The RestoreXL™ is manufactured in the United States by PathRight Medical, located in Orem, Utah.
The RestoreXL™ is marketed by Med'Arte, a French company specializing in the sale of medical devices for Urology to healthcare facilities.
RestoreX™ was designed to restore lost penile length following a history of radical prostatectomy or Peyronie's disease.
Unlike standard RestoreX™, it applies only axial traction to the penis, with a force between 2.5 and 3 kg, sufficient to counteract atrophy and improve erection quality.
✓ RestoreX™ was evaluated in patients who had undergone radical prostatectomy resulting in penile shortening¹:
94% of patients regained 1.6 cm of penile length after a 6-month treatment course starting 1 month after surgery.
73% of patients experienced improved erectile function. No adverse effects were reported during or after the clinical studies.
✓ The clinical study on Peyronie's disease showed an increase in penile length between 2 and 2.2 cm after 6 months of treatment.¹ᵃ
✓ There are no clinical studies on RestoreX™ for increasing the length of small penises, and we refrain from communicating information that has not been clinically validated. We know that RestoreX™ allows for stretching, but it does not provide lengthening, as this has not been clinically proven. Only surgery can achieve a very substantial increase in penis length.
Toussi & al: Efficacy of a Novel Penile Traction Device in Improving Penile Length and Erectile Function PostProstatectomy: Results from a Single-Center Randomized, Controlled Trial/AUA - The Journal of Urology -August 2021, Volume 206, Issue 2, Page: 416-426
Efficacy of a novel penile traction device in improving penile length and erectile function after prostatectomy: Results of a prospective randomized single-center study.
Amir Toussi, Matthew Ziegelmann, David Yang, Madeleine Manka, Igor Frank, Stephen A Boorjian, Matthew
Tollefson , Tobias Köhler , Landon Trost
Study summary
OBJECTIVE
RestoreX™ is a novel penile traction therapy device, with randomized controlled data demonstrating improvements in penile length and erectile function after 30-90 minutes of daily use in men with Lapeyronie's disease.
We sought to determine whether similar improvements could be achieved after prostatectomy.
MATERIALS AND METHODS
Men after prostatectomy were randomized to a control group or one of two penile traction therapy protocols for 6 months, followed by a 3-month open-access phase.
The present study presents data from the randomized phase.
The primary endpoint was changes in penile length in extension; secondary endpoints were changes in International Index of Erectile Function (IIEF) scores, adverse events, satisfaction and subjective measures.
RESULTS
Overall, 82 men (mean age 58.6 years) were randomized with data available at 6 months for 25 control group controls and a further 30 controls treated with penile traction therapy.
At 6 months, penile traction therapy resulted in:
- better improvements/preservation of penile length (+1.6 vs. +0.3 cm, p <0.01)
- erectile function (IIEF-Erectile function +0 vs. -6.5, p=0.03)
- sexual satisfaction with intercourse (IIEF-Satisfaction with intercourse +1 vs. -3.5, p <0.01)
- of overall sexual satisfaction (IIEF-Overall sexual satisfaction 0 vs -3, p <0.01).
The use of erectogenic therapies was lower in men treated with penile traction therapy (phosphodiesterase-5 inhibitors 86% vs. 94%, p=0.44; intracavernosal injections 19% vs. 50%, p <0.05).
More men treated with penile traction therapy reported satisfaction or improvement in penile length than control group controls.
Adverse events were transient and mild; 87% would choose to repeat the therapy, and 93% would recommend it to others.
CONCLUSION
The use of a novel penile traction therapy device results in significant improvements in both objective and subjective penile length after prostatectomy, as well as measures of erectile function, intercourse-related sexual satisfaction and overall sexual satisfaction.
External validation is warranted.
Zganjar et al.: Efficacy of RestoreX™ Post Prostatectomy: Open-label Phase of a Randomized, Controlled Trial / BJU International - 2023 Aug;132(2):217-226
Efficacy of RestoreX™ post-prostatectomy: First open-label phase of a randomized, controlled clinical trial.
Wolters Kluwer: New device helps restore penile length and sexual function after prostate cancer surgery / Newswise - June 1, 2021
