madman
Super Moderator
Outcomes of RestoreX Penile Traction Therapy in Men With Peyronie’s Disease: Results From Open Label and Follow-up Phases
ABSTRACT
Background: A randomized, controlled clinical trial evaluating the efficacy of RestoreX traction therapy in men with Peyronie’s disease (PD) has been completed, with the 3-month results previously reported. The present study presents outcomes from the open-label and follow-up phases of the original trial.
Aim: To report 6-month (open-label phase) and 9-month (follow-up phase) outcomes from a randomized, controlled trial (NCT03389854).
Methods: A randomized controlled trial was performed from 2017 to 2019 in 110 all-comer men with PD. Men were randomized 3:1 to RestoreX (PTT) or no therapy (control) for 3 months, followed by 3-month open-label and follow-up phases. Key outcomes included adverse events (AEs), changes in penile curvature and length, erectile function, and standardized and nonstandardized assessments of PD.
Outcomes: The primary outcomes are safety, penile length, penile curvature, Peyronie’s Disease Questionnaire, International Index of Erectile Function, and satisfaction.
Results: 6-month (n=64) and 9-month (n=63) outcomes were reported, with a mean duration of PTT use of 31.1 minutes. No significant AEs were reported, with temporary erythema and discomfort being most common and resolving within minutes. On intent-to-treat analysis, control-to-PTT men experienced significant length (1.7-2.0 cm) and curvature improvements (18-20%). PTT-to-PTT men also achieved additional length (0.6-0.8 cm) without further curvature improvements. An as-treated analysis of PTT uses ≥ 15 minutes/day demonstrated 2.0- to 2.3-cm length gains (largest of any PTT to date) and 18-21% curve improvement. All sexual function domains of the International Index of Erectile Function and Peyronie’s Disease Questionnaire were significantly improved (except the orgasmic domain). 95% of men treated for 6 months experienced length gains (mean 2.0-2.2 cm), and 61% had curve improvements (16.8-21.4 [32.8-35.8%]). RestoreX was preferred 3-4:1 over all other PD treatments, and 100% preferred it over other PTT devices.
Clinical Implications: Use of RestoreX 30 minutes daily results in significant length and curve improvements in PD men without significant AEs.
Strengths & Limitations: Strengths include the largest randomized study of PTT, blinded assessments, and inclusion of all-comers with few restrictions; limitations include sample size that precludes comparisons between treatment cohorts and lack of long-duration (>3-9 hours) treatment arm.
Conclusion: PTT with RestoreX results in significant improvements in length, curve, and subjective and objective measures of sexual function without significant AEs. RestoreX PTT represents a safe, conservative, low-cost option for managing men with PD.
INTRODUCTION
Penile traction therapy (PTT) represents a relatively newer class of treatments to restore length or correct deformities of the penis associated with various disease states, including Peyronie’s disease (PD) and diabetes mellitus (DM), or after prostatectomy, among others. Since the initial publication on PTT in 2008, multiple traction devices have been developed that use similar mechanisms, whereby sequential rods are screwed into place to provide elongation of the penis. However, these first-generation systems have several notable limitations, including minimal ability to extend when in use, difficulty in applying traction, pain, and other device issues that lessen the amount of force applied to the penis. Possibly due to these limitations, the first generation of traction devices require 2-9 hours of daily use to achieve benefits, with available data demonstrating conflicting outcomes.1-9 Given the extended treatment times required, many have questioned the clinical utility of such therapies, with actual utilization patterns suggesting only 9-56% of compliance with the recommended ≥ 3 hours of daily use.6,8
Given these limitations, a novel, second-generation PTT device (RestoreX; PathRight Medical, Plymouth, MN) was developed with 3 notable innovations: (i) modified clamp design to allow for greater force-displacement, (ii) counter bending to increase the force to diseased segments, and (iii) dynamic adjustment to assure appropriate traction during a treatment session (Figure 1). To evaluate the safety and efficacy of the new device, a randomized controlled trial (RCT; NCT03389854) was performed in 110 men with PD, with the 3- month randomized phase previously reported.10 Results demonstrated statistically significant improvements in length (94% with mean 1.6-cm gain), curve (77% of PTT men with mean 17.2 improvements), and sexual function (International Index of Erectile Function [IIEF]-erectile function domain,þ4.3) among men treated with RestoreX compared with controls. In contrast to prior PTT devices, results were achieved after a mean of 43 minutes of daily use, with both the counter bending and white-line indicator being validated as independent factors leading to improved outcomes.
Since the initial publication, additional data have been presented on the efficacy of RestoreX þ collagenase clostridium histolyticum (CCH) compared with CCH þ other PTT devices or CCH alone.11 Results demonstrated that men treated with RestoreX þ CCH were 3.5x more likely to achieve 50% curvature improvements and 10.7x more likely to experience 20% length improvements than the other groups, while other PTT þ CCH achieved no significant benefits compared with CCH alone. Two additional RCTs are currently ongoing evaluating the efficacy of RestoreX PTT in men with DM and after prostatectomy (NCT03756688, NCT03500419).
CONCLUSIONS
PTT with RestoreX results in significant subjective and objective improvements in penile length, curvature, and standardized assessments of erectile and sexual function. Patients in the present study preferred RestoreX PTT to all other PD treatment by 4:1. In contrast to other PTT devices that require 2-9 hours of daily use and are therefore of limited clinical utility, RestoreX achieves improvements in approximately 30 minutes per day. Although not all men who use RestoreX experience benefits, given the low cost and lack of significant AEs, these findings represent a notable paradigm shift in the role of PTT in managing men with PD.
