Kalyvianakis et al., 2022: The Effect of Low-Intensity Shock Wave Therapy on Moderate Erectile Dysfunction: A Double-Blind, Randomized, Sham-Controlled Clinical Trial

Thursday, 01 December 2022

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Kalyvianakis D, Mykoniatis I, Pyrgidis N, Kapoteli P, Zilotis F, Fournaraki A, Hatzichristou D.
First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Institute for the Study of Urological Diseases, Thessaloniki, Greece.

Abstract

Purpose: We conducted the first double-blind, randomized, sham-controlled trial evaluating the efficacy and safety of low-intensity shock wave therapy (LiST) exclusively in patients with moderate erectile dysfunction.

Materials and methods: Seventy patients were randomized to 12 sessions of LiST (35) or sham therapy (35) twice weekly. Patients were evaluated at 1 and 3 months after completion of treatment. The proportion of participants attaining minimal clinically important difference (MCID) in the International Index of Erectile Function-Erectile Function (IIEF-EF) and the effect of LiST on erectile function, as well as on safety, were the study outcomes.

Results: At 3 months, MCID was attained by 27 (79%) patients in the LiST group compared to 0 patients in the sham group. The risk difference between the 2 groups was 79% (95% confidence interval [CI]: 66-93, p <0.001) and the baseline-adjusted mean between-group-difference in the IIEF-EF was 4.4 points (95% CI: 3.4-5.4, p <0.001). At 1 month, MCID was attained by 20 (59%) patients in the LiST group compared to 1 (2.9%) patient in the sham group. The risk difference between the 2 groups was 56% (95% CI: 38-73, p <0.001) and the baseline-adjusted mean between-group-difference in the IIEF-EF was 3.9 points (95% CI: 2.7-5.2, p <0.001).

Conclusions: Twelve sessions of LiST twice weekly for 6 weeks with a treatment protocol of 5,000 impulses, 0.096 mJ/mm2 energy flux density and 5 Hz frequency are highly effective in patients with moderate erectile dysfunction. Still, further long-term randomized studies are warranted to corroborate our findings.
J Urol. 2022 Aug;208(2):388-395. doi: 10.1097/JU.0000000000002684. Epub 2022 May 6.

Comments 1

Jens Rassweiler on Thursday, 01 December 2022 09:30

The role of low- intensity shock wave therapy for severe erectile dysfunction (i.e. non-responder to PDE5-inhibitors) has been proven in several randomized studies, however in patients with moderate erectile dysfunction it remains uncaptured. This study represents the first double-blind, randomized, sham-controlled trial to evaluate the efficacy and safety of low-intensity shock wave therapy exclusively in patients with moderate vasculogenic erectile dysfunction.
The authors defined the following inclusion criteria:
1) sexually active male patients 40-70 years old in a stable, hetero- sexual relationship for more than 3 months,
2) presence of vasculogenic ED (defined after medical history by experi- enced clinicians) for at least 6 months,
3) regular use of any phosphodiesterase type 5 (PDE5) inhibitor with good or partial response to treatment (defined as at least 5/10 successful sexual intercourse attempts),
4) presence of moderate vasculogenic ED after a 1-month washout from PDE5 inhibitors, documented with an 11e16 score in the International Index of Erectile Function-Erectile Function (IIEF-EF).
Based on this, a total of 70 patients with moderate ED were randomized to Li-ESWT (35) or sham therapy (35). Patients allocated to LiST received during each session 5,000 impulses along the penis at an energy flux density of 0.096 mJ/mm2 and a frequency of 5 Hz (level 7 at the ARIES 2 electromagnetic generator, Dornier MedTech, Wessling). More specifically, 2,000 impulses were delivered to the corpora cavernosa, 2,000 to the crura cavernosa and 1,000 to the penile hila. They received 12 treatments (2xweekly)over 6 weeks.
At 1 month, MCID was attained by 20 (59%) pa- tients in the LiST group compared to 1 (2.9%) patient in the sham group. The risk difference between the 2 groups was 56% (95% CI: 38e73, p less than 0.001) and the baseline-adjusted mean between-group-difference in the IIEF-EF was 3.9 points (95% CI: 2.7e5.2, p less than 0.001). At 3 months, MCID was attained by 27 (79%) patients in the LiST group compared to 0 patients in the sham group. The risk difference between the 2 groups was 79% (95% confidence interval [CI]: 66e93, p less than 0.001) and the baseline-adjusted mean between-group-difference in the IIEF-EF was 4.4 points (95% CI: 3.4e5.4, p less than 0.001).
This study is very interesting, because if defines a theoretically ideal patient group suffering from moderate vasculogenic ED. The data are very clear, however, the follow-up of 3 months is very short. Unfortunately, the authors do not provide any data, how many of the patients were able to discontinue PDE5.inhibitors. Obviously a longer follow-up is necessary to define, whether these 12 treatment wit Li-ESWT are able to “regenerate” the cavernous tissue. As the authors already pointed out some more objective data like Color duplex flow-studies, Ultrasound of the penis (i.e. undr artificial erection) to add further data to this interesting trial.

