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Evaluation of the Relationship Between Vaginal and Lower Urinary Tract Microbiomes and Infection After Hysterectomy

14. srpna 2018 aktualizováno: John A. Occhino, Mayo Clinic

Evaluation of Vaginal and Urinary Microbiome Markers as Predictors of Post-Surgical Urinary Tract Infection

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Aktuální)

25

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené státy
    • Minnesota
      • Rochester, Minnesota, Spojené státy, 55905
        • Mayo Clinic in Rochester

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

40 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Postmenopausal women undergoing pelvic reconstructive surgery for pelvic organ prolapse.

Popis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Identification of baseline vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
Časové okno: 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.
1 day (Pre-operative Urogynecology surgical consultation visit)
Identification of baseline urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
Časové okno: 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.
1 day (Pre-operative Urogynecology surgical consultation visit)
Identification of pre-operative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
Časové okno: 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.
Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)
Identification of pre-operative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
Časové okno: 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.
Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)
Identification of the immediate postoperative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
Časové okno: 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.
Within 6 hours of collecting the pre-operative sample
Identification of the immediate postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
Časové okno: 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.
Within 6 hours of collecting the pre-operative sample
Identification of the postoperative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing
Časové okno: 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.
12-18 hours after surgery
Identification of the postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing
Časové okno: 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.
12-18 hours after surgery
Identification of vaginal microbiome in the setting of postoperative urinary tract infection through DNA extraction and 16S rRNA gene sequencing
Časové okno: 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.
Within the first 6 weeks after surgery
Identification of urinary tract microbiome in the setting of postoperative urinary tract infection through DNA extraction and 16S rRNA gene sequencing
Časové okno: 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.
Within the first 6 weeks after surgery
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
Časové okno: 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.
Within the first 6 weeks after surgery
Identification of the vaginal microbiome at least 6 weeks following surgery through DNA extraction and 16S rRNA gene sequencing
Časové okno: 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.
6 weeks (up to 8 weeks)
Identification of the postoperative urinary tract microbiome at least 6 weeks following surgery through DNA extraction and 16S rRNA gene sequencing
Časové okno: 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.
6 weeks (up to 8 weeks)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Mayo Clinic

Vyšetřovatelé

  • Vrchní vyšetřovatel: John A Occhino, M.D., Mayo Clinic

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. února 2016

Primární dokončení (Aktuální)

31. května 2017

Dokončení studie (Aktuální)

30. července 2018

Termíny zápisu do studia

První předloženo

22. února 2016

První předloženo, které splnilo kritéria kontroly kvality

21. dubna 2016

První zveřejněno (Odhad)

26. dubna 2016

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. srpna 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

14. srpna 2018

Naposledy ověřeno

1. srpna 2018

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 15-006300

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Podmínky

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