Raheem OA. et al., 2020: Novel Treatments of Erectile Dysfunction: Review of the Current Literature

Wednesday, 03 February 2021

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Raheem OA, Natale C, Dick B, Reddy AG, Yousif A, Khera M, Baum N.
Tulane University School of Medicine, Department of Urology, New Orleans, LA, USA.
Tulane University School of Medicine, Department of Urology, New Orleans, LA, USA.
Scott Department of Urology, Baylor College of Medicine, Houston, TX, USA.

Abstract

Introduction: Although available treatments for erectile dysfunction (ED) have expanded, there has been a concomitant shift in the treatment paradigm. Newer treatment options focus on disease modification and improving overall erectile function.

Objective: The objective of this study is to review the evidence of 3 promising novel ED treatments.

Methods: A thorough review of the literature was divided into sections corresponding to low-intensity extracorporeal shockwave therapy (Li-ESWT), stem cell therapy (SCT), and platelet-rich plasma (PRP). Search terms included "erectile dysfunction" or "ED" plus "extracorporeal shockwave therapy", "stem cell therapy" or "platelet rich plasma". International Index of Erectile Function (IIEF) scores were the primary outcome measure. Secondary outcome measures included peak systolic velocity and intracorporeal pressure.

Results: Li-ESWT section includes 1 randomized controlled study, 2 prospective studies, 1 animal study, and 2 meta-analyses. IIEF score improvement was 3.54 (range 1.99-6.40). Authors concluded statistically significant short-term effect and improvement in erectile function (EF) with Li-ESWT. SCT section included 4 case series and 1 open-label study. Intraperitoneal, venous, and cavernosal SCT injections improved EF in animal models. 3 studies (n = 6-8) demonstrated 83-100% and 29-50% of patients regained erection and penetration ability, respectively. 2 studies (n = 12-16) found that all patients improved IIEF scores after SCT. Literature review for PRP yielded 3 animal, 1 retrospective, and 1 prospective study. Animal studies have shown that rats sustaining crush cavernosal injuries treated with PRP significantly improved EF and preservation of cavernous nerve axons. One retrospective analysis on humans showed mean improvement by 4.14 in IIEF scores. One prospective study on humans (n = 75) demonstrated improved peak systolic velocity (P = .005) and IIEF scores (P = .046) with PRP therapy.

Conclusions: This review reveals limited published evidence on current novel ED treatment options. Further research on Li-ESWT, SCT, and PRP therapy is necessary to elucidate the role of these therapies in ED treatment regimens. Raheem OA, Natale C, Dick B, et al. Novel Treatments of Erectile Dysfunction: Review of the Current Literature. Sex Med Rev 2021;9:123-132.
Sex Med Rev. 2021 Jan;9(1):123-132. doi: 10.1016/j.sxmr.2020.03.005. Epub 2020 Jul 4. PMID: 32631812

Comments 1

Peter Alken on Wednesday, 03 February 2021 09:30

My first impression was that many original studies on Li-ESWT were not included and I initially thought it might be due to the rigid selection criteria mentioned in the abstract: “International Index of Erectile Function (IIEF) scores were the primary outcome measure. Secondary outcome measures included peak systolic velocity and intracorporeal pressure” But in the text the authors did not refer to these parameters. Furthermore animal experiments and meta-analyses were included. This paper is a narrative review on Li-ESWT, SCT, and PRP.
The section on Li-ESWT closes with “Li-ESWT is also not currently U.S. Food and Drug Administration (FDA) approved for the treatment of ED. Given the lack of FDA approval and/or AUA guidelines, there seems to be significant variation in what is being widely marketed as Li-ESWT for ED. Another potential drawback is that it is not cost effective. When clinicians use it off-label, outside the research setting, Li-ESWT protocols can cost from USD $3,000 to $6,000 per treatment protocol.”
I wonder how they could find out that Li-ESWT is not cost effective. I always thought that cost and charge do not matter, as men who want a cure of this problem are willing to pay whatever they can afford.
The same seems to apply for the other two non-FDA-approved treatments:
“SCT is not currently FDA approved for the treatment of ED. The cost of SCT treatment, when clinicians use it off-label, outside the research setting, ranges from
USD $900 to $6,000 per treatment protocol.”
“PRP is not currently FDA approved for the treatment of ED. Another potential drawback is the treatment cost. When clinicians use it off-label, outside the research setting, PRP can cost from US $1,500 to 2,200 per treatment protocol.” Obviously more experience with PRP and its efficacy may be needed before the effectiveness is claimed and the price is increased to the $ 6,000 limit .

Peter Alken

My first impression was that many original studies on Li-ESWT were not included and I initially thought it might be due to the rigid selection criteria mentioned in the abstract: “International Index of Erectile Function (IIEF) scores were the primary outcome measure. Secondary outcome measures included peak systolic velocity and intracorporeal pressure” But in the text the authors did not refer to these parameters. Furthermore animal experiments and meta-analyses were included. This paper is a narrative review on Li-ESWT, SCT, and PRP.
The section on Li-ESWT closes with “Li-ESWT is also not currently U.S. Food and Drug Administration (FDA) approved for the treatment of ED. Given the lack of FDA approval and/or AUA guidelines, there seems to be significant variation in what is being widely marketed as Li-ESWT for ED. Another potential drawback is that it is not cost effective. When clinicians use it off-label, outside the research setting, Li-ESWT protocols can cost from USD $3,000 to $6,000 per treatment protocol.” 
I wonder how they could find out that Li-ESWT is not cost effective. I always thought that cost and charge do not matter, as men who want a cure of this problem are willing to pay whatever they can afford.
The same seems to apply for the other two non-FDA-approved treatments:
“SCT is not currently FDA approved for the treatment of ED. The cost of SCT treatment, when clinicians use it off-label, outside the research setting, ranges from
USD $900 to $6,000 per treatment protocol.”
“PRP is not currently FDA approved for the treatment of ED. Another potential drawback is the treatment cost. When clinicians use it off-label, outside the research setting, PRP can cost from US $1,500 to 2,200 per treatment protocol.” Obviously more experience with PRP and its efficacy may be needed before the effectiveness is claimed and the price is increased to the $ 6,000 limit :).

Peter Alken

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