Urogate, Urological Practice, Bad Vilbel, Germany.
Strathmann GmbH & Co. KG, Hamburg, Germany.
Int Urol Nephrol. 2023 Jan;55(1):9-16. doi: 10.1007/s11255-022-03379-y. Epub 2022 Oct 1.
To evaluate efficacy and safety of vaccination with StroVac compared to placebo in patients with recurrent urinary tract infections (rUTI).
We performed a prospective, double-blinded, placebo-controlled study in patients with uncomplicated rUTI. Patients received three single intramuscular injections with StroVac every two weeks. Primary endpoint was the number of bacterial urinary tract infections (UTI) over 13.5 months after randomization and adjusted by the respective "baseline" value when comparing verum and placebo group. Secondary endpoints were the number of patients with non-recurrence, time to first recurrence, frequency of recurrences, and patients' self-assessment of quality of life using a validated questionnaire.
376 patients were randomized to both groups between January 2012 and March 2015. Mean age was 44.4 years. Patients were mainly female (98.4%). In the StroVac group (n = 188), the number of UTIs was reduced from 5.5 to 1.2, in the placebo group (n = 188) from 5.4 to 1.3 (p = 0.63). In patients with ≥ 7 UTIs prior to study inclusion, StroVac was statistically significantly superior to placebo (p = 0.048). However, in all other secondary endpoints, no statistical differences between the two groups could be seen (all p > 0.3).
StroVac reduced the number of clinically relevant UTIs like in former studies but did not show statistically significant better results than the chosen placebo. Most likely, that was due to a, since confirmed, prophylactic effect of the chosen placebo itself. Therefore, placebo-controlled and double-blinded studies using a different ineffective placebo preparation are needed to determine the importance of StroVac in prophylaxis of rUTI.
评估与安慰剂相比，StroVac 在复发性尿路感染（rUTI）患者中的疗效和安全性。
我们在患有单纯性 rUTI 的患者中进行了一项前瞻性、双盲、安慰剂对照研究。患者每两周接受三次单次肌肉注射 StroVac。主要终点是随机分组后 13.5 个月内细菌尿路感染（UTI）的数量，并在比较真实组和安慰剂组时通过各自的“基线”值进行调整。次要终点是无复发患者的数量、首次复发时间、复发频率以及患者使用经过验证的问卷对生活质量的自我评估。
2012 年 1 月至 2015 年 3 月期间，376 名患者被随机分配至两组。平均年龄为 44.4 岁。患者主要为女性（98.4%）。在 StroVac 组（n=188）中，UTI 数量从 5.5 减少到 1.2，在安慰剂组（n=188）中从 5.4 减少到 1.3（p=0.63）。在研究纳入前有≥7 次 UTI 的患者中，StroVac 与安慰剂相比具有统计学显著优势（p=0.048）。然而，在所有其他次要终点中，两组之间没有观察到统计学差异（所有 p>0.3）。
StroVac 像以前的研究一样减少了临床上相关的 UTI 数量，但与所选安慰剂相比，没有显示出统计学上显著的更好结果。最有可能的是，这是由于所选安慰剂本身的预防性作用，这一点已经得到证实。因此，需要进行安慰剂对照和双盲研究，使用不同的无效安慰剂制剂来确定 StroVac 在预防 rUTI 中的重要性。
