Wang D. et al., 2023: The Treatment Satisfaction in Patients and Their Partners Treated with Low-Intensity Extracorporeal Shock Wave Therapy and Sildenafil: A Prospective Non-Randomized Controlled Study

Wednesday, 21 June 2023

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Wang D, Wang SJ, Li YJ, Liu CH, Li YQ, Zhang YS, Yan S.
Department of Urology, Peking Union Medical College Hospital, Beijing, People's Republic of China.

Abstract

Background: Phosphodiesterase 5 inhibitors (PDE5Is) and other more invasive options merely provide symptomatic relief rather than a permanent improvement in erectile dysfunction (ED), whereas the long-term improvement in ED via low-intensity extracorporeal shockwave therapy (Li-ESWT) has been confirmed. So far, no comparative study of sildenafil versus Li-ESWT has been conducted with respect to treatment satisfaction.

Objective: In this study, we aim to compare erectile function status and satisfaction rates in patients who received sildenafil or Li-ESWT for ED.

Methods: Patients complaining of ED were considered candidates. Participants chose to enter one of two active treatment groups according to their treatment intention-either a 9-week Li-ESWT regimen or 100 mg on-demand sildenafil. The erectile function was evaluated using the erectile function domain of the International Index of Erectile Function questionnaires (IIEF-EF), while the treatment satisfaction was evaluated using the Erectile Dysfunction Inventory of Treatment Satisfaction questionnaires (EDITS).

Results: We enrolled 72 participants in the study (42 in the Li-ESWT group and 30 in the sildenafil group). Patients in both groups were young men. Four weeks after the last session, the IIEF-EF score for Li-ESWT and sildenafil was 16.3± 5.5 and 18.3± 6.5 (P > 0.05), respectively. The total EDITS index of the patient version and the partner version were similar in the two groups. Among EDITS questions measuring overall satisfaction and efficacy duration, the score was higher in the Li-ESWT group.

Conclusion: We found that Li-ESWT may have better satisfaction than on-demand sildenafil for young ED patients. However, further studies are needed to determine the factors influencing satisfaction.
Patient Prefer Adherence. 2023 Mar 8;17:583-589. doi: 10.2147/PPA.S399776. eCollection 2023. PMID: 36919185. FREE ARTICLE.

Comments 1

Jens Rassweiler on Wednesday, 21 June 2023 10:30

Phosphodiesterase 5 inhibitors (PDE5Is) and other more invasive options merely provide symptomatic relief rather than a permanent improvement in erectile dysfunction (ED), whereas the long-term improvement in ED via low-intensity extracorporeal shockwave therapy (Li-ESWT) has been confirmed. So far, no comparative study of sildenafil versus Li-ESWT has been conducted with respect to treatment satisfaction. In this study the authors compare the impact of sildenafil (100mg on-demand) versus Li-ESWT 4 weeks after a 9-week regimen. They also included the patient and partner satisfaction. The erectile function was evaluated using the erectile function domain of the International Index of Erectile Function questionnaires (IIEF-EF), while the treatment satisfaction was evaluated using the Erectile Dysfunction Inventory of Treatment Satisfaction questionnaires (EDITS).

Patients with diverse pathogenesis, including psychogenic, organic, and mixed ED, were enrolled. The organic pathogenesis was characterized by symptoms such as diabetes, cardiovascular comorbidities, and negative nocturnal and morning erections. Participants with substantial psychological problems and nocturnal or morning erections (determined by use of Rigiscan) were diagnosed as psychogenic. 72 participants were enrolled (42 in the Li-ESWT group and 30 in the sildenafil group). Patients in both groups were young men (31 vs 33 years).

For the Li-ESWT protocol, the treatment scheme entailed 2 sessions per week for 3 weeks and was repeated after a 3-week interval. Omnispec ED1000 (Medispec Ltd., Yehud, Israel) was used to produce low-intensity shock waves.10 Li-ESWT-applications were provided in each treatment session for 3 min at 5 different penile anatomical sites (3 locations on the penile shaft and 2 on the penile crura). Each Li-ESWT session comprised of 300 shocks per treatment point at an energy density of 0.09 mJ/mm2 and a frequency of 2 Hz.

Four weeks after the final session, the mean (SD) score in IIEF-EF for Li-ESWT and sildenafil was 16.3± 5.5 and 18.3± 6.5 (P > 0.05), respectively. According to MCID criteria, the ratio of patients who reported positive results was 80.0% in the sildenafil group and 59.5% in the Li-ESWT group, respectively (κ2 = 0.09, P > 0.05).

