Thomas J. et al., 2023: Stem-Cell, Shockwave, and Platelet Rich Plasma Therapy for the Treatment of Erectile Dysfunction and Peyronie’s Disease: A Survey of Clinics Across the US

Tuesday, 08 August 2023

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Thomas J, Sencaj M, Ghomeshi A, Zucker IJ, Best JC, Ramasamy R.
Desai Sethi Urology Institute, University of Miami Miller School of Medicine, Miami, FL.
Kiran C. Patel College of Osteopathic Medicine, Nova Southeastern University, Fort Lauderdale, FL.
Herbert Wertheim College of Medicine, Florida International University, Miami, FL.
Herbert Wertheim College of Medicine, Florida International University, Miami, FL.
Desai Sethi Urology Institute, University of Miami Miller School of Medicine, Miami, FL.
Desai Sethi Urology Institute, University of Miami Miller School of Medicine, Miami, FL.

Abstract

Objective: To identify clinics offering off-label therapies for erectile dysfunction (ED) and Peyronie's disease (Pyd) including stem cell, platelet-rich plasma (PRP), and shockwave therapy and to determine the transparency they provided to patients inquiring about these treatment modalities.

Methods: Clinics were identified in different regions in the US using a systematic search on online website directories and were approached by asking a series of standardized questions regarding the cost of treatment, duration of therapy, the medical staff involved, and patient outcome data. A total of 26 clinics were surveyed for stem cell therapy, 26 for PRP treatment, and 27 for shockwave therapy.

Results: Of the 79 clinics contacted, 93.7% provided some answers to the questions we asked, with a majority offering treatments for both ED and Pyd. The cost of treatment varied widely between clinics. The average cost per stem cell therapy injection was $5291, PRP per injection was $1336, and shockwave therapy per session was $413. A physician was involved in 67% of treatments, and only 6 of 79 clinics reported that a urologist was involved. Over 75% of the clinics reported patient satisfaction following treatment. Durability of benefits to patients ranged from months to years according to the clinics' reports.

Conclusion: Our data not only demonstrate the widespread use of off-label therapies for ED and PyD across the United States but also the lack of scientific data to support the claims made to patients. This study highlights the need for more oversight and standardization in novel regenerative therapies for ED and PyD.
Urology. 2023 Apr 17;S0090-4295(23)00323-0. doi: 10.1016/j.urology.2023.01.061. Online ahead of print. PMID: 37076023

Comments 1

Jens Rassweiler on Tuesday, 08 August 2023 10:30

The article discusses the increasing attention given to men's sexual health and the emergence of various treatment modalities for erectile dysfunction (ED) and Peyronie's disease (PyD). These include stem cell injections, shockwave therapy, and platelet-rich plasma (PRP) injections. However, these therapies have not been approved by the FDA for these conditions.
The article highlights the lack of long-term data on the efficacy and safety of these treatments and the high costs associated with them, as they are not covered by insurance. Many clinics offering these therapies do not provide clear information on side effects and outcomes, adding to the emotional stress experienced by patients. The study conducted surveys with clinics offering these therapies to determine if they provide proper patient care, clear outcome expectations, and safety information.
The results showed that most clinics offered consultations to provide detailed information about the procedures. The majority of PRP and stem cell clinics offered treatments for both ED and PyD, while only 54% of shockwave therapy clinics offered treatment for both conditions. Cost of therapy varied widely between and within treatment groups. The mean cost per session for stem cell therapy, PRP injection, and shockwave therapy was $5291, $1336, and $413, respectively. Most clinics offering shockwave therapy recommended 6 or more sessions for a complete treatment, which would raise the total cost in that group.
Physicians were involved in most clinics, although urologists were rarely present. Patient satisfaction rates were generally high, but there was limited data on the duration of treatment benefits.
The article emphasizes the need for further research and standardized processes for these therapies to ensure patient safety and provide accurate information. It concludes that while some studies suggest the efficacy of these treatments in the short term, caution should be exercised, and patients should be fully informed about the experimental nature of these therapies, as there is a lack of long-term data on their safety and efficacy. Unfortunately, the authors did not consider all important references of randomized trials on the effect of Li-ESWT on erectile dysfunction which lead to the approval of the treatment in the recent EAU-guidelines. This is a significant difference compared to the other two treatment options.

