title: Sono-electro-magnetic therapy for treating chronic pelvic pain syndrome in men: a randomized, placebo-controlled, double-blind trial.
abstract: OBJECTIVE
  To assess the efficacy and safety of sono-electro-magnetic therapy compared to placebo in men with refractory CPPS.
  
  
  METHODS
  In a randomized, placebo-controlled, double-blind single center trial, we assessed the effect of sono-electro-magnetic therapy in men with treatment refractory CPPS. Sixty male patients were randomly assigned to treatment with either sono-electro-magnetic (n = 30) or placebo therapy (n = 30) for 12 weeks. The primary outcome was a change in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) from baseline to 12 weeks.
  
  
  RESULTS
  The 12-week difference between sono-electro-magnetic and placebo therapy in changes of the NIH-CPSI total score was -3.1 points (95% CI -6.8 to 0.6, p = 0.11). In secondary comparisons of NIH-CPSI sub-scores, we found differences between groups most pronounced for the quality-of-life sub-score (difference at 12 weeks -1.6, 95% CI -2.8 to -0.4, p = 0.015). In stratified analyses, the benefit of sono-electro-magnetic therapy appeared more pronounced among patients who had a symptom duration of 12 months or less (difference in NIH-CPSI total score -8.3, 95% CI -14.5 to 2.6) than in patients with a longer symptom duration (-0.8, 95% CI -4.6 to 3.1; p for interaction = 0.023).
  
  
  CONCLUSIONS
  Sono-electro-magnetic therapy did not result in a significant improvement of symptoms in the overall cohort of treatment refractory CPPS patients compared to placebo treatment. Subgroup analysis indicates, however, that patients with a symptom-duration of 12 months or less may benefit from sono-electro-magnetic therapy, warranting larger randomized controlled trials in this subpopulation.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00688506.
authors.affiliation: Department of Urology, University of Bern, Bern, Switzerland; Neuro-Urology, Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital, Zürich, Switzerland.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Kessler
authors.affiliation: Department of Urology, University of Bern, Bern, Switzerland.
authors.forename: Livio
authors.initials: L
authors.lastname: Mordasini
authors.affiliation: Support Center for Advanced Neuroimaging (SCAN), University Institute of Diagnostic and Interventional Neuroradiology, Inselspital, University of Bern, Bern, Switzerland.
authors.forename: Christian
authors.initials: C
authors.lastname: Weisstanner
authors.affiliation: Institute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Bern, Switzerland.
authors.forename: Peter
authors.initials: P
authors.lastname: Jüni
authors.affiliation: Institute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Bern, Switzerland.
authors.forename: Bruno R
authors.initials: BR
authors.lastname: da Costa
authors.affiliation: Support Center for Advanced Neuroimaging (SCAN), University Institute of Diagnostic and Interventional Neuroradiology, Inselspital, University of Bern, Bern, Switzerland.
authors.forename: Roland
authors.initials: R
authors.lastname: Wiest
authors.affiliation: Department of Urology, University of Bern, Bern, Switzerland.
authors.forename: George N
authors.initials: GN
authors.lastname: Thalmann
mesh_terms: D000328:Adult; D059350:Chronic Pain / Q000628:therapy*; D004311:Double-Blind Method; D004599:Electric Stimulation Therapy; D006801:Humans; D055909:Magnetic Field Therapy; D008297:Male; D008875:Middle Aged; D017699:Pelvic Pain / Q000628:therapy*; D016896:Treatment Outcome; D014464:Ultrasonic Therapy