Back to resultsAlterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse
Primary Purpose
Pelvic Organ Prolapse
Status
Completed
Phase
Locations
Finland
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Pelvic Organ Prolapse focused on measuring Pelvic organ prolapse, Connective tissue, Elastin, Collagen
Eligibility Criteria
Inclusion Criteria:
- surgery for pelvic organ prolapse
- hysterectomy due to other benign reasons than pelvic organ prolapse
Exclusion Criteria:
- surgery due to malignancy
Sites / Locations
- Department of Obstetrics and Gynecology, Turku University Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Arm Label
Patients with pelvic organ prolapse
Patients without pelvic organ prolapse
Arm Description
Patients, who were operated on because of pelvic organ prolapse.
Patients, who had hysterectomy due to other reasons than pelvic organ prolapse.
Outcomes
Primary Outcome Measures
The elastin content in tissue samples in patients with or without pelvic organ prolapse.
Secondary Outcome Measures
The collagen content in tissue samples in women with or without pelvic organ prolapse.
Full Information
NCT ID
NCT01749696
First Posted
December 12, 2012
Last Updated
May 8, 2014
Sponsor
Turku University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01749696
Brief Title
Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse
Official Title
Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse.
Study Type
Observational
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
4. Oversight
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
Pelvic organ prolapse, Connective tissue, Elastin, Collagen
7. Study Design
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with pelvic organ prolapse
Arm Description
Patients, who were operated on because of pelvic organ prolapse.
Arm Title
Patients without pelvic organ prolapse
Arm Description
Patients, who had hysterectomy due to other reasons than pelvic organ prolapse.
Primary Outcome Measure Information:
Title
The elastin content in tissue samples in patients with or without pelvic organ prolapse.
Time Frame
september 2012
Secondary Outcome Measure Information:
Title
The collagen content in tissue samples in women with or without pelvic organ prolapse.
Time Frame
September 2012
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
surgery for pelvic organ prolapse
hysterectomy due to other benign reasons than pelvic organ prolapse
Exclusion Criteria:
surgery due to malignancy
Study Population Description
39 patients with pelvic organ prolapse and as controls 39 patients without prolapse.
Sampling Method
Non-Probability Sample
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Turku University Central Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland
12. IPD Sharing Statement
Learn more about this trial
Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse
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