Vardi Y. 2010 (99. Vardi Y, Appel B, Jacob G, Massarwi O, Gruenwald I. Can low-intensity extracorporeal shockwave therapy improve erectile function? A 6-month follow-up pilot study in patients with organic erectile dysfunction. Eur Urol. 2010;58:243-8.) |
Single arm |
Israel |
Responders |
20 |
1; without PDE5i |
A change in the IIEF-ED domain score of >5 points was used as the main measure of treatment success. |
At 1 mo follow-up, 1) 20.9±5.8 vs. 13.5±4.1(baseline), p < 0.001 in IIEF-ED scores remaining unchanged at 6 mo; 2) Significant increasing in the duration of erection and penile rigidity, and significant improvement in penile endothelial function; 3) Ten men did not require any PDE5-I therapy after 6-mo follow-up. |
Vardi Y. 2012 (1010. Vardi Y, Appel B, Kilchevsky A, Gruenwald I. Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study. J Urol. 2012;187:1769-75.) |
RCT |
Israel |
Responders |
40 (treatment) vs. 20 (placebo) |
1; without PDE5i |
Primary end point: A 5-point or greater improvement in the IIEF-EF between baseline and at 4 w after treatment. Secondary end point: Significant increase in the IIEF subcategories. An increase in EHS from ≤2 at baseline to ≥3 at 4w after treatment, and an improvement in penile blood flow. |
1) Increase in IIEF-EF score: 6.7±0.9 (LI-ESWT) vs. 3.0±1.4 (sham), p=0.0322; 2) 19 (LI- ESWT) vs. none (sham) in patients with baseline EHS ≤2 having EHS≥3 after treatment; 3) 8.2 vs. 0.1 ml/m/dl in FMD, p< 0.0001. |
Gruenwald I. 2012 (1111. Gruenwald I, Appel B, Vardi Y. Low-intensity extracorporeal shock wave therapy–a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. J Sex Med. 2012;9:259-64.) |
Single arm |
Israel |
Non-responders |
29 |
1; without PDE5i at 4w after completing LI-ESWT (FU1) and use it after 8w (FU2). |
Change in IIEF-ED, EHS and three parameters of penile hemodynamics and endothelial function. |
1) Mean IIEF-ED scores increased from 8.8±1 (baseline) to 12.3±1 at FU1 (P = 0.035). At FU2 (on active PDE5i treatment), their IIEF-ED further increased to 18.8±1 (P < 0.0001); 2) 72.4% (P < 0.0001) reached an EHS of≥3; 3) A significant improvement (P = 0.0001) in penile hemodynamics and this improvement significantly was correlating with increases in the IIEF-ED (P < 0.05). |
Olsen A.B. 2014 (1717. Olsen AB, Persiani M, Boie S, Hanna M, Lund L. Can low-intensity extracorporeal shockwave therapy improve erectile dysfunction? A prospective, randomized, double-blind, placebo-controlled study. Scand J Urol. 2015;49:329-33.) |
RCT |
Denmark |
Responders |
51 (treatment) vs. 54 (placebo) |
5; without PDE5i |
Primary end point: The treatment success threshold was set at EHS 3-4. Secondary end point: An increase in IIEF-EF domain score of at least 5 points. |
Twenty-nine men (57%, active group) were able to have sexual intercourse without the use of medication vs. 5 men (9%, placebo group, p = 0.0001) after 5 weeks of completing LI-ESWT. But no significant result was found with the use of the IIEF-EF. |
Yee C.H. 2014 (1818. Yee CH, Chan ES, Hou SS, Ng CF. Extracorporeal shockwave therapy in the treatment of erectile dysfunction: a prospective, randomized, double-blinded, placebo controlled study. Int J Urol. 2014;21:1041-5.) |
RCT |
China |
Unknown |
30 (treatment) vs. 28 (placebo) |
1; whether other modality being used was unknown. |
Primary end point: The 13-week change from baseline for IIEF-ED score after one course of Li-ESWT. Secondary end point: The interval change of EHS and adverse events from LI-ESWT therapy. |
At 4w follow-up, 1) mean IIEF-ED score: 17.8±4.8 (LI-ESWT) vs. 15.8±6.1 (sham), p=0.156; 2) mean EHS: 2.7±0.5 (LI-ESWT) and 2.4±0.9 (sham), p = 0.163. |
Bechara A. 2015 (1919. Bechara A, Casabé A, De Bonis W, Nazar J. [Effectiveness of low-intensity extracorporeal shock wave therapy on patients with Erectile Dysfunction (ED) who have failed to respond to PDE5i therapy. A pilot study]. Arch Esp Urol. 2015;68:152-60.) |
Single arm |
Argentina |
Non-responders |
25 |
3; use PDE5i |
