Among the numerous therapeutic approaches used in the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) only few have been assessed with a sufficient level of evidence. Safety and efficacy of pentosan polysulfate sodium (PPS) has been shown in several open-label and comparative clinical trials with different populations including two meta-analyses. In the context of the approval procedure of PPS for the treatment of IC/BPS by the European Medicines Agency we updated the findings of the previous analyses by incorporating the results of the latest studies.
Relevant studies based on a systematic review of PubMed/Medline and the Cochrane Library in June 2018 have been identified. For completeness control, clinical trial registries were also searched. Only randomized, placebo-controlled clinical trials providing sufficient information to estimate at least one relevant effect size measure to compare the efficacy of PPS versus placebo were included in an analysis.
Of the studies identified in the literature search 6 randomized placebo-controlled studies met the pre-defined eligibility criteria. Analyses showed no indication of heterogeneity or publication bias. Treatment with PPS led to a statistically significant improvement in the patient's overall response assessment (p < 0.001), pain (p = 0.009), and urgency (p = 0.005).
Our meta-analyses confirmed the results of preceding meta-analyses showing that PPS is efficacious compared to placebo in the treatment of bladder pain, urinary urgency and frequency of micturition and thus an evident option for the treatment of IC/BPS symptoms.
Current medical research and opinion. 2019 Mar 08 [Epub ahead of print]
Arndt van Ophoven, Kirsten Vonde, Winfried Koch, Günter Auerbach, Klaus P Maag
a Marien Hospital Herne, University Hospital Ruhr-Universität Bochum , Herne , Germany., b Granzer Regulatory Consulting & Services , Munich , Germany., c Biostatistical Data Services Koch , Schwetzingen , Germany., d bene-Arzneimittel GmbH , Munich , Germany (since 2017 Dr. Pfleger Arzneimittel GmbH, Bamberg, Germany)., e bene pharmaChem GmbH & Co.KG , Geretsried , Germany.