The RestoreX™ is the subject of a patent validating the exclusivity of the dual traction force technology. It is manufactured in the USA by PathRight Medical, based in Orem, Utah.
The RestoreX™ was invented by Dr. Landon TROST, an American Urologist specializing in Lapeyronie's disease and author of multiple studies and clinical recommendations concerning this pathology. He has no professional or financial ties with PathRight Medical, and his clinical publications concerning Lapeyronie's disease or the RestoreX™ have all been carried out in accordance with the ethical and scientific procedures defined by the AUA (American Urology Association).
The axial traction force is between 2.5 and 3 Kg and that on the counter-curvature between 4.5 and 5 Kg. The power of these 2 tractions is the main reason for the RestoreX™'s effectiveness and has no equivalent among other traction-therapy devices. To ensure that the penis does not escape when traction is applied, the glans is clamped onto a very wide base allowing it to be firmly secured and, to avoid pain, the pressure to be distributed over a large contact area.
The RestoreX™ is effective for correcting penile curvature but also for treating hourglass yards.
The RestoreX™ is, apart from surgery, the only treatment to have shown tangible results concerning recovery of penile length 1b, 2b.
The RestoreX™ benefits from CE marking, which classifies it as a genuine Medical Device.
M.J. Ziegelmann & al - 2019: Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial
110 patients, mean age 58 years, Lapeyronie anteriority: 49 months, mean curvature 59.3 degrees.
4 groups: 1 control group (number = 27) and 3 other RestoreX ™ groups with daily sessions of use: group 1 (number =28) → 30 min session, group 2 (number =28) → 60 min session, group 3 (number =27) → 90 min session. RestoreX use time divided equally (50/50) into axial traction and counter-curvature.
A. Results at 3 months, average use 47mn/day
- Curvature reduction of 17.2°or 28% for 77% of patients who responded to treatment (control group
= +1.3°). - Recovery of penis length : +1.6cm or +11% for 94% of patients who responded to treatment
(control group = +0.3cm). - Improved erectile function according to IIEF score of 4.3 (control group = 0.7).
- 47% of patients were unable to have sexual intercourse : at the end of 12 weeks, 80% of these reported having penetrative sex.
- No adverse effects were noted.
- 100% of patients who had previously tried another traction-therapy device said they preferred the RestoreX™.
B. 2 additional phases of clinical study at 6 (n=64) and 9 (n=63) months follow-up, daily use
average 31 min/day
- 63% of patients reported improvements in curvature and length (+0.5cm).
- The International Index of Erectile Function (IIEF) questionnaire score was also increased.
- 84% of patients continued to use RestoreX™ after 9 months.
The average curvature observed in this study was 59.3°, which almost classifies this value as severe (> 60°). The average curvature reported in clinical studies is generally between 30° and 50°.
The average duration of Peyronie's disease is 49 months, which implies an exponential increase in the hardness of the fibrotic plaque over time, as well as a progressive retraction of the tunica albuginea.
These two very demanding criteria represent a real challenge for the RestoreX™.
23% of patients did not experience any improvement. We tried to understand why these patients did not respond, and the explanations are varied: some were not using the device correctly, others were not using it at all, and still others were probably doing everything right but were not getting any response. We don't know why this last group didn't respond.
The reduction in curvature at 3 months is 17.2°, or a 28% improvement, which represents considerable progress. Degrees are an absolute way to measure angulation, while percentages are a relative value that varies depending on the degree of curvature.
For example, if a person has a 100° curvature that is reduced by 40° with RestoreX™, they will see a 60° improvement, also a 60% improvement. However, if another person with a 40° curvature experiences a 20° improvement, as in the clinical study, they will recognize a 50% improvement compared to their original curvature.
