Technological Advancements for Treating ED and PD

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Technological Advancements for Treating Erectile Dysfunction and Peyronie’s Disease (2022)
Jeffrey D. Campbell, MD, MPH*, Danny Matti, Haider Abed, MD, Andrew Di Pierdominico, MD


INTRODUCTION

Erectile dysfunction (ED) affects 30% to 65% of men in the general population between the ages of 40 and 80 years.1 Because of the rapidly aging population, United Nations data predict that greater than 320 million men worldwide will be diagnosed and require treatment for ED by 2025.2 ED affects the quality of life of men and their partners worldwide and costs the United States approximately $330 million annually.3 Advances in basic science research and medical understanding have allowed therapeutic technologies to advance substantially since the original options were first implemented more than 50 years ago. Peyronie’s disease (PD) is a connective tissue disease situated on the tunica albuginea of the penis. Screening studies have shown that currently there might be an underestimation of PD prevalence and incidence. A questionnaire-based survey in the United States revealed a definitive PD diagnosis in 0.7%, with an additional 11% having probable PD.4 There is an increasing prevalence with age, diabetes, and preexisting ED, up to 9% to 13%.4,5 Men between 50 and 60 years old seem to be most commonly affected, with a devastating impact on mental health; nearly half of all men with PD develop depressive symptoms.6

Restorative therapies, such as stem cell therapy and platelet-rich plasma, are being evaluated for their putative role in treating ED and PD; however, these are likely years away before mainstream acceptance and Food and Drug Administration (FDA) approval for routine use.7 In contrast, technological advancements in the past decade have really improved the way ED can be treated, and the future holds many prospects for further advancement.
Next, the authors discuss the advancements that have occurred in how men’s health is treated over the past decade and explore the rapid expansion of this subspecialty field of medicine.





Vacuum Erection Devices

Vacuum erection devices (VED) have been used as a therapeutic option for ED since 1982 and have generally occupied a role as second-line therapy in the case of pharmacologic failure or intolerance.8 The devices typically consist of a cylinder that encompasses the penis, a vacuum (manual or electric), and a constriction ring. Negative pressure is used to draw blood into the penile sinusoids and achieve rigidity, which is then maintained by the constriction ring at the penile base. Several recent studies highlight new insights into VED therapy.




Penile Traction Devices

Penile traction therapy (PTT) for PD is based on the premise of using mechanical force to achieve a molecular signal, resulting in a gradual curvature reduction by a process known as mechanotransduction.12

*Modern penile traction therapy

*Clostridium collagenase histolyticum and penile traction therapy





Shockwave Therapy


Shockwave therapy (SWT) relies on an external energy source that applies pulses of energy into a fluid environment and then propagates the harnessed energy until it meets the target tissue where the energy is used.30 In a low-intensity state, SWT has been shown to induce angiogenesis,31 regenerate nerve fibers, recruit progenitor cells, vasodilate penile microcirculation,32 and improve endothelial function.33,34 LiESWT has been suggested to induce long-term structural changes that may augment erectile function.35–3

*Shockwave Therapy for Erectile Dysfunction


*Shockwave Therapy for Peyronie’s Disease




Radial Wave Shock Wave Therapy


In contrast to LiESWT, radial wave generators produce dispersive waves away from the probe, and these waves have low tissue penetrance.37,56 In comparison, LiESWT focuses more energy with a deeper tissue penetration over a shorter time, which is implicated as a regenerative technology.




Current Clinical Applications

*LiESWT




PENILE PROSTHETICS


*The Evolution of Penile Prosthesis Surgery

*Malleable Penile Prosthesis

*One-Piece Inflatable Penile Prosthesis

*Two-Piece Inflatable Penile Prosthesis


*Three-Piece Inflatable Penile Prosthesis




Surgical Innovation and Future Advances in Penile Prosthesis


Although we have come a long way since rib cartilage-enhanced erections, a new frontier of penile prostheses is constantly on the lookout. Futuristic advances in operative technique and inflation mechanics reinvigorate hope for continued safe and effective prosthetic aid in men’s sexual health.

Over the past few decades, there have been many changes to the penile prosthesis to improve durability, improve comfort, and reduce rates of infection. Current prosthesis companies, such as Boston Scientific and Coloplast, aim to integrate software programming and shape memory alloys (SMA) into the upcoming penile prosthesis for the treatment of ED. In 2019, Boston Scientific designed Tactra, a semirigid penile prosthesis made up of silicone cylinders with a core of Nitinol (nickel-titanium alloy), which provides increased rigidity and flexibility. The novel semirigid prosthesis is not coated with Inhibizone, which has been associated with lower rates of postoperative infections.82 Second, a novel approach has been the integration of temperature into the SMA IPP, which “remembers” a predetermined shape. The mechanism of these involves setting a critical temperature point. Above the set temperature, the penis achieves a rigid state, whereas, below the temperature point, the SMA achieves a flaccid state. At this time, the critical temperature point has been set at 42C, which is above normal resting body temperature and below the threshold at which pain nociceptors activate. Furthermore, this allows transitions between flaccid and rigid states without the use of a reservoir or pump.83 Last, a novel physiologic technique also using SMAs involves the use of magnetic induction, instead of hydraulic pressure, to stimulate the transition to an erect penis. Done in animal models, an external inducer wand was used to successfully activate the SMA penile prosthesis with no direct contact in less than 45 seconds.84





SUMMARY

In summary, much progress has been made in technology that can improve male sexual health. Current limitations in advanced technology include a lack of multicenter clinical trials, studies evaluating complex patient populations, and well-established treatment protocols. As technology developments and artificial intelligence expand within the medical realm, one can only expect that treatments for men’s health will continue to improve over the next decade and beyond.
 

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madman

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Fig. 1. PeniMaster PRO device characterized by its unique vacuum-based glans fixation mechanism.20 (From Moncada I, Krishnappa P, Romero J, et al. 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. BJU Int. 04 2019;123(4):694-702. https://doi.org/10.1111/bju. 14602.)
Screenshot (16152).png
 

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Fig. 2. RestoreX device featuring improvements in (1) clamp design, (2) counter-traction, and (3) dynamic adjustment.21 (From Ziegelmann M, Savage J, Toussi A, et al. Outcomes of a Novel Penile Traction Device in Men with Peyronie’s Disease: A Randomized, Single-Blind, Controlled Trial. J Urol. 09 2019;202(3):599-610. Digital Object Identifier System 10.1097/JU.0000000000000245.)
Screenshot (16153).png
 

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KEY POINTS

*Penile traction should be considered part of the initial management of erectile dysfunction and Peyronie’s disease

*Further basic science and clinical evidence are needed to elucidate the underlying mechanism for low-intensity extracorporeal shockwave therapy for treating erectile dysfunction before this can become a mainstream option

*New penile prosthetic options will become available soon to ease the use for patients and it is hoped further improve patient-reported outcomes
 
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