Tao R. et al., 2022: The Efficacy of Li-ESWT Combined With VED in Diabetic ED Patients Unresponsive to PDE5is: A Single- Center, Randomized Clinical Trial

Tuesday, 13 December 2022

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Tao R, Chen J, Wang D, Li Y, Xiang J, Xiong L, Ji J, Wu J, Zhou S, Jia C, Lv J, Yang J, Tang Q.
Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China.
Department of Andrology, Jiangsu Province Hospital of Chinese Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, China.
Department of Ultrasound, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China.
Department of Urology, Jiangsu Provincial People's Hospital, First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Department of Urology, People's Hospital of Xinjiang Kizilsu Kirgiz Autonomous Prefecture, Xinjiang, China.

Abstract

Introduction: Phosphodiesterase type 5-inhibitors (PDE5is) are the first-line treatment for patients with diabetes mellitus-induced erectile dysfunction (DMED), however, some patients are non-responser to PDE5is. We performed a perspective, randomized, comparative study to explore the efficacy of low intensity extracorporeal shock wave treatment (Li-ESWT) combined with vacuum erectile device (VED) in the treatment of DMED patients who were unresponsive to PDE5is.

Methods: One hundred and five eligible patients were randomly divided into three groups: group A (VED), group B (Li-ESWT) and group C (VED plus Li-ESWT). Follow-up was conducted at 4 weeks, 8 weeks and 12 weeks after the end of treatment. The erectile function was estimated by the international index of erectile function-erectile function domain (IIEF-EF), erection hardness score (EHS), sexual encounter profile questions 2 and 3 (SEP2 and SEP3) and global assessment question 1 and 2 (GAQ1 and GAQ2) before and after treatment. The changes of five points in IIEF-EF were calculated as the minimal clinical important difference (MCID), which was considered as the main index of efficacy.

Results: The MCID was achieved in 14.7%, 14.7% and 17.6% patients in group A at the follow up on 4 weeks, 8 weeks and 12 weeks, respectively (36.4%, 39.4% and 36.4% in group B; 36.4%, 51.5%, and 66.7% in group C). There were significant differences in the percentage of MCID cases between group A and group C at the follow up on 12 weeks (P<0.001), as well as that between group B and group C (P=0.014). Additionally, comparison in MCID within group C showed that there were significant differences between 4 weeks and 12 weeks follow-up (P=0.014).

Conclusion: Our findings indicated the combined therapy Li-ESWT and VED was more beneficial to shift turn PDE5is non-responders to responders for moderate patients with DMED than VED or Li-ESWT monotherapy. Moreover, this study provided evidence that patients with DMED who failed after taking oral PDE5is could attempt to opt for an alternative physicotherapy (Li-ESWT or VED) prior to more invasive alternatives.
Front Endocrinol (Lausanne). 2022 Jun 23;13:937958. doi: 10.3389/fendo.2022.937958. eCollection 2022. FREE ARTICLE

Comments 1

Jens Rassweiler on Tuesday, 13 December 2022 09:30

Phosphodiesterase type 5-inhibitors (PDE5is) are the first-line treatment for patients with diabetes mellitus-induced erectile dysfunction (DMED), however, some patients are non-responser to PDE5is. This is a prospective, randomized, comparative study to explore the efficacy of low intensity extracorporeal shock wave treatment (Li-ESWT) combined with vacuum erectile device (VED) in the treatment of DMED patients unresponsive to PDE5is.
Evidently, this is a very critical group of patients.

105 patients were randomized into three groups: group A (VED), group B (Li-ESWT) and group C (VED plus Li-ESWT). Follow- up was conducted at 4, 8, and 12 weeks after the end of treatment. The erectile function was estimated by the international index of erectile function-erectile function domain (IIEF-EF), erection hardness score (EHS), sexual encounter profile questions 2 and 3 (SEP2 and SEP3) and global assessment question 1 and 2 (GAQ1 and GAQ2) before and after treatment. The changes of five points in IIEF-EF were calculated as the minimal clinical important difference (MCID) as the main index of efficacy.

MCID was achieved in 14.7%, 14.7% and 17.6% patients in group A (VED) at the follow up on 4, 8, and 12 weeks, respectively 36.4%, 39.4% and 36.4% in group B; 36.4%, 51.5%, and 66.7% in group C. There were significant differences in the percentage of MCID cases between group A and group C at the follow up on 12 weeks (P less than 0.001), as well as that between group B and group C (P=0.014). Additionally, comparison in MCID within group C showed that there were significant differences between 4 weeks and 12 weeks follow-up (P=0.014).

It is very interesting, that only the combination of Li-ESWT and VED had a better outcome with longer follow-up. It is known, that the long-term effect of Li-ESWT for diabetic ED is limited and there is a discussion about a maintenance therapy.

Also in another study, combined therapy VED and Li-ESWT was more effective than either monotherpy. This finding suggested that regular VED physiotherapy could improve the blood supply of penile artery, which was similar to spontaneous nocturnal erection. In addition, sufficient penile length might improve their confidence in treatment, and provide good conditions in various place of penis for Li-ESWT positioning.

