Fojecki GL et al, 2018: Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction-12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study.

Thursday, 16 August 2018

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Fojecki GL, Tiessen S, Osther PJS.
Department of Urology, Hospital of Southern Jutland, Sønderborg, Denmark.
Department of Urology, Odense University Hospital, Odense, Denmark.
Urological Research Center, Department of Urology, Lillebaelt Hospital, University of Southern, Denmark.

Abstract

INTRODUCTION: Short-term data on the effect of low-intensity extracorporeal shockwave therapy (Li-ESWT) on erectile dysfunction (ED) have been inconsistent. The suggested mechanisms of action of Li-ESWT on ED include stimulation of cell proliferation, tissue regeneration, and angiogenesis, which can be processes with a long generation time. Therefore, long-term data on the effect of Li-ESWT on ED are strongly warranted.AIM: To assess the outcome at 6 and 12 months of linear Li-ESWT on ED from a previously published randomized, double-blinded, sham-controlled trial.
METHODS: Subjects with ED (N = 126) who scored lower than 25 points in the erectile function domain of the International Index of Erectile Function (IIEF-EF) were eligible for the study. They were allocated to 1 of 2 groups: 5 weekly sessions of sham treatment (group A) or linear Li-ESWT (group B). After a 4-week break, the 2 groups received active treatment once a week for 5 weeks. At baseline and 6 and 12 months, subjects were evaluated by the IIEF-EF, the Erectile Hardness Scale (EHS), and the Sexual Quality of Life in Men.
MAIN OUTCOME MEASURES: The primary outcome measure was an increase of at least 5 points in the IIEF-EF (ΔIIEF-EF score). The secondary outcome measure was an increase in the EHS score to at least 3 in men with a score no higher than 2 at baseline. Data were analyzed by linear and logistic regressions.
RESULTS: Linear regression of the ΔIIEF-EF score from baseline to 12 months included 95 patients (dropout rate = 25%). Adjusted for the IIEF-EF score at baseline, the difference between groups B and A was -1.30 (95% CI = -4.37 to 1.77, P = .4). The success rate based on the main outcome parameter (ΔIIEF-EF score ≥ 5) was 54% in group A vs 47% in group B (odds ratio = 0.67, P = .28). Improvement based on changes in the EHS score in groups A and B was 34% and 24%, respectively (odds ratio = 0.47, P = .82).
CONCLUSION: Exposure to 2 cycles of linear Li-ESWT for ED is not superior to 1 cycle at 6- and 12-month follow-ups.

Sex Med. 2018 Mar;6(1):1-7. doi: 10.1016/j.esxm.2017.09.002. Epub 2017 Dec 21. FREE ARTICLE

Comments 1

Peter Alken on Thursday, 16 August 2018 11:13

A well done study with long term data of a previously published series (Fojecki GL, Tiessen S, Osther PJ. Effect of low-energy linear shockwave therapy on erectile dysfunction—a double-blinded, sham-controlled, randomized clinical trial. J Sex Med 2017;
14:106-112).
The method in the present study was:
“Treatment sessions consisted of 600 shockwave (SW) pulses with an energy flux density (EFD) of 0.09 mJ/mm2 and a frequency of 5 Hz delivered within 15 minutes. SWs were given in 3 areas: 300 impulses were administered to the corpora cavernosa in the upright position and 150 impulses were administered to each penile crus in the lithotomy position. The ESWT device was equipped with a piezoelectric linear therapy source (FBL10; Richard Wolf GmbH). Penetration depth in this device is adjusted by applying different gel pads. In our
study we used a 0-mm gel pad that allowed treatment of an organ area 1 cm deep and 5 cm wide.”
The interested reader should compare this study with: Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment. Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. J Sex Med. 2018 Mar;15(3):334-345. The treatment technique was different and so was the evaluation of the results.
The treatment method was: “Patients were treated with a low-energy shockwave generator (ARIES 2 and Smart Focus probe; Dornier MedTech GmbH, Wessling, Germany). Shockwaves were delivered at an energy flux density of 0.05 mJ/mm2, effective energy (E12mm) of 3.4 mJ, and frequency of 8 Hz (level 4 of the ARIES 2 device). Application was performed by slowly moving the shockwave probe back and forth from the glans penis to the pubis at the left and right sides of the penis to reach the corpora and avoid the urethra.
This technique allowed equal application of the energy along the 2 corpora cavernosa. 5,000 shockwaves were applied during each treatment session: 1,000 shockwaves each to the left and right shaft, 1,000 shockwaves each to the 2 crura, and 500 shockwaves each to the left and right penile hilum. A standard commercial gel normally used for sonography was applied to the subject’s penis and to the membrane of the shockwave applicator. Each treatment session lasted approximately 20 minutes.”

