The efficacy of pentosan polysulfate monotherapy for preventing recurrent urinary tract infections in women: A multicenter open-label randomized controlled trial

Abstract

Pentosan polysulfate sodium (PPS), a semi-synthetic polysaccharide that adheres to bladder mucosa, is effective in treating interstitial cystitis. We evaluated the clinical benefit of PPS for the prevention of recurrent urinary tract infection (UTI) in women. We conducted a multicenter, open-label, prospective, phase II, randomized controlled trial enrolling women with recurrent UTI≥2 times in the past 6 months or≥3 times in the past 12 months. Patients received oral PPS monotherapy for 16 weeks in treatment group. All patients were followed every 28 days until UTI recurrence or up to 112 days. Theprimary endpoint was the UTI recurrence-free survival. Adverse events were recorded as secondary endpoint. A total of 26 women were eligible for analysis. In the PPS group, none (0%) of the 12 patients had UTI recurrence during the study period. However, 9 (64%) of 14 patients had UTI recurrence in the control group. The UTI recurrence-free survival was significantly higher in the PPS group than in the control group (log-rank test p=0.0004). One adverse event which led to discontinuation of the trial regimen was regarded as irrelevance of PPS treatment. Thelimitation was the small number of cases. Among women with recurrent UTI, 16-week PPS monotherapy significantly reduced UTI recurrence when compared with the control group.