Rui-Jie Yao et al., 2024: Retrospective analysis of the efficacy of low-intensity extracorporeal shock wave therapy on young and middle-aged patients with erectile dysfunction responsive to PDE5Is: reducing the use of PDE5Is

Tuesday, 08 April 2025

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Rui-Jie Yao 1, Mao-Yuan Wang 1, Qiang Chen 1, Hong Xiao 1, Peng Yang 1, Yi-Lang Ding 1, Xi Chen 1, Song-Xi Tang 1, Hui-Liang Zhou 1
1Department of Andrology and Sexual Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou 350005, China.

Abstract

Background: Low-intensity extracorporeal shock wave therapy (Li-ESWT) is a new method for treating erectile dysfunction (ED), but there are no standards yet for its indications.

Aim: The study aimed to suggest the early clinical efficacy of Li-ESWT and explore its related factors in young and middle-aged patients with ED who responded to phosphodiesterase type 5 Inhibitors (PDE5Is).

Methods: Data from 61 patients with ED who had previously responded to oral PDE5Is and subsequently underwent Li-ESWT were collected. This included information on age, body mass index, total testicular volume, sex hormones, as well as IIEF-EF scores before treatment and at 1, 3, and 6 months after treatment. The treatment regimen involves a weekly session for four consecutive weeks, with each session administering 5000 shock wave pulses. Linear regression analysis was utilized to identify factors associated with the efficacy of Li-ESWT treatment. Additionally, the improvement in different severity groups of ED before and after treatment, along with their IIEF-EF scores, was compared.

Outcomes: Li-ESWT was more targeted and effective for young and middle-aged patients with erectile dysfunction who responded to PDE5Is.

Results: The age of enrolled patients ranges from 22 to 53 years old, and the IIEF-EF scores at 1 month, 3 months, and 6 months after treatment were compared to baseline for efficacy assessment, showing significant improvements (P < .0001) in all instances. Linear regression analysis using baseline data revealed predictive factors associated with treatment efficacy: treatment efficacy was negatively correlated with baseline IIEF-EF scores (t = -2.599, P = .013) and positively correlated with baseline LH levels (t = 2.170, P = .036).

Clinical implications: Given the considerable cost of Li-ESWT treatment and the emphasis on treatment continuity, we hope to identify the most suitable candidates for Li-ESWT therapy, thereby optimizing its application.

Strengths and limitations: Our findings provide a better solution for nonelderly ED patients who are responsive to PDE5Is. This study was limited by our sample size and follow-up time.

Conclusion: After 3 months of Li-ESWT, the IIEF-EF score gradually stabilizes and short-term maintenance of PDE5Is medication increases the responsiveness to shock wave therapy.

Sex Med. 2024 Sep 29;12(4):qfae065. doi: 10.1093/sexmed/qfae065. eCollection 2024 Aug.
PMID: 39346801 PMCID: PMC11438993

Comments 1

Jens Rassweiler on Tuesday, 08 April 2025 11:00

Introduction
Erectile dysfunction (ED) affects a significant portion of the male population, particularly among older men, with prevalence rates between 30% and 65%. While phosphodiesterase type 5 inhibitors (PDE5Is) like Sildenafil and Tadalafil are effective treatments, some patients experience limitations in using these medications due to various factors such as cost, lack of efficacy, or psychological barriers. Low-intensity extracorporeal shock wave therapy (Li-ESWT) has emerged as a non-invasive treatment option that may improve ED by promoting vascular regeneration through mechanisms such as increasing vascular endothelial growth factor (VEGF) expression. This study aims to assess whether Li-ESWT can reduce or eliminate the need for PDE5Is in young and middle-aged patients who respond to these medications.