ABSTRACT
Background: A randomized, controlled clinical trial evaluating the efficacy of RestoreX traction therapy in men with Peyronie’s disease (PD) has been completed, with the 3-month results previously reported. The present study presents outcomes from the open-label and follow-up phases of the original trial.
Aim: To report 6-month (open-label phase) and 9-month (follow-up phase) outcomes from a randomized, controlled trial (NCT03389854).
Methods: A randomized controlled trial was performed from 2017 to 2019 in 110 all-comer men with PD. Men were randomized 3:1 to RestoreX (PTT) or no therapy (control) for 3 months, followed by 3-month open-label and follow-up phases. Key outcomes included adverse events (AEs), changes in penile curvature and length, erectile function, and standardized and nonstandardized assessments of PD.
Outcomes: The primary outcomes are safety, penile length, penile curvature, Peyronie’s Disease Questionnaire, International Index of Erectile Function, and satisfaction.
Results: 6-month (n=64) and 9-month (n=63) outcomes were reported, with a mean duration of PTT use of 31.1 minutes. No significant AEs were reported, with temporary erythema and discomfort being most common and resolving within minutes. On intent-to-treat analysis, control-to-PTT men experienced significant length (1.7-2.0 cm) and curvature improvements (18-20%). PTT-to-PTT men also achieved additional length (0.6-0.8 cm) without further curvature improvements. An as-treated analysis of PTT uses ≥ 15 minutes/day demonstrated 2.0- to 2.3-cm length gains (largest of any PTT to date) and 18-21% curve improvement. All sexual function domains of the International Index of Erectile Function and Peyronie’s Disease Questionnaire were significantly improved (except the orgasmic domain). 95% of men treated for 6 months experienced length gains (mean 2.0-2.2 cm), and 61% had curve improvements (16.8-21.4 [32.8-35.8%]). RestoreX was preferred 3-4:1 over all other PD treatments, and 100% preferred it over other PTT devices.
Clinical Implications: Use of RestoreX 30 minutes daily results in significant length and curve improvements in PD men without significant AEs.
Strengths & Limitations: Strengths include the largest randomized study of PTT, blinded assessments, and inclusion of all-comers with few restrictions; limitations include sample size that precludes comparisons between treatment cohorts and lack of long-duration (>3-9 hours) treatment arm.
Conclusion: PTT with RestoreX results in significant improvements in length, curve, and subjective and objective measures of sexual function without significant AEs. RestoreX PTT represents a safe, conservative, low-cost option for managing men with PD.
INTRODUCTION
Penile traction therapy (PTT) represents a relatively newer class of treatments to restore length or correct deformities of the penis associated with various disease states, including Peyronie’s disease (PD) and diabetes mellitus (DM), or after prostatectomy, among others. Since the initial publication on PTT in 2008, multiple traction devices have been developed that use similar mechanisms, whereby sequential rods are screwed into place to provide elongation of the penis. However, these first-generation systems have several notable limitations, including minimal ability to extend when in use, difficulty in applying traction, pain, and other device issues that lessen the amount of force applied to the penis. Possibly due to these limitations, the first generation of traction devices require 2-9 hours of daily use to achieve benefits, with available data demonstrating conflicting outcomes.1-9 Given the extended treatment times required, many have questioned the clinical utility of such therapies, with actual utilization patterns suggesting only 9-56% of compliance with the recommended ≥ 3 hours of daily use.6,8
Given these limitations, a novel, second-generation PTT device (RestoreX; PathRight Medical, Plymouth, MN) was developed with 3 notable innovations: (i) modified clamp design to allow for greater force-displacement, (ii) counter bending to increase the force to diseased segments, and (iii) dynamic adjustment to assure appropriate traction during a treatment session (Figure 1). To evaluate the safety and efficacy of the new device, a randomized controlled trial (RCT; NCT03389854) was performed in 110 men with PD, with the 3- month randomized phase previously reported.10 Results demonstrated statistically significant improvements in length (94% with mean 1.6-cm gain), curve (77% of PTT men with mean 17.2 improvements), and sexual function (International Index of Erectile Function [IIEF]-erectile function domain,þ4.3) among men treated with RestoreX compared with controls. In contrast to prior PTT devices, results were achieved after a mean of 43 minutes of daily use, with both the counter bending and white-line indicator being validated as independent factors leading to improved outcomes.
Since the initial publication, additional data have been presented on the efficacy of RestoreX þ collagenase clostridium histolyticum (CCH) compared with CCH þ other PTT devices or CCH alone.11 Results demonstrated that men treated with RestoreX þ CCH were 3.5x more likely to achieve 50% curvature improvements and 10.7x more likely to experience 20% length improvements than the other groups, while other PTT þ CCH achieved no significant benefits compared with CCH alone. Two additional RCTs are currently ongoing evaluating the efficacy of RestoreX PTT in men with DM and after prostatectomy (NCT03756688, NCT03500419).
CONCLUSIONS
PTT with RestoreX results in significant subjective and objective improvements in penile length, curvature, and standardized assessments of erectile and sexual function. Patients in the present study preferred RestoreX PTT to all other PD treatment by 4:1. In contrast to other PTT devices that require 2-9 hours of daily use and are therefore of limited clinical utility, RestoreX achieves improvements in approximately 30 minutes per day. Although not all men who use RestoreX experience benefits, given the low cost and lack of significant AEs, these findings represent a notable paradigm shift in the role of PTT in managing men with PD.