The total EDITS score and index score of both, the patient version and partner version, were similar in the two groups. More detailed analysis of each question in EDITS indicated that a significantly higher number of patients and partners in the Li-ESWT group responded 3 or 4 (very satisfied or somewhat satisfied) to question 1 in the patient and partner version assessing overall satisfaction with treatment than those in the sildenafil group. Furthermore, patients and partners gave the same response to question 6 in the EDITS patient version and question 4 in the partner version, respectively, which address the satisfaction with the duration of intercourse.

In comparison with the previous results, the improvement in erectile function in the Li-ESWT group for ED in this study is relatively low. For example, significant increases in IIEF-EF scores were recorded in all men in a precursor study by application of Li-ESWT for ED in 20 middle-aged men. The reason for the less obvious improvement in this trial may be related to the large proportion of psychogenic ED-patients (30 %). The main reason, however, seems to be the relatively short follow-up time of 4 weeks after termination of the Li-ESWT-regimen.
The authors should provide longer follow-up data to clarify this further.

Interestingly, more patients and their partners in the Li-ESWT group were very satisfied with the duration of intercourse compared with those in the sildenafil group. The improvement effect sustained 1 month after Li-ESWT treatment without any additional active intervention, implying that LI-ESWT exerted a genuine physiologic effect on cavernosal tissue. However, this has again to be substantiated by longer follow-up data.

Unfortunately, the authors did not perform any Duplex-Ultrasound measurements to objectivate their clinical findings. Due to the finally low numbers in each group a subgroup analysis (ie. effect on psychogenic ED) was not possible.

In summary, the authors demonstrate some new forms of analysis including the partners, when dealing with erectile dysfunction. They found some prove of evidence, that the idea to regenerate erectile function by use of Li-ESWT using an electrohydraulic device. However, there are still a lot of open questions.

Jens Rassweiler

Patients with diverse pathogenesis, including psychogenic, organic, and mixed ED, were enrolled. The organic pathogenesis was characterized by symptoms such as diabetes, cardiovascular comorbidities, and negative nocturnal and morning erections. Participants with substantial psychological problems and nocturnal or morning erections (determined by use of Rigiscan) were diagnosed as psychogenic. 72 participants were enrolled (42 in the Li-ESWT group and 30 in the sildenafil group). Patients in both groups were young men (31 vs 33 years).

For the Li-ESWT protocol, the treatment scheme entailed 2 sessions per week for 3 weeks and was repeated after a 3-week interval. Omnispec ED1000 (Medispec Ltd., Yehud, Israel) was used to produce low-intensity shock waves.10 Li-ESWT-applications were provided in each treatment session for 3 min at 5 different penile anatomical sites (3 locations on the penile shaft and 2 on the penile crura). Each Li-ESWT session comprised of 300 shocks per treatment point at an energy density of 0.09 mJ/mm2 and a frequency of 2 Hz. 
 
Four weeks after the final session, the mean (SD) score in IIEF-EF for Li-ESWT and sildenafil was 16.3± 5.5 and 18.3± 6.5 (P > 0.05), respectively. According to MCID criteria, the ratio of patients who reported positive results was 80.0% in the sildenafil group and 59.5% in the Li-ESWT group, respectively (κ2 = 0.09, P > 0.05).

The total EDITS score and index score of both, the patient version and partner version, were similar in the two groups. More detailed analysis of each question in EDITS indicated that a significantly higher number of patients and partners in the Li-ESWT group responded 3 or 4 (very satisfied or somewhat satisfied) to question 1 in the patient and partner version assessing overall satisfaction with treatment than those in the sildenafil group. Furthermore, patients and partners gave the same response to question 6 in the EDITS patient version and question 4 in the partner version, respectively, which address the satisfaction with the duration of intercourse.

In comparison with the previous results, the improvement in erectile function in the Li-ESWT group for ED in this study is relatively low. For example, significant increases in IIEF-EF scores were recorded in all men in a precursor study by application of Li-ESWT for ED in 20 middle-aged men. The reason for the less obvious improvement in this trial may be related to the large proportion of psychogenic ED-patients (30 %). The main reason, however, seems to be the relatively short follow-up time of 4 weeks after termination of the Li-ESWT-regimen.
The authors should provide longer follow-up data to clarify this further.

Interestingly, more patients and their partners in the Li-ESWT group were very satisfied with the duration of intercourse compared with those in the sildenafil group. The improvement effect sustained 1 month after Li-ESWT treatment without any additional active intervention, implying that LI-ESWT exerted a genuine physiologic effect on cavernosal tissue. However, this has again to be substantiated by longer follow-up data.

