RestoreX® for PD, 6 Month Data
The following data set represents results for those men having used RestoreX for 6 months. The first 3 months they used the device either 30, 60 or 90 minutes per day in 30-minute sessions. In the second 3 months they used any of the three time interval options.
The 6-month results are presented differently than the 3 months results. The 3 month clinical results shows the averages for those individuals that responded to RestoreX® treatments. This includes the 94% of men that had length improvement and the 77% of men that experience an improvement in curvature. The results of the 3 and 6 month clinical trial data shown below, are the averages of all men in the trial, even those that experienced no improvement.
Figure demonstrates results of various sexual function domains. All were statistically significantly improved when compared to baseline after treatment with RestoreX except for orgasmic function (improved, but not statistically significant). Data for the erectile function domain represent men who had erectile dysfunction at baseline.
Figure demonstrates results from various domains of the Peyronie’s Disease Questionnaire (PDQ). The questionnaire specifically looks at psychological, pain, and bother aspects of Peyronie’s Disease. Lower numbers represent a better result. All results are statistically significantly improved after treatment with RestoreX.
Of men who continued to use the device for 6-months, the average length increase was 2.0 cm, or approximately 15%. Note that the average daily use was less than 40 minutes. Also note that ongoing length improvements were achieved with additional use.
Among men who had used the device for 6-months, penile curvature continued to improve, although at a slower pace than the initial 3-months (p<0.0001). The average curvature improvement at 6-months was 15 degrees or 21%.
Hourglass, Indentations, or Other Deformities
Of those reporting an improvement in deformity:
What if my curvature is toward the base of the penis and isn’t able to be located under the fulcrum of the device?
Of men who’s curvature was 7 cm or further back from the tip of the penis (i.e. near the base of the penis), results showed an average of 13 degree curvature improvement, which was statistically significant compared to baseline and not statistically different compared to men who had curvatures more in the middle or end of the penis. This finding suggests that RestoreX may effectively be used in men with curvatures, regardless of where the curvature is located.
Was the device equally effective with all directions of curvature?
Although relatively few men in the study had pure side or down curvatures, no differences in outcomes were noticed between different curvature directions.