Frequently Asked Questions
Use of RestoreX with Xiaflex is a discussion you should have with your physician. Mayo Clinic completed a clinical trial with RestoreX and Xiaflex to determine if RestoreX would be helpful in reducing the curvature associated with Peyronie's disease. The study demonstrated that with the use of RestoreX, the average reduction in curvature of approximately 20º using Xiaflex alone increased to 34º when using RestoreX during the cycles of Xiaflex injections.
Please note: Xiaflex is a registered trademark of Endopharmaceuticals
At the current time, insurance companies and Medicare do not have specific coverage for the RestoreX penile traction therapy device. Depending on your plan, however, you may qualify for coverage. Many men are receiving partial coverage for the RestoreX device. You can either call your insurance company in advance of ordering to determine your coverage level or you can submit a claim after you purchase RestoreX. We recommend you submit a prescription from your Doctor as well as a letter from him/her stating why you need the RestoreX device. Finally, you should submit your invoice or order confirmation email as proof of payment.
If you have a Flexible Spending Account (FSA) or Health Savings Account (HSA) you can use funds from either of these accounts to cover the cost of RestoreX. It may not be necessary for your plan but we recommend getting a physician prescription to submit to your FSA or HSA.
No, you can order on-line. RestoreX is an over-the-counter device for at-home use.
We do accept PayPal as a form of payment for RestoreX. You can apply through PayPal Credit to receive a credit line for the full amount with no-interest for purchases over $99.00. If approved, the balance does need to be paid in full in 6 months. Interest will be charged to your account from the purchase date if the balance is not paid in full within 6 months. Minimum monthly payments required. See PayPal.com to learn more.
No. There is no benefit to using the device for more than 1 hour daily. This is confirmed by preliminary findings from a clinical trial being performed at Mayo Clinic using the RestoreX device in men with PD.
Maybe. In the clinical trial performed at Mayo Clinic, men who used the device for 12 additional weeks (24 in total) experienced some additional improvement in regaining lost length. The preliminary data is only suggestive and not a definitive recommendation.
A clinical study is ongoing at the Mayo Clinic to help address this question, with data anticipated near the end of 2019. To maintain results, we suggest using RestoreX 1-2 times per week.
Many physicians believe a traction therapy device like RestoreX can treat congenital deformities. PathRight Medical, however, cannot recommend the use of RestoreX since no clinical study has been performed for use in this group of patients. We recommend contacting your physician to discuss the benefits of traction therapy for this indication.
Yes, the RestoreX device can be used by uncircumcised men. To use, retract the foreskin and use some of the provided self-adherent wraps to keep the skin retracted during use.
RestoreX utilizes several unique and patented technologies which improve the effectiveness of the traction therapy. These changes overcome many of the limitations of other devices and provide for continuous and targeted traction at safe and effective levels. The RestoreX “traction zone” provides user feedback to tell if therapeutic levels of traction are being delivered. If the white bands appear during use, the user can easily advance the device without removing it to stay within the acceptable treatment “zone.” In addition, RestoreX utilizes a patented, opposite angular force to provide targeted traction to the disease site. The counter-bending force is delivered during the second half of the treatment time. Clinical trial results have confirmed the importance of this counter-bending force in achieving improvements in curvature. Finally, RestoreX has a proprietary pelvic ring and penile clamp that disperse forces over a broader area. This is important because it allows the user to apply traction forces comfortably and without injury.
RestoreX is the only device that has been clinically tested and proven using a randomized, controlled study design. Similarly, the clinical studies with RestoreX have shown the above improvements in men using the device for 30-90 minutes daily for 12 weeks. No other traction devices have shown similar improvements with such short treatment times.
The concepts behind RestoreX were developed by a Mayo Clinic Urologist specializing in Peyronie’s disease and RestoreX was designed and is manufactured in the United States. Customer service is also based in the United States. Repairs and warranty services are processed at our offices in Minnesota.
RestoreX is shipped in discreet packaging with no specific branding. The return address on the UPS label reads, “Shipping Department, PathRight Medical, Inc.”
PathRight Medical is currently seeking a CE mark for the RestoreX device. Until this is obtained, PathRight Medical is unable to ship to European nations. RestoreX is currently only available in the US and Canada.
Flaccid. RestoreX treatment is to be delivered when the penis is flaccid. The measurements used in determining the settings for RestoreX may, in part, be derived by what your penis looks like during an erection but the treatment itself is applied to a flaccid penis.
In our clinical trial, we asked patients if they had an indentation or houglassing. Of those reporting “yes”, 52% indicated their indentation or hourglassing improved after 12 weeks of treatment. Furthermore, they characterized the change as either significant (7%), moderate (50%), or minimal (43%). Measuring changes in indentation our hourglassing is very difficult so the trial relied on subjective reporting from the patient. While we hope this information is helpful it should be noted that not all men have the same definition of significant, moderate or minimal.
Of men whose 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 degrees 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.
Although relatively few men in the study had pure side or down curvatures, no differences in outcomes were noticed between different directions in curvature.