Evaluation of Vaginal and Urinary Microbiome Markers as Predictors of Post-Surgical Urinary Tract Infection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Identification of the postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
研究概览
简要总结
The purpose of this study is to learn more about the microbes (bacteria) that live in the vagina and the bladder. The investigators are doing this research study to understand the relationship between microbes (the microbiome) and the occurrence of urinary tract infection following surgical removal of the uterus and pelvic organ prolapse repair. The investigators expect Lactobacillus and Gardnerella will be the dominant organisms for most women. Non-Lactobacillus dominant microbiome communities will be more common in women who ultimately develop postoperative urinary tract infection.
详细描述
The goal of this pilot study is to characterize the presence and stability of the microbial community in the vagina and lower urinary tract in a cohort of 20 postmenopausal women undergoing transvaginal hysterectomy with pelvic reconstruction for pelvic organ prolapse. The investigators intend to collect longitudinal samples in the preoperative, intraoperative, and postoperative time period in order to understand the pervasiveness of the microbes in the vagina and lower urinary tract, and to identify, in a very preliminary way, particular microbes that may be associated with postoperative urinary tract infection.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal females (defined by cessation of menses for one full year)
- •Planned surgical correction of pelvic organ prolapse with transvaginal hysterectomy and concomitant pelvic reconstruction for uterovaginal prolapse
- •Scheduled surgery date within 4 weeks of study consent
- •Physically able to self-collect vaginal swabs and clean-catch urine samples
排除标准
- •Women who are premenopausal, pregnant or nursing
- •Currently taking or have taken antibiotics in the past 2 weeks
- •History of recurrent urinary tract infections
- •History of mesh complications, including erosion/extrusion
- •Non-vaginal approach to hysterectomy or prolapse repair
结局指标
主要结局
Identification of the postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
时间窗: 12-18 hours after surgery
Urine sample will be collected from participants the morning following surgery, after removal of the vaginal packing. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract.
Identification of urinary tract microbiome in the setting of postoperative urinary tract infection through DNA extraction and 16S rRNA gene sequencing
时间窗: Within the first 6 weeks after surgery
Urine sample will be collected at the onset of symptomatic urinary tract infection during the time period between hospital dismissal and 6-week postoperative surgical visit. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract in the setting of urinary tract infection and compare to microbiome of the urinary tract during the perioperative period.
Identification of the postoperative urinary tract microbiome at least 6 weeks following surgery through DNA extraction and 16S rRNA gene sequencing
时间窗: 6 weeks (up to 8 weeks)
Urine sample will be collected from participants at the Urogynecology post-surgical consultation. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract.
Identification of baseline vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
时间窗: 1 day (Pre-operative Urogynecology surgical consultation visit)
Vaginal swabs will be collected from participants at the surgical consultation visit. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the vagina.
Identification of the immediate postoperative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
时间窗: Within 6 hours of collecting the pre-operative sample
Vaginal swabs will be collected from participants at the end of the surgical procedure. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the vagina.
Identification of vaginal microbiome in the setting of postoperative urinary tract infection through DNA extraction and 16S rRNA gene sequencing
时间窗: Within the first 6 weeks after surgery
Vaginal swabs will be collected at the onset of symptomatic urinary tract infection during the time period between hospital dismissal and 6-week postoperative surgical visit. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition in the vagina in the setting of urinary tract infection and compare to microbiome of vagina during the perioperative period.
Identification of key biomarkers associated with risk of postoperative urinary tract infection through proteomic mass spectrometry analysis of vaginal swab collected in the setting of postoperative urinary tract infection
时间窗: Within the first 6 weeks after surgery
Vaginal swab collected at onset of symptomatic urinary tract infection during the time period between hospital dismissal and 6-week postoperative surgical visit. Proteomic mass spectrometry analysis of vaginal swab will be conducted. The investigators will use this proteomic information together with the microbial community identified with 16S rRNA to identify a transition point or key biomarkers associated with risk of postoperative urinary tract infection.
Identification of the vaginal microbiome at least 6 weeks following surgery through DNA extraction and 16S rRNA gene sequencing
时间窗: 6 weeks (up to 8 weeks)
Vaginal swabs will be collected from participants at the Urogynecology post-surgical consultation. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the vagina.
Identification of baseline urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
时间窗: 1 day (Pre-operative Urogynecology surgical consultation visit)
Urine sample will be collected from participants at the surgical consultation visit. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract.
Identification of pre-operative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
时间窗: Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)
Vaginal swabs will be collected from participants on the day of surgery, prior to entering the surgical suite. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the vagina.
Identification of pre-operative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
时间窗: Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)
Urine sample will be collected from participants on the day of surgery, prior to entering the surgical suite. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract.
Identification of the immediate postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
时间窗: Within 6 hours of collecting the pre-operative sample
Urine sample will be collected from participants at the end of the surgical procedure. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the urinary tract.
Identification of the postoperative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
时间窗: 12-18 hours after surgery
Vaginal swabs will be collected from participants the morning following surgery, after removal of the vaginal packing. DNA extraction and 16S rRNA gene sequencing undertaken to analyze the microbial community composition of the vagina.
次要结局
未报告次要终点
研究者
John A. Occhino
Assistant Professor of Obstetrics-Gynecology
Mayo Clinic