title: [Effectiveness of low-intensity extracorporeal shock wave therapy on patients with Erectile Dysfunction (ED) who have failed to respond to PDE5i therapy. A pilot study].
abstract: Low-intensity extracorporeal shock wave therapy (LIESWT) of the penis has recently emerged as a promising modality in the treatment of ED.
  
  
  OBJECTIVE
  The objective of this paper is to assess the effectiveness and safety of LIESWT on patients with ED who have failed to respond to PDE5i treatment.
  
  
  METHODS
  Open label, prospective, longitudinal observational study. The study involved an uncontrolled population of 25 patients. The treatment consisted in applying 20,000 shock waves during a period of four weeks. In each session the patient received 5000 shock waves of 0.09 mJ/mm2: 1800 were applied on the penis (900 on each corpus cavernosum), and 3200 were applied on the perineum (1600 on each crus). During the active treatment and follow-up phases, all patients remained on their regular high on demand or once-a-day dose PDE5i schedules.
  
  
  METHODS
  Effectiveness was assessed by IIEF-6, SEP2, SEP3 and GAQ. Patients were considered to be responders whenever they improved on all three erection assessment parameters and respond positively to the GAQ at three months post-treatment. Adverse events were recorded. Statistical variables were applied and findings were considered to be statistically significant whenever the P value was<0.05.
  
  
  RESULTS
  Eighty percent (median age 63) of the patients (20/25) completed the study. Five patients were lost to follow-up and were excluded from the analysis. Sixty percent (60%) of the patients responded to the treatment, improved the 3 efficacy evaluating parameters and responded positively to the GAQ. The increase in mean IIEF-6 score was of 9 points after the third post-treatment month. There were no patients reporting treatment-related adverse events.
  
  
  CONCLUSIONS
  LIESWT for men with ED and that are PDE5i non-responders was safe and effective and restoring PDE5i response in more than 50% of patients.A large-scale multicenter study is required to determine the benefits of this treatment for ED.
authors.affiliation: Jefe de Unidad de la División Urología del Hospital Durand. Buenos Aires, Argentina. Profesor de Urología de la UBA. Co-Director Médico del Instituto Médico Especializado (IME).
authors.forename: Amado
authors.initials: A
authors.lastname: Bechara
authors.affiliation: Encargado del Sector Medicina Sexual de la División Urología del Hospital Durand. Co-Director Médico del IME Buenos Aires, Argentina.
authors.forename: Adolfo
authors.initials: A
authors.lastname: Casabé
authors.affiliation: Urólogo de la División Urología del Hospital Durand y del IME. Buenos Aires, Argentina.
authors.forename: Walter
authors.initials: W
authors.lastname: De Bonis
authors.affiliation: Urólogo de la División Urología del Hospital Durand. Buenos Aires, Argentina.
authors.forename: Julián
authors.initials: J
authors.lastname: Nazar
mesh_terms: D000368:Aged; D007172:Erectile Dysfunction / Q000628:therapy*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000627:therapeutic use; D010865:Pilot Projects; D011446:Prospective Studies; D017211:Treatment Failure; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000379:methods*
chemical_list: D058986:Phosphodiesterase 5 Inhibitors