Participants and Methods
Study Population: The study involved 61 young and middle-aged patients (ages 22 to 53, mean age 35.44) who had ED and were responsive to PDE5Is. Follow-ups were conducted at 1, 3, and 6 months post-treatment.
Inclusion Criteria: Participants had to have ED for more than 3 months, be aged 20 to 55, have stable sexual partners, and engage in regular sexual activity. Patients had to discontinue PDE5Is for at least 3 months prior to treatment.
Exclusion Criteria: Patients with congenital abnormalities, spinal cord injuries, penile fibrosis (Peyronie’s disease), a history of trauma or surgery, or bleeding disorders were excluded.
Treatment Protocol: Patients underwent Li-ESWT treatment for four weeks, receiving 20,000 shock wave pulses. This includes 1600 pulses each to the left and right crus penis, and 900 pulses each to the left and right corpus cavernosum. The energy density is 0.09 mJ/mm2, and the frequency is 150 pulses per minute using RENOVA (manufacturer: Initia Lid; 68 Amal SL(P.O. Box 4159).49513 Petah Tikva, Israel), a mobile electromagnetic linear shock wave therapy device, consisting of a mechanical and an electrical module including a transducer (electromagnetic head).
Results
Erectile Function Improvement: The Baseline IIEF-EF Score was 15.26 ± 7.47 before treatment. Post-Treatment IIEF-EF Scores were:
o 1 Month After Treatment: 21.73 ± 7.69 (significant improvement, p 0.01)
o 3 Months After Treatment: 23.68 ± 5.73 (further significant improvement, p 0.05)
Improvement in IIEF-EF scores was observed at 1 and 3 months, indicating that patients reached a stable phase of improvement at around 3 months post-treatment. Patients with severe ED showed the most significant improvement over the treatment period.
Patients Achieving Normal IIEF-EF Scores:The percentage of patients achieving IIEF-EF scores of 26 or higher (indicating normal erectile function) increased significantly at follow-up:
o 1 Month: 34.43% (21 out of 61)
o 3 Months: 49.15% (29 out of 59)
o 6 Months: 47.06% (16 out of 34)
Treatment efficacy was negatively correlated with baseline IIEF-EF scores (t = −2.599, P = .013) and positively correlated with baseline LH levels (t = 2.170, P = .036).
Discussion
The discussion section of the study on low-intensity extracorporeal shock wave therapy (Li-ESWT) provides insights into the efficacy and implications of the treatment for erectile dysfunction (ED) in young and middle-aged patients responsive to phosphodiesterase type 5 inhibitors (PDE5Is). Here are the key points summarized:
Efficacy of Li-ESWT
Improvement in Erectile Function: The study found that Li-ESWT significantly improved erectile function as measured by the IIEF-EF scores at 1, 3, and 6 months post-treatment. The results align with previous studies indicating that Li-ESWT enhances local blood supply and promotes the formation of new blood vessels, which are critical for improving erectile function.
Durability of Results: The sustained improvement in IIEF-EF scores up to 6 months suggests that Li-ESWT can provide lasting benefits for patients with ED, particularly those with vascular or organic causes of the condition.
Mechanism of Action
Vascular Regeneration: The mechanism behind the efficacy of Li-ESWT is believed to involve the stimulation of vascular endothelial growth factor (VEGF) production, which aids in the regeneration of penile blood vessels. This effect is essential for restoring adequate blood flow necessary for achieving and maintaining an erection.
Synergistic Effect with PDE5Is: The study indicates that using low-dose PDE5Is during and after Li-ESWT may enhance the overall treatment efficacy. PDE5Is work by inhibiting the breakdown of cGMP, which is necessary for smooth muscle relaxation and erection, thereby complementing the vascular improvements induced by Li-ESWT.
Patient Selection and Outcomes
Target Demographic: The study focused on young and middle-aged men who were already responsive to PDE5Is, highlighting that this demographic may benefit the most from Li-ESWT. Patients with varying degrees of ED experienced improvements, with those having mild ED achieving normalization of erectile function at higher rates.
Correlation with Hormone Levels: The findings suggest that higher luteinizing hormone (LH) levels correlate positively with treatment efficacy, indicating that hormonal factors may play a role in the response to Li-ESWT. Conversely, lower pretreatment IIEF-EF scores were associated with more significant improvements, suggesting that more severe initial ED may have greater potential for improvement. The study found that higher LH levels and lower pretreatment IIEF-EF scores were positively correlated with treatment efficacy. This suggests that hormonal assessments may be valuable in predicting individual responses to Li-ESWT.
Future Research Directions:
The study emphasizes the need for further research with larger sample sizes and longer follow-up periods to validate these findings. It also suggests exploring the role of Li-ESWT in patients with comorbidities and in older age groups to better understand its broader applications in ED treatment. Assessment of the LH-level might be helpful to predict the success of the treatment.
In summary, Li-ESWT appears to be a promising treatment for young and middle-aged men with ED who are responsive to PDE5Is, offering significant improvements in erectile function and potentially reducing the reliance on medications.

