Patient Satisfaction and Long-term Safety of Intravesical Aminoglycoside Instillations in UTI Prevention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Treatment satisfaction regarding intravesical aminoglycoside instillations (IAI)
研究概览
简要总结
Antimicrobial prophylactic treatment of recurrent UTI is limited by emerging resistance, antibiotic allergies and intolerances. Intravesical aminoglycoside instillations (IAI) have been shown to reduce recurrence rate, without a short-term decline in kidney function or hearing. Thus far, treatment satisfaction has not yet been assessed, while this may play an important role in treatment adherence and persistence. Moreover, there is no data on the long-term safety of IAI, e.g. regarding the development of (pre)malignant bladder lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Currently receiving or having received (no minimal duration) continuous or post-coital IAI (gentamicin, tobramycin or amikacin) for recurrent UTI prophylaxis and treatment
排除标准
- •Exclusively receiving IAI for 'on-demand' treatment of UTI and not prophylactic purposes
- •Receiving IAI as suppressive therapy for chronic prostatitis
- •Presence of a chronic indwelling catheter
- •Patient has objected to the use of his/her data
- •Inability to provide informed consent
结局指标
主要结局
Treatment satisfaction regarding intravesical aminoglycoside instillations (IAI)
时间窗: 1 year
Measured with Treatment Satisfaction Questionnaire for Medication version II (TSQM-II), value ranging from 0 to 100 (with a score of 100 indicating the highest treatment satisfaction)
次要结局
- Number of UTI recurrences that are treated with IAI alone (no systemic antimicrobial therapy)(First 6 months of IAI)
- Number of patients that wish to (dis)continue IAI(6 months after initiation of IAI)
- Proportion of patients that have a UTI episode caused by the same MDRO uropathogen as before start of IAI(6 months after initiation of IAI)
- Number of UTI recurrences(First 6 months of IAI)
- Time to first UTI recurrence after initiation of IAI(First 6 months of IAI)
研究者
Manu Bilsen, MD
MD, PhD student, Department of Infectious Diseases, Principle Investigator
Leiden University Medical Center