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

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Colporrhaphy; Procedure: Hysterectomy

• Registration Number: NCT03748693
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-19
• Study First Submitted QC: 2018-11-19
• Last Update Submitted: 2018-11-19
• Study First Posted: 2018-11-21
• Last Update Posted: 2018-11-21
• Study Start: 2018-12
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Women with POP undergoing colporrhaphy
• Women undergoing hysterectomy

Exclusion Criteria

• Autoimmune and connective tissue disorders
• Cancer in genital tract

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
POP Group	Colporrhaphy	Women with POP undergoing surgery in our OB/GYN department.
Non-POP Group	Hysterectomy	Women undergoing hysterectomy for other indications.

Primary Outcome Measures

Name	Time	Method
Immune response in POP	Two weeks	Tissue biopsy will analyzed for IMC and compared to control group
Cytokine environment in POP	Two weeks	Tissue biopsy will analyzed for cytokine environment and compared to control group