NCT02890498

Brief Summary

Retrospective analysis of vaginal microbiota in the post-operative course of patient operated for genital prolapse with vaginal mesh with or without mesh related complication

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

2.1 years

First QC Date

August 26, 2016

Last Update Submit

June 15, 2026

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

  • Microbiota diversity (Shannon's H index)

    Day 0

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Females aged 18 and over who have consented for vaginal mesh surgery for pelvic organ prolapse at the Nîmes University Hospital, France

You may qualify if:

  • Females aged 18 and over who have consented for vaginal mesh surgery for pelvic organ prolapse at the the Nîmes University Hospital, France

You may not qualify if:

  • Pregnant or breast feeding
  • Unwilling or unable to complete questionnaire or give valid consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2016

First Posted

September 7, 2016

Study Start

December 10, 2015

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

June 16, 2026

Record last verified: 2026-06

Locations

FR(1)