Inflammation and Cellular Immunity in Vaginal Tissue in Patients With Pelvic Organ Prolapse

November 19, 2018 updated by: Hillel Yaffe Medical Center

The aim of this study is to investigate the inflammatory and maturation processes of immature myeloid cells (IMC) in the vaginal tissue in women with advanced pelvic organ prolapse (POP) (stage III-IV) and in normal non-POP controls.

We hypothesize that the processes contributing to POP may be related to immune response and changes in myeloid cell populations and the cytokine environment.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women attending our OB/GYN department because of POP and other gynecological disorders

Description

Inclusion Criteria:

  • Women with POP undergoing colporrhaphy
  • Women undergoing hysterectomy

Exclusion Criteria:

  • Autoimmune and connective tissue disorders
  • Cancer in genital tract

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
POP Group
Women with POP undergoing surgery in our OB/GYN department.
Procedure: Colporrhaphy
Surgery performed on women with POP
Non-POP Group
Women undergoing hysterectomy for other indications.
Procedure: Hysterectomy
Surgery performed on women with a variety of gynecological indications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune response in POP
Time Frame: Two weeks
Tissue biopsy will analyzed for IMC and compared to control group
Two weeks
Cytokine environment in POP
Time Frame: Two weeks
Tissue biopsy will analyzed for cytokine environment and compared to control group
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 1, 2019

Study Registration Dates

First Submitted

November 19, 2018

First Submitted That Met QC Criteria

November 19, 2018

First Posted (Actual)

November 21, 2018

Study Record Updates

Last Update Posted (Actual)

November 21, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC-0073-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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