Bocchino AC. et al., 2023: Low-intensity extracorporeal shock wave therapy for erectile dysfunction: Myths and realities

Wednesday, 28 June 2023

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Bocchino AC, Pezzoli M, Martínez-Salamanca JI, Russo GI, Giudice AL, Cocci A.
Department of Urology, University of Cagliari, Santissima Trinità Hospital, Cagliari, Italy.
Department of Urology, University of Florence, Careggi Hospital, Florence, Italy.
Department of Urology, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain.
Department of Urology, University of Catania, Catania, Italy.
Department of Urology, University of Florence, Careggi Hospital, Florence, Italy.

Abstract

To review the evidence of clinical efficacy of low-intensity extracorporeal shock wave therapy (Li-ESWT) for the treatment of erectile dysfunction (ED). A search on PubMed using Medical Subject Headings terms [((low intensity extracorporeal shockwave therapy) OR (Li-ESWT)) AND (erectile dysfunction)] was conducted in August 2022, to obtain studies on the use of Li-ESWT for the treatment of ED. Its success rate in terms of International Index of Erectile Function-5 (IIEF-5) score and Erection Hardness Score (EHS) improvement was recorded and analysed. A total of 139 articles were reviewed. Overall, 52 studies were included in the final review. 17 studies were on vasculogenic ED, 5 on post pelvic surgery ED, 4 specifically on ED in diabetic patients, 24 on non-specified origin ED and 2 on mixed pathophysiological origin ED. The mean age of patients was 55.87±7.91 (standard deviation) years and the duration of ED was 4.36±2.08 years. The mean IIEF-5 score went from 12.04±2.67 at baseline to 16.12±5.72, 16.30±3.26 and 16.85±1.63 respectively at 3, 6 and 12 months. The mean EHS went from 2.00±0.46 at baseline to 2.58±0.60, 2.75±0.46 and 2.87±0.16 respectively at 3, 6 and 12 months. Li-ESWT may be a safe and efficacy option for the treatment and cure of ED. Further studies are needed to assess which patients are more suitable for this procedure and which Li-ESWT protocol can lead to the best outcomes.
Investig Clin Urol. 2023 Mar;64(2):118-125. doi: 10.4111/icu.20220327. PMID: 36882170. FREE ARTICLE

Comments 1

Jens Rassweiler on Wednesday, 28 June 2023 10:30

In recent years, low-intensity extracorporeal shock wave therapy (Li-ESWT) has been suggested as a promising treatment for vasculogenic ED, being the only currently available treatment that could provide a cure, which is the most desired outcome for most men suffering from ED. The healing rationale is the documented effect of this acoustic waves in inducing cellular pathways that increase the expression of local growth factors, improving endothelial function, angiogenesis, and perhaps even regeneration of nerve fibers.

Following the first reporting of Li-ESWT in the treatment of ED by Vardi et al. in 2010, several studies have evaluated the efficacy of Li-ESWT in different pathways of ED, either organic (vasculogenic or neurogenic) or mixed. The patients included in the studies show significant differences as regard cardiovascular risk factors, response to PDE5I, duration and severity of ED. Furthermore, there is a wide heterogeneity among shock-wave generators, type of shockwaves emitted, setting parameters, and treatment protocols used.

To acquire evidence on the myths and the realities of the efficacy of Li- ESWT for the treatment of ED, the authors reviewed the available literature considering the achievable outcomes when applied to different patients, erectile disfunction etiologies and protocols.
A total of 139 articles were reviewed. Overall, 52 studies were included in the final review. 17 studies were on vasculogenic ED, 5 on post pelvic surgery ED, 4 specifically on ED in diabetic patients, 24 on non-specified origin ED and 2 on mixed pathophysiological origin ED.
As concerning the characteristics of Li-ESWT, the pooled mean of number of shocks per treatment was 3,230±2,138, the pooled mean of total number of shocks was 26,310±18,324 and the pooled EFD was 0.01±0.03 mJ/mm2. Analyzing the base- line characteristics of the patients, the pooled mean IIEF-5 was 12.04±2.67 while the pooled mean EHS was 2.00±0.46.
However, the low energy density reported (0.01 mJ/mm2) does not correlate to recent meta-analyses where the range of EFD was 0.09 to 0.25 mJ/mm2! This needs further clarification.

