Atlanta-Using extracorporeal shockwave therapy (ESWT) to reduce pain and to correct some deviation in Peyronie's disease is a relatively new concept whose application appears to be more extensive in Europe than in the United States. The majority of European studies on this topic involve small cohorts of 30 or fewer patients, and although several have included control groups who did not undergo treatment, none of these trials included sham treatment to define the strength of the placebo effect.
A German study presented here at the AUA annual meeting assessing the efficacy of ESWT in treating Peyronie's disease pain is unique in that it is large and used sham treatment to identify the placebo effect.
"We designed this study to determine the efficacy of extracorporeal shockwave therapy in Peyronie's. There have been a number of such studies published, but none of them included a placebo group. The primary finding of our study was that 85% of the patients in the verum (treatment) group showed improvement in pain compared to 48% of those in the placebo group," Georgios Hatzichristodoulou, MD, of the department of urology, St. Trudpert Hospital, Pforzheim, Germany, told Urology Times.
To blind the patient to the ESWT, a plastic shim was placed between the gel pad and the Piezoson 100 ESWT device (Richard Wolf Co., Knittlingen, Germany) in a random fashion to block the shockwaves. Dr. Hatzichristodoulou treated all patients with 2,000 shockwaves at weekly intervals for 6 weeks. Follow-up data were collected 6 weeks after the last treatment. Pain was assessed by the patient on a visual analog scale of 1 to 10.
Reduction in pain was reported by 85% of the patients in the treatment group compared with 48% in the placebo group (p=.013). Not only did more patients in the treatment group report pain reduction following the treatments, the reduction appeared to be greater than that reported by the placebo group. The treatment group reported a drop of 2.5 points from 4.0 to 1.5 on the visual analog scale of pain perception compared with a one-point drop from 4 to 3 reported by the placebo group.
Penile deviation, measured by a goniometer after artificial erection, improved in 32% of the patients in the treatment group (mean, 44 degrees to 33 degrees) and in 24.5% of the placebo group (mean, 43 degrees to 38 degrees), but these findings did not achieve significance.
The improvement in pain score seen in 85% of the patients is in line with pain improvement seen in other studies, according to Dr. Hatzichristodoulou. In eight studies conducted since 1998, he said, pain improvement ranged from 71% to 100% of the patients, depending on the study.
Corrective capability unresolved
Whether the therapy corrects penile deviation remains an open question. Of the eight studies discussed by Dr. Hatzichristodoulou, one reported that patients had subjective improvements in deviation, four reported deviation improvement in 15% to 79% of patients in the trials, and three studies reported no improvement.
"We are proud of this study," he said. "ESWT has been studied in Peyronie's for 17 years, but none of the studies included a placebo group, which is necessary to evaluate the efficacy of the therapy."
Dr. Hatzichristodoulou told Urology Times that ESWT is a standard treatment option for patients with pain associated with Peyronie's, regardless of whether the patients were proceeding to therapy. He said ESWT technology is applied to many patients scheduled for surgical treatment of Peyronie's disease to reduce discomfort prior to the operation.
This study was conducted under the direction of Sven Lahme, MD, chief, department of urology, St. Trudpert, and was conducted at the University of Tubingen Medical School, where both physicians worked prior to accepting positions at St. Trudpert.