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Therapeutic Trends in the Treatment of Patients with Peyronie's Disease
By: Landon Trost, MD | Posted on: 01 Mar 2021
Like many things in life, management of medical conditions often trends from one therapy to another over time. This seems particularly true for certain conditions, such as Peyronie’s disease (PD), where an optimal treatment has not been clearly defined. However, as anyone with a silk shirt, fidget spinner, planking personal record, or PTSD from an ice bucket challenge can attest, some trends are good, while others are best left in the past.
Peyronie’s disease itself has become a notably trendy topic, with nearly a third of all manuscripts ever written on PD published within the past 5 years. Regarding therapies, arguably, the 3 most prominent trends with PD in the past several years have been with collagenase clostridium histolyticum (CCH), traction devices, and shockwave/restorative therapy. Each of these trends will be briefly reviewed regarding their prominence, efficacy and projected future role in the management of PD.
Since FDA approval of CCH, it has increasingly been used as a first line therapy for the management of PD (unpublished data).1 Recent publications evaluating national CCH use demonstrated that while first line treatment with CCH was 1:1 with surgery after FDA release, by 2017 it had increased to 2:1 despite similar rates of PD diagnosis.2 Concomitantly, the use of intralesional verapamil dropped from 11% in 2007 to <1% by 2018, with meta-analyses suggesting superiority of CCH over verapamil.3,4 With few exceptions, reported efficacy rates after FDA release have demonstrated similar or slightly improved success rates compared to original phase III randomized, controlled trials, suggesting ongoing efficacy when used in real-to-life clinical scenarios by PD specialists.5–8
Independent of efficacy, a key debate with CCH has been its cost, which has contributed to the development of modified, shortened protocols and even withdrawal from select international markets.9 Several cost-effectiveness studies have been reported with varying conclusions as to superiority of one therapy over another due in part to differences in methodological rigor.10,11 However, recent data suggest that these debates are ultimately short-sighted as contemporary management of PD is often multifaceted with several categories of therapies often combined. Specifically, the previously cited trending data suggest that the introduction of CCH resulted in >50% more PD men seeking treatment rather than the cannibalization of other therapies. Otherwise stated, the introduction of CCH has created a novel treatment niche wherein more patients are receiving effective therapy compared to before CCH. In this context, comparing surgery vs CCH for PD would be akin to debating the cost-effectiveness of docetaxel vs surgery for men with prostate cancer.
An additional trend and debate worth mentioning is the appropriate pattern of administration of CCH. Recent strategies and market forces have led more general urologists and even nonurologists to administer CCH, which represents a notable change from prior use predominantly among subspecialty urologists (andrologists). The long-term impacts of this change on patient safety, efficacy, and healthcare/insurance utilization restrictions are indeterminate. However, extrapolating data from other disease conditions would suggest that a change from more to less specialization is associated with poorer outcomes, worsened complications and eventual payer restrictions leading to reduced availability.
Penile traction therapy (PTT) is a second trending topic in the field of PD. Please also note my specific conflict of interest in this regard, as I was involved in the development of a new class of PTT device during my time at Mayo Clinic. Penile traction is being increasingly used in men with PD as a primary treatment for penile length and curvature as well as an adjunctive therapy in men undergoing surgery or CCH.12–14 In contrast to other therapies (ie vacuum devices), PTT has demonstrated more robust and consistent data on restoring or improving penile length in this population without long-term adverse events. Additionally, with newer technology, PTT may be effectively used for 30 to 60 minutes daily compared to a historical need for 3 to 9 hours, which has greatly improved use and expanded the clinical utility. Therefore, PTT is becoming one of a combination of treatments that are recommended in the management of PD.
The third notable trending topic with PD is with restorative therapies, including low intensity shock wave/acoustic wave, stem cells and platelet-rich plasma. These treatments are increasingly among the most discussed therapies for several sexual conditions, including erectile dysfunction, PD and other sexual dysfunctions. Although these treatments have demonstrated some preliminary data in animal and in vitro models, none have gone through standard regulatory pathways to assess for clinical efficacy and are therefore off label.
