Abstract
Background: Erectile dysfunction (ED) remains an emotional wrench to patients and a therapeutic challenge to urologists in andrology clinics worldwide. This is, in part, related to refraction to, or transient effect of phosphodiesterase 5 inhibitors (PDE5i), coupled with patients’ dissatisfaction with this treatment modality. Low-intensity extracorporeal shockwave therapy (Li-ESWT) is an evolving treatment option, with promising curative potential. Current international guidelines are inconclusive, bear weak recommendation strength, and lack ethnogeographic consensus. Objectives: This study evaluated the safety, efficacy, and effect duration of Li-ESWT, as well as exploring disease-associated determinants of treatment success in Taiwanese males with ED. Methods: A cohort of 69 eligible cases treated with 12 sessions of Li-ESWT and followed up for at least 12 months after treatment, between January 2018 and December 2019 at our medical facility, was used. The present single-center, retrospective, non-randomized, single-arm study employed standardized erectile function evaluation indices, namely, the five-item International Index of Erectile Function (IIEF-5) and Erection Hardness Score (EHS). Clinicopathological analyses of selected variables and comparative analyses of time-phased changes in the EF indices relative to baseline values were performed. Evaluation of treatment success was based on minimal clinically important difference (MCID), using a binomial logistic regression model. Results: The median age and duration of ED for our Taiwanese cohort were 55 years and 12 months, respectively, and an average of 31.3% presented with co-morbidities. The mean improvement in IIEF-5, EHS, and quality of life (QoL) domain scores relative to the baseline values was statistically very significant (p < 0.001) at all indicated follow-up time-points. When stratified, Taiwanese patients with severe and moderate ED benefited more from Li-ESWT, compared with those in the mild or mild-to-moderate group. Patients’ pre-Li-ESWT PDE5i response status was not found to significantly influence Li-ESWT response. Univariate analysis showed that age > 45 years (p = 0.04), uncontrolled diabetes mellitus (p = 0.04), and uncontrolled hyperlipidemia (p = 0.01) were strongly associated with Li-ESWT efficacy; however, only age > 45 years (p = 0.04) and uncontrolled hyperlipidemia (p = 0.03) were found to be independent negative predictors of Li-ESWT success by the multivariate logistic model. Follow-up was uneventful, with no treatment-related adverse events or side effects reported. Of the treated patients, 86.1% indicated satisfaction with the treatment regimen, and over 90% indicated they would recommend the same therapy to others. Conclusions: Li-ESWT is a safe and efficacious therapeutic modality for Taiwanese patients with ED. Uncontrolled hyperlipidemia and age > 45 years are independent negative predictors of treatment success for this cohort.
Highlights
Erectile dysfunction (ED), entailing the recurrent or consistent inability to achieve and/or maintain penile erection sufficient for coitus, remains a clinically challenging male-specific medical condition with high incidence and quality of life (QoL) implications, globally, especially with one in every two males over the age of 40 years being affected [1,2].Aging and the presence of co-morbidities such as diabetes mellitus (DM), hypertension (HTN), hyperlipidemia, hypogonadism, cardiovascular diseases (CVDs), and tobacco smoking have been implicated in the high incidence and severity of this multifactorial pathology [1,3].Despite improved understanding of the pathoetiology of ED, advances in diagnostics, and novel therapeutic strategies, ED continues to defy treatment success, with high prevalence
Consistent with reports that indicate an association between ED and other morbidities [21], we found an average of 31.3% patients with co-morbidities, namely, DM, HTN, hyperlipidemia, chronic kidney disease (CKD), and hypogonadism (Table 1)
Since contextualizing therapy-induced changes in terms of clinically relevant improvement is fundamental for an objective evaluation of treatment efficacy, proper interpretation of results across studies, and effective management of patients, adopting Rosen et al.’s minimal clinically important difference (MCID) model for treatment success, we found that low-intensity shockwave therapy (Li-ESWT) elicited a clinically relevant improvement in Index of Erectile Function (IIEF)-5 for
Summary
Erectile dysfunction (ED), entailing the recurrent or consistent inability to achieve and/or maintain penile erection sufficient for coitus, remains a clinically challenging male-specific medical condition with high incidence and quality of life (QoL) implications, globally, especially with one in every two males over the age of 40 years being affected [1,2].Aging and the presence of co-morbidities such as diabetes mellitus (DM), hypertension (HTN), hyperlipidemia, hypogonadism, cardiovascular diseases (CVDs), and tobacco smoking have been implicated in the high incidence and severity of this multifactorial pathology [1,3].Despite improved understanding of the pathoetiology of ED, advances in diagnostics, and novel therapeutic strategies, ED continues to defy treatment success, with high prevalence. 1990s, and their adoption as first-line therapy for ED [2], the touted success of PDE5i has been beleaguered by suboptimal satisfaction from about 50% of all treated patients [4] This disparaging therapy satisfaction status, which in part is attributable to disease duration and severity, has been suggested to affect patients’ compliance and the perceived efficacy of PDE5i [4,5], necessitating therapy recalibration to elicit optimal satisfaction or initiation of an alternative highly efficacious therapeutic modality in patients with ED that are non-responsive or poorly responsive to PDE5i. Erectile dysfunction (ED) remains an emotional wrench to patients and a therapeutic challenge to urologists in andrology clinics worldwide This is, in part, related to refraction to, or transient effect of phosphodiesterase 5 inhibitors (PDE5i), coupled with patients’. The mean improvement in IIEF-5, EHS, and quality of life (QoL) domain scores relative to the baseline values was statistically very significant (p < 0.001)
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