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Immunostimulation in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS): a one-year prospective, double-blind, placebo-controlled study

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Abstract

Purpose

Inflammation/immunological dysfunction are discussed etiological causes of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). OM-89 is an orally immunostimulating agent. We performed a phase three multicentre, randomized, double-blind, placebo-controlled, long-term (12 months) study with OM-89 produced with a different lysis process in patients with moderate-to-severe CP/CPPS type III.

Methods

Patients were randomized to OM-89 or placebo. Primary efficacy variable was difference of responders at the end of treatment (month 9) in patients receiving OM-89 versus placebo.

Results

Two hundred and three patients were screened, 185 patients (47.8 ± 8.4 years) (90 % of CP/CPPS type IIIb) were enrolled in 30 centers and included in the safety set. Ninety-four were randomized to OM-89, 91 to placebo. One hundred and seventy-six patients were subjected to the full analysis (FAS), 150 to the per protocol set (PPS). Baseline NIH-CPSI score in FAS was 21.8 ± 3.8 (OM-89) and 23.0 ± 5.6 (placebo). At primary efficacy endpoint (month 9), in the OM-89 group, 67.0 % in FAS (PPS 72.7 %) and in the placebo group, 64.3 % in FAS (PPS 64.4 %) were responders [FAS: OR 1.19, p = 0.59; PPS: p = 0.19]. Mean relative decrease in NIH-CPSI was 40.5 and 44.0 % in the FAS. Treatment-related adverse events were low: 8.5 % with OM-89 and 5.5 % with placebo. Because of small numbers, no conclusion could be drawn regarding the potential benefit of OM-89 in CP/CPPS IIIa.

Conclusions

This placebo-controlled study evaluating OM-89 in patients with CP/CPPS showed a significant and long-lasting (12 months) favorable response with OM-89, but also with placebo. OM-89 was safe and well tolerated.

EudraCT

2007-004609-85.

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Acknowledgments

The study was supported by Vifor Pharma/OM Pharma SA, Geneva. Data management and statistical analysis were performed by ICTA, Fontaines-les-Dijon (France), a contract research organization.

Conflict of interest

Florian M.E. Wagenlehner has served as a paid consultant for Astellas, AstraZeneca, Bionorica, Cernelle, Cubist, OM-Pharma, Lilly Pharma, Pierre Fabre, Rosen-Pharma. He has received lecture honoraria from AstraZeneca, Bionorica, OM-Pharma, Pierre Fabre, Rosen Pharma, Serag Wiessner, Zambon. He has been paid for performing clinical trials on behalf of Astellas, AstraZeneca, Calixa, Cerexa, Cernelle, Cubist, GSK, Merlion, OM-Pharma, Janssen-Cilag, Johnson & Johnson, Lilly Pharma, Pharmacia, Pierre-Fabre, Rosen Pharma, Sanofi-Aventis, Strathmann, Zambon. Stefania Ballarini is a Vifor Pharma/OM Pharma Global Medical Affairs employee. Kurt G. Naber has served as paid consultant for Basilea, Bionorica, Cubist, Galenus, MerLion, OM Pharma/Vifor, Paratek, Pierre Fabre, Rempex, Rosen Pharma, Zambon. He has received lecture honoraria from Angelini, Daiichi Sankyo, OM Pharma/Vifor, Pierre Fabre, Zambon. He has been paid for performing clinical trials on behalf of Basilea, Bionorica, MerLion, OM Pharma/Vifor, Rosen Pharma, Zambon.

Author information

Authors and Affiliations

  1. Clinic for Urology, Pediatric Urology and Andrology, Justus-Liebig-University Giessen, Rudolf-Buchheim-Str. 7, 35385, Giessen, Germany

    Florian M. E. Wagenlehner

  2. Vifor Pharma/OM Pharma, Meyrin, Geneva, Switzerland

    Stefania Ballarini

  3. Technical University, Munich, Germany

    Kurt G. Naber

Authors
  1. Florian M. E. Wagenlehner
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  2. Stefania Ballarini
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  3. Kurt G. Naber
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Corresponding author

Correspondence to Florian M. E. Wagenlehner.

Additional information

On behalf of the OM-89 UV-2005/01 Study investigators (see appendix).

Appendix: Investigators of active sites

Appendix: Investigators of active sites

Germany Pilatz A. (Giessen), Wagenlehner F.M.E. (Giessen), Weidner W. (Giessen), Antwerpen C. (Altötting), Vilmar W.(Nürnberg), Kisskalt B.-M. (Nürnberg), Geiges G. (Berlin), Ludwig M. (Marburg), Schwickardi M. (Marburg), Brands F·H. (Kerken), Kieffer C. (Krefeld), Ziola C. (Krefeld), Heidrich A. (Wesseling), Bücker M. (Wesseling), Amiri-Sani A. (Borken), Bauer H. (München), Bauer U. (München), Mumperow E. (Langenfeld), Fischer H.-F. (Koblenz), Willgerodt J. (Leipzig), Johann K.-U. (Berlin), Shurwanz C. (Berlin), Aust C. (Hamburg), Schmidt-Enghusen C. (Hamburg), Jürgenhake V. (Pulheim), Langhorst W.K.H. (Erkrath), Szymula S. (Leipzig), Eckert R. (Lutherstadt Eisleben), Plate H. (Dessau), Allihn H.-J. (Dessau), Wicht A.R. (Sangerhausen), Siebel-Eggeling G. (Essen), Schmidt M.E. (Bonn), Hanitzsch H. (Bonn).

Austria Kuber W. (Wien), Dörfler C. (Wien), Pfleger G. (Oberwart), Diehl K.F. (Tulln), Jungwirth A. (Salzburg).

Poland Darewicz B. (Bialystok), Kudelski J. (Bialystok), Lapinska J. (Bialystok), Galezia M. (Kielce), Kieres P. (Kielce), Zapata A. (Kielce), Pliszek K. (Bielsko-Biala), Kies G. (Bielsko-Biala), Marszolik M. (Bielsko-Biala), Pawlaczek P. (Bielsko-Biala), Szkarlat K. (Koscierzyna), Draczynski M. (Koscierzyna), Nieradka A. (Koscierzyna), Szyperski J. (Bydoszcz), Jarzemski P. (Bydoszcz), Slupski P. (Bydoszcz).

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Wagenlehner, F.M.E., Ballarini, S. & Naber, K.G. Immunostimulation in chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS): a one-year prospective, double-blind, placebo-controlled study. World J Urol 32, 1595–1603 (2014). https://doi.org/10.1007/s00345-014-1247-z

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  • DOI: https://doi.org/10.1007/s00345-014-1247-z

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