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QuoteAlom M1, Sharma KL1, Toussi A1, Kohler T1, Trost L2.Author informationAbstractBACKGROUND:Previous studies of penile traction therapy (PTT) devices have demonstrated limited/no efficacy when combined with intralesional therapies for Peyronie's disease (Peyronies Disease). Recently, randomized data have demonstrated the efficacy of a novel PTT device, RestoreX, developed in cooperation with the Mayo Clinic, in men with Peyronies Disease.AIM:To assess the safety and efficacy of treatment with the RestoreX device plus collagenase Clostridium histolyticum (CCH) compared with CCH alone and CCH with other PTT devices.METHODS:A prospective registry has been maintained of all men undergoing CCH injections for Peyronies Disease between March 2014 and January 2019. Assessments were performed at baseline, during each series, and after completion of treatment. Those completing therapy (8 injections or sooner if satisfied) were categorized into group 1 (CCH alone), group 2 (CCH plus any PTT device other than RestoreX), or group 3 (CCH plus RestoreX).OUTCOMES:Changes in penile length, curvature, and subjective perception and the occurrence of adverse events.RESULTS:Of 287 men with data on PTT use, 113 had completed therapy with all objective data available and compose the current cohort. Baseline demographic and pathophysiological variables were similar among the 3 groups except penile length and previous Peyronies Disease medications. Following treatment, group 3 demonstrated significantly greater improvements in curvature (mean, 20.3°/31% for group 1, 19.2°/30% for group 2, and 33.8°/49% for group 3), length (-0.7 cm/-4%, -0.4 cm/-2%, and +1.9 cm/+17%, respectively), and subjectively estimated curvature improvement (44%, 32%, and 63% respectively), despite shorter daily PTT use (0.9 vs 1.9 hours/day). Group 3 was more likely than the other groups to experience ≥20°, ≥20%, and ≥50% curvature improvements, ≥1 cm length gain, and ≥20% length improvement. All results were statistically significant for group 3 versus groups 1 and 2, but not between groups 1 and 2, even after controlling for baseline features and isolating a subset of ≥3 hours/day PTT use (group 2). Group 3 was 6.9 times more likely to achieve ≥20° curvature improvement, and 3.5 times more likely to achieve ≥50% curvature improvement, and 10.7 times more likely to experience ≥20% length improvement. Adverse events were similar among the 3 groups.CLINICAL IMPLICATIONS:Use of the RestoreX device enhances mean curvature outcomes by 71% and increases penile length in men with Peyronies Disease receiving CCH therapy.STRENGTHS & LIMITATIONS:Study strengths include a prospective registry, consistent assessments, the largest single-site series with complete posttreatment outcomes reported to date, the largest PTT series reported to date, and a true-to-life clinical design. Limitations include the nonrandomized methodology and single-site setting.CONCLUSION:The combination of RestoreX and CCH is associated with significantly greater curvature and length improvements compared with CCH alone or CCH with other PTT devices. Alom M, Sharma KL, Toussi A, et al. Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie's Disease. J Sex Med 2019;XX:XXX-XXX.
Quote from: Throwaway23123 on April 29, 2019, 02:27:55 PMGuys note that sponsor of this study was Mayo Clinic - founder of the device.
Quote from: TonySa on April 29, 2019, 11:27:31 PMIf anyone purchase the article, please let us know anything else you learn from it. https://www.jsm.jsexmed.org/article/S1743-6095(19)30119-5/fulltext
Quote from: skunkworks on May 01, 2019, 02:22:19 AMI wish they'd managed to get more than 16 people on Restorex for the study, but I think we can all understand how that could be difficult. New device, rare disease.
QuoteStudy Type : Interventional (Clinical Trial)Actual Enrollment : 117 participantsAllocation: RandomizedIntervention Model: Factorial AssignmentIntervention Model Description: Men will be randomized into one of four groups: no traction therapy, penile traction 30 minutes once daily, penile traction 30 minutes twice daily, and penile traction 30 minutes three times daily. This treatment will continue for 3 months, after which men will enter an open label phase for 3 months. Primary and secondary outcomes will be evaluated at the completion of the 3 month and 6 month time points. Additional AEs will be assessed at 9 months after study initiation.Masking: Double (Investigator, Outcomes Assessor)Masking Description: Objective outcomes including penile length and curvature will be masked for the investigator and outcome assessor by obtaining photographs of the penis in the lateral and dorsal planes. Curvatures will also be assessed by a clinician in the case where photographs are not able to be obtained or if the participant refuses photographs. These will be assessed without any knowledge as to which grouping the patient is located by two independent reviewers. If there are differences >5 degrees (curvature), or 0.5 cm (length), a 3rd individual will mediate the difference.Primary Purpose: Basic ScienceOfficial Title: Efficacy of Penile Traction Therapy Using a Novel Device: A Controlled, Single-blinded, Randomized TrialActual Study Start Date : October 2, 2017Estimated Primary Completion Date : May 30, 2019Estimated Study Completion Date : August 30, 2019
Quote from: TonySa on April 29, 2019, 08:11:30 PMMayo Clinic developed the device but makes no money from the sale, so I don't really see any conflict of interest. Great study, it's so encouraging a major medical researcher is focusing on peyronies.