A Prospective Double-Blind Clinically Controlled Multicenter Trial of Sodium Pentosanpolysulfate in the Treatment of Interstitial Cystitis and Related Painful Bladder Disease

Abstract

Painful bladder disease, sensory bladder disease, chronic abacterial cystitis and interstitial cystitis are ill-defined conditions of unknown etiology and pathogenesis, and, therefore, they are without any rational therapy. Pathogenetic theories concerning defects in the epithelium and/or mucous surface coat (including glycosaminoglycans) of the bladder, and theories concerning immunological disturbances predominate. Sodium pentosanpolysulfate (Elmiron) acts by substituting a defective glycosaminoglycan layer and inhibits complement reactions in inflammatory processes. We compared sodium pentosanpolysulfate versus placebo in a prospective double-blind, clinically controlled multicenter trial of 115 patients with painful bladder disease. Two protocols were used. Protocol A included 43 patients with clinically and pathologically anatomically verified interstitial cystitis (28 or more mast cells per mm.2), and protocol B included 72 patients with a painful bladder and unspecific histological findings. The patients were randomized to receive either sodium pentosanpolysulfate (200 mg. twice daily) or placebo capsules for 4 months. Before and after the trial the patients were evaluated with symptom grading, urodynamics and cystoscopy with distension and deep bladder biopsies. The results showed no difference between the pre-trial and post-trial values in the sodium pentosanpolysulfate and placebo groups in both protocols in regard to symptoms, urodynamic parameters, cystoscopic appearance and mast cell counts. A significant increase in the cystoscopically determined bladder capacity in the sodium pentosanpolysulfate group in protocol A was found. We conclude that no statistically or clinically significant effect of sodium pentosanpolysulfate was found compared to placebo in patients with painful bladder disease.

Long-term efficacy and tolerability of pentosan polysulphate sodium in the treatment of bladder pain syndrome

“…Patients had improvement with PPS therapy regarding pain, frequency and urgency, but not the nocturia. 24 Detrusor overactivity was associated with a poor response to treatment in our study. This finding was more prominent during the first 12 months of follow-up.…”

CUA guideline: Diagnosis and treatment of interstitial cystitis/ bladder pain syndrome

“…Multiple placebo-controlled RCTs exist comparing PPS to placebo [85][86][87][88][89] reporting contradictory results. A meta-analysis including data on 448 patients has summarized the findings of four of these trials.…”

Distinctive Ultrastructural Pathology of Nonulcerative Interstitial Cystitis

“…A high mast cell count in bladder muscularis (>20 or >28/mm2) has been promoted as a diagnostic histopatho logic feature of IC [15][16][17][18], to the extent that 'detrusor mastocytosis' was suggested as a more appropriate name for the disease [15], or even that the term IC should be reserved for bladders with 'detrusor mastocytosis' [9], Although there is sufficient evidence that mast cells play a role in IC, the nature and scope of this role have not been resolved [ 19], The results of several studies indicate, how ever, that a high mast cell count in detrusor is not an auto matic histologic marker for IC, nor does a low count or even absence of mast cells exclude it [10. 13, 20-23].…”