From a broader guideline standpoint, the American Urological Association has specifically indicated that extracorporeal shock wave therapy should not be used for the reduction of penile curvature or plaque size (Statement 14). Similarly, the Sexual Medicine Society of North America (SMSNA) has released a position statement on the role of regenerative therapies for sexual conditions and has concluded, “shock waves or stem cells/SVF or platelet rich plasma [are] experimental and should only be conducted under research protocols in compliance with Institutional Review Board approval at little or no cost to the patient” (emphasis added; unpublished data). The statement goes on to indicate, “the SMSNA does not feel that it is appropriate or ethical for providers to advertise or otherwise make implicit or explicit claims of efficacy for these therapies pending further data. Similarly, patients considering such therapies should be fully informed as to the lack of data demonstrating clinically relevant efficacy and consented regarding the potential benefits and risks. In summary, at the current time, the SMSNA does not advocate for restorative therapies to be offered or used in routine clinical practice.”
Clearly, and as with other disease states, the management of PD is frequently changing, and the introduction of novel therapies offers new potential avenues for treatment. However, it is important to recognize that the trendiness of any particular therapy is not a surrogate for efficacy. Therefore, distinguishing providers must incorporate data and societal recommendations to develop optimal patient care pathways and identify which therapies are truly beneficial.
Disclosure: Dr. Landon Trost is the inventor of a penile traction therapy technology in coordination with Mayo Clinic Ventures. The technology has been licensed by PathRight Medical and is used with the RestoreX penile traction therapy device.
- Sukumar S, Pijush DB and Brandes S: Impact of the advent of collagenase clostridium histolyticum on the surgical management of Peyronie’s disease: a population-based analysis. J Sex Med 2020; 17: 111.
- Sun AJ, Li S, Eisenberg ML: The impact of clostridium histolyticum collagenase on the prevalence and management of Peyronie’s disease in the United States. World J Mens Health 2019; 37: 234.
- Loftus CJ, Rajanahally S, Holt SK et al: Treatment trends and cost associated with Peyronie’s disease. Sex Med 2020; 8: 673.
- Russo GI, Cacciamani G, Cocci A et al: Comparative effectiveness of intralesional therapy for Peyronie’s disease in controlled clinical studies: a systematic review and network meta-analysis. J Sex Med 2019; 16: 289.
- Gelbard M, Goldstein I, Hellstrom WJ et al: Clinical efficacy, safety and tolerability of collagenase clostridium histolyticum for the treatment of Peyronie disease in 2 large double-blind, randomized, placebo controlled phase 3 studies. J Urol 2013; 190: 199.
- Yafi FA, Diao L, DeLay KJ et al: Multi-institutional prospective analysis of intralesional injection of collagenase clostridium histolyticum, tunical plication, and partial plaque excision and grafting for the management of Peyronie’s disease. Urology 2018; 120: 138.
- Cocci A, Russo, GI, Salonia A et al: Predictive factors of patients’ and their partners’ sexual function improvement after collagenase clostridium histolyticum injection for Peyronie’s disease: results from a multi-center single-arm study. J Sex Med 2018; 15: 716.
- Yang KK, Bennett N: Peyronie’s disease and injectable collagenase clostridium histolyticum: safety, efficacy, and improvements in subjective symptoms. Urology 2016; 94: 143.
- Abdel Raheem A, Capece M, Kalejaiye O et al: Safety and effectiveness of collagenase clostridium histolyticum in the treatment of Peyronie’s disease using a new modified shortened protocol. BJU Int 2017; 120: 717.
- Wymer K, Kohler T, Trost L: Comparative cost-effectiveness of surgery, collagenase clostridium histolyticum, and penile traction therapy in men with Peyronie’s disease in an era of effective clinical treatment. J Sex Med 2019; 16: 1421.
- Harvey N, Pearce I: At what cost is collagenase clostridium histolyticum viable for treating Peyronie’s disease in a public healthcare system? Andrology 2020; 8: 1304.
- Joseph J, Ziegelmann MJ, Alom M et al: Outcomes of RestoreX penile traction therapy in men with Peyronie’s disease: results from open label and follow-up phases. J Sex Med 2020; 17: 2462.
- Moncada I, Krishnappa P, Romero J et al: Penile traction therapy with the new device‘˜Penimaster PR’ is effective and safe in the stable phase of Peyronie’s disease: a controlled multicentre study. BJU Int 2019; 123: 694.
- Ziegelmann MJ, Viers BR, Montgomery, BD et al: Clinical experience with penile traction therapy among men undergoing collagenase clostridium histolyticum for Peyronie disease. Urology 2017; 104: 102.
- Trost L, Huang H, Han X et al: Treatment patterns and healthcare outcomes with collagenase clostridium histolyticum versus surgery in Peyronie’s disease: a retrospective claims database analysis. Sex Med Open Access 2021; unpublished data.