The Effect of Short Term Solifenacin for Overactive Bladder on the Female Urinary Microbiome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Bacterial Genomic Sequencing
研究概览
简要总结
No one really knows what causes overactive bladder syndrome (OAB). Urinary tract infection (UTI)causes similar symptoms to OAB with the difference being the presence of bacteria, as evidenced by routine microbiology cultures. Recent work by the group on the genitourinary microbiome (GUM) has shown that female urine, even in the absence of culture evidence of bacteria does have evidence of bacterial DNA. Bacterial 16S rRNA can be isolated from urine and sequenced to identify bacterial species present in urine. From this the investigators can hypothesize that urinary bacteria contribute to urinary symptoms and that there is a difference in the bacterial communities in the urine of women who respond to Solifenacin, a drug used to treat OAB, versus those that do not.
详细描述
This is a prospective study with two groups: Women who have accepted a clinical recommendation for OAB treatment with solifenacin and a comparator (control) group of women unaffected by OAB. All women will have a baseline urine assessment with bacterial genome sequencing. Solifenacin treated patients will also have urine assessments with bacterial genomic sequencing at 4 and 12 weeks on treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Controls: Women without bother from urinary symptoms will be screened for potential study participation using the pelvic floor distress inventory (PFDI). Women with negative urinary responses will be further screened for participation using the following eligibility criteria:
- •no anticholinergic medications for bladder conditions,
- •no antibiotic exposure in the past 4 weeks for any reason,
- •no immunologic deficiency,
- •no pelvic malignancy or pelvic radiation, and
- •Untreated symptomatic POP > POP-Q Stage II.
- •OAB cohort: Women with bother from overactive bladder symptoms will be screened for potential study participation using the pelvic floor distress inventory (PFDI). Women with positive urinary responses for urge predominant symptoms will be further screened for participation using the following eligibility criteria:
- •willing to take Solifenacin as treatment for OAB,
- •no neurological disease known to affect the lower urinary tract,
- •no current UTI (based on urine dipstick) or recurrent UTI,
- •no antibiotic exposure in the past 4 weeks for any reason,
- •no immunologic deficiency,
- •no pelvic malignancy or pelvic radiation,
- •untreated symptomatic POP > POP-Q Stage II,
- •no contraindications to receiving Solifenacin.
排除标准
- •Women who are of child-bearing potential who are pregnant, nursing, intending to become pregnant during the study or not practicing a reliable form of contraception are also excluded.
研究组 & 干预措施
Women using Solifenacin for OAB treatment
Solifenacin treated women: Women with OAB who are prescribed solifenacin
干预措施: Solifenacin (Drug)
结局指标
主要结局
Bacterial Genomic Sequencing
时间窗: 12 weeks
Participants were classified into Low Biomass, Lactobacillus, Gardnerella, Diverse, and Other urotypes based on the bacterial DNA at baseline.
次要结局
- Assessment of Pelvic Floor Disease Inventory (PFDI) Questionnaire(12 weeks)
- Assessment of Overactive Bladder Questionnaire (OABQ)(End of study (Week 12))
研究者
Alan J. Wolfe
Professor, Microbiology Immunology
Loyola University