Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse

Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse.

The aim of our study is to investigate the alterations in connective tissue of vaginal wall in patients with and without pelvic organ prolapse (POP).

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse

Detailed Description

The tissue samples were taken from the anterior wall of vagina in the midline close to cervix or apex. The tissue samples were collected from the vaginal wall of the patients with pelvic organ prolapse (n=39) during vaginal prolapse surgery. Control samples (n=39) were taken from patients after vaginal or laparoscopic removal of the uterus.

The formalin-fixed and paraffin embedded tissue samples were stained with Verhoeff van Gieson and Movat's pentachrome. Samples were examined by pathologist and gynecologist blinded as to the other investigator and to the pelvic organ prolapse status. In case of discrepancy investigators evaluated the samples together to gain consensus.

• Study Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20520
    • Department of Obstetrics and Gynecology, Turku University Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

39 patients with pelvic organ prolapse and as controls 39 patients without prolapse.

Description

Inclusion Criteria:

• surgery for pelvic organ prolapse
• hysterectomy due to other benign reasons than pelvic organ prolapse

Exclusion Criteria:

• surgery due to malignancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patients with pelvic organ prolapse; Patients, who were operated on because of pelvic organ prolapse.
Patients without pelvic organ prolapse; Patients, who had hysterectomy due to other reasons than pelvic organ prolapse.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The elastin content in tissue samples in patients with or without pelvic organ prolapse.	september 2012

Secondary Outcome Measures

Outcome Measure	Time Frame
The collagen content in tissue samples in women with or without pelvic organ prolapse.	September 2012

Collaborators and Investigators

• Sponsor: Turku University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: December 12, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Estimate): May 9, 2014
• Last Update Submitted That Met QC Criteria: May 8, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Collagen; Pelvic organ prolapse; Elastin; Connective tissue
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 33/180/2009