Whenever patients improved on all IIEF-6, SEP2 and SEP3 and to respond positively to the GAQ at 3 months post-treatment. |
60% (12/20) of the patients responded to the treatment. |
Chung E. 2015 (2020. Chung E, Cartmill R. Evaluation of clinical efficacy, safety and patient satisfaction rate after low-intensity extracorporeal shockwave therapy for the treatment of male erectile dysfunction: an Australian first open-label single-arm prospective clinical trial. BJU Int. 2015;115 (Suppl 5):46-9.) |
Single arm |
Australia |
Failed or unsatisfactory outcome with oral PDE5i and/or vasoactive agents |
30 |
4; Whether other modality being used was unknown. |
Change in IIEF-5 and EDITS scores, and overall satisfaction rate were recorded at 6 weeks and 4 months after completion of LI-ESWT. |
At 6 weeks and 4m, 60% of patients reported an improvement in IIEF-5 score by 5 points, 70% improvement in EDITS Index score by > 50%. 67% of patients satisfied (scoring 4 out of 5) and 80% would recommend the therapy. |
Qi T. 2015 (2121. Qi T, Wang B, Chen J. Comparison of clinical efficacy on penile erectile dysfunction between extracorporeal shock wave and vacuum erectile device: a randomized controlled clinical trial. J N Med. 2015; 46: 597-9.) |
RCT |
China |
Unknown |
30 (LI- ESWT) vs. 30 (vacuum erectile device) |
7; unknown |
At 1 mo after LI-ESWT. 1) Cure: IIEF-5 score ≥ 22pts, or SEP, GAQ and EHS is 5, 2 and 4pts, respectively; 2) Relief: when IIEF-5 score<22pts, a 5 point or greater improvement in the IIEF-5, or SEP≥4pts, GAQ≥1pts, EHS≥3pts; 3) Fail: IIEF-5 score<21pts and improvement score ≤4pts, SEP<3pts, GAQ=0pts, EHS<2pts. |
The number of cured patient was 14 and the number of relief was 8. Effective rate was 73% (22/30) in LI-ESWT group. |
Pelayo-Nieto M. 2015 (2222. Pelayo-Nieto M, Linden-Castro E, Alias-Melgar A, Espinosa-Pérez Grovas D, Carreño-de la Rosa F, Bertrand-Noriega F, et al. Linear shock wave therapy in the treatment of erectile dysfunction. Actas Urol Esp. 2015;39:456-9.) |
Single arm |
Mexico |
Unknown |
15 |
3; unknown medication history |
In IIEF-EF, success of treatment was defined as an increase of >2 points and >5 points in groups of mild and moderate, respectively. Results were evaluated by using IIEF, EHS, SEP, GAQ at 1 and 6 months after treatment. |
The rate of success was 80%. 1) IIEF: 15 (1111. Gruenwald I, Appel B, Vardi Y. Low-intensity extracorporeal shock wave therapy–a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. J Sex Med. 2012;9:259-64.
12. Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee YC, Lue TF. Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis. Eur Urol. 2017;71:223-233.
13. Angulo JC, Arance I, de Las Heras MM, Meilán E, Esquinas C, Andrés EM. Efficacy of low-intensity shock wave therapy for erectile dysfunction: A systematic review and meta-analysis. Actas Urol Esp. 2016. pii:S0210-480630117-6.
14. Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535.
15. Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011; 343:d5928.
16. Slim K, Nini E, Forestier D, Kwiatkowski F, Panis Y, Chipponi J. Methodological index for non-randomized studies (minors): development and validation of a new instrument. ANZ J Surg. 2003;73:712-6.
17. Olsen AB, Persiani M, Boie S, Hanna M, Lund L. Can low-intensity extracorporeal shockwave therapy improve erectile dysfunction? A prospective, randomized, double-blind, placebo-controlled study. Scand J Urol. 2015;49:329-33.-1818. Yee CH, Chan ES, Hou SS, Ng CF. Extracorporeal shockwave therapy in the treatment of erectile dysfunction: a prospective, randomized, double-blinded, placebo controlled study. Int J Urol. 2014;21:1041-5.) pts at baseline vs. 20 (1111. Gruenwald I, Appel B, Vardi Y. Low-intensity extracorporeal shock wave therapy–a novel effective treatment for erectile dysfunction in severe ED patients who respond poorly to PDE5 inhibitor therapy. J Sex Med. 2012;9:259-64.
12. Lu Z, Lin G, Reed-Maldonado A, Wang C, Lee YC, Lue TF. Low-intensity Extracorporeal Shock Wave Treatment Improves Erectile Function: A Systematic Review and Meta-analysis. Eur Urol. 2017;71:223-233.