The vascular damage of penile cavernous in non-diabetes patients is basically less than that in diabetes patients. Therefore, a combined therapy could be more effective in patients with diabetes than in patients without diabetes. However, this problem needed to be explored by further studies with increasing sample size and type.

Most importantly, this study provided evidence that patients with DMED who failed after taking oral PDE5is could attempt to opt for an alternative physicotherapy (Li-ESWT or VED) prior to more invasive alternatives. Of course, the working mechanism of such combined approach needs further evaluation

Jens Rassweiler

105 patients were randomized into three groups: group A (VED), group B (Li-ESWT) and group C (VED plus Li-ESWT). Follow- up was conducted at 4, 8, and 12 weeks after the end of treatment. The erectile function was estimated by the international index of erectile function-erectile function domain (IIEF-EF), erection hardness score (EHS), sexual encounter profile questions 2 and 3 (SEP2 and SEP3) and global assessment question 1 and 2 (GAQ1 and GAQ2) before and after treatment. The changes of five points in IIEF-EF were calculated as the minimal clinical important difference (MCID) as the main index of efficacy.

MCID was achieved in 14.7%, 14.7% and 17.6% patients in group A (VED) at the follow up on 4, 8, and 12 weeks, respectively 36.4%, 39.4% and 36.4% in group B; 36.4%, 51.5%, and 66.7% in group C. There were significant differences in the percentage of MCID cases between group A and group C at the follow up on 12 weeks (P less than 0.001), as well as that between group B and group C (P=0.014). Additionally, comparison in MCID within group C showed that there were significant differences between 4 weeks and 12 weeks follow-up (P=0.014).

It is very interesting, that only the combination of Li-ESWT and VED had a better outcome with longer follow-up. It is known, that the long-term effect of Li-ESWT for diabetic ED is limited and there is a discussion about a maintenance therapy.

Also in another study, combined therapy VED and Li-ESWT was more effective than either monotherpy. This finding suggested that regular VED physiotherapy could improve the blood supply of penile artery, which was similar to spontaneous nocturnal erection. In addition, sufficient penile length might improve their confidence in treatment, and provide good conditions in various place of penis for Li-ESWT positioning.

The vascular damage of penile cavernous in non-diabetes patients is basically less than that in diabetes patients. Therefore, a combined therapy could be more effective in patients with diabetes than in patients without diabetes. However, this problem needed to be explored by further studies with increasing sample size and type.

Most importantly, this study provided evidence that patients with DMED who failed after taking oral PDE5is could attempt to opt for an alternative physicotherapy (Li-ESWT or VED) prior to more invasive alternatives. Of course, the working mechanism of such combined approach needs further evaluation

Jens Rassweiler

Phosphodiesterase type 5-inhibitors (PDE5is) are the first-line treatment for patients with diabetes mellitus-induced erectile dysfunction (DMED), however, some patients are non-responser to PDE5is. This is a prospective, randomized, comparative study to explore the efficacy of low intensity extracorporeal shock wave treatment (Li-ESWT) combined with vacuum erectile device (VED) in the treatment of DMED patients unresponsive to PDE5is. Evidently, this is a very critical group of patients. 105 patients were randomized into three groups: group A (VED), group B (Li-ESWT) and group C (VED plus Li-ESWT). Follow- up was conducted at 4, 8, and 12 weeks after the end of treatment. The erectile function was estimated by the international index of erectile function-erectile function domain (IIEF-EF), erection hardness score (EHS), sexual encounter profile questions 2 and 3 (SEP2 and SEP3) and global assessment question 1 and 2 (GAQ1 and GAQ2) before and after treatment. The changes of five points in IIEF-EF were calculated as the minimal clinical important difference (MCID) as the main index of efficacy. MCID was achieved in 14.7%, 14.7% and 17.6% patients in group A (VED) at the follow up on 4, 8, and 12 weeks, respectively 36.4%, 39.4% and 36.4% in group B; 36.4%, 51.5%, and 66.7% in group C. There were significant differences in the percentage of MCID cases between group A and group C at the follow up on 12 weeks (P less than 0.001), as well as that between group B and group C (P=0.014). Additionally, comparison in MCID within group C showed that there were significant differences between 4 weeks and 12 weeks follow-up (P=0.014). It is very interesting, that only the combination of Li-ESWT and VED had a better outcome with longer follow-up. It is known, that the long-term effect of Li-ESWT for diabetic ED is limited and there is a discussion about a maintenance therapy. Also in another study, combined therapy VED and Li-ESWT was more effective than either monotherpy. This finding suggested that regular VED physiotherapy could improve the blood supply of penile artery, which was similar to spontaneous nocturnal erection. In addition, sufficient penile length might improve their confidence in treatment, and provide good conditions in various place of penis for Li-ESWT positioning. The vascular damage of penile cavernous in non-diabetes patients is basically less than that in diabetes patients. Therefore, a combined therapy could be more effective in patients with diabetes than in patients without diabetes. However, this problem needed to be explored by further studies with increasing sample size and type. Most importantly, this study provided evidence that patients with DMED who failed after taking oral PDE5is could attempt to opt for an alternative physicotherapy (Li-ESWT or VED) prior to more invasive alternatives. Of course, the working mechanism of such combined approach needs further evaluation Jens Rassweiler

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