results from the current study demonstrate significantly longer penile lengths in men who were treated with RestoreX compared to controls.

Chart - Control vs RestoreX - Centimeters

Figure demonstrates significantly longer penile lengths in men treated with RestoreX (p=0.001) compared to controls. The median change in length for controls was 0 cm compared to 2 cm with RestoreX.

Changes in Sexual Function

Following prostatectomy, men most often will experience a worsening of several aspects of sexual function. Results showed that men treated with RestoreX had maintained intercourse satisfaction compared to a 3.0 point loss in men who were controls. Currently, the data appear to be trending towards preserving erectile function (p=0.08) and overall satisfaction (p=0.03), however, these are not statistically significant with data available on only 33 patients at the present time.

Changes in sexual function - Erectile Function ( Control: -8, RestoreX -3.5 ), Intercourse Satisfaction ( Control: -3, RestoreX -0.5 ); measures change against baseline score where 0 equals no change and negative values indicates worsening.

Figure – Results from men who were treated with nothing (control) or RestoreX for 5 months following prostatectomy. Various sexual function domains are represented. Lower = worse outcomes.

Overall Satisfaction

79% of men, or approximately 4 out of 5, that were asked if they would choose to use RestoreX again if they were starting the process of recovering from surgery said “Yes.”  No men responded “no.”  Likewise, 83% of men using RestoreX to recover from surgery said the use of RestoreX was meaningful / worthwhile.

Would you choose to use RestoreX again? - 21% Unsure, 79% Yes
Was the therapy meaningful / worthwhile? - 17% No, 83% Yes