The Effect of Duration of Penile Traction Therapy in Patients Undergoing Intralesional Injection Therapy for Peyronie's Disease

Yafi, Faysal A.; Pinsky, Michael R.; Stewart, Carrie; Sangkum, Premsant; Ateş, Erhan; Trost, Landon; Sikka, Suresh C.; Hellstrom, Wayne J.G.

doi:10.1016/j.juro.2015.03.092

Cited by 57 publications

(48 citation statements)

References 16 publications

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“…In a cohort of men with PD receiving therapy with intralesional interferon and PTT, only 31% were able to use the PTT device for 2 hours/day, of whom 56% were able to use it for 3 hours/day (overall compliance of 17% for 3 hours/day). 11 In contrast, in the present study, 92% of men in the CCH þ RestoreX group and 87% in the CCH þ other PTT group were able to use the device for 30 minutes/day. Thus, the ability to achieve significant improvements with a shorter duration of PTT use is critical to the clinical utility of this therapy.…”

Section: Discussioncontrasting

confidence: 85%

“…Given previous publications demonstrating improvements with other PTT devices only at durations of 3 hours/day, we performed a subset analysis of men who reported a mean duration of use of 3 hours/day with other PTT devices during the CCH injection period. 6e9, 11 Overall, 16% (7 of 45) of the men in whom use for 3 hours/day was recommended were able to achieve this duration, with no significant differences noted compared with CCH alone in absolute curvature (-22.9 vs -20.3 ; P ¼ .70), percent curvature (40.8% vs 31.2%; P ¼ .64), absolute length (þ0.67 cm vs -0.7 cm; P ¼ .14), and percent length (5.8% vs -3.5%; P ¼ .21).…”

Section: Resultsmentioning

confidence: 99%

“…11e13 Results from these series failed to demonstrate statistically significant improvements in penile length or curvature, with the exception of 1 subset analysis identifying a þ0.4 cm length increase among men using the devices for 3 hours/day. 11 To address some of the limitations of existing devices, a novel PTT (RestoreX) has been developed in cooperation with the Mayo Clinic and licensed to PathRight Medical (Plymouth, MN, USA). Among other changes, the device incorporates a new clamping mechanism, greater traction force, the ability to dynamically lengthen traction without removing the device, visible indicators of adequate traction, and counterbending in 4 primary directions.…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease

Alom¹,

Sharma²,

Toussi³

et al. 2019

The Journal of Sexual Medicine

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Background: Previous studies of penile traction therapy (PTT) devices have demonstrated limited/no efficacy when combined with intralesional therapies for Peyronie's disease (PD). Recently, randomized data have demonstrated the efficacy of a novel PTT device, RestoreX, developed in cooperation with the Mayo Clinic, in men with PD. 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 PD 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 PD 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 þ1.9 cm/þ17%, 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 PD 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 R...

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Section: Discussioncontrasting

confidence: 85%

Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease

Alom¹,

Sharma²,

Toussi³

et al. 2019

The Journal of Sexual Medicine

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“…Hellstrom's group has recently reported that routine penile traction therapy during intralesional injection with interferon α-2b for Peyronie's disease may result in a small but subjectively meaningful improvement in stretched penile length, without affecting curvature, if used for at least 3 hours a day. 61 It must be noted that all studies vary in time the devices are applied, and the manner in which this is performed. For many patients, there is no defined teaching and follow-up protocol, and use is self-reported; as with any physiotherapy, a "perfect" stretch may be more useful than a prolonged traction session with the device improperly used or incomplete traction.…”

Section: Mechanical Therapy -Penile Tractionmentioning

confidence: 99%

2018 Canadian Urological Association guideline for Peyronie's disease and congenital penile curvature

Bella

Lee

Grober

et al. 2018

CUAJ

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Peyronie’s disease (PD) is a highly prevalent condition that affects the physical and psychosocial well-being and quality of life (QoL) for thousands of Canadian men. The specific etiology of PD remains poorly understood and there remains a paucity of randomized placebo-controlled trials evaluating treatment interventions.1-3 PD can be found in up to 8.9% of men, a remarkable increase in cited prevalence that is attributable to growing awareness (as historical data suggested a rate of less than 1%); the burden of disease is significant, and PD is often present in otherwise healthy men. The following guidelines were crafted by the committee with a full awareness of the limitations of the literature, and sought to provide actionable recommendations to guide PD care in the Canadian health system.

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“…However, while modeling possibly improves curvature, it may have a negative effect on penile length when not performing simultaneous PTT [51]. Nonetheless, Yafi et al [52] studied patients undergoing intralesional IFN α2β treatment and showed that those who received PTT daily had a very modest (3 mm), yet significant increase in stretched penile length. While PTT does not appear to be effective in isolation to treat PD, it may have a role in combination treatment, particularly with the goal of maintaining or improving penile length.…”

Section: Other Nonsurgical Treatmentsmentioning

confidence: 99%

Nonsurgical Interventions for Peyronie's Disease: Update as of 2016

Joice

Burnett

2016

World J Mens Health

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Peyronie's disease (PD) is a debilitating condition of the penis that leads to significant pain, erectile dysfunction, and emotional distress in men. PD is likely underreported due to lack of knowledge of the disease and the absence of well-established available treatments. Surgical treatment can lead to sustained improvements, but is often associated with penile shortening and places the patient at risk for perioperative morbidity. Nonsurgical management has been studied for several years as an alternative to surgery for men with PD. Currently, much of the data on nonsurgical management is conflicting, with only one treatment that has been recently approved by the US Food and Drug Administration. Significant effort has been devoted to advancing non-surgical treatments for PD that can be implemented outside of the operating room. This review aims to describe the research behind current nonsurgical therapies for PD and to highlight the recent advances that have been made within the last three years.

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The Effect of Duration of Penile Traction Therapy in Patients Undergoing Intralesional Injection Therapy for Peyronie's Disease

Abstract: Routine penile traction therapy during intralesional injection with interferon α-2b for Peyronie's disease may result in a small but subjectively meaningful improvement in stretched penile length, without affecting curvature, if used for at least 3 hours a day.

Cited by 57 publications

References 16 publications

Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease

Efficacy of Combined Collagenase Clostridium histolyticum and RestoreX Penile Traction Therapy in Men with Peyronie’s Disease

2018 Canadian Urological Association guideline for Peyronie's disease and congenital penile curvature

Nonsurgical Interventions for Peyronie's Disease: Update as of 2016

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