What seems to be lacking among proponents of Li-ESWT is a generally accepted standard of therapy. As long as this is not done there will be conflicting results.

A well done study with long term data of a previously published series (Fojecki GL, Tiessen S, Osther PJ. Effect of low-energy linear shockwave therapy on erectile dysfunction—a double-blinded, sham-controlled, randomized clinical trial. J Sex Med 2017;
14:106-112).
The method in the present study was:
“Treatment sessions consisted of 600 shockwave (SW) pulses with an energy flux density (EFD) of 0.09 mJ/mm2 and a frequency of 5 Hz delivered within 15 minutes. SWs were given in 3 areas: 300 impulses were administered to the corpora cavernosa in the upright position and 150 impulses were administered to each penile crus in the lithotomy position. The ESWT device was equipped with a piezoelectric linear therapy source (FBL10; Richard Wolf GmbH). Penetration depth in this device is adjusted by applying different gel pads. In our
study we used a 0-mm gel pad that allowed treatment of an organ area 1 cm deep and 5 cm wide.”
The interested reader should compare this study with: Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment. Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. J Sex Med. 2018 Mar;15(3):334-345.  The treatment technique was different and so was the evaluation of the results. 
The treatment method was: “Patients were treated with a low-energy shockwave generator (ARIES 2 and Smart Focus probe; Dornier MedTech GmbH, Wessling, Germany). Shockwaves were delivered at an energy flux density of 0.05 mJ/mm2, effective energy (E12mm) of 3.4 mJ, and frequency of 8 Hz (level 4 of the ARIES 2 device). Application was performed by slowly moving the shockwave probe back and forth from the glans penis to the pubis at the left and right sides of the penis to reach the corpora and avoid the urethra.
This technique allowed equal application of the energy along the 2 corpora cavernosa. 5,000 shockwaves were applied during each treatment session: 1,000 shockwaves each to the left and right shaft, 1,000 shockwaves each to the 2 crura, and 500 shockwaves each to the left and right penile hilum. A standard commercial gel normally used for sonography was applied to the subject’s penis and to the membrane of the shockwave applicator. Each treatment session lasted approximately 20 minutes.”

What seems to be lacking among proponents of Li-ESWT is a generally accepted standard of therapy. As long as this is not done there will be conflicting results.

A well done study with long term data of a previously published series (Fojecki GL, Tiessen S, Osther PJ. Effect of low-energy linear shockwave therapy on erectile dysfunction—a double-blinded, sham-controlled, randomized clinical trial. J Sex Med 2017; 14:106-112). The method in the present study was: “Treatment sessions consisted of 600 shockwave (SW) pulses with an energy flux density (EFD) of 0.09 mJ/mm2 and a frequency of 5 Hz delivered within 15 minutes. SWs were given in 3 areas: 300 impulses were administered to the corpora cavernosa in the upright position and 150 impulses were administered to each penile crus in the lithotomy position. The ESWT device was equipped with a piezoelectric linear therapy source (FBL10; Richard Wolf GmbH). Penetration depth in this device is adjusted by applying different gel pads. In our study we used a 0-mm gel pad that allowed treatment of an organ area 1 cm deep and 5 cm wide.” The interested reader should compare this study with: Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment. Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. J Sex Med. 2018 Mar;15(3):334-345. The treatment technique was different and so was the evaluation of the results. The treatment method was: “Patients were treated with a low-energy shockwave generator (ARIES 2 and Smart Focus probe; Dornier MedTech GmbH, Wessling, Germany). Shockwaves were delivered at an energy flux density of 0.05 mJ/mm2, effective energy (E12mm) of 3.4 mJ, and frequency of 8 Hz (level 4 of the ARIES 2 device). Application was performed by slowly moving the shockwave probe back and forth from the glans penis to the pubis at the left and right sides of the penis to reach the corpora and avoid the urethra. This technique allowed equal application of the energy along the 2 corpora cavernosa. 5,000 shockwaves were applied during each treatment session: 1,000 shockwaves each to the left and right shaft, 1,000 shockwaves each to the 2 crura, and 500 shockwaves each to the left and right penile hilum. A standard commercial gel normally used for sonography was applied to the subject’s penis and to the membrane of the shockwave applicator. Each treatment session lasted approximately 20 minutes.” What seems to be lacking among proponents of Li-ESWT is a generally accepted standard of therapy. As long as this is not done there will be conflicting results.

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