13. Angulo JC, Arance I, de Las Heras MM, Meilán E, Esquinas C, Andrés EM. Efficacy of low-intensity shock wave therapy for erectile dysfunction: A systematic review and meta-analysis. Actas Urol Esp. 2016. pii:S0210-480630117-6.
14. Moher D, Liberati A, Tetzlaff J, Altman DG; PRISMA Group. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ. 2009;339:b2535.
15. Higgins JP, Altman DG, Gøtzsche PC, Jüni P, Moher D, Oxman AD, et al. The Cochrane Collaboration's tool for assessing risk of bias in randomised trials. BMJ. 2011; 343:d5928.
16. Slim K, Nini E, Forestier D, Kwiatkowski F, Panis Y, Chipponi J. Methodological index for non-randomized studies (minors): development and validation of a new instrument. ANZ J Surg. 2003;73:712-6.
17. Olsen AB, Persiani M, Boie S, Hanna M, Lund L. Can low-intensity extracorporeal shockwave therapy improve erectile dysfunction? A prospective, randomized, double-blind, placebo-controlled study. Scand J Urol. 2015;49:329-33.
18. Yee CH, Chan ES, Hou SS, Ng CF. Extracorporeal shockwave therapy in the treatment of erectile dysfunction: a prospective, randomized, double-blinded, placebo controlled study. Int J Urol. 2014;21:1041-5.
19. Bechara A, Casabé A, De Bonis W, Nazar J. [Effectiveness of low-intensity extracorporeal shock wave therapy on patients with Erectile Dysfunction (ED) who have failed to respond to PDE5i therapy. A pilot study]. Arch Esp Urol. 2015;68:152-60.
20. Chung E, Cartmill R. Evaluation of clinical efficacy, safety and patient satisfaction rate after low-intensity extracorporeal shockwave therapy for the treatment of male erectile dysfunction: an Australian first open-label single-arm prospective clinical trial. BJU Int. 2015;115 (Suppl 5):46-9.
21. Qi T, Wang B, Chen J. Comparison of clinical efficacy on penile erectile dysfunction between extracorporeal shock wave and vacuum erectile device: a randomized controlled clinical trial. J N Med. 2015; 46: 597-9.
22. Pelayo-Nieto M, Linden-Castro E, Alias-Melgar A, Espinosa-Pérez Grovas D, Carreño-de la Rosa F, Bertrand-Noriega F, et al. Linear shock wave therapy in the treatment of erectile dysfunction. Actas Urol Esp. 2015;39:456-9.-2323. Reisman Y, Hind A, Varaneckas A, Motil I. Initial experience with linear focused shockwave treatment for erectile dysfunction: a 6-month follow-up pilot study. Int J Impot Res. 2015;27:108-12.) pts at 1 and 6 mo, p<0.013; 2) EHS: 2 (22. Abu-Ghanem Y, Kitrey ND, Gruenwald I, Appel B, Vardi Y. Penile low-intensity shock wave therapy: a promising novel modality for erectile dysfunction. Korean J Urol. 2014;55:295-9.-33. Wang CJ, Wang FS, Yang KD, Weng LH, Hsu CC, Huang CS, et al. Shock wave therapy induces neovascularization at the tendon-bone junction. A study in rabbits. J Orthop Res. 2003;21:984-9.) pts at baseline vs. 4 (22. Abu-Ghanem Y, Kitrey ND, Gruenwald I, Appel B, Vardi Y. Penile low-intensity shock wave therapy: a promising novel modality for erectile dysfunction. Korean J Urol. 2014;55:295-9.
