Abstract Introduction • Erectile Dysfunction (ED): A persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance, affecting ~30–65% of men aged 40–80. Conventional ED therapies include lifestyle modifications, psychosocial counseling, and oral phosphodiesterase-5 inhibitors (e.g., sildenafil). However, a significant subset of patients do not respond adequately to these treatments and may experience side effects (e.g. flushing, headache). • LI-ESWT as a Novel Therapy: Low-intensity extracorporeal shockwave therapy (LI-ESWT) has emerged in the last decade as a non-invasive, regenerative treatment alternative for ED. Unlike high-energy shockwaves used for lithotripsy, low-intensity shockwaves are thought to stimulate neoangiogenesis (new blood vessel formation) and improve penile blood flow, aiming for more durable improvements in erectile function. Preclinical and early clinical studies reported enhanced penile hemodynamics after LI-ESWT, sparking growing interest in this therapy. Objective • Objective: This work is a PRISMA-guided systematic review (2010–2025) evaluating the efficacy and safety of LI-ESWT for male ED. We synthesized evidence across all severities and age groups, focusing on clinical outcomes (erectile function scores, erection hardness, successful intercourse rates) and adverse events. Methods Methods • Literature Search: A comprehensive search was conducted in multiple databases (Google Scholar, Virtual Health Library/BVS, SciELO, and CAPES journals portal) for publications from 2010 through 2025. Keywords in English and Portuguese (e.g., “low-intensity shock wave therapy”, "LI-ESWT", “erectile dysfunction”, “ondas de choque disfunção erétil”) were used to identify relevant studies. • Study Selection: The review followed PRISMA guidelines for study screening and selection. After removing duplicates, two independent reviewers screened titles/abstracts and evaluated full texts for eligibility. Inclusion criteria: clinical studies assessing LI-ESWT for ED – primarily randomized controlled trials (RCTs) and meta-analyses of RCTs – that reported efficacy outcomes (e.g., International Index of Erectile Function IIEF scores, Erection Hardness Score EHS, Sexual Encounter Profile success rates) and/or safety data. No restrictions on language or publication status were applied. Exclusion: uncontrolled case series, single-case reports, conference abstracts without full data, and narrative reviews were excluded. • Data Extraction: From the included studies, we extracted the number of participants, patient characteristics (age, ED etiology, prior treatment response), LI-ESWT treatment protocols (device type, energy intensity, number of shockwaves per session, total sessions, treatment duration), and efficacy/safety outcomes. Over 20 RCTs were identified in the literature (many compiled in recent systematic reviews), providing a substantial evidence base. Qualitative synthesis was combined with quantitative meta-analytic data (when available) to summarize the therapeutic impact of LI-ESWT. Results • Improvements in Erectile Function (IIEF): Most RCTs and meta-analyses report significant improvements in erectile function with LI-ESWT compared to sham treatment. For example, a meta-analysis of 7 RCTs (602 patients) found the LI-ESWT group’s IIEF-Erectile Function domain score increased by ~6 points from baseline versus ~1.6 points in the placebo group (a statistically significant difference). A larger 2022 review (16 RCTs, 1,064 patients) observed a more modest but significant ~3-point higher total IIEF score in LI-ESWT–treated men at 1–6 months post-therapy compared to controls. These gains suggest a measurable clinical improvement in self-reported erectile function due to LI-ESWT. • Erection Hardness (EHS): LI-ESWT tends to improve the rigidity of erections. Patients receiving shockwave therapy were more likely to achieve erections firm enough for penetration (EHS ≥3) than those receiving sham. In one meta-analysis, 8 studies reporting EHS showed the odds of attaining a higher hardness category were roughly 5 times greater with LI-ESWT vs placebo (OR ≈5.1, 95% CI 1.8–14.4). Similarly, another analysis found about an 8-fold higher likelihood of recovering sufficient rigidity one month post-treatment in the LI-ESWT group (OR ~8.3, 95% CI ~3.9–17.8). These results indicate that shockwave therapy can meaningfully improve the physical quality of erections for many patients. • Sexual Activity Success: Some trials evaluated functional outcomes like the Sexual Encounter Profile (SEP) questions 2 and 3, which measure successful penetration and completed intercourse, respectively. Overall, meta-analyses have not found a statistically significant difference in SEP2 or SEP3 success rates between LI-ESWT and placebo groups. For instance, although more patients in the treatment arm reported positive outcomes, the difference did not reach significance (e.g., one meta-analysis reported OR ~4.2 for improved SEP3 in LI-ESWT vs sham, p = 0.13). This suggests that while LI-ESWT improves erection quality, it may not uniformly translate into higher short-term intercourse success without adjunctive therapy in some patients. • Duration of Benefit: Follow-up periods in RCTs ranged from 3 to 12 months. Short-term follow-up (up to ~3 months) consistently shows a mild-to-moderate improvement favoring LI-ESWT. Importantly, several studies indicate that benefits can persist for at least 6 months post-treatment – treated patients often maintained higher IIEF scores than sham controls at 6-month follow-up. Conclusions • Promise of LI-ESWT: Low-intensity shockwave therapy appears to be a promising addition to the ED treatment armamentarium, particularly for vasculogenic ED. This systematic review of 2010–2025 studies found that LI-ESWT yields significant but modest improvements in erectile function (IIEF scores) and erection hardness compared to sham therapy. Benefits typically emerge within a few weeks of treatment and can persist for several months. The therapy is also very safe and well tolerated, making it an attractive option for patients who cannot or do not wish to use long-term medications. • Need for Caution: However, current evidence is not yet robust enough to recommend LI-ESWT as a standalone first-line treatment for ED. The lack of standardized treatment parameters and limited long-term data prevent definitive conclusions about the durability and optimal use of shockwave therapy. At present, major sexual medicine guidelines remain cautious, and LI-ESWT is considered an experimental or investigational therapy pending further research. • Future Directions: Ongoing clinical trials and future studies (including larger RCTs with extended follow-up) are needed to establish the ideal LI-ESWT protocol and to determine which patient populations will benefit most. If evidence continues to accumulate, LI-ESWT could represent a paradigm shift by treating the underlying vascular causes of ED rather than just managing symptoms. Patients who do not respond to conventional treatments might particularly benefit from this regenerative approach. Continued rigorous investigation will clarify the long-term role of LI-ESWT in the management of erectile dysfunction worldwide. Disclosure No
Sarnoski et al. (Mon,) studied this question.
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