***Trost Commentary and Key Take-Home Points***
This study was one that we conducted soon after RestoreX became available. Our goal was to determine if the device resulted in any benefits or not in treating Peyronie’s Disease. My experience with traction devices to that point had not been very good. Specifically, we had previously performed a study where we evaluated whether traction resulted in any benefits in men undergoing Xiaflex injections. The results showed that regardless of the device used (Penimaster, Phallosan Forte, X4, Andropenis, etc.), there were no benefits, even among men who reported using it for >5 hours daily! Because of those findings, we decided to develop a new traction device which addressed many of the limitations of other devices (namely inability to provide consistent, forceful traction). Mayo Clinic is a wonderful place, and they basically have a group that will help you develop any type of medical device that you feel will help treat a particular disease. After we developed RestoreX, Mayo gave me the option of #1 Investing in the company which licensed the device (PathRight Medical), or #2 be able to perform clinical studies on the device. I chose the latter because I really wanted to see if it actually worked or not. We then set up 3 randomized, controlled trials, and this study reports outcomes of the latter half of the first of these studies.
With that background, this study basically is reporting outcomes of men once they entered the ‘open label’ phase of the study. During that phase, men from the treatment and control groups can choose to utilize RestoreX as much or as little as they would like. Overall results showed that those who continued to use it beyond 3 months experienced additional length improvements, but not many more curve improvements. While those who began using it for the first time experienced both length and curve improvements (similar to the results from the initial publication). None of the men experienced any long-term side effects with use, which was an important outcome of the study.
Introduction
Traction therapy is a process used in the treatment of various conditions, including Dupuytren’s contracture and Peyronie’s Disease, which have some relation to each other. Traction therapy uses mechano-transduction on the extracellular matrix, apoptosis and cell proliferation which aim to treat the fibrotic plaques that occur with Peyronie’s disease.
Various data have proven the efficacy of penile traction therapy (PTT) in the treatment of Peyronie’s disease. An issue faced by physicians and patients is the quality and ease of use of existing PTT devices, which have limited adjustability, they secure the penis in ways that can cause further complications and they only provide traction in one direction.
A novel PTT device (RestoreX) has been developed to combat these limitations and provide a better option which offers safer, faster and more efficacious treatment than existing devices. This study of the RestoreX device analyzes the safety and efficacy when used on men with Peyronie’s disease.
Materials and Methods
This study of 110 men was organized into three groups of patients: no therapy (control), RestoreX for 30 minutes for 1 time a day, 2 times a day or 3 times a day. Each arm of the study had 27-28 men. Patients were instructed in the use of the ResoreX device and keeping a diary of usage duration and extent of counter-bending. Baseline, 3 month, 6 month and 9 month levels of penile length, curvature, adverse events, International Index of Erectile Function (IIEF) score and Peyronie’s Disease Questionnaires (PDQ) were recorded.
The study cohort consisted of men with Peyronie’s disease who were 18 years or older with greater than 30 degree curvature. Men were only excluded if they had a penile length less than 7” and severe diabetes. The primary outcome of the study was to determine the safety of the RestoreX device and compare changes in curvature, length IIEF and PDQ scores, satisfaction, penetration ability and surgical need to other PTT devices.
Results
Demographics among each arm of the study were comparable with a mean Peyronie’s disease duration of 49.7 months, 40% with indentation, 39.9% with hourglass deformity, 60% with multiplanar curvature, 16% with calcification, 97% in the chronic phase and 67% with prior therapy for Peyronie’s disease. Only mild adverse events occurred and all were temporary, resolving quicky after discontinuation of treatment.
Compared to the control arm, men using PTT saw improvements in all outcomes with 77% having curvature improvement of a mean 17.2 degrees and 98% saw length improvements of a mean 1.6 cm. Additionally, patients in the treatments groups saw significant improvements in IIEF and PDQ scores, and reported increased erectile function, reduction in pain and improved ability to penetrate. Some men reported having previously used other devices (6 devices reported) and all of them preferred RestoreX. There was not a significant difference in improvements between the 3 treatment groups of 1x, 2x and 3x daily.
Discussion
Results of this study demonstrated the safety and efficacy of the RestoreX device for PTT in men with Peyronie’s disease. Comparable studies have shown a greater number of adverse events and more severe events, sometimes causing discontinuation while the current study of RestoreX showed all adverse events to be mild and none causing discontinuation of treatment. Improvements in penile length, curvature and erectile function were significant, despite a mean use of 43 minutes a day.
This small-time requirement with such significant results sets RestoreX apart from all other PTT devices, as they require 2-8 hours of use a day, which is not practical for the majority of men. Two other characteristics that set RestoreX apart are its counter-bending ability and white-line indicator, both of which are unique to RestoreX. The counter-bending feature provides a safe way to bend and stretch the penis, with results showing greater improvements with this capability. The white-line indicator provides a way for users to see if they are exerting >3 lbs of force, which data has shown to result in greater improvements for Peyronie’s disease patients.
Conclusion
The RestoreX device has demonstrated safety of use and significant improvements in penile length, curvature and erectile function despite a much smaller time requirement, of only 30-90 minutes a day versus 2-8 hours required for most other devices. Additionally, its unique features of counter-bending and a white-line indicator have resulted in greater overall success for PTT in men with Peyronie’s disease.
References
Ziegelmann M, Savage J, Toussi A, Alom M, Yang D, Kohler T, Trost L. Outcomes of a Novel Penile Traction Device in Men with Peyronie’s Disease: A Randomized, Single-Blind, Controlled Trial. J Urol. 2019 Sep;202(3):599-610. doi: 10.1097/JU.0000000000000245. Epub 2019 Aug 8. PMID: 30916626.