Sono-electro-magnetic therapy for treating chronic pelvic pain syndrome in men: a randomized, placebo-controlled, double-blind trial

Thomas M Kessler; Livio Mordasini; Christian Weisstanner; Peter Jüni; Bruno R da Costa; Roland Wiest; George N Thalmann

doi:10.1371/journal.pone.0113368

Sono-electro-magnetic therapy for treating chronic pelvic pain syndrome in men: a randomized, placebo-controlled, double-blind trial

PLoS One. 2014 Dec 29;9(12):e113368. doi: 10.1371/journal.pone.0113368. eCollection 2014.

Authors

Thomas M Kessler¹, Livio Mordasini², Christian Weisstanner³, Peter Jüni⁴, Bruno R da Costa⁴, Roland Wiest³, George N Thalmann²

Affiliations

¹ Department of Urology, University of Bern, Bern, Switzerland; Neuro-Urology, Spinal Cord Injury Center & Research, University of Zürich, Balgrist University Hospital, Zürich, Switzerland.
² Department of Urology, University of Bern, Bern, Switzerland.
³ Support Center for Advanced Neuroimaging (SCAN), University Institute of Diagnostic and Interventional Neuroradiology, Inselspital, University of Bern, Bern, Switzerland.
⁴ Institute of Social and Preventive Medicine and Clinical Trials Unit, University of Bern, Bern, Switzerland.

Abstract

Objective: To assess the efficacy and safety of sono-electro-magnetic therapy compared to placebo in men with refractory CPPS.

Patients and 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.

Trial registration: ClinicalTrials.gov NCT00688506.

Publication types

Clinical Trial
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Chronic Pain / therapy*
Double-Blind Method
Electric Stimulation Therapy*
Humans
Magnetic Field Therapy*
Male
Middle Aged
Pelvic Pain / therapy*
Treatment Outcome
Ultrasonic Therapy*

Associated data

ClinicalTrials.gov/NCT00688506

Grants and funding

This research was supported by the Sonodyn Corporation AG (Solothurn, Switzerland) and the University Hospital Inselspital (Bern, Switzerland). The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.