Jens Rassweiler

The article discusses the increasing attention given to men's sexual health and the emergence of various treatment modalities for erectile dysfunction (ED) and Peyronie's disease (PyD). These include stem cell injections, shockwave therapy, and platelet-rich plasma (PRP) injections. However, these therapies have not been approved by the FDA for these conditions.
The article highlights the lack of long-term data on the efficacy and safety of these treatments and the high costs associated with them, as they are not covered by insurance. Many clinics offering these therapies do not provide clear information on side effects and outcomes, adding to the emotional stress experienced by patients. The study conducted surveys with clinics offering these therapies to determine if they provide proper patient care, clear outcome expectations, and safety information.
The results showed that most clinics offered consultations to provide detailed information about the procedures. The majority of PRP and stem cell clinics offered treatments for both ED and PyD, while only 54% of shockwave therapy clinics offered treatment for both conditions. Cost of therapy varied widely between and within treatment groups. The mean cost per session for stem cell therapy, PRP injection, and shockwave therapy was $5291, $1336, and $413, respectively. Most clinics offering shockwave therapy recommended 6 or more sessions for a complete treatment, which would raise the total cost in that group. 
Physicians were involved in most clinics, although urologists were rarely present. Patient satisfaction rates were generally high, but there was limited data on the duration of treatment benefits.
The article emphasizes the need for further research and standardized processes for these therapies to ensure patient safety and provide accurate information. It concludes that while some studies suggest the efficacy of these treatments in the short term, caution should be exercised, and patients should be fully informed about the experimental nature of these therapies, as there is a lack of long-term data on their safety and efficacy. Unfortunately, the authors did not consider all important references of randomized trials on the effect of Li-ESWT on erectile dysfunction which lead to the approval of the treatment in the recent EAU-guidelines. This is a significant difference compared to the other two treatment options.

Jens Rassweiler

The article discusses the increasing attention given to men's sexual health and the emergence of various treatment modalities for erectile dysfunction (ED) and Peyronie's disease (PyD). These include stem cell injections, shockwave therapy, and platelet-rich plasma (PRP) injections. However, these therapies have not been approved by the FDA for these conditions. The article highlights the lack of long-term data on the efficacy and safety of these treatments and the high costs associated with them, as they are not covered by insurance. Many clinics offering these therapies do not provide clear information on side effects and outcomes, adding to the emotional stress experienced by patients. The study conducted surveys with clinics offering these therapies to determine if they provide proper patient care, clear outcome expectations, and safety information. The results showed that most clinics offered consultations to provide detailed information about the procedures. The majority of PRP and stem cell clinics offered treatments for both ED and PyD, while only 54% of shockwave therapy clinics offered treatment for both conditions. Cost of therapy varied widely between and within treatment groups. The mean cost per session for stem cell therapy, PRP injection, and shockwave therapy was $5291, $1336, and $413, respectively. Most clinics offering shockwave therapy recommended 6 or more sessions for a complete treatment, which would raise the total cost in that group. Physicians were involved in most clinics, although urologists were rarely present. Patient satisfaction rates were generally high, but there was limited data on the duration of treatment benefits. The article emphasizes the need for further research and standardized processes for these therapies to ensure patient safety and provide accurate information. It concludes that while some studies suggest the efficacy of these treatments in the short term, caution should be exercised, and patients should be fully informed about the experimental nature of these therapies, as there is a lack of long-term data on their safety and efficacy. Unfortunately, the authors did not consider all important references of randomized trials on the effect of Li-ESWT on erectile dysfunction which lead to the approval of the treatment in the recent EAU-guidelines. This is a significant difference compared to the other two treatment options. Jens Rassweiler

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