Hypothesis / aims of study
Penile erection involves a complex interaction between neurological, vascular, and tissue components. As such, improving endothelial function and penile hemodynamics has been a focus in the development of novel treatments for erectile dysfunction (ED). This study aimed to evaluate the safety and efficacy of focused low-intensity extracorporeal shockwave therapy (Li-ESWT) in the treatment of vasculogenic ED compared to medical management over a 12-week period.
Study design, materials and methods
This was a prospective clinical study designed to compare the effectiveness of Li-ESWT with standard medical management in treating vasculogenic ED. Fifty participants diagnosed with vasculogenic ED were randomly assigned to one of two groups: Group A (n = 25): Received Li-ESWT.
and Group B (n = 25): Received medical management alone. Both groups were followed for 12 weeks, and treatment outcomes were evaluated using the International Index of Erectile Function-5 (IIEF-5), Erection Hardness Score (EHS), and the Self-Esteem and Relationship (SEAR) questionnaire.
Results
Baseline demographic characteristics were similar between the two groups (P > 0.05). Both groups showed significant improvements in IIEF-5 and EHS scores at 6 and 12 weeks (P < 0.05), though no statistically significant difference was observed between the two groups (P > 0.05). Significant improvements in SEAR scores were noted in both groups, with Li-ESWT showing a significant advantage at both 6 weeks and 12 weeks (P = 0.02). In terms of safety, Li-ESWT was associated with minimal adverse effects (8% mild penile pain, 4% bruising), while the medical management group reported a higher incidence of side effects (44%), including muscle pain (20%), headache (16%), and nausea (8%) (P < 0.05).
Interpretation of results
The study demonstrated that Li-ESWT resulted in improvements in erectile function and self-esteem comparable to medical management. The significant advantage observed with Li-ESWT in improving self-esteem and relationship scores suggests potential additional benefits beyond physical erectile function. The low incidence of adverse effects associated with Li-ESWT makes it an appealing non-invasive option compared to pharmacological treatments.