Department of Urology, National Taiwan University Hospital, National Taiwan University, No. 7, Chung-Shan South Road, Taipei, 100, Taiwan.
Department of Urology, Taipei Tzu Chi Hospital, New Taipei City, Taiwan.
Sci Rep. 2022 Oct 6;12(1):16733. doi: 10.1038/s41598-022-21100-y.
For women with recurrent urinary tract infection (UTI), previous U101 study has shown that pentosan polysulfate sodium (PPS) monotherapy for 16 weeks significantly reduced UTI episodes in the treatment group throughout the trial period. In this follow-up study, we aimed to assess whether the effects of PPS would last after completion of the trial to prevent recurrent UTIs. Conducted from 2018 to 2019, the U101 study was a multicenter, prospective, phase 2a, randomized trial, enrolling women with recurrent UTI to study the effects of a 16-week oral PPS monotherapy. After approximately two years, the follow-up was conducted by phone interview, obtaining data including self-reported UTI events, quality of life questionnaire, and adverse events. The primary endpoint of follow-up study was UTI recurrence-free survival and the secondary endpoints were quality of life and adverse events. Approximately two years after completion of the trial, the rate of recurrent UTI was 25% (3 of the 12 patients) in the PPS group and 85.7% (12 of the 14 patients) in the control group. Over the entire follow-up period, the UTI recurrence-free survival was significantly better in the PPS group than in the control group (log-rank test p < 0.001). The quality of life at two years was significantly improved in the PPS when compared to the control group (91.7 vs. 77.5, p < 0.001). No late adverse event was observed after cessation of the treatment. In this study, sixteen weeks of PPS monotherapy in women with recurrent UTI significantly reduced the numbers of recurrent UTI episodes during the 2-year follow-up.
对于复发性尿路感染（UTI）的女性患者，先前的 U101 研究表明，戊聚糖多硫酸酯钠（PPS）单药治疗 16 周可显著减少整个试验期间治疗组的 UTI 发作次数。在这项随访研究中，我们旨在评估 PPS 的疗效是否在试验结束后仍能持续，以预防复发性 UTI。该研究于 2018 年至 2019 年进行，是一项多中心、前瞻性、2a 期、随机试验，招募复发性 UTI 女性患者，研究 16 周口服 PPS 单药治疗的效果。大约两年后，通过电话访谈进行随访，获取包括自我报告的 UTI 事件、生活质量问卷和不良事件在内的数据。随访研究的主要终点是 UTI 无复发生存，次要终点是生活质量和不良事件。在试验完成后大约两年，PPS 组的复发性 UTI 率为 25%（12 例患者中的 3 例），而对照组为 85.7%（14 例患者中的 12 例）。在整个随访期间，PPS 组的 UTI 无复发生存明显优于对照组（对数秩检验 p<0.001）。与对照组相比，PPS 组在两年时的生活质量显著改善（91.7 比 77.5，p<0.001）。治疗停止后未观察到迟发性不良事件。在这项研究中，16 周的 PPS 单药治疗可显著减少复发性 UTI 女性患者在 2 年随访期间的 UTI 发作次数。