3. Wang CJ, Wang FS, Yang KD, Weng LH, Hsu CC, Huang CS, et al. Shock wave therapy induces neovascularization at the tendon-bone junction. A study in rabbits. J Orthop Res. 2003;21:984-9.-44. Aicher A, Heeschen C, Sasaki K, Urbich C, Zeiher AM, Dimmeler S. Low-energy shock wave for enhancing recruitment of endothelial progenitor cells: a new modality to increase efficacy of cell therapy in chronic hind limb ischemia. Circulation. 2006;114:2823-30.) pts at 1 mo, p<0.01; 3) SEP3:7 patients at baseline vs. 12 patients at 1 mo, p=0.0013. |
Reisman Y. 2015 (2323. Reisman Y, Hind A, Varaneckas A, Motil I. Initial experience with linear focused shockwave treatment for erectile dysfunction: a 6-month follow-up pilot study. Int J Impot Res. 2015;27:108-12.) |
Single arm |
Netherlands, et al |
Responders and Non-responders |
58 |
2; without PDE5i until 1 month post treatments. |
Primary end point: An increase of IIEF-EF score from baseline to the third follow-up (6m post treatment) according to the initial ED severity: >2-point increase for mild symptoms; >5 points for moderate symptoms; and >7 points for severe symptoms. |
47(81%) had a successful treatment. |
Ruffo A. 2015 (2424. Ruffo A, Capece M, Prezioso D, Romeo G, Illiano E, Romis L, et al. Safety and efficacy of low intensity shockwave (LISW) treatment in patients with erectile dysfunction. Int Braz J Urol. 2015;41:967-74.) |
Single arm |
Italy |
Non-responders |
31 |
2; without PDE5i during treatment. |
Primary end point: An increase of IIEF-EF score from baseline to 1 and 3 months after LI-ESWT. Secondary end point: Improvement in SEP2, 3 and GAQ. |
1) IIEF-EF: 16.54±6.35 (baseline) vs. 21.13±6.31 (1 mo), 21.03±6.38 (3 mo). 2) SEP2 (yes): 61% (baseline) vs. 86% (1mo). 89% (3 mo). 3) SEP3 (yes): 32% (baseline) vs. 58% (1mo), 62% (3 mo); all p<0.05.4) GAQ: at 1 and 3 mo, difference is not significant. |
Srini V.S. 2015 (2525. Srini VS, Reddy RK, Shultz T, Denes B. Low intensity extracorporeal shockwave therapy for erectile dysfunction: a study in an Indian population. Can J Urol. 2015;22:7614-22.) |
RCT |
India |
Responders |
60 (treatment) vs. 17 (placebo) |
1; without PDE5i |
Primary end point: ≥5 points improvement in the IIEF-EF between baseline and 1 mo (also 12 mo). Secondary end point: Significant increase in the CGIC and an increase in EHS from ≤2 at baseline to ≥ 3 at FU1 and FU5. |
1) Increase in IIEF-EF: at 1 mo, 12.5 pts in LI- ESWT group vs. 1.4 pts in control group; at 12 mo. 8.7 pts in LI-ESWT group vs. NA in control group. 2) Effective rate in EHS: 90% (1m), 83% (12m) vs. none (placebo group). 3) Data about CGIC were not provided. |
Hisasue S. 2016 (2626. Hisasue S, China T, Horiuchi A, Kimura M, Saito K, Isotani S, et al. Impact of aging and comorbidity on the efficacy of low-intensity shock wave therapy for erectile dysfunction. Int J Urol. 2016;23:80-4.) |
Single arm |
Japan |
Unknown |
56 |
1; use PDE5i on-demand after LI-ESWT. |
Assessing the patients with SHIM, EHS, and MPCC at 1, 3 and 6 months after the final LI-SWT. |
64.2% patients showed improvement in SHIM scores, and 57.1% patients achieved an EHS 3 or 4 without PDE5i within 6 months after LI-SWT. MPCC showed significant improvement in 64% patients from 1 month after treatment, maintaining it until 6 months. |
Frey A. 2016 (2727. Frey A, Sønksen J, Fode M. Low-intensity extracorporeal shockwave therapy in the treatment of postprostatectomy erectile dysfunction: a pilot study. Scand J Urol. 2016;50:123-7.) |
Single arm |
Denmark |
Postprostatectomy ED with unknown sensitivity to PDE5i |
16 |
6; use of erectogenic aids |
Primary end point: Changes in IIEF-5 scores. Secondary end point: A global satisfaction question ranging from “very dissatisfied” to “very satisfied”. |
The median change in IIEF-5 scores was +3.5 (range −1 to 8; p=0.0049) and +1 (range −3 to 14; p=0.046); 11 and 7 patients reported being either satisfied or very satisfied at 1 mo follow up and 1 year follow up, respectively. |
Kitrey N.D. 2016 (2828. Kitrey ND, Gruenwald I, Appel B, Shechter A, Massarwa O, Vardi Y. Penile Low Intensity Shock Wave Treatment is Able to Shift PDE5i Nonresponders to Responders: A Double-Blind, Sham Controlled Study. J Urol. 2016;195:1550-5.) |
RCT |
Israel |
Non-responders |
37 (treatment) vs. 18 (placebo) |
1; use PDE5i when evaluating results. |
Main outcomes: 1) EHS was 3 or greater; 2) A change in IIEF-EF was greater than 7 points for severe ED and 5 points for moderate ED. Secondary outcome: FMD penile time-flow AUC as an indicator of penile endothelial function and the CGIC questionnaire. They were evaluated at 1 month after the end of treatment. |
1) 54.1% (LIST) vs. none (sham) had EHS=3, p<0.0001; 2) in IIEF-EF, 40.5% (LIST) vs. none (sham), p=0.001; 3) 56.3% of the patients treated with active LIST after sham treatment achieved an erection hard enough for penetration (p<0.005); 4) The change in penile hemodynamic parameters was statistically significant; 5) According to CGIC, 56.8% of patients (LIST) vs. 27.8% (sham)(p=0.051) reported clinical improvement. |