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

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.

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. CONSORT flow diagram.
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. Means and 95% CI for…
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. Stratified analysis according to patient…
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.

References

    1. Fall M, Baranowski AP, Elneil S, Engeler D, Hughes J, et al. (2010) EAU guidelines on chronic pelvic pain. Eur Urol 57:35–48.
    1. McNaughton Collins M, Barry MJ (1998) Epidemiology of chronic prostatitis. Curr Opin Urol 8:33–37.
    1. Schaeffer AJ (2008) Epidemiology and evaluation of chronic pelvic pain syndrome in men. Int J Antimicrob Agents 31 Suppl 1 S108–111.
    1. Duloy AM, Calhoun EA, Clemens JQ (2007) Economic impact of chronic prostatitis. Curr Urol Rep 8:336–339.
    1. Alexander RB, Propert KJ, Schaeffer AJ, Landis JR, Nickel JC, et al. (2004) Ciprofloxacin or tamsulosin in men with chronic prostatitis/chronic pelvic pain syndrome: a randomized, double-blind trial. Ann Intern Med 141:581–589.
    1. Shoskes DA, Katz E (2005) Multimodal therapy for chronic prostatitis/chronic pelvic pain syndrome. Curr Urol Rep 6:296–299.
    1. Anothaisintawee T, Attia J, Nickel JC, Thammakraisorn S, Numthavaj P, et al. (2011) Management of chronic prostatitis/chronic pelvic pain syndrome: a systematic review and network meta-analysis. JAMA 305:78–86.
    1. Nickel JC, Downey J, Ardern D, Clark J, Nickel K (2004) Failure of a monotherapy strategy for difficult chronic prostatitis/chronic pelvic pain syndrome. J Urol 172:551–554.
    1. Vallejo R, Kramer J, Benyamin R (2007) Neuromodulation of the cervical spinal cord in the treatment of chronic intractable neck and upper extremity pain: a case series and review of the literature. Pain Physician 10:305–311.
    1. Nnoaham KE, Kumbang J (2008) Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Cochrane Database Syst Rev CD003222.
    1. Peters KM, Carey JM, Konstandt DB (2003) Sacral neuromodulation for the treatment of refractory interstitial cystitis: outcomes based on technique. Int Urogynecol J Pelvic Floor Dysfunct 14:223–228 discussion 228.
    1. Kessler TM, Z′Brun S, Haeni K, C. BF, Studer UE, et al. (2008) Combined sono-electro-magnetic therapy for treatment of refractory chronic pelvic pain syndrome: A new therapeutic possibility? Eur Urol Suppl 7 159.
    1. Mehnert U, Birzele J, Reuter K, Schurch B (2010) The effect of botulinum toxin type a on overactive bladder symptoms in patients with multiple sclerosis: a pilot study. Journal of Urology 184:1011–1016.
    1. Propert KJ, Litwin MS, Wang Y, Alexander RB, Calhoun E, et al. (2006) Responsiveness of the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). Qual Life Res 15:299–305.
    1. Nickel JC, Krieger JN, McNaughton-Collins M, Anderson RU, Pontari M, et al. (2008) Alfuzosin and symptoms of chronic prostatitis-chronic pelvic pain syndrome. N Engl J Med 359:2663–2673.
    1. Vickers AJ, Altman DG (2001) Statistics notes: Analysing controlled trials with baseline and follow up measurements. BMJ 323:1123–1124.
    1. Brookes ST, Whitely E, Egger M, Smith GD, Mulheran PA, et al. (2004) Subgroup analyses in randomized trials: risks of subgroup-specific analyses; power and sample size for the interaction test. J Clin Epidemiol 57:229–236.
    1. Cohen J (1988) Statistical power analysis for the behavioral sciences. 2 ed. Hillsdale: Lawrence Erlbaum.
    1. Melzack R, Wall PD (1965) Pain mechanisms: a new theory. Science 150:971–979.
    1. Sluka KA, Walsh D (2003) Transcutaneous electrical nerve stimulation: basic science mechanisms and clinical effectiveness. J Pain 4:109–121.
    1. Butrick CW (2009) Pathophysiology of pelvic floor hypertonic disorders. Obstet Gynecol Clin North Am 36:699–705.
    1. Farmer MA, Chanda ML, Parks EL, Baliki MN, Apkarian AV, et al. (2011) Brain functional and anatomical changes in chronic prostatitis/chronic pelvic pain syndrome. J Urol 186:117–124.
    1. Mordasini L, Weisstanner C, Rummel C, Thalmann GN, Verma RK, et al. (2012) Chronic pelvic pain syndrome in men is associated with reduction of relative gray matter volume in the anterior cingulate cortex compared to healthy controls. J Urol 188:2233–2237.
    1. Kothari S (2007) Neuromodulatory approaches to chronic pelvic pain and coccygodynia. Acta Neurochir Suppl 97 365–371.
    1. Lee SH, Lee BC (2009) Electroacupuncture relieves pain in men with chronic prostatitis/chronic pelvic pain syndrome: three-arm randomized trial. Urology 73:1036–1041.
    1. Wöllner J, Hampel C, Kessler TM (2012) Sacral neuromodulation. BJU Int 110:146–159.
    1. Marcelissen T, Jacobs R, van Kerrebroeck P, de Wachter S (2011) Sacral neuromodulation as a treatment for chronic pelvic pain. J Urol 186:387–393.
    1. Hassouna MM, Elkelini MS (2007) Early versus late treatment of voiding dysfunction with pelvic neuromodulation. Can Urol Assoc J 1:106–110.
    1. Peters KM, Feber KM, Bennett RC (2007) A prospective, single-blind, randomized crossover trial of sacral vs pudendal nerve stimulation for interstitial cystitis. BJU Int 100:835–839.
    1. Hrobjartsson A, Gotzsche PC (2010) Placebo interventions for all clinical conditions. Cochrane Database Syst Rev: CD003974.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