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Penile traction therapy with the new device ‘Penimaster PRO’ is effective and safe in the stable phase of Peyronie's disease: a controlled multicentre study

Published on Apr 1, 2019in BJUI4.524
· DOI :10.1111/bju.14602
Ignacio Moncada21
Estimated H-index: 21
,
Pramod Krishnappa1
Estimated H-index: 1
+ 5 AuthorsLaurence A. Levine51
Estimated H-index: 51
(Rush University Medical Center)
Abstract
  • References (18)
  • Citations (6)
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References18
Newest
#1Matthew J. Ziegelmann (Mayo Clinic)H-Index: 9
#2Boyd R. Viers (Mayo Clinic)H-Index: 13
Last. Landon Trost (Mayo Clinic)H-Index: 16
view all 6 authors...
Objective To evaluate the outcomes in men undergoing collagenase Clostridium histolyticum (CCH) with concurrent penile traction therapy (PTT) for the treatment of Peyronie disease (PD). Materials and Methods We identified patients treated with CCH between March 2014 and July 2016. Patients were recommended to perform modeling and PTT between injection series. A final curve assessment was performed after patients completed CCH. A prospective database was maintained, including patient-reported fre...
16 CitationsSource
#1Benjamin A. Sherer (Rush University Medical Center)H-Index: 7
#2Laurence A. Levine (Rush University Medical Center)H-Index: 51
Peyronie's disease (PD) is a penile wound-healing disorder resulting in fibrotic plaque in the tunica albuginea, likely resulting from micro trauma. Due to variable disease presentations, a myriad of proposed treatment options, physician misconceptions about the disorder, and severe psychological distress in afflicted patients, PD can be a difficult to manage entity. This review seeks to provide a current and comprehensive overview of oral, topical, intralesional, mechanical, and surgical therap...
7 CitationsSource
Penile traction therapy (PTT) is a new therapeutic option for men with Peyronie’s disease (PD). However, it has a long history of use in other fields of medicine including bone, skin, skeletal muscle, and Dupuytren’s. Mechanotransduction, or gradual expansion of tissue by traction, leads to the formation of new collagen tissue by cellular proliferation. As a molecular result, continuous extension of the fibrous plaque causes significant increases in collagenase and metalloproteinases, and, ultim...
5 CitationsSource
#1Ajay Nehra (American Urological Association)H-Index: 43
#2Ralph Alterowitz (American Urological Association)H-Index: 1
Last. Arthur L. Burnett (American Urological Association)H-Index: 67
view all 15 authors...
Purpose: The purpose of this guideline is to provide a clinical framework for the diagnosis and treatment of Peyronie’s disease.Materials and Methods: A systematic review of the literature using the PubMed®, EMBASE® and Cochrane databases (search dates 1/1/1965 to 1/26/15) was conducted to identify peer-reviewed publications relevant to the diagnosis and treatment of PD. The review yielded an evidence base of 303 articles after application of inclusion/exclusion criteria.Results: The systematic ...
115 CitationsSource
#1Marco Oderda (UNITO: University of Turin)H-Index: 13
#2Paolo Gontero (UNITO: University of Turin)H-Index: 32
Abstract Introduction Most men seeking penile enhancement techniques have a normal penile size. They are either misinformed or suffer from penile dysmorphophobia and should be discouraged from undergoing invasive procedures. Less invasive techniques including penile extenders are not associated with major complications and may be beneficial from a psychological perspective. Aim We conducted this study to assess the efficacy and safety of AndroPenis® (Andromedical, Madrid, Spain) penile extender....
10 CitationsSource
#1Laurence A. Levine (Rush University Medical Center)H-Index: 51
#2Beatrice CuzinH-Index: 6
Last. David J. Ralph (UCLH: University College Hospital)H-Index: 46
view all 9 authors...
