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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01749696
First received: December 12, 2012
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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).


Condition
Pelvic Organ Prolapse

Study Type: Observational
Official Title: Alterations in Connective Tissue in Patients With or Without Pelvic Organ Prolapse.

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • The elastin content in tissue samples in patients with or without pelvic organ prolapse. [ Time Frame: september 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The collagen content in tissue samples in women with or without pelvic organ prolapse. [ Time Frame: September 2012 ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: November 2009
Study Completion Date: April 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • surgery due to malignancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749696

Locations
Finland
Department of Obstetrics and Gynecology, Turku University Central Hospital
Turku, Finland, 20520
Sponsors and Collaborators
Turku University Hospital
  More Information

No publications provided

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01749696     History of Changes
Other Study ID Numbers: 33/180/2009
Study First Received: December 12, 2012
Last Updated: May 8, 2014
Health Authority: Ethics committee, Turku, Finland':'

Keywords provided by Turku University Hospital:
Pelvic organ prolapse
Connective tissue
Elastin
Collagen

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 26, 2014