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Pelvic Organ ProlapseNCT02751073

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

An observational study of Pelvic Organ Prolapse and Hysterectomy, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 40 years and older, women only
How many people
25 participants
Where
1 siteUnited States
Study dates
Feb 2016to 30 Jul 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Postmenopausal women undergoing pelvic reconstructive surgery for pelvic organ prolapse.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Keywords
Microbiota, Proteome
Medical subject headings
Pelvic Organ Prolapse, Urinary Tract Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identification of baseline vaginal microbiome through DNA extraction and 16S rRNA gene sequencing

    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.

    Measured: 1 day (Pre-operative Urogynecology surgical consultation visit)

  2. Identification of baseline urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing

    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.

    Measured: 1 day (Pre-operative Urogynecology surgical consultation visit)

  3. Identification of pre-operative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing

    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.

    Measured: Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)

  4. Identification of pre-operative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing

    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.

    Measured: Within 4 weeks of baseline sample collected at Urogynecology surgical consultation visit)

  5. Identification of the immediate postoperative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing

    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.

    Measured: Within 6 hours of collecting the pre-operative sample

  6. Identification of the immediate postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing

    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.

    Measured: Within 6 hours of collecting the pre-operative sample

  7. Identification of the postoperative vaginal microbiome through DNA extraction and 16S rRNA gene sequencing

    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.

    Measured: 12-18 hours after surgery

  8. Identification of the postoperative urinary tract microbiome through DNA extraction and 16S rRNA gene sequencing

    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.

    Measured: 12-18 hours after surgery

  9. Identification of vaginal microbiome in the setting of postoperative urinary tract infection through DNA extraction and 16S rRNA gene sequencing

    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.

    Measured: Within the first 6 weeks after surgery

  10. Identification of urinary tract microbiome in the setting of postoperative urinary tract infection through DNA extraction and 16S rRNA gene sequencing

    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.

    Measured: Within the first 6 weeks after surgery

  11. 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

    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.

    Measured: Within the first 6 weeks after surgery

  12. Identification of the vaginal microbiome at least 6 weeks following surgery through DNA extraction and 16S rRNA gene sequencing

    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.

    Measured: 6 weeks (up to 8 weeks)

  13. Identification of the postoperative urinary tract microbiome at least 6 weeks following surgery through DNA extraction and 16S rRNA gene sequencing

    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.

    Measured: 6 weeks (up to 8 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completion31 May 2017
  4. Study completion30 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02751073
Sponsor's protocol ID
15-006300
Status last verified
Aug 2018
First submitted
22 Feb 2016
Last updated
16 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Occhino JA, Byrnes JN, Wu PY, Chen J, Walther-Antonio MR. Preoperative vaginal microbiome as a predictor of postoperative urinary tract infection. Sci Rep. 2024 Nov 22;14(1):28990. doi: 10.1038/s41598-024-78809-1.

    PubMed 39578602

Questions about this trial

What is this clinical trial studying?

An observational study of Pelvic Organ Prolapse and Hysterectomy, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of baseline vaginal microbiome through DNA extraction and 16S rRNA gene sequencing (time frame: 1 day (Pre-operative Urogynecology surgical consultation visit)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02751073, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.

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