title: Extracorporeal shock wave therapy in Peyronie's disease: results of a placebo-controlled, prospective, randomized, single-blind study.
abstract: BACKGROUND
  Extracorporeal shock wave therapy (ESWT) for treatment of Peyronie's disease (PD) is controversial.
  
  
  OBJECTIVE
  To study the efficacy of ESWT by a placebo-controlled, randomized trial.
  
  
  METHODS
  Patients with PD (n=102) were randomly assigned (n=51) to each group (ESWT or placebo). All patients were given 6 weekly treatments. Patients in the ESWT-group received 2,000 shock waves per session, using the Piezoson 100 lithotripter (Richard Wolf, Knittlingen, Germany). Patients in the placebo-group were treated with interposition of a plastic membrane, which prevented any transmission of shock waves.
  
  
  METHODS
  Primary end point was decrease of pain between baseline and after 4 weeks follow-up. Secondary end points were changes in deviation, plaque size, and sexual function. Pain was assessed by a visual analog scale. Deviation was measured by a goniometer after artificial erection using Alprostadil (Viridal®, Schwarz Pharma, Monheim, Germany). Plaque size was measured with a ruler and sexual function assessed by a scale regarding the ability to perform sexual intercourse.
  
  
  RESULTS
  Overall, only 45 patients experienced pain at baseline. In the subgroup analysis of these patients, pain decreased in 17/20 (85.0%) patients in the ESWT group and 12/25 (48.0%) patients in the placebo group (P=0.013, relative risk [RR]=0.29, 95% confidence interval: 0.09-0.87). Penile deviation was not reduced by ESWT (P=0.66) but worsened in 20/50 (40%) and 12/49 (24.5%) patients of the ESWT and placebo-group, respectively (P=0.133). Plaque size reduction was not different between the two groups (P=0.33). Additional, plaque size increased in five patients (10.9%) of the ESWT group only. An improvement in sexual function could not be verified (P=0.126, RR=0.46).
  
  
  CONCLUSIONS
  Despite some potential benefit of ESWT in regard to pain reduction, it should be emphasized that pain usually resolves spontaneously with time. Given this and the fact that deviation may worsen with ESWT, this treatment cannot be recommended.
authors.affiliation: Department of Urology, Technische Universität München, Klinikum rechts der Isar, Munich, Germany.
authors.forename: Georgios
authors.initials: G
authors.lastname: Hatzichristodoulou
authors.forename: Christoph
authors.initials: C
authors.lastname: Meisner
authors.forename: Jürgen E
authors.initials: JE
authors.lastname: Gschwend
authors.forename: Arnulf
authors.initials: A
authors.lastname: Stenzl
authors.forename: Sven
authors.initials: S
authors.lastname: Lahme
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D019220:High-Energy Shock Waves / Q000627:therapeutic use*; D006801:Humans; D008096:Lithotripsy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010410:Penile Erection / Q000502:physiology; D010411:Penile Induration / Q000503:physiopathology / Q000628:therapy*; D010919:Placebos; D011446:Prospective Studies; D016037:Single-Blind Method
chemical_list: D010919:Placebos
keywords: Extracorporeal Shock Wave Therapy; Peyronie's Disease; Placebo-Controlled Study; Randomized Clinical Trial