Mortensen J. et al., 2021: A Randomized, Single-Blinded Clinical Trial Evaluating the Effect of Extracorporeal Shockwave Treatment (ESWT) as Add-On Therapy to Vacuum Erectile Device on Peyronie's Disease.
Mortensen J, Skov-Jeppesen SM, Ladegaard PBJ, Lund L.
Department of Urology, Odense University Hospital, Odense, Denmark.
Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.
Purpose: The aim of this study was to investigate whether ESWT with a higher energy as an add-on therapy to vacuum-pump followed by manipulation exercises could reduce the penile curvature, pain and improve IIEF-5 score.
Materials and methods: Men aged >18 and <80 years and diagnosed with PD in stable phase with no history of penile surgery or previous ESWT treatment were eligible to participate. They were randomised to either active ESWT (n = 16) or sham ESWT (n = 16). Both groups were treated once a week for five weeks. Each treatment session consisted of 2000 shockwaves at 0.5mJ/mm2. All patients in both groups used a vacuum pump followed by manipulation exercises.
Results: Thirty men completed the study protocol. Mean age in the treatment group was 61.7 (SD 8.3) and 63 (SD 7.35) in the control group. After six months, mean change in penile curvature was -12.8 (SD 13) degrees in the treatment group and -6.6 (SD 8.9) in the control group (p = 0.204). Mean IIEF-5 score decreased by 0.17 (SD 3) in the treatment group and 3.06 (SD 5.5) in the control group (p = 0.086) at six-month follow-up. Pain was assessed using both VAS and PDQ and demonstrated no difference between the groups after six months (p = 0.648).
Conclusion: In the treatment group, we observed a greater but non-significant change in penile curvature and no adverse effects.
Res Rep Urol. 2021 Sep 16;13:715-722. doi: 10.2147/RRU.S325929. eCollection 2021. PMID: 34557454 Clinical Trial.
I feel confirmed in my prejudice that Scandinavian authors have a very pleasant way not to milk out the last drop of the study data and a neutral way of summarising their study results. A well done RCT!
In the present series 4/16 patients in the control group and 9/14 in the treatment arm had calcifications. I was surprised to read that the authors expected calcified plaques to respond better to ESWT. My surgical experience with calcified plaques was that they were more difficult to dissect and treat than the non-calcified. This is the authors’ comment on their experience: “We performed a secondary stratified analysis based on plaque calcification. We expected that calcified PD plaques were more likely to dissolve than non-calcified ones. However, in patients with calcified plaques, we found that the curvature reduction was comparable between the treatment group and the control group.
On the contrary, non-calcified plaques had a substantially higher curvature reduction when treated with active ESWT. In view of the overall result that showed no statistically significant benefit of ESWT on penile curvature, it has to be taken into consideration that there were more patients with calcified plaques in the treatment group, which potentially biased the result. Further studies need to take into account plaque calcification as a factor, which may influence the efficacy of ESWT.” The numbers were obviously too small to put this into the result section.