Jens Rassweiler

Participants and Methods
Study Population: The study involved 61 young and middle-aged patients (ages 22 to 53, mean age 35.44) who had ED and were responsive to PDE5Is. Follow-ups were conducted at 1, 3, and 6 months post-treatment.
Inclusion Criteria: Participants had to have ED for more than 3 months, be aged 20 to 55, have stable sexual partners, and engage in regular sexual activity. Patients had to discontinue PDE5Is for at least 3 months prior to treatment.
Exclusion Criteria: Patients with congenital abnormalities, spinal cord injuries, penile fibrosis (Peyronie’s disease), a history of trauma or surgery, or bleeding disorders were excluded.
Treatment Protocol: Patients underwent Li-ESWT treatment for four weeks, receiving 20,000 shock wave pulses. This includes 1600 pulses each to the left and right crus penis, and 900 pulses each to the left and right corpus cavernosum. The energy density is 0.09 mJ/mm2, and the frequency is 150 pulses per minute using RENOVA (manufacturer: Initia Lid; 68 Amal SL(P.O. Box 4159).49513 Petah Tikva, Israel), a mobile electromagnetic linear shock wave therapy device, consisting of a mechanical and an electrical module including a transducer (electromagnetic head).
Results
Erectile Function Improvement: The Baseline IIEF-EF Score was 15.26 ± 7.47 before treatment. Post-Treatment IIEF-EF Scores were:
o	1 Month After Treatment: 21.73 ± 7.69 (significant improvement, p  0.01)
o	3 Months After Treatment: 23.68 ± 5.73 (further significant improvement, p  0.05)
Improvement in IIEF-EF scores was observed at 1 and 3 months, indicating that patients reached a stable phase of improvement at around 3 months post-treatment. Patients with severe ED showed the most significant improvement over the treatment period.
Patients Achieving Normal IIEF-EF Scores:The percentage of patients achieving IIEF-EF scores of 26 or higher (indicating normal erectile function) increased significantly at follow-up:
o	1 Month: 34.43% (21 out of 61)
o	3 Months: 49.15% (29 out of 59)
o	6 Months: 47.06% (16 out of 34)
Treatment efficacy was negatively correlated with baseline IIEF-EF scores (t = −2.599, P = .013) and positively correlated with baseline LH levels (t = 2.170, P = .036). 
Discussion
The discussion section of the study on low-intensity extracorporeal shock wave therapy (Li-ESWT) provides insights into the efficacy and implications of the treatment for erectile dysfunction (ED) in young and middle-aged patients responsive to phosphodiesterase type 5 inhibitors (PDE5Is). Here are the key points summarized:
Efficacy of Li-ESWT
Improvement in Erectile Function: The study found that Li-ESWT significantly improved erectile function as measured by the IIEF-EF scores at 1, 3, and 6 months post-treatment. The results align with previous studies indicating that Li-ESWT enhances local blood supply and promotes the formation of new blood vessels, which are critical for improving erectile function.
Durability of Results: The sustained improvement in IIEF-EF scores up to 6 months suggests that Li-ESWT can provide lasting benefits for patients with ED, particularly those with vascular or organic causes of the condition.
Mechanism of Action
Vascular Regeneration: The mechanism behind the efficacy of Li-ESWT is believed to involve the stimulation of vascular endothelial growth factor (VEGF) production, which aids in the regeneration of penile blood vessels. This effect is essential for restoring adequate blood flow necessary for achieving and maintaining an erection.
Synergistic Effect with PDE5Is: The study indicates that using low-dose PDE5Is during and after Li-ESWT may enhance the overall treatment efficacy. PDE5Is work by inhibiting the breakdown of cGMP, which is necessary for smooth muscle relaxation and erection, thereby complementing the vascular improvements induced by Li-ESWT.
Patient Selection and Outcomes
Target Demographic: The study focused on young and middle-aged men who were already responsive to PDE5Is, highlighting that this demographic may benefit the most from Li-ESWT. Patients with varying degrees of ED experienced improvements, with those having mild ED achieving normalization of erectile function at higher rates.
Correlation with Hormone Levels: The findings suggest that higher luteinizing hormone (LH) levels correlate positively with treatment efficacy, indicating that hormonal factors may play a role in the response to Li-ESWT. Conversely, lower pretreatment IIEF-EF scores were associated with more significant improvements, suggesting that more severe initial ED may have greater potential for improvement. The study found that higher LH levels and lower pretreatment IIEF-EF scores were positively correlated with treatment efficacy. This suggests that hormonal assessments may be valuable in predicting individual responses to Li-ESWT.
Future Research Directions:
The study emphasizes the need for further research with larger sample sizes and longer follow-up periods to validate these findings. It also suggests exploring the role of Li-ESWT in patients with comorbidities and in older age groups to better understand its broader applications in ED treatment. Assessment of the LH-level might be helpful to predict the success of the treatment.
In summary, Li-ESWT appears to be a promising treatment for young and middle-aged men with ED who are responsive to PDE5Is, offering significant improvements in erectile function and potentially reducing the reliance on medications.

