Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction—12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study

Abstract

IntroductionShort-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.AimTo assess the outcome at 6 and 12 months of linear Li-ESWT on ED from a previously published randomized, double-blinded, sham-controlled trial.MethodsSubjects 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 MeasuresThe 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.ResultsLinear 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).ConclusionExposure to 2 cycles of linear Li-ESWT for ED is not superior to 1 cycle at 6- and 12-month follow-ups.Fojecki GL, Tiessen S, Osther PJS. Effect of Linear Low-Intensity Extracorporeal Shockwave Therapy for Erectile Dysfunction—12-Month Follow-Up of a Randomized, Double-Blinded, Sham-Controlled Study. Sex Med 2018;6:1–7.

A systematic review of the long-term efficacy of low-intensity shockwave therapy for vasculogenic erectile dysfunction

“…2 ). However, the results from two randomised, sham-controlled studies, Fojecki et al and Olsen et al, did not reach the authors’ set threshold for significance at follow-ups of over 6 months [ 21 , 22 ]. The effects of LISWT were followed up for 24 months in one study, 12 months in four studies and 6 months in the remaining six studies.…”

“…No studies identified an ongoing improvement at 12 months when compared to 6 months with two studies demonstrating plateauing of IIEF scores [ 15 , 18 ]. Three studies showed there was a gradual diminishing effect of effectiveness of LISWT beyond 6 months; however, scores remained at above baseline erectile function in all cases [ 13 , 16 , 21 ]. The largest of these studies demonstrating a gradual decline was conducted by Kitrey et al This prospective single-armed trial of 156 patients demonstrated an initial response rate of 63.5% at 1 month, decreasing to 42.9% at 12 months and declining to just 34% at 2-year follow-up.…”

“…Risk of bias assessment of randomised trials (Online Resource 2) showed the largest concern to be regarding selection bias, introduced by attrition of study participants. Whilst higher attrition rates are expected due to the longer follow-up in our selected articles, unusually high dropout rates in some studies such as Srini and Fojecki et al (over 20%) which was identified to be more heavily weighted towards the placebo or the 5-week treatment group [ 16 , 21 ]. This could skew results towards those receiving the treatment, generating false-positive results.…”

Low-intensity extracorporeal shock wave therapy of vasculogenic erectile dysfunction - three-week treatment in a cohort of North Italian patients

“…We used a scientifically tested machine that had already been proven through 'sham control' to have certain positive effects on penile hemodynamics over a longer follow-up period. Recently, Fojecki et al [21] showed that exposure to two cycles of linear ESWT to treat ED was not superior to one cycle at the six-month and 12-month follow-up. Although they used a different machine with a linear probe and a five-week treatment session, the number of shockwaves and the energy flux density were the same.…”

Erectile Dysfunction: A Review of Comprehensive Treatment Options for Optimal Outcome

“…A recent RCT performed on 126 men in a Danish hospital compared men who received five versus ten sessions at 6 and 12 months; treatment was approximately 38% effective in both groups, suggesting that additional sessions may not improve outcome. 150,151 In a 2 year follow-up of an open-label trial of 156 men, 63% improved at 4 weeks with 53% effectiveness sustained at 2 years. 152 Not surprisingly, men with severe ED had earlier failure.…”