Dr. Kade Pharmazeutische Fabrik GmbH, Berlin, Germany.
Pharmalog Institut für klinische Forschung GmbH, Ismaning, Germany.
Arch Gynecol Obstet. 2021 Aug;304(2):409-417. doi: 10.1007/s00404-021-06040-8. Epub 2021 Mar 27.
The main objective of this open, prospective, multicentre, observational study is to investigate the relapse rate and tolerability of lactic acid gels in adult female patients with recurrent urinary tract infections during routine practice.
Data were collected from patients undergoing intermittent short courses of intravaginal treatment with lactic acid gel for prevention of recurrent urinary tract infections. The observation period for individual patients was 4 months, aimed at covering four short courses of intravaginal treatment. Data on UTI relapses, tolerability, handling and satisfaction with the treatment were collected via patient diaries and physician assessments and comprised any adverse events (AEs).
In total, 72 patients were treated. During the last 12 months prior to the study, patients had on average 4.0 UTIs. In the 4 months after commencing treatment, 63.5% of patients had no recurrence of UTI symptoms. Overall efficacy was rated by physicians as 'excellent/good' for 96.7% of patients. The patients' overall acceptance of local treatment was high with 94.1% being '(very) satisfied'. Similarly, handling was rated as '(very) easy' by 94.2% of patients. The tolerability was assessed as 'highly tolerable/tolerable' by over 98% of patients and physicians alike. Safety analyses reported six AEs of mild intensity, all of which had resolved by the end of the study.
Treatment with lactic acid gel may increase resilience against uropathogens, possibly preventing the need for antibiotic prevention of recurrent urinary tract infections. Treatment was positively assessed by the patients. The physician assessments corroborate these findings.
DRKS00016760, 18.02.2019.
本开放性、前瞻性、多中心、观察性研究的主要目的是在常规实践中调查乳酸凝胶在复发性尿路感染成年女性患者中的复发率和耐受性。
从接受间歇性阴道内短疗程乳酸凝胶治疗以预防复发性尿路感染的患者中收集数据。每位患者的观察期为 4 个月，旨在涵盖 4 个阴道内短疗程治疗。通过患者日记和医生评估收集尿路感染复发、耐受性、处理和对治疗的满意度的数据，包括任何不良事件（AE）。
共有 72 名患者接受了治疗。在研究开始前的最后 12 个月，患者平均发生 4.0 次尿路感染。在开始治疗后的 4 个月内，63.5%的患者没有出现尿路感染症状复发。96.7%的医生认为总体疗效为“优秀/良好”。患者对局部治疗的总体接受度很高，94.1%的患者表示“非常满意”。同样，94.2%的患者认为处理非常容易。98%以上的患者和医生均认为耐受性为“高度耐受/耐受”。安全性分析报告了 6 起轻度强度的不良事件，所有不良事件均在研究结束时得到解决。
乳酸凝胶治疗可能会增加对尿路病原体的抵抗力，可能无需使用抗生素预防复发性尿路感染。患者对治疗的评估是积极的。医生的评估也证实了这一发现。
DRKS00016760，2019 年 2 月 18 日。