Jens Rassweiler

Introduction Erectile dysfunction (ED) affects a significant portion of the male population, particularly among older men, with prevalence rates between 30% and 65%. While phosphodiesterase type 5 inhibitors (PDE5Is) like Sildenafil and Tadalafil are effective treatments, some patients experience limitations in using these medications due to various factors such as cost, lack of efficacy, or psychological barriers. Low-intensity extracorporeal shock wave therapy (Li-ESWT) has emerged as a non-invasive treatment option that may improve ED by promoting vascular regeneration through mechanisms such as increasing vascular endothelial growth factor (VEGF) expression. This study aims to assess whether Li-ESWT can reduce or eliminate the need for PDE5Is in young and middle-aged patients who respond to these medications. Participants and Methods Study Population: The study involved 61 young and middle-aged patients (ages 22 to 53, mean age 35.44) who had ED and were responsive to PDE5Is. Follow-ups were conducted at 1, 3, and 6 months post-treatment. Inclusion Criteria: Participants had to have ED for more than 3 months, be aged 20 to 55, have stable sexual partners, and engage in regular sexual activity. Patients had to discontinue PDE5Is for at least 3 months prior to treatment. Exclusion Criteria: Patients with congenital abnormalities, spinal cord injuries, penile fibrosis (Peyronie’s disease), a history of trauma or surgery, or bleeding disorders were excluded. Treatment Protocol: Patients underwent Li-ESWT treatment for four weeks, receiving 20,000 shock wave pulses. This includes 1600 pulses each to the left and right crus penis, and 900 pulses each to the left and right corpus cavernosum. The energy density is 0.09 mJ/mm2, and the frequency is 150 pulses per minute using RENOVA (manufacturer: Initia Lid; 68 Amal SL(P.O. Box 4159).49513 Petah Tikva, Israel), a mobile electromagnetic linear shock wave therapy device, consisting of a mechanical and an electrical module including a transducer (electromagnetic head). Results Erectile Function Improvement: The Baseline IIEF-EF Score was 15.26 ± 7.47 before treatment. Post-Treatment IIEF-EF Scores were: o 1 Month After Treatment: 21.73 ± 7.69 (significant improvement, p 0.01) o 3 Months After Treatment: 23.68 ± 5.73 (further significant improvement, p 0.05) Improvement in IIEF-EF scores was observed at 1 and 3 months, indicating that patients reached a stable phase of improvement at around 3 months post-treatment. Patients with severe ED showed the most significant improvement over the treatment period. Patients Achieving Normal IIEF-EF Scores:The percentage of patients achieving IIEF-EF scores of 26 or higher (indicating normal erectile function) increased significantly at follow-up: o 1 Month: 34.43% (21 out of 61) o 3 Months: 49.15% (29 out of 59) o 6 Months: 47.06% (16 out of 34) Treatment efficacy was negatively correlated with baseline IIEF-EF scores (t = −2.599, P = .013) and positively correlated with baseline LH levels (t = 2.170, P = .036). Discussion The discussion section of the study on low-intensity extracorporeal shock wave therapy (Li-ESWT) provides insights into the