Abstract Introduction Collagenase clostridium histolyticum (CCH; Xiaflex, Auxilium Pharmaceuticals, Inc., Chesterbrook, PA, USA) is a Food and Drug Administration‐approved, intralesional treatment for Peyronie's disease (PD). Aim The aim of this study was to assess the safety and effectiveness of CCH in the treatment of PD. Methods This phase 3, open‐label study enrolled subjects who were CCH‐naive, were enrolled in a previous pharmacokinetic study, or had received placebo in an earlier phase 2 ...
53 CitationsSource
#1Juan I. Martínez-Salamanca (UAM: Autonomous University of Madrid)H-Index: 23
#2Alejandra Egui (UAM: Autonomous University of Madrid)H-Index: 1
Last. Joaquín Carballido (UAM: Autonomous University of Madrid)H-Index: 16
view all 8 authors...
Abstract Introduction Outcome data of penile traction therapy (PTT) for the acute phase (AP) of Peyronie's disease (PD) have not been specifically studied. Aim The aim of this study was to assess the effectiveness of a penile extender device for the treatment of patients with AP of PD. Methods A total of 55 patients underwent PTT for 6 months and were compared with 41 patients with AP of PD who did not receive active treatment (“no intervention group” [NIG]). Main Outcomes Measures Pre‐ and post...
39 CitationsSource
#1Vincent G. Laurence (UCI: University of California, Irvine)H-Index: 3
#2Jenna B. Martin (UCI: University of California, Irvine)H-Index: 2
Last. Garrett A. Wirth (UCI: University of California, Irvine)H-Index: 14
view all 3 authors...
8 CitationsSource
#1Michael R. Abern (Rush University Medical Center)H-Index: 35
#2Stephen Larsen (Rush University Medical Center)H-Index: 8
Last. Laurence A. Levine (Rush University Medical Center)H-Index: 51
view all 3 authors...
ABSTRACT Introduction There is no current consensus as to the most effective nonsurgical therapy for Peyronie's disease (PD). Aim This study aims to assess the benefit of penile traction therapy (PTT) when added to intralesional verapamil injections (IVIs) combined with oral L‐arginine 1 g b.i.d. and pentoxifylline 400 mg t.i.d. in men with PD. Methods Seventy‐four men with PD completed 12 IVIs. Patients electing to add PTT were advised to wear the device for 2–8 hours daily and no longer than 2...
65 CitationsSource
#1David J. RalphH-Index: 46
#2Nestor F. Gonzalez-Cadavid (UCLA: University of California, Los Angeles)H-Index: 59
Last. Laurence A. Levine (Rush Medical College)H-Index: 51
view all 7 authors...
ABSTRACT Introduction The field of Peyronie's disease is evolving and there is need for a state-of-the-art information in this area. Aim To develop an evidence-based state-of-the-art consensus report on the management of Peyronie's disease. Methods To provide state-of-the-art knowledge regarding the prevalence, etiology, medical and surgical management of Peyronie's Disease, representing the opinion of leading experts developed in a consensus process over a 2-year period. Main Outcome Measures E...
242 CitationsSource
Cited By6
Newest
The aim of this paper is to analyze our experience with intraplaque administration of collagenase from Clostridium Histolyticum (CCH) together with penile modeling for selected patients with Peyronie’s disease (PD). We conducted a prospective, multicenter, single-arm study. Patients were included from October 2015 to August 2019. We carried out the I + E PROTOCOL (IMPRESS + extender). Each cycle involved administration of two injections of CCH separated 24–72 h, up to a maximum of four cycles. 2...
Source
#1Matthew J. Ziegelmann (Rush University Medical Center)H-Index: 9
#2Petar Bajic (Rush University Medical Center)H-Index: 1
Last. Laurence A. Levine (Rush University Medical Center)H-Index: 51
view all 3 authors...
Peyronie's disease is a common yet poorly understood condition characterized by penile pain, curvature, sexual dysfunction and psychological bother. Peyronie's disease represents a penile wound healing disorder, and is thought to arise from exuberant scarring in response to penile trauma in genetically predisposed men. In the absence of active treatment, the majority of men experience stable or worsening symptoms, with few reporting spontaneous resolution in penile curvature or other deformity. ...