Unfortunately, the authors did not perform any Duplex-Ultrasound measurements to objectivate their clinical findings. Due to the finally low numbers in each group a subgroup analysis (ie. effect on psychogenic ED) was not possible.

In summary, the authors demonstrate some new forms of analysis including the partners, when dealing with erectile dysfunction. They found some prove of evidence, that the idea to regenerate erectile function by use of Li-ESWT using an electrohydraulic device. However, there are still a lot of open questions.

Jens Rassweiler

Phosphodiesterase 5 inhibitors (PDE5Is) and other more invasive options merely provide symptomatic relief rather than a permanent improvement in erectile dysfunction (ED), whereas the long-term improvement in ED via low-intensity extracorporeal shockwave therapy (Li-ESWT) has been confirmed. So far, no comparative study of sildenafil versus Li-ESWT has been conducted with respect to treatment satisfaction. In this study the authors compare the impact of sildenafil (100mg on-demand) versus Li-ESWT 4 weeks after a 9-week regimen. They also included the patient and partner satisfaction. The erectile function was evaluated using the erectile function domain of the International Index of Erectile Function questionnaires (IIEF-EF), while the treatment satisfaction was evaluated using the Erectile Dysfunction Inventory of Treatment Satisfaction questionnaires (EDITS). Patients with diverse pathogenesis, including psychogenic, organic, and mixed ED, were enrolled. The organic pathogenesis was characterized by symptoms such as diabetes, cardiovascular comorbidities, and negative nocturnal and morning erections. Participants with substantial psychological problems and nocturnal or morning erections (determined by use of Rigiscan) were diagnosed as psychogenic. 72 participants were enrolled (42 in the Li-ESWT group and 30 in the sildenafil group). Patients in both groups were young men (31 vs 33 years). For the Li-ESWT protocol, the treatment scheme entailed 2 sessions per week for 3 weeks and was repeated after a 3-week interval. Omnispec ED1000 (Medispec Ltd., Yehud, Israel) was used to produce low-intensity shock waves.10 Li-ESWT-applications were provided in each treatment session for 3 min at 5 different penile anatomical sites (3 locations on the penile shaft and 2 on the penile crura). Each Li-ESWT session comprised of 300 shocks per treatment point at an energy density of 0.09 mJ/mm2 and a frequency of 2 Hz. Four weeks after the final session, the mean (SD) score in IIEF-EF for Li-ESWT and sildenafil was 16.3± 5.5 and 18.3± 6.5 (P > 0.05), respectively. According to MCID criteria, the ratio of patients who reported positive results was 80.0% in the sildenafil group and 59.5% in the Li-ESWT group, respectively (κ2 = 0.09, P > 0.05). The total EDITS score and index score of both, the patient version and partner version, were similar in the two groups. More detailed analysis of each question in EDITS indicated that a significantly higher number of patients and partners in the Li-ESWT group responded 3 or 4 (very satisfied or somewhat satisfied) to question 1 in the patient and partner version assessing overall satisfaction with treatment than those in the sildenafil group. Furthermore, patients and partners gave the same response to question 6 in the EDITS patient version and question 4 in the partner version, respectively, which address the satisfaction with the duration of intercourse. In comparison with the previous results, the improvement in erectile function in the Li-ESWT group for ED in this study is relatively low. For example, significant increases in IIEF-EF scores were recorded in all men in a precursor study by application of Li-ESWT for ED in 20 middle-aged men. The reason for the less obvious improvement in this trial may be related to the large proportion of psychogenic ED-patients (30 %). The main reason, however, seems to be the relatively short follow-up time of 4 weeks after termination of the Li-ESWT-regimen. The authors should provide longer follow-up data to clarify this further. Interestingly, more patients and their partners in the Li-ESWT group were very satisfied with the duration of intercourse compared with those in the sildenafil group. The improvement effect sustained 1 month after Li-ESWT treatment without any additional active intervention, implying that LI-ESWT exerted a genuine physiologic effect on cavernosal tissue. However, this has again to be substantiated by longer follow-up data. Unfortunately, the authors did not perform any Duplex-Ultrasound measurements to objectivate their clinical findings. Due to the finally low numbers in each group a subgroup analysis (ie. effect on psychogenic ED) was not possible. In summary, the authors demonstrate some new forms of analysis including the partners, when dealing with erectile dysfunction. They found some prove of evidence, that the idea to regenerate erectile function by use of Li-ESWT using an electrohydraulic device. However, there are still a lot of open questions. Jens Rassweiler

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