Level B· Emerging clinical evidence with positive signalsRandomized Controlled TrialEurope PMCOpen access

Enhancing penile function: the impact of a regenerative multimodal protocol on erectile dysfunction

Soto-Rodríguez A., Pastora-Sesín C., Valverde-Espinoza JA., Campos-Sanchez S., Mauro-Stamati M., Giampapa V.

Randomized Controlled Trial with a reported sample of 22 on Systemic / IV, published in Front Reprod Health (2025) — summary generated from the PubMed abstract.

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Level B· Emerging clinical evidence with positive signalsEvidence level of this study

Several human studies show positive signals, while research methods and sample sizes continue to develop.

  • Level A · Stronger Clinical Evidence
  • Level B · Emerging clinical evidence with positive signals
  • Level C · Early human research exploring benefits
  • Level D · Scientific groundwork from lab and animal studies
  • Emerging · Emerging topic under active research
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This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.

Study type
Randomized Controlled Trial
Journal
Front Reprod Health (2025)
Reported sample size
22
Source database
Europe PMC
PMID
41089526
PMCID
PMC12515801
DOI
10.3389/frph.2025.1601354

Abstract (original English)

Background Erectile dysfunction (ED) is a prevalent condition impacting men's quality of life and is often linked to cardiovascular and metabolic disorders. Conventional treatments like phosphodiesterase type 5 (PDE5) inhibitors could be ineffective for severe cases, indicating a need for innovative approaches. This study aimed to evaluate the efficacy and safety of a multimodal protocol combining low-intensity shockwave therapy (LiST), intrapenile and intravenous umbilical cord-mesenchymal stem cell (UC-MSCs) therapy, and hyperbaric oxygen therapy (HBOT) in men with ED. A retrospective pragmatic observational study was performed by reviewing medical records of 22 men treated at a private clinic in Costa Rica. Erectile function was measured using the Sexual Health Inventory for Men (SHIM) questionnaire before treatment and three months post-treatment. Results The protocol significantly improved SHIM scores, with a mean increase of 3 points from baseline ( p = 0.0017). No major adverse events were reported during follow-up. Conclusion The multimodal protocol demonstrated a significant improvement in erectile function with a favorable safety profile, suggesting potential as a viable option for patients with ED. Further prospective randomized controlled trials are needed to validate these findings.

What this study does not prove

  • • This study does not prove SVF is an approved treatment or a replacement for standard care.

Evidence level

Several human studies show positive signals, while research methods and sample sizes continue to develop.

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