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

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

Thomas M Kessler  1 , Livio Mordasini  2 , Christian Weisstanner  3 , Peter Jüni  4 , Bruno R da Costa  4 , Roland Wiest  3 , George N Thalmann  2
Affiliations
Clinical Trial

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

Thomas M Kessler et al. PLoS One. .

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.

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Conflict of interest statement

Competing Interests: The authors declare that Sonodyn Corporation AG (Solothurn, Switzerland) provided all stimulation devices. This does not alter the authors' adherence to PLOS ONE policies on sharing data and materials.

Figures

Figure 1
Figure 1. CONSORT flow diagram.
Not reaching the cut-off values for study inclusion in NIH-CPSI total score was the most common reason for ineligibility. Most subjects who declined to participate considered the treatment as being too cumbersome or were not bothered enough by symptoms.
Figure 2
Figure 2. Means and 95% CI for NIH-CPSI total and sub-scores.
Higher NIH-CPSI scores indicate more severe symptoms. Score ranges are as follows: total score 0 to 43; pain sub-score 0 to 21; urinary symptoms sub-score 0 to 10; quality-of-life sub-score 0 to 12. CI: confidence interval; NIH-CPSI: National Institutes of Health Chronic Prostatitis Symptom Index.
Figure 3
Figure 3. Stratified analysis according to patient characteristics.
Stratified analysis of the primary outcome (NIH-CPSI total score, range 0 to 43) according to patient characteristics. CI: confidence interval; NIH-CPSI: National Institutes of Health Chronic Prostatitis Symptom Index.
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Associated data

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.
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