Jens Rassweiler

The role of low- intensity shock wave therapy for severe erectile dysfunction (i.e. non-responder to PDE5-inhibitors) has been proven in several randomized studies, however in patients with moderate erectile dysfunction it remains uncaptured. This study represents the first double-blind, randomized, sham-controlled trial to evaluate the efficacy and safety of low-intensity shock wave therapy exclusively in patients with moderate vasculogenic erectile dysfunction. 
The authors defined the following inclusion criteria:
1) sexually active male patients 40-70 years old in a stable, hetero- sexual relationship for more than 3 months, 
2) presence of vasculogenic ED (defined after medical history by experi- enced clinicians) for at least 6 months, 
3) regular use of any phosphodiesterase type 5 (PDE5) inhibitor with good or partial response to treatment (defined as at least 5/10 successful sexual intercourse attempts), 
4) presence of moderate vasculogenic ED after a 1-month washout from PDE5 inhibitors, documented with an 11e16 score in the International Index of Erectile Function-Erectile Function (IIEF-EF).
Based on this, a total of 70 patients with moderate ED were randomized to Li-ESWT (35) or sham therapy (35). Patients allocated to LiST received during each session 5,000 impulses along the penis at an energy flux density of 0.096 mJ/mm2 and a frequency of 5 Hz (level 7 at the ARIES 2 electromagnetic generator, Dornier MedTech, Wessling). More specifically, 2,000 impulses were delivered to the corpora cavernosa, 2,000 to the crura cavernosa and 1,000 to the penile hila. They received 12 treatments (2xweekly)over 6 weeks.
At 1 month, MCID was attained by 20 (59%) pa- tients in the LiST group compared to 1 (2.9%) patient in the sham group. The risk difference between the 2 groups was 56% (95% CI: 38e73, p  less than 0.001) and the baseline-adjusted mean between-group-difference in the IIEF-EF was 3.9 points (95% CI: 2.7e5.2, p less than 0.001). At 3 months, MCID was attained by 27 (79%) patients in the LiST group compared to 0 patients in the sham group. The risk difference between the 2 groups was 79% (95% confidence interval [CI]: 66e93, p less than 0.001) and the baseline-adjusted mean between-group-difference in the IIEF-EF was 4.4 points (95% CI: 3.4e5.4, p less than 0.001). 
This study is very interesting, because if defines a theoretically ideal patient group suffering from moderate vasculogenic ED. The data are very clear, however, the follow-up of 3 months is very short. Unfortunately, the authors do not provide any data, how many of the patients were able to discontinue PDE5.inhibitors. Obviously a longer follow-up is necessary to define, whether these 12 treatment  wit Li-ESWT are able to “regenerate” the cavernous tissue. As the authors already pointed out some more objective data like Color duplex flow-studies, Ultrasound of the penis (i.e. undr artificial erection) to add further data to this interesting trial.

Jens Rassweiler

The role of low- intensity shock wave therapy for severe erectile dysfunction (i.e. non-responder to PDE5-inhibitors) has been proven in several randomized studies, however in patients with moderate erectile dysfunction it remains uncaptured. This study represents the first double-blind, randomized, sham-controlled trial to evaluate the efficacy and safety of low-intensity shock wave therapy exclusively in patients with moderate vasculogenic erectile dysfunction. The authors defined the following inclusion criteria: 1) sexually active male patients 40-70 years old in a stable, hetero- sexual relationship for more than 3 months, 2) presence of vasculogenic ED (defined after medical history by experi- enced clinicians) for at least 6 months, 3) regular use of any phosphodiesterase type 5 (PDE5) inhibitor with good or partial response to treatment (defined as at least 5/10 successful sexual intercourse attempts), 4) presence of moderate vasculogenic ED after a 1-month washout from PDE5 inhibitors, documented with an 11e16 score in the International Index of Erectile Function-Erectile Function (IIEF-EF). Based on this, a total of 70 patients with moderate ED were randomized to Li-ESWT (35) or sham therapy (35). Patients allocated to LiST received during each session 5,000 impulses along the penis at an energy flux density of 0.096 mJ/mm2 and a frequency of 5 Hz (level 7 at the ARIES 2 electromagnetic generator, Dornier MedTech, Wessling). More specifically, 2,000 impulses were delivered to the corpora cavernosa, 2,000 to the crura cavernosa and 1,000 to the penile hila. They received 12 treatments (2xweekly)over 6 weeks. At 1 month, MCID was attained by 20 (59%) pa- tients in the LiST group compared to 1 (2.9%) patient in the sham group. The risk difference between the 2 groups was 56% (95% CI: 38e73, p less than 0.001) and the baseline-adjusted mean between-group-difference in the IIEF-EF was 3.9 points (95% CI: 2.7e5.2, p less than 0.001). At 3 months, MCID was attained by 27 (79%) patients in the LiST group compared to 0 patients in the sham group. The risk difference between the 2 groups was 79% (95% confidence interval [CI]: 66e93, p less than 0.001) and the baseline-adjusted mean between-group-difference in the IIEF-EF was 4.4 points (95% CI: 3.4e5.4, p less than 0.001). This study is very interesting, because if defines a theoretically ideal patient group suffering from moderate vasculogenic ED. The data are very clear, however, the follow-up of 3 months is very short. Unfortunately, the authors do not provide any data, how many of the patients were able to discontinue PDE5.inhibitors. Obviously a longer follow-up is necessary to define, whether these 12 treatment wit Li-ESWT are able to “regenerate” the cavernous tissue. As the authors already pointed out some more objective data like Color duplex flow-studies, Ultrasound of the penis (i.e. undr artificial erection) to add further data to this interesting trial. Jens Rassweiler

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