Chung E. et al., 2022: A Prospective, Randomized, Double-Blinded, Clinical Trial Using a Second-Generation Duolith SD1 Low-Intensity Shockwave Machine in Males with Vascular Erectile Dysfunction

Thursday, 19 May 2022

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Chung E, Bailey W, Wang J.
Department of Urology, Princess Alexandra Hospital, University of Queensland, Brisbane, QLD, Australia.
AndroUrology Centre, St Andrew's War Memorial Hospital, Brisbane, QLD, Australia.
AndroUrology Centre, St Andrew's War Memorial Hospital, Brisbane, QLD, Australia.

Abstract

Purpose: To evaluate the clinical efficacy and patient satisfaction rates of low-intensity extracorporeal shockwave therapy LIESWT) in men with vasculogenic erectile dysfunction (ED) using Duolith SD1 machine.

Materials and methods: This prospective, randomized, double-blinded clinical trial included 60 men who were randomly assigned to LIESWT (n=30, active group) or placebo (n=30) over 6 weeks. Patient demographics, change in International Index of Erectile Function (IIEF)-5, Erection Hardness Score (EHS) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores, and an overall satisfaction score (on a 5-point scale), were recorded. All patients were reviewed at 1, 3, and 6 months after completion of therapy.

Results: There were 21 (70%) patients in the LIESWT group and 3 (10%) patients in the placebo group who had a 5-point or greater increase in IIEF-5 score (p=0.018). At 6-month study period, the mean IIEF-5 score was 18.8 (standard deviation [SD], 3.8) in the LIESWT group versus 14.8 (SD, 3.6) in the placebo group, difference in means between groups was 4.0 (95% confidence interval, 2.1-5.9; p<0.001). The EHS scores were higher in the LIESWT group with a mean of greater than 1.2 across the 1, 3, and 6 months compared to the placebo group (p<0.05). All patients completed the treatment study and there was no adverse event reported in terms of penile pain, bruising or deformity. There was a positive correlation between men who reported improvement in EF and treatment satisfaction level with LiESWT (p=0.008).

Conclusions: LIESWT improves erectile function in the short-term especially in men with mild to moderate ED, and those without a cardiometabolic disease.
World J Mens Health. 2022 Jan 2. doi: 10.5534/wjmh.210123. Online ahead of print. PMID: 35021310. FREE ARTICLE

Comments 1

Jens Rassweiler on Thursday, 19 May 2022 10:30

This study focuses on patients with vasculogenic ED. nclusion crite- ria included patient age ≥18 years, has a poor response to medical therapy, a minimum 6-month history of ED, International Index of Erectile Function (IIEF)-5 score ≥12, and is in a stable sexual relationship for more than 3 months. Poor response to medical therapy was defined as a lack of adequate penile erection for sexual intercourse with the aids of oral phosphodiesterase type-5 inhibitors and/or intra-cavernosal therapy, with an IIEF-5 score less than 21.

Interestingly, washout of existing erectile medications was performed for 4 weeks prior to entry into the study and patients were refrained from using erectile medications during the study period. patients received 3,000 shocks at an energy density of 0.25 mJ/mm2 and emis- sion frequency of 6 Hz, twice weekly for 6 weeks. The treatment sites were distal penis (1,000 shockwaves), base of penis (1,000 shockwaves) and corporal bodies on the perineum (500 shockwaves to each crura). The sham treatment was performed using the same device and handpiece as in active LIESWT with the difference, namely a standoff device at the end of the handpiece that did not transmit any shockwaves despite providing the same sound as the actual LIESWT system. Only the technician operating the shockwave machine was aware of the type of treatment an individual patient had.

Changes in International Index of Erectile Function (IIEF-5), Erection Hardness Score (EHS) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores were recorded at 1-, 3-, and 6-months following completion of LIESWT study. The mean differences in the IIEF-5 scores between LIESWT and placebo groups were 2.8, 3.6 and 4.0 at 1-, 3-, and 6month follow-up period. At 6-month the mean IIEF-5 score was 18.8 in the LIESWT group versus 14.8 in the placebo group. Interestingly, most men in the placebo group reported a return to baseline IIEF-5 scores at 6 months. The EHS scores were significantly higher in the LIESWT group with more than two-thirds of men reporting a score of 4 out of 4. An improvement in EDITS Index score >50% were reported in 22 (73%) patients.

This is a very well designed RCT-trial, which clearly demonstrates the benefit of ESWT when using a standardized approach (ie. 0.25 mJ/mm2 , 3000 SW distributed on six sites per 500 impulses (basis, shaft, crura). There was no additional use of any PDE-5-inhibitors. In contrast the study design included a washout period of 4 weeks of these drugs. The patients were also all non-responders to PDE-5-inhibitors. It is also interesting, that the placebo effect diminished completely after 6 weeks. I am convinced, that such studies are important to evaluate the real advantages of ESWT in vasculogenic ED.

The limitation of the study is the short follow-up of 6 months, which has been addressed by the authors. They comment on a paper of their group with a long- term follow-up study in men following LIESWT showing a gradual decline in EF over time although this effect appeared to plateau at 48 to 60 months. This is in line with the existing literature and leads to the question of any maintenance protocol (ie. 2 treatment / week every 3 months).

