Al Hashimi M. et al., 2024: The Role of Different Modalities of Regenerative Therapies in the Treatment of Erectile Dysfunction: A Global Survey and Global Andrology Forum Expert Recommendations
Manaf Al Hashimi 1 2 3, Germar-M Pinggera 3 4, Taymour Mostafa 3 5, Rupin Shah 3 6, Bahadir Sahin 3 7, Eric Chung 3 8, Amarnath Rambhatla 3 9, Selahittin Cayan 3 10, Hiva Alipour 3 11, Maged Ragab 3 12, Omer Raheem 3 13, Mohamed Arafa 3 5 14 15, Hussain Alnajjar 3 16 17, Ateş Kadioglu 3 18, Abheesh Varma Hegde 3 19, Ahmed Harraz 3 20, Ashok Agarwa 13 21
1Department of Urology, Burjeel Hospital, Abu Dhabi, UAE.
2Department of Clinical Urology, College of Medicine and Health Science, Khalifa University, Abu Dhabi, UAE.
3Global Andrology Forum, Moreland Hills, OH, USA.
4Department of Urology, Innsbruck Medical University, Innsbruck, Austria.
5Andrology, Sexology & STIs Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
6Division of Andrology, Department of Urology, Lilavati Hospital and Research Centre, Mumbai, India.
7Department of Urology, Marmara University School of Medicine, Istanbul, Turkey.
8Department of Urology, Princess Alexandra Hospital, University of Queensland, Brisbane, Australia.
9Department of Urology, Henry Ford Health System, Vattikuti Urology Institute, Detroit, MI, USA.
10Department of Urology, University of Mersin School of Medicine, Mersin, Türkiye.
11Department of Health Science and Technology, Aalborg University Faculty of Medicine, Aalborg, Denmark.
12Urology Department, Tanta University Faculty of Medicine, Tanta, Egypt.
13Department of Urology, Cleveland Clinic Abu Dhabi, Abu Dhabi, UAE.
14Department of Urology, Hamad Medical Corporation, Doha, Qatar.
15Department of Urology, Weill Cornell Medicine-Qatar, Doha, Qatar.
16Institute of Andrology, University College London Hospital, London, UK.
17Division of Surgery and Interventional Science, University College London, London, UK.
18Section of Andrology, Department of Urology, Istanbul University Faculty of Medicine, Istanbul, Türkiye.
19Andrology Department, Father Muller Medical College, Mangalore, India.
20Urology Department, Faculty of Medicine, Mansoura University, Mansoura, Egypt.
21Cleveland Clinic, Cleveland, OH, USA.
Abstract
Purpose: There is increased interest in regenerative therapies (RTs) to treat erectile dysfunction (ED). However, the need for society's guidelines has led to varied practices. This study aims to investigate current global practices, address the heterogeneity in treatment protocols and evaluations, and establish expert recommendations in clinical practice.
Materials and methods: Senior experts from the Global Andrology Forum (GAF) created a 32-question survey to evaluate the clinical aspects of various RT modalities and compare them with each other and with phosphodiesterase type 5 inhibitors (PDE5is). The survey was distributed worldwide to ED specialists through online Google Forms, the GAF website, international professional societies, and direct emails. The responses were analyzed and are presented as percentage frequencies. Additionally, an expert consensus on recommendations for RT use was reached at via a modified Delphi method.
Results: Out of 163 respondents from 39 countries, the majority (80.1%) were using low-intensity shockwave therapy (LISWT), followed by platelet-rich plasma (PRP) 61.3% and stem cell therapy (SCT) 17.8%. Efficacy comparisons revealed no perceived significant differences among RT modalities (p=0.124). Compared to PDE5is, the efficacy of LISWT and PRP was considered lower by the respondents, while SCT was rated better by almost half of those who used SCT. The duration of improvement varied (p=0.279), with most improvements lasting 1 to 6 months. The treatment protocols used for LISWT were mainly consistent but varied widely for PRP and SCT. Adverse effects were minimal, particularly for LISWT (p<0.001). The costs varied significantly (p<0.001), with SCT being the most expensive. The evidence for efficacy was rated as primarily moderate to strong for LISWT but poor for PRP and SCT (p=0.027).