1 CitationsSource
#1R. Bole (Mayo Clinic)H-Index: 2
#2Lindsay A. White (Mayo Clinic)
Last. Matthew J. Ziegelmann (Mayo Clinic)H-Index: 9
view all 6 authors...
Peyronie’s disease (PD)-related penile deformity is managed with multiple treatment modalities including oral medications, intralesional injections, and surgery. Penile traction therapy (PTT) is one such modality with purported benefits, albeit with notable differences in the characteristics of available traction devices and published study protocols. We provide a comprehensive review of the available data supporting PTT for PD treatment. We performed a rigorous database search to identify all s...
Source
#1Edward Capoccia (Rush University Medical Center)H-Index: 2
#2Matthew J. Ziegelmann (Rush University Medical Center)H-Index: 9
Last. Laurence A. Levine (Rush University Medical Center)H-Index: 51
view all 6 authors...
Peyronie’s disease (PD) has a negative impact on overall quality of life for many patients and their partners. There is a significant portion of patients who elect noninvasive therapy and in this scenario we have little data with which to counsel patients. We aim to evaluate long-term patient-reported outcomes in a cohort of men with PD who elected conservative treatment. We identified all males with a diagnosis of PD evaluated at our institution by a single provider between May 2012 and January...
Source
#1Jesse Ory (Dal: Dalhousie University)
Last. Gavin M. LangilleH-Index: 4
view all 3 authors...
Abstract Introduction Evidence for noninvasive management of Peyronie’s disease contains many options with varying levels of evidence for each. Many first-line treatments recommended by urologists lack strong evidence for their use. Aim We summarize the noninvasive (oral medications, topical medications, traction, vacuum erection devices, extracorporeal shock wave therapy, intracavernosal injections and electromotive therapy) treatment options for Peyronie’s disease and provide the levels of evi...
Source
Peyronie’s disease is a condition that causes abnormal healing of the tunica albuginea, causing penile curvature. It is difficult to treat and its management is continuing to evolve. Proposed non-surgical treatments have included oral, topical, intralesional, extracorporeal shockwave, and traction therapy. The study of Peyronie’s disease is made difficult by heterogeneity in the timing of presentation, severity and characteristics of deformity, and associated complaints. Moreover, meta-analyses ...
Source
#1Kiran L. Sharma (Mayo Clinic)H-Index: 1
#2Manaf Alom (Mayo Clinic)H-Index: 4
Last. Landon Trost (Mayo Clinic)H-Index: 16
view all 3 authors...
Purpose of Review To summarize data on lengthening treatments from PubMed-indexed scientific publications.
Source
#1K. Wymer (Mayo Clinic)H-Index: 1
#2Tobias S. Köhler (Mayo Clinic)H-Index: 15
Last. Landon Trost (Mayo Clinic)H-Index: 16
view all 3 authors...
Abstract Background Traditionally, surgery has been considered the gold standard treatment for Peyronie’s disease (PD). Less-invasive alternatives, such as collagenase Clostridium histolyticum (CCH) and traction therapy, have been proposed and proven effective. Aim To compare cost-effectiveness of management options for PD. Methods A Markov analytic model was created to compare the cost-effectiveness of treatment with a novel traction device, RestoreX (RXPTT), vs CCH vs surgery. Outcomes were de...
1 CitationsSource
#1Manaf Alom (Mayo Clinic)H-Index: 4
#2Kiran L. Sharma (Mayo Clinic)H-Index: 1
Last. Landon Trost (Mayo Clinic)H-Index: 16
view all 5 authors...
Abstract 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 wit...
1 CitationsSource
#1R. Valenzuela (ISMMS: Icahn School of Medicine at Mount Sinai)H-Index: 1
#2Matthew J. Ziegelmann (Mayo Clinic)H-Index: 9
Last. J. Hillelsohn (ISMMS: Icahn School of Medicine at Mount Sinai)H-Index: 1
view all 4 authors...
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