Interestingly, washout of existing erectile medications was performed for 4 weeks prior to entry into the study and patients were refrained from using erectile medications during the study period. patients received 3,000 shocks at an energy density of 0.25 mJ/mm2 and emis- sion frequency of 6 Hz, twice weekly for 6 weeks. The treatment sites were distal penis (1,000 shockwaves), base of penis (1,000 shockwaves) and corporal bodies on the perineum (500 shockwaves to each crura). The sham treatment was performed using the same device and handpiece as in active LIESWT with the difference, namely a standoff device at the end of the handpiece that did not transmit any shockwaves despite providing the same sound as the actual LIESWT system. Only the technician operating the shockwave machine was aware of the type of treatment an individual patient had.

Changes in International Index of Erectile Function (IIEF-5), Erection Hardness Score (EHS) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores were recorded at 1-, 3-, and 6-months following completion of LIESWT study. The mean differences in the IIEF-5 scores between LIESWT and placebo groups were 2.8, 3.6 and 4.0 at 1-, 3-, and 6month follow-up period. At 6-month the mean IIEF-5 score was 18.8 in the LIESWT group versus 14.8 in the placebo group. Interestingly, most men in the placebo group reported a return to baseline IIEF-5 scores at 6 months. The EHS scores were significantly higher in the LIESWT group with more than two-thirds of men reporting a score of 4 out of 4. An improvement in EDITS Index score >50% were reported in 22 (73%) patients.

This is a very well designed RCT-trial, which clearly demonstrates the benefit of ESWT when using a standardized approach (ie. 0.25 mJ/mm2 , 3000 SW distributed on six sites per 500 impulses (basis, shaft, crura). There was no additional use of any PDE-5-inhibitors. In contrast the study design included a washout period of 4 weeks of these drugs. The patients were also all non-responders to PDE-5-inhibitors. It is also interesting, that the placebo effect diminished completely after 6 weeks. I am convinced, that such studies are important to evaluate the real advantages of ESWT in vasculogenic ED.

The limitation of the study is the short follow-up of 6 months, which has been addressed by the authors. They comment on a paper of their group with a long- term follow-up study in men following LIESWT showing a gradual decline in EF over time although this effect appeared to plateau at 48 to 60 months. This is in line with the existing literature and leads to the question of any maintenance protocol (ie. 2 treatment / week every 3 months).

This study focuses on patients with vasculogenic ED. nclusion crite- ria included patient age ≥18 years, has a poor response to medical therapy, a minimum 6-month history of ED, International Index of Erectile Function (IIEF)-5 score ≥12, and is in a stable sexual relationship for more than 3 months. Poor response to medical therapy was defined as a lack of adequate penile erection for sexual intercourse with the aids of oral phosphodiesterase type-5 inhibitors and/or intra-cavernosal therapy, with an IIEF-5 score less than 21. Interestingly, washout of existing erectile medications was performed for 4 weeks prior to entry into the study and patients were refrained from using erectile medications during the study period. patients received 3,000 shocks at an energy density of 0.25 mJ/mm2 and emis- sion frequency of 6 Hz, twice weekly for 6 weeks. The treatment sites were distal penis (1,000 shockwaves), base of penis (1,000 shockwaves) and corporal bodies on the perineum (500 shockwaves to each crura). The sham treatment was performed using the same device and handpiece as in active LIESWT with the difference, namely a standoff device at the end of the handpiece that did not transmit any shockwaves despite providing the same sound as the actual LIESWT system. Only the technician operating the shockwave machine was aware of the type of treatment an individual patient had. Changes in International Index of Erectile Function (IIEF-5), Erection Hardness Score (EHS) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores were recorded at 1-, 3-, and 6-months following completion of LIESWT study. The mean differences in the IIEF-5 scores between LIESWT and placebo groups were 2.8, 3.6 and 4.0 at 1-, 3-, and 6month follow-up period. At 6-month the mean IIEF-5 score was 18.8 in the LIESWT group versus 14.8 in the placebo group. Interestingly, most men in the placebo group reported a return to baseline IIEF-5 scores at 6 months. The EHS scores were significantly higher in the LIESWT group with more than two-thirds of men reporting a score of 4 out of 4. An improvement in EDITS Index score >50% were reported in 22 (73%) patients. This is a very well designed RCT-trial, which clearly demonstrates the benefit of ESWT when using a standardized approach (ie. 0.25 mJ/mm2 , 3000 SW distributed on six sites per 500 impulses (basis, shaft, crura). There was no additional use of any PDE-5-inhibitors. In contrast the study design included a washout period of 4 weeks of these drugs. The patients were also all non-responders to PDE-5-inhibitors. It is also interesting, that the placebo effect diminished completely after 6 weeks. I am convinced, that such studies are important to evaluate the real advantages of ESWT in vasculogenic ED. The limitation of the study is the short follow-up of 6 months, which has been addressed by the authors. They comment on a paper of their group with a long- term follow-up study in men following LIESWT showing a gradual decline in EF over time although this effect appeared to plateau at 48 to 60 months. This is in line with the existing literature and leads to the question of any maintenance protocol (ie. 2 treatment / week every 3 months).

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