An Observational Study of the Effect of Antibiotics on the Microbiology of the Bladder in Patients With Overactive Bladder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in bladder microbiology in patients treated with antibiotics.
研究概览
简要总结
The concept of organisms living on or in the human body without causing overt signs of an infection is common in medicine and has been termed a microbiome. Urine from patients with Overactive bladder (OAB) grows different organisms from controls without OAB. However, it is not known if the bacteria that have been identified are innocent commensals or pathogenic organism responsible for the symptoms of OAB. Previous data suggests that treatment with antibiotics does lead to an improvement in overactive bladder symptoms in a large number of patients. On this basis the investigators now treat are patients with similar antibiotic regimes. If antibiotics improve symptoms it would be expected that they would return the microbiome back to how it is in patients without OAB. This study aims to identify the effects of antibiotics on the urinary microbiome and to identify/confirm if antibiotic treatments cause improvement in OAB.
详细描述
This study is a consecutive cohort study. Subjects will be recruited from Urogynaecology clinics at Medway NHS Foundation Trust. Patients will be identified from previous records and also prospectively from new patients. They will be sent information regarding the trial before attending their first appointment.
Patients attending urogynaecology clinics will provide a fresh clean catch specimen of urine. A conventional hospital Mid stream speciemn of urine (MSU) will be sent. Urine will be dipsticked for nitrites and leucocyte esterase. The urine will then be spun and undergo microscopy using a special stain (looking for intracellular organisms in shed urothelial cells). The urothelial cells will be cleaned with antibiotics. The cells will then be lysed and their contents cultured. The contents will undergo Polymerase Chain Reaction (PCR) sequencing to identify bacteria. Sensitivity testing will be used to assess and deliver the appropriate antibiotic regime.
Women will be treated with a 6 week course of antibiotics as per their usual treatment. Broad spectrum antibiotics will be prescribed to all women based on the previous successful therapeutic regime as described by Vijaya. Six weeks after the end of antibiotic therapy patients will be reviewed and their urine retested.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •> age 18 years
- •Negative urine dipstick (nitrites) and culture (x10 to the power 5 colony forming units) x105 cfu
- •Idiopathic overactive bladder as per International Continence Society definition
排除标准
- •Patients treated with antibiotics for any infection within the last 6 weeks.
- •Patients with known multiple sclerosis, stroke, spinal injury, or other neurological disease
- •Urinary tract infection diagnosed by nitrite positivity or positive urine culture (x105 cfu)
- •Undiagnosed macroscopic or persistent microscopic haematuria needing investigation
- •Previous or current cancer of the urogenital tract.
- •Contraindication to multiple antibiotics
- •No suitable oral antibiotic regime
- •Patients unable to understand the study or complete the questionnaires.
结局指标
主要结局
Change in bladder microbiology in patients treated with antibiotics.
时间窗: 6 weeks
The number and type of different organisms will be quantified and compared to the pre treatment organisms
次要结局
- Change in the overactive bladder questionnaire (OAB-q) before and after treatment(6 weeks)
- Changes in symptoms using (change from baseline to assessment)(6 weeks)
- To identify adverse effects of the treatment(6 weeks)
- Change in Patient Perception of Bladder Condition (PPBC)(6 weeks)
- To identify adherence to the treatment regime(6 weeks)
研究者
Professor Jonathan Duckett
Consultant Urogynaecologist
Medway NHS Foundation Trust