efficacy and implications of the treatment for erectile dysfunction (ED) in young and middle-aged patients responsive to phosphodiesterase type 5 inhibitors (PDE5Is). Here are the key points summarized: Efficacy of Li-ESWT Improvement in Erectile Function: The study found that Li-ESWT significantly improved erectile function as measured by the IIEF-EF scores at 1, 3, and 6 months post-treatment. The results align with previous studies indicating that Li-ESWT enhances local blood supply and promotes the formation of new blood vessels, which are critical for improving erectile function. Durability of Results: The sustained improvement in IIEF-EF scores up to 6 months suggests that Li-ESWT can provide lasting benefits for patients with ED, particularly those with vascular or organic causes of the condition. Mechanism of Action Vascular Regeneration: The mechanism behind the efficacy of Li-ESWT is believed to involve the stimulation of vascular endothelial growth factor (VEGF) production, which aids in the regeneration of penile blood vessels. This effect is essential for restoring adequate blood flow necessary for achieving and maintaining an erection. Synergistic Effect with PDE5Is: The study indicates that using low-dose PDE5Is during and after Li-ESWT may enhance the overall treatment efficacy. PDE5Is work by inhibiting the breakdown of cGMP, which is necessary for smooth muscle relaxation and erection, thereby complementing the vascular improvements induced by Li-ESWT. Patient Selection and Outcomes Target Demographic: The study focused on young and middle-aged men who were already responsive to PDE5Is, highlighting that this demographic may benefit the most from Li-ESWT. Patients with varying degrees of ED experienced improvements, with those having mild ED achieving normalization of erectile function at higher rates. Correlation with Hormone Levels: The findings suggest that higher luteinizing hormone (LH) levels correlate positively with treatment efficacy, indicating that hormonal factors may play a role in the response to Li-ESWT. Conversely, lower pretreatment IIEF-EF scores were associated with more significant improvements, suggesting that more severe initial ED may have greater potential for improvement. The study found that higher LH levels and lower pretreatment IIEF-EF scores were positively correlated with treatment efficacy. This suggests that hormonal assessments may be valuable in predicting individual responses to Li-ESWT. Future Research Directions: The study emphasizes the need for further research with larger sample sizes and longer follow-up periods to validate these findings. It also suggests exploring the role of Li-ESWT in patients with comorbidities and in older age groups to better understand its broader applications in ED treatment. Assessment of the LH-level might be helpful to predict the success of the treatment. In summary, Li-ESWT appears to be a promising treatment for young and middle-aged men with ED who are responsive to PDE5Is, offering significant improvements in erectile function and potentially reducing the reliance on medications. Jens Rassweiler

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