After treatment, the pooled IIEF-5 at 3 months was 16.12±5.72, the pooled IIEF-5 at 6 months was 16.30±3.26 and the pooled IIEF-5 at 12 months was 16.85±1.63. After treatment, the pooled EHS at 3 months was 2.58±0.60, the pooled EHS at 6 months was 2.75±0.46 and the pooled EHS at 12 months was 2.87±0.16. The pooled IIEF-5 score at three months after the procedure compared with baseline suggests that Li-ESWT can induce a fast and effective result on the sexual function, which lasts up at least to twelve months. As regards EHS, compared to the baseline value the improvement achieved at 3 months tends to increase at six and twelve months. The increase of EHS in the short term appears more evident than the one of IIEF-5 score. The reason could be that the treatment rapidly allows to reach a greater penile hardness, but it improves less significantly the ability to maintain the erection in the first months.

Interestingly, up to now, there is no evidence, hat the type of shock wave source has a significant impact on the outcome of Li-ESWT. In the management of ED, it seems to be irrelevant, whether the acoustic energy is administered via a focused or linear transducer. Nevertheless, other meta-analyses found a positive impact of higher energy flux density. Thus, the actual recommendation of the German Society of Shock Wave Therapy (DIGEST) and the German Society of Shockwave Lithotripsy and Therapy (DGSWL) is to use 3000 Shocks at 6 positions (proximal shaft, distal shaft, crura) applying each 500 impulses at 0.2 mJ/mm2 with 6 weekly sessions.

The result of this review indicates that Li-ESWT can be a valid option in the wide range of treatments for ED, especially in patients who poorly respond to oral medications and who are unwilling to face more invasive procedures. Surely, further studies are needed to understand which patients may mostly benefit from treatment and which protocol it can give the best outcomes.

Jens Rassweiler

Following the first reporting of Li-ESWT in the treatment of ED by Vardi et al. in 2010, several studies have evaluated the efficacy of Li-ESWT in different pathways of ED, either organic (vasculogenic or neurogenic) or mixed. The patients included in the studies show significant differences as regard cardiovascular risk factors, response to PDE5I, duration and severity of ED. Furthermore, there is a wide heterogeneity among shock-wave generators, type of shockwaves emitted, setting parameters, and treatment protocols used.

To acquire evidence on the myths and the realities of the efficacy of Li- ESWT for the treatment of ED, the authors reviewed the available literature considering the achievable outcomes when applied to different patients, erectile disfunction etiologies and protocols. 
A total of 139 articles were reviewed. Overall, 52 studies were included in the final review. 17 studies were on vasculogenic ED, 5 on post pelvic surgery ED, 4 specifically on ED in diabetic patients, 24 on non-specified origin ED and 2 on mixed pathophysiological origin ED. 
As concerning the characteristics of Li-ESWT, the pooled mean of number of shocks per treatment was 3,230±2,138, the pooled mean of total number of shocks was 26,310±18,324 and the pooled EFD was 0.01±0.03 mJ/mm2. Analyzing the base- line characteristics of the patients, the pooled mean IIEF-5 was 12.04±2.67 while the pooled mean EHS was 2.00±0.46. 
However, the low energy density reported (0.01 mJ/mm2) does not correlate to recent meta-analyses where the range of EFD was 0.09 to 0.25 mJ/mm2! This needs further clarification.

After treatment, the pooled IIEF-5 at 3 months was 16.12±5.72, the pooled IIEF-5 at 6 months was 16.30±3.26 and the pooled IIEF-5 at 12 months was 16.85±1.63. After treatment, the pooled EHS at 3 months was 2.58±0.60, the pooled EHS at 6 months was 2.75±0.46 and the pooled EHS at 12 months was 2.87±0.16.  The pooled IIEF-5 score at three months after the procedure compared with baseline suggests that Li-ESWT can induce a fast and effective result on the sexual function, which lasts up at least to twelve months. As regards EHS, compared to the baseline value the improvement achieved at 3 months tends to increase at six  and twelve months. The increase of EHS in the short term appears more evident than the one of IIEF-5 score. The reason could be that the treatment rapidly allows to reach a greater penile hardness, but it improves less significantly the ability to maintain the erection in the first months.

