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 31 men, with data presented below.

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 5.5 point loss in men who were controls (p<0.01). Currently, the data appear to be trending towards preserving erectile function (p=0.07) and overall satisfaction (p=0.12), however, these are not statistically significant with data available on only 31 patients at the present time.

Changes in Sexual Function - Erectile Function ( Control -9, RestoreX -1 ), Orgasmic Function ( Control -6, RestoreX -5 ), Sexual Desire ( Control -1, RestoreX 0 ), Intercourse ( Control -5.5, RestoreX 0 ), Overall Satisfaction ( Control -3, RestoreX -1.5 )

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

Of men who were asked, “Overall, was the therapy meaningful for you” 82% responded yes.

Would you recommend this treatment to a friend who had to undergo a prostatectomy? 0% Discourage, 11% Indifferent, 11% Mildly Recommend, 29% Moderately Recommend, 39% Strongly Recommend
Overall, if you could start over, would you choose to use RestoreX after your prostatectomy? - 0% No, 22% Unsure, 6% Yes with some reservation, 72% Yes without reservation
Overall, was the therapy meaningful for you? - Control 0%, RestoreX 82%