Fode M. 2025: Regenerative therapies for male sexual dysfunction - a review article.

Mikkel Fode
Dan Med J. 2025 Oct 29;72(12):A04250307. doi: 10.61409/A04250307 FREE ARTICLE

Abstract

Low-intensity extracorporeal shock wave therapy (Li-ESWT), stem cell therapy and platelet-rich plasma (PRP) injections have emerged as possible treatments for erectile dysfunction (ED) and Peyronie's disease (PD). Li-ESWT appears to work by prompting angiogenesis, yet clinical trials in ED and PD have yielded contradictory results, often compromised by methodological limitations. Similarly, while preliminary studies on stem cell therapy and PRP suggest potential benefits, their clinical efficacy remains uncertain. Standardised research is needed to establish the possible effect of these approaches.

Comment Jens Rassweiler

The article provides a comprehensive review of regenerative therapies for male sexual dysfunction, specifically focusing on erectile dysfunction (ED) and Peyronie’s disease (PD).

Overview

Erectile Dysfunction (ED): Affects about 30% of men over 40, with prevalence increasing with age. ED is characterized by the inability to achieve or maintain an erection sufficient for satisfactory intercourse.

Peyronie’s Disease (PD): A connective tissue disorder affecting about 5-10% of men, resulting in fibrotic plaques that cause painful erections and penile curvature, significantly impacting quality of life.

Current Treatments

- Conventional treatments (e.g., PDE5 inhibitors, vacuum devices, injections) provide temporary relief but do not cure ED or PD. Surgical options are invasive and reserved for severe cases.

- Regenerative Therapies

1. Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT):

   - Mechanism: Uses acoustic shock waves to induce mechanical stress, promoting angiogenesis and potentially nerve regeneration.

   - Clinical Evidence: Mixed results; some studies show improvement in ED while others do not. Trials often have methodological limitations, and treatment protocols vary significantly. The author does not mention, that Li-ESWT is recommended in EAU-guidelines for treatment of vasculogenic ED.

For PD, Li-ESWT has shown pain reduction but inconsistent results regarding curvature improvement.

2. Stem Cell Therapy:

   - Mechanism: Aims to repair damaged tissue through the regenerative capabilities of stem cells.

   - Clinical Evidence: Limited and largely derived from small studies. Some trials indicate modest improvements in erectile function post-treatment, but robust evidence is lacking. For PD, preliminary studies suggest potential curvature improvements, but results are inconsistent.

3. Platelet-Rich Plasma (PRP) Therapy:

   - Mechanism: Utilizes concentrated platelets from the patient’s blood to release growth factors that promote tissue repair and angiogenesis.

   - Clinical Evidence: Early studies show promise, but three randomized controlled trials report mixed results. Some trials indicate significant improvements in erectile function, while others do not show any benefits. For PD, research is scarce, and outcomes vary.

Conclusion

The article concludes that while regenerative therapies like Li-ESWT, stem cell therapy, and PRP show promise in treating male sexual dysfunction, the current evidence is limited and contradictory. None have yet proven to be effective as curative treatments for ED or as reliable conservative options for PD. The authors emphasize the need for large-scale, high-quality randomized controlled trials to establish efficacy and safety before these therapies can be integrated into clinical practice. Until then, these treatments remain experimental and controversial.

Discussion

The article presents a critical and cautious perspective on regenerative therapies for male sexual dysfunction, which is both necessary and valuable for a few reasons:

1. Evidence-Based Medicine: The article emphasizes the importance of robust clinical evidence before adopting new treatments. It highlights that many studies on regenerative therapies have methodological limitations, small sample sizes, and inconsistent results. This critique is essential to ensure that patients are not exposed to treatments that may be ineffective or carry unknown risks.

2. Patient Safety and Expectations: By labeling these treatments as experimental and not yet established, the article serves to manage patient expectations. Many individuals seeking relief from ED and PD may be drawn to regenerative therapies due to dissatisfaction with conventional options. A critical stance helps prevent the potential exploitation of vulnerable patients by providers offering unproven therapies at high costs.

3. Call for Standardization: The article stresses the need for standardized research protocols and larger, well-designed trials. This is crucial for advancing the field and ensuring that any future recommendations are based on solid evidence, rather than anecdotal success stories or small pilot studies.

4. Balanced Perspective: While the article is critical, it does not dismiss the potential of regenerative therapies outright. It acknowledges that there is preliminary data suggesting some benefits but emphasizes the need for more comprehensive research. This balanced approach encourages continued exploration of these therapies while prioritizing patient safety and scientific rigor.

5. Impact on Treatment Landscape: The article's critical message reflects the broader challenges within the medical community regarding the integration of innovative therapies. It underscores the need for ongoing dialogue about the effectiveness and safety of emerging treatments, ensuring that advancements in regenerative medicine are rigorously evaluated.

In summary, the article's critical stance is justified, as it prioritizes patient care, safety, and the necessity for evidence-based practice. It serves as a reminder that while the potential for regenerative therapies exists, caution and rigorous scientific evaluation are essential before they can be widely accepted and recommended in clinical settings.

Jens Rassweiler