Conclusions: Most respondents utilized LISWT, followed by PRP, with SCT being the least commonly utilized. The high break heterogeneity in treatment protocols and evaluation of RT underscores the need for further studies and guidelines to establish best practices.
Mens Health. 2024 Nov 27. doi: 10.5534/wjmh.240214. Online ahead of print. PMID: 39743219
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Introduction: Erectile Dysfunction (ED) is a prevalent condition, negatively impacting a man's quality of life. The causes of ED are multifactorial, including age, smoking, diabetes, obesity, depression, cardiovascular diseases, and more. Current treatment options range from lifestyle changes, oral medications, and injections to implants. Phosphodiesterase type 5 inhibitors (PDE5is) are often the first-line treatment but have limitations for some patients.
In response to this, regenerative therapies (RT), including low-intensity shock wave therapy (LISWT), platelet-rich plasma (PRP), and stem cell therapy (SCT), have been explored as promising alternatives or adjuncts. RT seeks to repair or replace damaged tissue, stimulating the body’s regenerative capabilities for long-term improvement. However, these therapies remain experimental, with no consensus on their standard use.
Material and Methods: A global survey conducted by the Global Andrology Forum (GAF) in 2023 investigated worldwide practices related to RT in ED treatment. 479 participants from 63 countries shared insights into their clinical use of these therapies. The main reasons for adopting RT included adverse effects from other treatments, poor response to conventional therapies, and the hope for long-term cures. LISWT was the most frequently used RT modality, followed by PRP, while SCT was the least used.
Survey Findings: The survey gathered responses from urologists, andrologists, sexologists, and other specialists, with the majority having over 15 years of experience in ED management. The highest number of respondents came from the United Arab Emirates, Turkey, and Egypt.
Types of Regenerative Therapy used: LISWT was used by 81% of respondents. PRP was utilized by 61.3%. SCT was the least used, with only 17.8% of respondents.
Efficacy Comparisons:
LISWT: One-third of participants felt it was more effective than other RTs. However, a significant portion (42.5%) rated it less effective compared to PDE5is. LISWT showed improvements lasting 3–6 months in many patients.
PRP: Most responses rated it similarly to LISWT, with many respondents unsure about its relative efficacy. PRP improvements typically lasted 1–3 months.
SCT: A significant portion of SCT users rated it more effective than PDE5is. However, there was variability in perceived effectiveness. SCT showed variable results, with effects lasting between 1–3 months in some cases.
Protocols for RT Application: Most clinicians used consistent protocols, with LISWT and PRP protocols being more standardized than SCT, which had more variable application methods. LISWT often followed a 6-session/month regimen, while PRP varied widely in its application, ranging from one to multiple sessions.
Adverse Effects: LISWT had minimal adverse effects, with most participants reporting no side effects. PRP had minor side effects such as bruising, while SCT showed a higher incidence of minor adverse effects, including penile curvature and hematoma.
Combination Therapies: LISWT was most often used alone, but many participants combined it with PRP (39.4%). PRP was frequently combined with LISWT (61%) and less so with SCT. SCT was more often used in combination with LISWT than as a standalone treatment.
Evidence and Recommendations: Perceptions of available evidence for RT in ED treatment varied: LISWT had moderate evidence (53.8% of respondents), with a significant portion rating its evidence as weak. PRP and SCT were perceived as having weaker evidence, with poor to no evidence reported by many respondents.
GAF Expert Recommendations: Their consensus emphasized cautious use of RT therapies for ED until further research is conducted to confirm their efficacy. Standardized protocols, consistent application, and monitoring for adverse effects were highlighted as important clinical practices.
Conclusion:
Although RT modalities like LISWT, PRP, and SCT show promise, their use in ED treatment is still largely experimental. While LISWT is the most frequently applied and well-studied modality, PRP and SCT have variable effectiveness and are associated with less conclusive evidence. The Global Andrology Forum continues to encourage more rigorous research and clinical trials to better define the role of RT in ED treatment and establish standardized protocols.
Jens Rassweiler