Extracorporeal shock wave therapy (ESWT) may ease Peyronie’s disease (PD) pain and stabilize plaque size and curvature, an Italian study shows.

In a prospective, randomized, double-blind trial, investigators at University Federico II of Naples compared ESWT and placebo in 100 men who had received a diagnosis of PD within the previous 12 months and had had no PD-related treatments. Each study arm had 50 patients.

Researchers evaluated erectile function, pain during erection, plaque size, penile curvature, and quality of life (QoL) at baseline and at 12- and 24-week follow-up visits. They measured erectile function using the shortened version of the International Index of Erectile Function (IIEF-5) and evaluated pain using a 0-10 visual analog scale (VAS). The researchers scored QoL using a five-item questionnaire.

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Subjects underwent four weekly treatments. Each ESWT session consisted of 2,000 focused shock waves. For the placebo patients, investigators used a nonfunctioning transducer.

Mean IIEF-5 scores improved significantly from 14 at baseline to 19.4 in the ESWT group and did not change significantly in the placebo arm (14.16 at baseline and 14.74 at 24 weeks), according to a report in European Urology (2009; published online ahead of print).

The ESWT group had a significantly greater improvement in mean VAS scores than the placebo arm. Mean VAS scores declined from 5.51 at baseline to 0.46 at 24 weeks in the ESWT group and from 5.19 to 2.66 in the placebo group. At 24 weeks, mean QoL scores were significantly higher compared with baseline in both groups; the increase was significantly greater in the ESWT group.

Mean plaque size and degree of curvature remained unchanged in the ESWT group at the 24-week evaluation but increased significantly compared with baseline in the placebo group.

“Although no significant differences in terms of mean plaque size and pre-existing mean penile curvature were evident in patients receiving ESWT, the worsening of such values in the placebo group may suggest a potential protective effect of ESWT on disease progression,” the authors concluded.

In an accompanying editorial, Antonio Martin Morales, MD, of Carlos Haya University Hospital in Málaga, Spain, observed: “The authors must be congratulated for undertaking this sound study to clarify the role of ESWT in PD.”