Manfredi C. et al., 2022: Impact of extracorporeal shockwave therapy for erectile dysfunction and Peyronie’s disease on reproductive and hormonal testicular function

Tuesday, 20 December 2022

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Manfredi C, Arcaniolo D, Amicuzi U, Napolitano L, Crocerossa F, Paoletta M, Cirillo P, Crocetto F, Bellastella G, Imbimbo C, Spirito L, Gisone S, De Sio M.
Unit of Urology, Department of Woman, Child and General and Specialized Surgery, University of Campania "Luigi Vanvitelli,", Naples, Italy.
Unit of Urology, Department of Neurosciences, Reproductive Sciences, and Odontostomatology, University of Naples "Federico II,", Naples, Italy.
Department of Urology, Magna Graecia University of Catanzaro, Catanzaro, Italy.
Department of Mental and Physical Health and Preventive Medicine, University of Campania "Luigi Vanvitelli,", Naples, Italy.
Department of Emergency and Organ Transplantation-Urology, Andrology and Kidney Transplantation Unit, University of Bari, Bari, Italy.
Unit of Endocrinology and Metabolic Diseases, Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli,", Naples, Italy.

Abstract

Introduction: Extracorporeal shock wave therapy is an established treatment for erectile dysfunction and Peyronie's disease. Concerns regarding the safety of extracorporeal shock wave therapy for andrological purposes on testicular function were raised by animal studies.

Aim: To evaluate the impact of extracorporeal shock wave therapy for erectile dysfunction or Peyronie's disease on reproductive and hormonal testicular function.

Methods: We designed a prospective controlled study in which consecutive patients were enrolled. Males aged between 18 and 40 years with mild vasculogenic erectile dysfunction or acute inflammatory Peyronie's disease and normozoospermia were included. All enrolled patients were offered extracorporeal shock wave therapy, and subjects who refused extracorporeal shock wave therapy for any reason were considered as the Control group. All patients in the Intervention group were treated with DUOLITH SD1 T-TOP by a single expert urologist. Semen analysis and serum total testosterone dosage were performed before the start (T0) and 3 months after the end of extracorporeal shock wave therapy (T1) in Intervention group. The same parameters were evaluated after the extracorporeal shock wave therapy refusal (T0) and at the end of the following 3 months (T1) in Control group. Normozoospermia was chosen as the primary outcome, serum total testosterone concentration was selected as the secondary outcome.

Results: A total of 94 patients were enrolled in the study (48 Group A, 46 Group B). At T0, all patients were normozoospermic in both groups (p = 0.563), and no significant difference in mean ± SD total testosterone levels was recorded between the groups (582.5 ± 107.2 vs. 634.6 ± 108.4 ng/dl; p = 0.221). At T1, no significant deterioration (p > 0.05) in semen parameters was recorded in both groups. Only a statistically significant reduction in seminal pH was found after extracorporeal shock wave therapy compared to baseline (7.9 ± 0.3 vs. 7.5 ± 0.2; p < 0.001) and untreated patients (7.8 ± 0.2 vs. 7.5 ± 0.2; p < 0.001). No significant difference in total testosterone levels was recorded in Intervention group after extracorporeal shock wave therapy compared to baseline (p = 0.584).

Conclusion: Extracorporeal shock wave therapy in erectile dysfunction and Peyronie's disease patients does not seem to affect reproductive and hormonal testicular function.
Andrology. 2022 Oct;10(7):1368-1375. doi: 10.1111/andr.13240. Epub 2022 Aug 17. FREE ARTICLE

Comments 1

Jens Rassweiler on Tuesday, 20 December 2022 09:30

Extracorporeal shock wave therapy is an established treatment for erectile dysfunction and Peyronie’s disease. Concerns regarding the safety of extracor- poreal shock wave therapy for andrological purposes on testicular function were raised by animal studies. Impairment of spermatogenesis and worsening of seminal parameters have recently been described in adult rats undergoing ESWT on the penile surface; however, there are currently no human studies available evaluating the effects of ESWT for andrological purposes on testicular function (Zang ZJ, Liu Q, Hu J, et al. The impact of low-intensity extracorporeal shock wave therapy on testicular function in adult rats. Andrology. 2018;6(6):936-942)

This is a prospective randomized study including 94 patients (n= 48 intervention, n=46 control). The intervention group consisted of 32 ED and 16 patients with Peyronie`s disease-PD).

All patients in the Intervention group were treated with DUOLITH SD1 T-TOP (Storz Medical AG, Tägerwilen, Switzerland) by a single expert urologist. The protocol applied for ED consisted of two sessions per week for 3 weeks. Each session included 3000 shock waves addressed to two penile sites (1000 proximal + 1000 distal) and to the crura (500 right + 500 left). The protocol used for PD consisted of one session per week for 4 weeks. Each session included 3000 shock waves addressed to the major penile plaque. The energy setting was 0.10–0.25 mJ/mm2 and 4–6 Hz in both cases.