Interestingly, up to now, there is no evidence, hat the type of shock wave source has a significant impact on the outcome of Li-ESWT. In the management of ED, it seems to be irrelevant, whether the acoustic energy is administered via a focused or linear transducer. Nevertheless, other meta-analyses found a positive impact of higher energy flux density. Thus, the actual recommendation of the German Society of Shock Wave Therapy (DIGEST) and the German Society of Shockwave Lithotripsy and Therapy (DGSWL) is to use 3000 Shocks at 6 positions (proximal shaft, distal shaft, crura) applying each 500 impulses at 0.2 mJ/mm2 with 6 weekly sessions.

The result of this review indicates that Li-ESWT can be a valid option in the wide range of treatments for ED, especially in patients who poorly respond to oral medications and who are unwilling to face more invasive procedures. Surely, further studies are needed to understand which patients may mostly benefit from treatment and which protocol it can give the best outcomes.

Jens Rassweiler

In recent years, low-intensity extracorporeal shock wave therapy (Li-ESWT) has been suggested as a promising treatment for vasculogenic ED, being the only currently available treatment that could provide a cure, which is the most desired outcome for most men suffering from ED. The healing rationale is the documented effect of this acoustic waves in inducing cellular pathways that increase the expression of local growth factors, improving endothelial function, angiogenesis, and perhaps even regeneration of nerve fibers. Following the first reporting of Li-ESWT in the treatment of ED by Vardi et al. in 2010, several studies have evaluated the efficacy of Li-ESWT in different pathways of ED, either organic (vasculogenic or neurogenic) or mixed. The patients included in the studies show significant differences as regard cardiovascular risk factors, response to PDE5I, duration and severity of ED. Furthermore, there is a wide heterogeneity among shock-wave generators, type of shockwaves emitted, setting parameters, and treatment protocols used. To acquire evidence on the myths and the realities of the efficacy of Li- ESWT for the treatment of ED, the authors reviewed the available literature considering the achievable outcomes when applied to different patients, erectile disfunction etiologies and protocols. A total of 139 articles were reviewed. Overall, 52 studies were included in the final review. 17 studies were on vasculogenic ED, 5 on post pelvic surgery ED, 4 specifically on ED in diabetic patients, 24 on non-specified origin ED and 2 on mixed pathophysiological origin ED. As concerning the characteristics of Li-ESWT, the pooled mean of number of shocks per treatment was 3,230±2,138, the pooled mean of total number of shocks was 26,310±18,324 and the pooled EFD was 0.01±0.03 mJ/mm2. Analyzing the base- line characteristics of the patients, the pooled mean IIEF-5 was 12.04±2.67 while the pooled mean EHS was 2.00±0.46. However, the low energy density reported (0.01 mJ/mm2) does not correlate to recent meta-analyses where the range of EFD was 0.09 to 0.25 mJ/mm2! This needs further clarification. After treatment, the pooled IIEF-5 at 3 months was 16.12±5.72, the pooled IIEF-5 at 6 months was 16.30±3.26 and the pooled IIEF-5 at 12 months was 16.85±1.63. After treatment, the pooled EHS at 3 months was 2.58±0.60, the pooled EHS at 6 months was 2.75±0.46 and the pooled EHS at 12 months was 2.87±0.16. The pooled IIEF-5 score at three months after the procedure compared with baseline suggests that Li-ESWT can induce a fast and effective result on the sexual function, which lasts up at least to twelve months. As regards EHS, compared to the baseline value the improvement achieved at 3 months tends to increase at six and twelve months. The increase of EHS in the short term appears more evident than the one of IIEF-5 score. The reason could be that the treatment rapidly allows to reach a greater penile hardness, but it improves less significantly the ability to maintain the erection in the first months. Interestingly, up to now, there is no evidence, hat the type of shock wave source has a significant impact on the outcome of Li-ESWT. In the management of ED, it seems to be irrelevant, whether the acoustic energy is administered via a focused or linear transducer. Nevertheless, other meta-analyses found a positive impact of higher energy flux density. Thus, the actual recommendation of the German Society of Shock Wave Therapy (DIGEST) and the German Society of Shockwave Lithotripsy and Therapy (DGSWL) is to use 3000 Shocks at 6 positions (proximal shaft, distal shaft, crura) applying each 500 impulses at 0.2 mJ/mm2 with 6 weekly sessions. The result of this review indicates that Li-ESWT can be a valid option in the wide range of treatments for ED, especially in patients who poorly respond to oral medications and who are unwilling to face more invasive procedures. Surely, further studies are needed to understand which patients may mostly benefit from treatment and which protocol it can give the best outcomes. Jens Rassweiler

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