Outcome analysis consisted of complete semen examination and testosterone levels before Li-ESWT and 3 months after treatment. At this time, no significant deterioration (p > 0.05) in semen parameters was recorded in both groups. No significant difference in total testosterone levels was recorded in Intervention group after extracorporeal shock wave therapy compared to baseline (p = 0.584). The authors concluded that Extracorporeal shock wave therapy in erectile dysfunction and Peyronie’s disease patients does not seem to affect reproductive and hormonal testicular function.

This is a methodically interesting study and it it not surprising, that the authors did not encounter any differences. The authors describe also possible reasons of the previous findings in the animal model, because the shock waves were applied via the scrotal skin. The anatomical situation in the men is completely different. On the other hand, Tian et al. 2022 found the contrary effect of Li-ESWT on scrotal tissue. Using an androgen-deficient model of the rat, they were able to stimulate the Leydig cells by enhanced VEGF-production. Thus further clinical studies in this direction should be awaited. Nevertheless, testicular damage during ESWT-applications at the penis can be widely excluded.

Jens Rassweiler

This is a prospective randomized study including 94 patients (n= 48 intervention, n=46 control). The intervention group consisted of 32 ED and 16 patients with Peyronie`s disease-PD).

All patients in the Intervention group were treated with DUOLITH SD1 T-TOP (Storz Medical AG, Tägerwilen, Switzerland) by a single expert urologist. The protocol applied for ED consisted of two sessions per week for 3 weeks. Each session included 3000 shock waves addressed to two penile sites (1000 proximal + 1000 distal) and to the crura (500 right + 500 left). The protocol used for PD consisted of one session per week for 4 weeks. Each session included 3000 shock waves addressed to the major penile plaque. The energy setting was 0.10–0.25 mJ/mm2 and 4–6 Hz in both cases.

Outcome analysis consisted of complete semen examination and testosterone levels before Li-ESWT and 3 months after treatment. At this time, no significant deterioration (p > 0.05) in semen parameters was recorded in both groups. No significant difference in total testosterone levels was recorded in Intervention group after extracorporeal shock wave therapy compared to baseline (p = 0.584).  The authors concluded that Extracorporeal shock wave therapy in erectile dysfunction and Peyronie’s disease patients does not seem to affect reproductive and hormonal testicular function.

This is a methodically interesting study and it it not surprising, that the authors did not encounter any differences. The authors describe also possible reasons of the previous findings in the animal model, because the shock waves were applied via the scrotal skin. The anatomical situation in the men is completely different. On the other hand, Tian et al. 2022 found the contrary effect of Li-ESWT on scrotal tissue. Using an androgen-deficient model of the rat, they were able to stimulate the Leydig cells by enhanced VEGF-production. Thus further clinical studies in this direction should be awaited. Nevertheless, testicular damage during ESWT-applications at the penis can be widely excluded.

Jens Rassweiler

Extracorporeal shock wave therapy is an established treatment for erectile dysfunction and Peyronie’s disease. Concerns regarding the safety of extracor- poreal shock wave therapy for andrological purposes on testicular function were raised by animal studies. Impairment of spermatogenesis and worsening of seminal parameters have recently been described in adult rats undergoing ESWT on the penile surface; however, there are currently no human studies available evaluating the effects of ESWT for andrological purposes on testicular function (Zang ZJ, Liu Q, Hu J, et al. The impact of low-intensity extracorporeal shock wave therapy on testicular function in adult rats. Andrology. 2018;6(6):936-942) This is a prospective randomized study including 94 patients (n= 48 intervention, n=46 control). The intervention group consisted of 32 ED and 16 patients with Peyronie`s disease-PD). All patients in the Intervention group were treated with DUOLITH SD1 T-TOP (Storz Medical AG, Tägerwilen, Switzerland) by a single expert urologist. The protocol applied for ED consisted of two sessions per week for 3 weeks. Each session included 3000 shock waves addressed to two penile sites (1000 proximal + 1000 distal) and to the crura (500 right + 500 left). The protocol used for PD consisted of one session per week for 4 weeks. Each session included 3000 shock waves addressed to the major penile plaque. The energy setting was 0.10–0.25 mJ/mm2 and 4–6 Hz in both cases. Outcome analysis consisted of complete semen examination and testosterone levels before Li-ESWT and 3 months after treatment. At this time, no significant deterioration (p > 0.05) in semen parameters was recorded in both groups. No significant difference in total testosterone levels was recorded in Intervention group after extracorporeal shock wave therapy compared to baseline (p = 0.584). The authors concluded that Extracorporeal shock wave therapy in erectile dysfunction and Peyronie’s disease patients does not seem to affect reproductive and hormonal testicular function. This is a methodically interesting study and it it not surprising, that the authors did not encounter any differences. The authors describe also possible reasons of the previous findings in the animal model, because the shock waves were applied via the scrotal skin. The anatomical situation in the men is completely different. On the other hand, Tian et al. 2022 found the contrary effect of Li-ESWT on scrotal tissue. Using an androgen-deficient model of the rat, they were able to stimulate the Leydig cells by enhanced VEGF-production. Thus further clinical studies in this direction should be awaited. Nevertheless, testicular damage during ESWT-applications at the penis can be widely excluded. Jens Rassweiler

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